- Email: [email protected]
IMpower133: Updated overall survival (OS) analysis of first-line (1L) atezolizumab (atezo) + carboplatin + etoposide in extensive-stage SCLC (ES-SCLC)
Annals of Oncology 30 (Supplement 5): v710–v717, 2019 doi:10.1093/annonc/mdz264
SCLC 1736O
IMpower133: Updated overall survival (OS) analysis of first-line (1L) atezolizumab (atezo) 1 carboplatin 1 etoposide in extensive-stage SCLC (ES-SCLC)
Background: IMpower133 (NCT02763579), a global phase I/III, double-blind, randomized, placebo-controlled trial, showed that adding atezo (anti–PD-L1) to 1L carboplatin þ etoposide for ES-SCLC led to a statistically and clinically significant improvement in OS and progression-free survival (PFS) vs carboplatin þ etoposide alone. This combination was US FDA–approved in March 2019. Here we present an exploratory updated OS analysis of IMpower133. Methods: Patients (pts) without prior systemic tx for ES-SCLC were enrolled. PD-L1 testing was not required for enrolment eligibility, but tissue was collected when possible. Pts were randomised 1:1 to receive four 21-day cycles of carboplatin (AUC 5 mg•mL/min IV, Day 1) þ etoposide (100 mg/m2 IV, Days 1-3) with either atezo (1200 mg IV, Day 1) or placebo (PBO), then maintenance therapy with atezo or PBO until intolerable toxicity or progression. Pts meeting predefined criteria could receive tx beyond progression. Coprimary endpoints were OS and investigator-assessed PFS. OS interim and final analyses were planned for 240 and 306 OS events, respectively. Since OS was statistically significant at the interim analysis, an exploratory updated OS analysis was conducted, and exploratory biomarker analyses are in progress. Results: 201 pts were randomized to the atezo group and 202 to the PBO group. At this updated analysis, 302 OS events had been observed. Median follow-up was 22.9 mo. Median OS remained 12.3 mo in the atezo group and 10.3 mo in the PBO group (HR, 0.76 [95% CI: 0.60, 0.95]; descriptive P ¼ 0.0154). 13% more pts were alive in the atezo group than the PBO group at 12 and 18 mo (Table). Other efficacy analyses, including by PD-L1 status, will be presented. Conclusions: The addition of atezo to carboplatin and etoposide continued to provide improvement in OS for 1L ES-SCLC. These results further support this regimen as the new standard of care for untreated ES-SCLC.
Table: 1736O Landmark OS
Atezo þ Carboplatin þ Etoposiden ¼ 201
PBO þ Carboplatin þ Etoposiden ¼ 202
6 mo 12 mo 18 mo
86% (n ¼ 159) 52% (n ¼ 93) 34% (n ¼ 61)
83% (n ¼ 160) 39% (n ¼ 74) 21% (n ¼ 39)
Clinical trial identification: NCT02763579. Editorial acknowledgement: Kshipra Desai, PhD, CMPP, of Health Interactions, funded by F. Hoffmann-La Roche. Legal entity responsible for the study: F. Hoffmann-La Roche, Ltd. Funding: F. Hoffmann-La Roche, Ltd.
C European Society for Medical Oncology 2019. Published by Oxford University Press on behalf of the European Society for Medical Oncology. V
All rights reserved. For permissions, please email: [email protected].
Downloaded from https://academic.oup.com/annonc/article-abstract/30/Supplement_5/mdz264/5577128 by guest on 18 October 2019
M. Reck1, S.V. Liu2, A.S. Mansfield3, T.S.K. Mok4, A. Scherpereel5, N. Reinmuth6, M.C. Garassino7, J. De Castro Carpeno8, R. Califano9, M. Nishio10, F. Orlandi11, J.A. Alatorre Alexander12, T.A. Leal13, Y. Cheng14, J-S. Lee15, S. Lam16, M. McCleland16, Y. Deng17, S. Phan18, L. Horn19 1 Thoracic Oncology, Lung Clinic Grosshansdorf, Airway Research Center North, German Center of Lung Research, Grosshansdorf, Germany, 2Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC, USA, 3Division of Medical Oncology, Mayo Clinic, Rochester, MN, USA, 4State Key Laboratory of South China, The Chinese University of Hong Kong, Hong Kong, China, 5University of Lille, CHU Lille, Inserm, U1189 - ONCO-THAI - F-59000, Lille, France, 6Thoracic Oncology, Asklepios Clinics Munich-Gauting, Gauting, Germany, 7Thoracic Oncology Unit, Instituto Nazionale dei Tumori, Milan, Italy, 8Medical Oncology, Hospital Universitario La Paz, Madrid, Spain, 9 Department of Medical Oncology, The Christie NHS Foundation Trust, Manchester, UK, 10 The Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, orax, Prosalud Oncologıa, Santiago, Chile, 12Oncology, Japan, 11Instituto Nacional del T Health Pharma Professional Research, Mexico City, Mexico, 13Division of Hematology & Oncology, University of Wisconsin Carbone Cancer Center, Madison, WI, USA, 14Medical Oncology, Jilin Cancer Hospital, Changchun, China, 15Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea, 16 Product Development Oncology (PDO), Genentech, Inc., South San Francisco, CA, USA, 17Biostatistics, Genentech, Inc., South San Francisco, CA, USA, 18US Medical Affairs, Genentech, Inc., South San Francisco, CA, USA, 19Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA
Disclosure: M. Reck: Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: AbbVie; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: Amgen; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: AstraZeneca; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: BMS; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: Boehringer Ingelheim; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: Celgene; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: Lilly ; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: Merck; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: MSD; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: Novartis; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: Pfizer; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: Roche . S.V. Liu: Advisory / Consultancy: Apollomics; Advisory / Consultancy, Research grant / Funding (institution): AstraZeneca; Advisory / Consultancy: Boehringer Ingelheim; Advisory / Consultancy, Research grant / Funding (institution): BMS; Advisory / Consultancy: Celgene; Advisory / Consultancy: G1 Therapeutics; Advisory / Consultancy, Research grant / Funding (institution): Genentech/Roche; Advisory / Consultancy: Heron; Advisory / Consultancy: Ignyta; Advisory / Consultancy: Inivata; Advisory / Consultancy: Janssen; Advisory / Consultancy: Lilly ; Advisory / Consultancy, Research grant / Funding (institution): Merck; Advisory / Consultancy, Research grant / Funding (institution): Pfizer; Advisory / Consultancy: Regeneron; Advisory / Consultancy: Taiho, Takeda/Ariad, Tempus; Research grant / Funding (institution): Bayer, Esanex, Lycera; Research grant / Funding (institution): Blueprint, Clovis, Corvus, Esanex, Molecular Partners, OncoMed; Research grant / Funding (institution): Rain Therapeutics, Threshold. A.S. Mansfield: Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Genentech/Roche; Honoraria (institution), Advisory / Consultancy: AbbVie; Honoraria (institution), Advisory / Consultancy: BMS; Research grant / Funding (institution): Novartis; Officer / Board of Directors: Mesothelioma Applied Research Foundation; Officer / Board of Directors: Friends of Patan Hospital. T.S.K. Mok: Honoraria (self), Advisory / Consultancy: ACEA Pharmam, Bayer, BI, Blueprint, Celgene; Honoraria (self): Amgen; Honoraria (self): Cstone Pharmaceuticals; Honoraria (self), Advisory / Consultancy: Eli Lilly, Fishawack Facilitate Ltd; Honoraria (self): Hengrui Therapeutics; Honoraria (self), Advisory / Consultancy: Ignyta, Janssen, Loxo-Oncology; Honoraria (self): InMed Medical Communication; Honoraria (self), Advisory / Consultancy: Merck Serono; Honoraria (self), Advisory / Consultancy: Oncogenex, OrigiMed; Honoraria (self), Advisory / Consultancy: Sanofi-Aventis, Vertex, Yuhan; Advisory / Consultancy: ChiMed, Cirina, Hengrui Therapeutics; Honoraria (self): PrIME Oncology; Advisory / Consultancy: Virtus Medical Group; Leadership role, Officer / Board of Directors: ASCO, IASLC, Hutchinson ChiMed, Chinese Lung Cancer Research Foundation, CSCO, HKCTS, ATORG; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Roche, Genentech, AstraZeneca, BMS, MSD, Novartis, Pfizer, SFJ Pharmaceutical; Research grant / Funding (institution): Clovis Oncology, Xcovery; Shareholder / Stockholder / Stock options: Sanomics, Hutchinson Chi-Med; Full / Part-time employment: The Chinese University of Hong Kong; Advisory / Consultancy, Nonremunerated activity/ies: geneDecode Ltd. A. Scherpereel: Advisory / Consultancy, Travel / Accommodation / Expenses: AstraZeneca; Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: BMS; Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Research grant / Funding (institution), Travel / Accommodation / Expenses: MSD. N. Reinmuth: Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Hoffmann La Roche; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: BMS; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: MSD; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Boehringer Ingelheim; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: AstraZeneca; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Novartis; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Takeda. M.C. Garassino: Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Eli Lilly; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: Boehringer Ingelheim; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Otsuka Pharma, BMS, Takeda, Celgene; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: Dephaforum Srl; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Novartis; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Pfizer; Honoraria (self), Advisory / Consultancy: Inivata; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): MSD; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses: AstraZeneca, Roche; Honoraria (self), Speaker Bureau / Expert testimony: ACCMED; Honoraria (self), Speaker Bureau / Expert testimony: Forum Service Srl; Honoraria (self), Speaker Bureau / Expert testimony: Medscape; Honoraria (self), Speaker Bureau / Expert testimony: McCann Healthcare; Honoraria (self), Speaker Bureau / Expert testimony: SOS Srl; Honoraria (self), Speaker Bureau / Expert testimony: Crems Srl; Honoraria (self), Speaker Bureau / Expert testimony, Research grant / Funding (institution): Incyte; Research grant / Funding (institution): Tiziana Sciences, Clovis, Merck, Bayer, GSK; Officer / Board of Directors: Women for Oncology Italy, AIOT; Non-remunerated activity/ies, Scientific Committee/General Member: AIOM, ASCO, AIOT, IASCL, IPOP, TUTOR. J. De Castro Carpeno: Advisory / Consultancy, Travel / Accommodation / Expenses: AstraZeneca; Advisory / Consultancy, Travel / Accommodation / Expenses: Boehringer Ingelheim; Advisory / Consultancy, Travel / Accommodation / Expenses: BMS; Advisory / Consultancy, Travel / Accommodation / Expenses: Merck Sharp and Dohme; Advisory / Consultancy, Travel / Accommodation / Expenses: Novartis; Advisory / Consultancy: Pfizer; Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Advisory / Consultancy: Takeda; Travel / Accommodation / Expenses: Pierre Favre. R. Califano: Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses: AZ; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses: BMS; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Boehringer Ingelheim; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses: Lilly Oncology; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution),
abstracts
Annals of Oncology
1737O
Interim toxicity analysis for patients with limited stage small cell lung cancer (LSCLC) treated on the experimental thoracic radiotherapy (TRT) arms of CALGB 30610 (Alliance) / RTOG 0538
J. Bogart1, X. Wang2, G. Masters3, H. Zhu2, R. Komaki4, L. Gaspar5, M.C. Dobelbower6, C. Kuzma7, J. Heymach8, E.E. Vokes9, T. Stinchcombe10 1 Radiation Oncology, SUNY Upstate Medical University, Syracuse, NY, USA, 2 Biostatistics, Alliance for Clinical Trials in Oncology, Durham, NC, USA, 3Medical Oncology, Helen Graham Cancer Center, Newark, DE, USA, 4Radiation oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA, 5Radiation Oncology, UC Denver, Denver, CO, USA, 6Radiation Oncology, UAB, Birmingham, AL, USA, 7Medical Oncology, Outpatient Cancer Center of FirstHealth, Pinehurst, NC, USA, 8 The University of Texas MD Anderson Cancer Center, Thoracic/Head & Neck Medical Oncology, MD Anderson, Houston, TX, USA, 9Medicine, University of Chicago Department of Medicine - Section of Hematology/Oncology, Chicago, IL, USA, 10 Medical Oncology, Duke Cancer Center, Durham, NC, USA Background: The optimal TRT regimen for LSCLC remains to be defined. CALGB 30610/RTOG 0538 started as a 3 arm study designed to discontinue one of 2 experimental TRT arms based on interim toxicity assessment, while the remaining arm would be compared against standard 4500 cGy (twice-daily) TRT. Methods: Per protocol, the interim endpoint was calculated based on treatment related grade 3þ non-hematologic toxicity, grade 4 hematologic toxicity, failure to complete 4 cycles of chemotherapy, and any grade 5 toxicity. The analysis included the initial 70 patients assigned to each of the 7000 cGy (once daily) and the 6120 cGy (concomitant boost) study arms. The initial analysis was conducted May 21, 2012 and an updated analysis of the same patient population was performed April 15, 2019. Results: There was not a significant difference in toxicity scoring between the regimens, either in the 2012 assessment or the updated analysis. Overall grade 3, 4, and 5 treatment related adverse events were 21.4%, 54.3%, and 0% for 7000 cGy TRT compared with 20.0%, 57.1% and 1.4% for 6120 cGy TRT, while rates of non-hematologic toxicity were 10.0%. 12.9% and 0% for 7000 cGy TRT compared with 12.9%, 14.3%, and 1.4% with 6120 cGy TRT. Grade 3 pneumonitis was reported in 2 patients (2.9 %) in each cohort. Grade 4 dyspnea was observed in 4 patients (5.7 %) in the 6120 cGy cohort but was not reported in patients treated with 7000 cGy. Conclusions: Both TRT regimens, 7000 cGy daily and 6120 cGy concomitant boost, concurrent with cisplatin and etoposide chemotherapy, appear to be tolerable without unexpected toxicity. A decision to discontinue the 6120 cGy arm in December 2012 was
Volume 30 | Supplement 5 | October 2019
based on the toxicity distribution, as a significant difference in overall toxicity was not observed. Further details of toxicity and the scoring system applied will be presented. The phase III portion of the study comparing 7000 cGy TRT to 4500 cGy TRT is near completion. Clinical trial identification: CALGB 30610 / RTOG 0538 Identifier: NCT00632853. Legal entity responsible for the study: Alliance for Clinical Trials in Oncology. Funding: National Cancer Institute. Support: U10CA180821, U10CA180882, U10CA180868, U10CA180820, U10CA233330, U10CA180888; https://acknowledg ments.alliancefound.org. Disclosure: All authors have declared no conflicts of interest.
1738O
Overall survival (OS) update in ALTER 1202: Anlotinib as third-line or further-line treatment in relapsed small-cell lung cancer (SCLC)
Y. Cheng1, Q. Wang2, K. Li3, J. Shi4, Y. Liu1, L. Wu5, B. Han6, G. Chen7, J. He8, J. Wang9, D. Lou10, H. Yu10, H. Qin11, X-L. Li12 1 Medical Oncology, Jilin Cancer Hospital, Changchun, China, 2Medical Oncology, Henan Cancer Hospital, Zhengzhou, China, 3Medical Oncology, Tianjin Medical University Cancer Hospital, Tianjin, China, 4Medical Oncology, Linyi Cancer Hospital, Linyi, China, 5Medical Oncology, Hunan Cancer Hospital, Changsha, China, 6Medical Oncology, Shanghai Chest Hospital, Shanghai, China, 7Medical Oncology, Harbin Medical University Cancer Hospital, Harbin, China, 8Medical Oncology, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China, 9Department of Medical Oncology, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China, 10Department of Biostatistics, School of public health, nanjing medical university, Nanjing, China, 11Medical Oncology, The fifth medical center of chinese PLA general hospital, Beijing, China, 12Medical Oncology, Cancer Hospital of China Medical University Liaoning Cancer Hospital & Institute, Shenyang, China Background: As a multicentre, randomized, double-blind phase II trial, ALTER 1202 (NCT03059797) suggests that anlotinib is a promising treatment option for patients with relapsed SCLC who failed 2 lines of chemotherapy. The median progress-free survival (PFS) was significantly longer in the anlotinib group compared with the placebo group (4.1 months vs 0.7 months; HR 0.19, 95% CI 0.12 to 0.32], P < 0.0001) as per the 30 June 2018, data cutoff date. Here we report updated OS results in the ITT population while OS events occurred in about 78% patients. Methods: Eligible either limited- or extensive-stage SCLC patients with disease progression after 2 lines of chemotherapy were randomized 2:1 to anlotinib or placebo (12 mg PO QD from day 1 to 14, every 3 weeks). The primary endpoint was PFS. OS was a pre-specified secondary endpoint. Results: Between March 2017 and May 2018, 120 patients from 11 centers were randomized to either anlotinib arm (n ¼ 82) or placebo arm (n ¼ 38). In the final analysis (04 APR 2019), median OS was significantly prolonged about 2.4 months in anlotinib arm (7.3 months vs 4.9 months). OS at this date showed 60 events in anlotinib arm and 33 events in placebo arm (HR 0.53, 95%CI 0.3-0.8; p ¼ 0.0029). Six-month, 1-y survival rates were 63.9%, 30.6% in the anlotinib group and 32.7%, 13.1% in the placebo group. The hazard ratio for OS favored anlotinib in most subgroups, especially for patients with brain metastases (OS 6.3m vs 2.6m; HR 0.23, 95%CI 0.09-0.59; p ¼ 0.0009) and patients that received study drug as third-line therapy (OS 7.3m vs 4.9m; HR 0.50, 95%CI 0.31-0.82; p ¼ 0.0051). No newly adverse events were observed. Conclusions: The updated results showed that anlotinib prolonged not only PFS but also OS significantly than placebo with favorable safety profile. These data suggested that anlotinib is a promising treatment option for patients with relapsed SCLC who have experienced treatment failure with two lines of chemotherapy. Clinical trial identification: NCT03059797. Legal entity responsible for the study: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Funding: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Disclosure: All authors have declared no conflicts of interest.
1739O
A phase I study evaluating rovalpituzumab tesirine (ROVA-T) in frontline treatment of patients (pts) with extensive stage small cell lung cancer (ES-SCLC)
C. Hann1, T. Burns2, A. Dowlati3, D. Morgensztern4, M. Koch5, Y-W. Chang5, P. Komarnitsky5, C. Ludwig5, H. Nimeiri5, D.R. Camidge6 1 Medical Oncology, Johns Hopkins University, Baltimore, MD, USA, 2Division of Hematology-Oncology, UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh, PA, USA, 3Medicine Division of Hematology and Oncology, University Hospitals Seidman Cancer Center and Case Western Reserve University, Cleveland, OH, USA, 4Medical Oncology, Washington University School of Medicine, St. Louis, MO, USA, 5 Oncology Development, AbbVie Inc., North Chicago, IL, USA, 6Medical Oncology, University of Colorado-Denver, Aurora, CO, USA Background: ROVA-T is an antibody-drug conjugate targeting delta-like protein 3 (DLL3) that is highly expressed in 80% of SCLC. The reported study (NCT02819999) evaluated ROVA-T alone or in combination with platinum-based chemotherapy (CE) in frontline treatment of ES-SCLC.
doi:10.1093/annonc/mdz264 | v711
Downloaded from https://academic.oup.com/annonc/article-abstract/30/Supplement_5/mdz264/5577128 by guest on 18 October 2019
Travel / Accommodation / Expenses: MSD; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses: Novartis; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses: Pfizer; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses: Roche ; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses: Takeda; Research grant / Funding (institution): AbbVie; Leadership role, Non-remunerated activity/ ies: ESMO; Research grant / Funding (institution): Clovis; Shareholder / Stockholder / Stock options: The Christie Private Care; Non-remunerated activity/ies: EORTC. M. Nishio: Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Ono Pharmaceutical; Honoraria (self), Advisory / Consultancy: BMS; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Pfizer; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Chugai Pharmaceutical; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Eli Lilly; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Taiho; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): AstraZeneca; Honoraria (self), Advisory / Consultancy: Boehringer Ingelheim; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): MSD; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Novartis; Advisory / Consultancy: Daiichi Sankyo; Advisory / Consultancy: Merck Serono. F. Orlandi: Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses, Non-remunerated activity/ies: F. Hoffmann-La Roche; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): AstraZeneca/MedImmune; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: BMS; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: MSD; Honoraria (self), Advisory / Consultancy: Lilly; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Pfizer; Research grant / Funding (institution): Amgen, Boehringer Ingelheim, Astellas Medivation, Celltrion, . J.A. Alatorre Alexander: Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Merck-Sharp & Domme; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: AstraZeneca; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Pfizer; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Boehringer Ingelheim; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Eli Lilly; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Novartis; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: F. Hoffmann La Roche; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: BMS; Leadership role, Travel / Accommodation / Expenses, Full / Part-time employment: Head of Oncology National Institute of Respiratory Diseases Mexico. T.A. Leal: Advisory / Consultancy: Genentech; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: BMS; Advisory / Consultancy: Bayer; Travel / Accommodation / Expenses, Non-remunerated activity/ies: Mirati Therapeutics. S. Lam: Shareholder / Stockholder / Stock options, Full / Part-time employment: Roche/Genentech. M. McCleland: Full / Parttime employment: Genentech, Inc. Y. Deng: Full / Part-time employment: Genentech, Inc. S. Phan: Full / Part-time employment: Genentech, Inc. L. Horn: Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: AbbVie; Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: BMS; Advisory / Consultancy: Genentech/Roche; Advisory / Consultancy: EMD Serono; Advisory / Consultancy: Incyte; Advisory / Consultancy, Research grant / Funding (institution): Xcovery; Advisory / Consultancy: Merck; Research grant / Funding (institution): Boehringer Ingelheim. All other authors have declared no conflicts of interest.
SCLC 1736O
IMpower133: Updated overall survival (OS) analysis of first-line (1L) atezolizumab (atezo) 1 carboplatin 1 etoposide in extensive-stage SCLC (ES-SCLC)
Background: IMpower133 (NCT02763579), a global phase I/III, double-blind, randomized, placebo-controlled trial, showed that adding atezo (anti–PD-L1) to 1L carboplatin þ etoposide for ES-SCLC led to a statistically and clinically significant improvement in OS and progression-free survival (PFS) vs carboplatin þ etoposide alone. This combination was US FDA–approved in March 2019. Here we present an exploratory updated OS analysis of IMpower133. Methods: Patients (pts) without prior systemic tx for ES-SCLC were enrolled. PD-L1 testing was not required for enrolment eligibility, but tissue was collected when possible. Pts were randomised 1:1 to receive four 21-day cycles of carboplatin (AUC 5 mg•mL/min IV, Day 1) þ etoposide (100 mg/m2 IV, Days 1-3) with either atezo (1200 mg IV, Day 1) or placebo (PBO), then maintenance therapy with atezo or PBO until intolerable toxicity or progression. Pts meeting predefined criteria could receive tx beyond progression. Coprimary endpoints were OS and investigator-assessed PFS. OS interim and final analyses were planned for 240 and 306 OS events, respectively. Since OS was statistically significant at the interim analysis, an exploratory updated OS analysis was conducted, and exploratory biomarker analyses are in progress. Results: 201 pts were randomized to the atezo group and 202 to the PBO group. At this updated analysis, 302 OS events had been observed. Median follow-up was 22.9 mo. Median OS remained 12.3 mo in the atezo group and 10.3 mo in the PBO group (HR, 0.76 [95% CI: 0.60, 0.95]; descriptive P ¼ 0.0154). 13% more pts were alive in the atezo group than the PBO group at 12 and 18 mo (Table). Other efficacy analyses, including by PD-L1 status, will be presented. Conclusions: The addition of atezo to carboplatin and etoposide continued to provide improvement in OS for 1L ES-SCLC. These results further support this regimen as the new standard of care for untreated ES-SCLC.
Table: 1736O Landmark OS
Atezo þ Carboplatin þ Etoposiden ¼ 201
PBO þ Carboplatin þ Etoposiden ¼ 202
6 mo 12 mo 18 mo
86% (n ¼ 159) 52% (n ¼ 93) 34% (n ¼ 61)
83% (n ¼ 160) 39% (n ¼ 74) 21% (n ¼ 39)
Clinical trial identification: NCT02763579. Editorial acknowledgement: Kshipra Desai, PhD, CMPP, of Health Interactions, funded by F. Hoffmann-La Roche. Legal entity responsible for the study: F. Hoffmann-La Roche, Ltd. Funding: F. Hoffmann-La Roche, Ltd.
C European Society for Medical Oncology 2019. Published by Oxford University Press on behalf of the European Society for Medical Oncology. V
All rights reserved. For permissions, please email: [email protected].
Downloaded from https://academic.oup.com/annonc/article-abstract/30/Supplement_5/mdz264/5577128 by guest on 18 October 2019
M. Reck1, S.V. Liu2, A.S. Mansfield3, T.S.K. Mok4, A. Scherpereel5, N. Reinmuth6, M.C. Garassino7, J. De Castro Carpeno8, R. Califano9, M. Nishio10, F. Orlandi11, J.A. Alatorre Alexander12, T.A. Leal13, Y. Cheng14, J-S. Lee15, S. Lam16, M. McCleland16, Y. Deng17, S. Phan18, L. Horn19 1 Thoracic Oncology, Lung Clinic Grosshansdorf, Airway Research Center North, German Center of Lung Research, Grosshansdorf, Germany, 2Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC, USA, 3Division of Medical Oncology, Mayo Clinic, Rochester, MN, USA, 4State Key Laboratory of South China, The Chinese University of Hong Kong, Hong Kong, China, 5University of Lille, CHU Lille, Inserm, U1189 - ONCO-THAI - F-59000, Lille, France, 6Thoracic Oncology, Asklepios Clinics Munich-Gauting, Gauting, Germany, 7Thoracic Oncology Unit, Instituto Nazionale dei Tumori, Milan, Italy, 8Medical Oncology, Hospital Universitario La Paz, Madrid, Spain, 9 Department of Medical Oncology, The Christie NHS Foundation Trust, Manchester, UK, 10 The Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, orax, Prosalud Oncologıa, Santiago, Chile, 12Oncology, Japan, 11Instituto Nacional del T Health Pharma Professional Research, Mexico City, Mexico, 13Division of Hematology & Oncology, University of Wisconsin Carbone Cancer Center, Madison, WI, USA, 14Medical Oncology, Jilin Cancer Hospital, Changchun, China, 15Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea, 16 Product Development Oncology (PDO), Genentech, Inc., South San Francisco, CA, USA, 17Biostatistics, Genentech, Inc., South San Francisco, CA, USA, 18US Medical Affairs, Genentech, Inc., South San Francisco, CA, USA, 19Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA
Disclosure: M. Reck: Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: AbbVie; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: Amgen; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: AstraZeneca; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: BMS; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: Boehringer Ingelheim; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: Celgene; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: Lilly ; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: Merck; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: MSD; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: Novartis; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: Pfizer; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: Roche . S.V. Liu: Advisory / Consultancy: Apollomics; Advisory / Consultancy, Research grant / Funding (institution): AstraZeneca; Advisory / Consultancy: Boehringer Ingelheim; Advisory / Consultancy, Research grant / Funding (institution): BMS; Advisory / Consultancy: Celgene; Advisory / Consultancy: G1 Therapeutics; Advisory / Consultancy, Research grant / Funding (institution): Genentech/Roche; Advisory / Consultancy: Heron; Advisory / Consultancy: Ignyta; Advisory / Consultancy: Inivata; Advisory / Consultancy: Janssen; Advisory / Consultancy: Lilly ; Advisory / Consultancy, Research grant / Funding (institution): Merck; Advisory / Consultancy, Research grant / Funding (institution): Pfizer; Advisory / Consultancy: Regeneron; Advisory / Consultancy: Taiho, Takeda/Ariad, Tempus; Research grant / Funding (institution): Bayer, Esanex, Lycera; Research grant / Funding (institution): Blueprint, Clovis, Corvus, Esanex, Molecular Partners, OncoMed; Research grant / Funding (institution): Rain Therapeutics, Threshold. A.S. Mansfield: Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Genentech/Roche; Honoraria (institution), Advisory / Consultancy: AbbVie; Honoraria (institution), Advisory / Consultancy: BMS; Research grant / Funding (institution): Novartis; Officer / Board of Directors: Mesothelioma Applied Research Foundation; Officer / Board of Directors: Friends of Patan Hospital. T.S.K. Mok: Honoraria (self), Advisory / Consultancy: ACEA Pharmam, Bayer, BI, Blueprint, Celgene; Honoraria (self): Amgen; Honoraria (self): Cstone Pharmaceuticals; Honoraria (self), Advisory / Consultancy: Eli Lilly, Fishawack Facilitate Ltd; Honoraria (self): Hengrui Therapeutics; Honoraria (self), Advisory / Consultancy: Ignyta, Janssen, Loxo-Oncology; Honoraria (self): InMed Medical Communication; Honoraria (self), Advisory / Consultancy: Merck Serono; Honoraria (self), Advisory / Consultancy: Oncogenex, OrigiMed; Honoraria (self), Advisory / Consultancy: Sanofi-Aventis, Vertex, Yuhan; Advisory / Consultancy: ChiMed, Cirina, Hengrui Therapeutics; Honoraria (self): PrIME Oncology; Advisory / Consultancy: Virtus Medical Group; Leadership role, Officer / Board of Directors: ASCO, IASLC, Hutchinson ChiMed, Chinese Lung Cancer Research Foundation, CSCO, HKCTS, ATORG; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Roche, Genentech, AstraZeneca, BMS, MSD, Novartis, Pfizer, SFJ Pharmaceutical; Research grant / Funding (institution): Clovis Oncology, Xcovery; Shareholder / Stockholder / Stock options: Sanomics, Hutchinson Chi-Med; Full / Part-time employment: The Chinese University of Hong Kong; Advisory / Consultancy, Nonremunerated activity/ies: geneDecode Ltd. A. Scherpereel: Advisory / Consultancy, Travel / Accommodation / Expenses: AstraZeneca; Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: BMS; Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Research grant / Funding (institution), Travel / Accommodation / Expenses: MSD. N. Reinmuth: Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Hoffmann La Roche; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: BMS; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: MSD; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Boehringer Ingelheim; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: AstraZeneca; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Novartis; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Takeda. M.C. Garassino: Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Eli Lilly; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: Boehringer Ingelheim; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Otsuka Pharma, BMS, Takeda, Celgene; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: Dephaforum Srl; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Novartis; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Pfizer; Honoraria (self), Advisory / Consultancy: Inivata; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): MSD; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses: AstraZeneca, Roche; Honoraria (self), Speaker Bureau / Expert testimony: ACCMED; Honoraria (self), Speaker Bureau / Expert testimony: Forum Service Srl; Honoraria (self), Speaker Bureau / Expert testimony: Medscape; Honoraria (self), Speaker Bureau / Expert testimony: McCann Healthcare; Honoraria (self), Speaker Bureau / Expert testimony: SOS Srl; Honoraria (self), Speaker Bureau / Expert testimony: Crems Srl; Honoraria (self), Speaker Bureau / Expert testimony, Research grant / Funding (institution): Incyte; Research grant / Funding (institution): Tiziana Sciences, Clovis, Merck, Bayer, GSK; Officer / Board of Directors: Women for Oncology Italy, AIOT; Non-remunerated activity/ies, Scientific Committee/General Member: AIOM, ASCO, AIOT, IASCL, IPOP, TUTOR. J. De Castro Carpeno: Advisory / Consultancy, Travel / Accommodation / Expenses: AstraZeneca; Advisory / Consultancy, Travel / Accommodation / Expenses: Boehringer Ingelheim; Advisory / Consultancy, Travel / Accommodation / Expenses: BMS; Advisory / Consultancy, Travel / Accommodation / Expenses: Merck Sharp and Dohme; Advisory / Consultancy, Travel / Accommodation / Expenses: Novartis; Advisory / Consultancy: Pfizer; Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Advisory / Consultancy: Takeda; Travel / Accommodation / Expenses: Pierre Favre. R. Califano: Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses: AZ; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses: BMS; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Boehringer Ingelheim; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses: Lilly Oncology; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution),
abstracts
Annals of Oncology
1737O
Interim toxicity analysis for patients with limited stage small cell lung cancer (LSCLC) treated on the experimental thoracic radiotherapy (TRT) arms of CALGB 30610 (Alliance) / RTOG 0538
J. Bogart1, X. Wang2, G. Masters3, H. Zhu2, R. Komaki4, L. Gaspar5, M.C. Dobelbower6, C. Kuzma7, J. Heymach8, E.E. Vokes9, T. Stinchcombe10 1 Radiation Oncology, SUNY Upstate Medical University, Syracuse, NY, USA, 2 Biostatistics, Alliance for Clinical Trials in Oncology, Durham, NC, USA, 3Medical Oncology, Helen Graham Cancer Center, Newark, DE, USA, 4Radiation oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA, 5Radiation Oncology, UC Denver, Denver, CO, USA, 6Radiation Oncology, UAB, Birmingham, AL, USA, 7Medical Oncology, Outpatient Cancer Center of FirstHealth, Pinehurst, NC, USA, 8 The University of Texas MD Anderson Cancer Center, Thoracic/Head & Neck Medical Oncology, MD Anderson, Houston, TX, USA, 9Medicine, University of Chicago Department of Medicine - Section of Hematology/Oncology, Chicago, IL, USA, 10 Medical Oncology, Duke Cancer Center, Durham, NC, USA Background: The optimal TRT regimen for LSCLC remains to be defined. CALGB 30610/RTOG 0538 started as a 3 arm study designed to discontinue one of 2 experimental TRT arms based on interim toxicity assessment, while the remaining arm would be compared against standard 4500 cGy (twice-daily) TRT. Methods: Per protocol, the interim endpoint was calculated based on treatment related grade 3þ non-hematologic toxicity, grade 4 hematologic toxicity, failure to complete 4 cycles of chemotherapy, and any grade 5 toxicity. The analysis included the initial 70 patients assigned to each of the 7000 cGy (once daily) and the 6120 cGy (concomitant boost) study arms. The initial analysis was conducted May 21, 2012 and an updated analysis of the same patient population was performed April 15, 2019. Results: There was not a significant difference in toxicity scoring between the regimens, either in the 2012 assessment or the updated analysis. Overall grade 3, 4, and 5 treatment related adverse events were 21.4%, 54.3%, and 0% for 7000 cGy TRT compared with 20.0%, 57.1% and 1.4% for 6120 cGy TRT, while rates of non-hematologic toxicity were 10.0%. 12.9% and 0% for 7000 cGy TRT compared with 12.9%, 14.3%, and 1.4% with 6120 cGy TRT. Grade 3 pneumonitis was reported in 2 patients (2.9 %) in each cohort. Grade 4 dyspnea was observed in 4 patients (5.7 %) in the 6120 cGy cohort but was not reported in patients treated with 7000 cGy. Conclusions: Both TRT regimens, 7000 cGy daily and 6120 cGy concomitant boost, concurrent with cisplatin and etoposide chemotherapy, appear to be tolerable without unexpected toxicity. A decision to discontinue the 6120 cGy arm in December 2012 was
Volume 30 | Supplement 5 | October 2019
based on the toxicity distribution, as a significant difference in overall toxicity was not observed. Further details of toxicity and the scoring system applied will be presented. The phase III portion of the study comparing 7000 cGy TRT to 4500 cGy TRT is near completion. Clinical trial identification: CALGB 30610 / RTOG 0538 Identifier: NCT00632853. Legal entity responsible for the study: Alliance for Clinical Trials in Oncology. Funding: National Cancer Institute. Support: U10CA180821, U10CA180882, U10CA180868, U10CA180820, U10CA233330, U10CA180888; https://acknowledg ments.alliancefound.org. Disclosure: All authors have declared no conflicts of interest.
1738O
Overall survival (OS) update in ALTER 1202: Anlotinib as third-line or further-line treatment in relapsed small-cell lung cancer (SCLC)
Y. Cheng1, Q. Wang2, K. Li3, J. Shi4, Y. Liu1, L. Wu5, B. Han6, G. Chen7, J. He8, J. Wang9, D. Lou10, H. Yu10, H. Qin11, X-L. Li12 1 Medical Oncology, Jilin Cancer Hospital, Changchun, China, 2Medical Oncology, Henan Cancer Hospital, Zhengzhou, China, 3Medical Oncology, Tianjin Medical University Cancer Hospital, Tianjin, China, 4Medical Oncology, Linyi Cancer Hospital, Linyi, China, 5Medical Oncology, Hunan Cancer Hospital, Changsha, China, 6Medical Oncology, Shanghai Chest Hospital, Shanghai, China, 7Medical Oncology, Harbin Medical University Cancer Hospital, Harbin, China, 8Medical Oncology, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China, 9Department of Medical Oncology, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China, 10Department of Biostatistics, School of public health, nanjing medical university, Nanjing, China, 11Medical Oncology, The fifth medical center of chinese PLA general hospital, Beijing, China, 12Medical Oncology, Cancer Hospital of China Medical University Liaoning Cancer Hospital & Institute, Shenyang, China Background: As a multicentre, randomized, double-blind phase II trial, ALTER 1202 (NCT03059797) suggests that anlotinib is a promising treatment option for patients with relapsed SCLC who failed 2 lines of chemotherapy. The median progress-free survival (PFS) was significantly longer in the anlotinib group compared with the placebo group (4.1 months vs 0.7 months; HR 0.19, 95% CI 0.12 to 0.32], P < 0.0001) as per the 30 June 2018, data cutoff date. Here we report updated OS results in the ITT population while OS events occurred in about 78% patients. Methods: Eligible either limited- or extensive-stage SCLC patients with disease progression after 2 lines of chemotherapy were randomized 2:1 to anlotinib or placebo (12 mg PO QD from day 1 to 14, every 3 weeks). The primary endpoint was PFS. OS was a pre-specified secondary endpoint. Results: Between March 2017 and May 2018, 120 patients from 11 centers were randomized to either anlotinib arm (n ¼ 82) or placebo arm (n ¼ 38). In the final analysis (04 APR 2019), median OS was significantly prolonged about 2.4 months in anlotinib arm (7.3 months vs 4.9 months). OS at this date showed 60 events in anlotinib arm and 33 events in placebo arm (HR 0.53, 95%CI 0.3-0.8; p ¼ 0.0029). Six-month, 1-y survival rates were 63.9%, 30.6% in the anlotinib group and 32.7%, 13.1% in the placebo group. The hazard ratio for OS favored anlotinib in most subgroups, especially for patients with brain metastases (OS 6.3m vs 2.6m; HR 0.23, 95%CI 0.09-0.59; p ¼ 0.0009) and patients that received study drug as third-line therapy (OS 7.3m vs 4.9m; HR 0.50, 95%CI 0.31-0.82; p ¼ 0.0051). No newly adverse events were observed. Conclusions: The updated results showed that anlotinib prolonged not only PFS but also OS significantly than placebo with favorable safety profile. These data suggested that anlotinib is a promising treatment option for patients with relapsed SCLC who have experienced treatment failure with two lines of chemotherapy. Clinical trial identification: NCT03059797. Legal entity responsible for the study: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Funding: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Disclosure: All authors have declared no conflicts of interest.
1739O
A phase I study evaluating rovalpituzumab tesirine (ROVA-T) in frontline treatment of patients (pts) with extensive stage small cell lung cancer (ES-SCLC)
C. Hann1, T. Burns2, A. Dowlati3, D. Morgensztern4, M. Koch5, Y-W. Chang5, P. Komarnitsky5, C. Ludwig5, H. Nimeiri5, D.R. Camidge6 1 Medical Oncology, Johns Hopkins University, Baltimore, MD, USA, 2Division of Hematology-Oncology, UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh, PA, USA, 3Medicine Division of Hematology and Oncology, University Hospitals Seidman Cancer Center and Case Western Reserve University, Cleveland, OH, USA, 4Medical Oncology, Washington University School of Medicine, St. Louis, MO, USA, 5 Oncology Development, AbbVie Inc., North Chicago, IL, USA, 6Medical Oncology, University of Colorado-Denver, Aurora, CO, USA Background: ROVA-T is an antibody-drug conjugate targeting delta-like protein 3 (DLL3) that is highly expressed in 80% of SCLC. The reported study (NCT02819999) evaluated ROVA-T alone or in combination with platinum-based chemotherapy (CE) in frontline treatment of ES-SCLC.
doi:10.1093/annonc/mdz264 | v711
Downloaded from https://academic.oup.com/annonc/article-abstract/30/Supplement_5/mdz264/5577128 by guest on 18 October 2019
Travel / Accommodation / Expenses: MSD; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses: Novartis; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses: Pfizer; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses: Roche ; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses: Takeda; Research grant / Funding (institution): AbbVie; Leadership role, Non-remunerated activity/ ies: ESMO; Research grant / Funding (institution): Clovis; Shareholder / Stockholder / Stock options: The Christie Private Care; Non-remunerated activity/ies: EORTC. M. Nishio: Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Ono Pharmaceutical; Honoraria (self), Advisory / Consultancy: BMS; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Pfizer; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Chugai Pharmaceutical; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Eli Lilly; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Taiho; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): AstraZeneca; Honoraria (self), Advisory / Consultancy: Boehringer Ingelheim; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): MSD; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Novartis; Advisory / Consultancy: Daiichi Sankyo; Advisory / Consultancy: Merck Serono. F. Orlandi: Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses, Non-remunerated activity/ies: F. Hoffmann-La Roche; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): AstraZeneca/MedImmune; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: BMS; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: MSD; Honoraria (self), Advisory / Consultancy: Lilly; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Pfizer; Research grant / Funding (institution): Amgen, Boehringer Ingelheim, Astellas Medivation, Celltrion, . J.A. Alatorre Alexander: Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Merck-Sharp & Domme; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: AstraZeneca; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Pfizer; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Boehringer Ingelheim; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Eli Lilly; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Novartis; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: F. Hoffmann La Roche; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: BMS; Leadership role, Travel / Accommodation / Expenses, Full / Part-time employment: Head of Oncology National Institute of Respiratory Diseases Mexico. T.A. Leal: Advisory / Consultancy: Genentech; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: BMS; Advisory / Consultancy: Bayer; Travel / Accommodation / Expenses, Non-remunerated activity/ies: Mirati Therapeutics. S. Lam: Shareholder / Stockholder / Stock options, Full / Part-time employment: Roche/Genentech. M. McCleland: Full / Parttime employment: Genentech, Inc. Y. Deng: Full / Part-time employment: Genentech, Inc. S. Phan: Full / Part-time employment: Genentech, Inc. L. Horn: Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: AbbVie; Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: BMS; Advisory / Consultancy: Genentech/Roche; Advisory / Consultancy: EMD Serono; Advisory / Consultancy: Incyte; Advisory / Consultancy, Research grant / Funding (institution): Xcovery; Advisory / Consultancy: Merck; Research grant / Funding (institution): Boehringer Ingelheim. All other authors have declared no conflicts of interest.