FIGHT-202: A phase II study of pemigatinib in patients (pts) with previously treated locally advanced or metastatic cholangiocarcinoma (CCA)

abstracts LBA40

FIGHT-202: A phase II study of pemigatinib in patients (pts) with previously treated locally advanced or metastatic cholangiocarcinoma (CCA)

Background: Fibroblast growth factor receptor (FGFR) 2 alterations are implicated in CCA. Pemigatinib is a selective, potent, oral FGFR1, 2, and 3 inhibitor. We present data from a phase II, open label, single arm study of pemigatinib in pts with previously treated locally advanced or metastatic CCA (NCT02924376). Methods: Eligible adults had disease progression after 1 prior treatment and documented FGF/FGFR gene status. Pts assigned to cohorts A (FGFR2 gene rearrangements/fusions), B (other FGF/FGFR gene alterations), or C (no FGF/FGFR gene alterations) received oral pemigatinib 13.5 mg QD (21-day cycle; 2 weeks on, 1 week off) until disease progression/unacceptable toxicity. Primary endpoint was centrally confirmed objective response rate (ORR; cohort A); secondary endpoints were ORR (cohorts B, AþB, and C); duration of response (DOR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety. Results: At data cutoff (Mar 22, 2019), 146 pts were enrolled (cohort A, n ¼ 107; B, n ¼ 20; C, n ¼ 18; 1 pt undetermined). Median (range) age was 59 (26–78) years; 61% and 39% had 1 and 2 prior therapies, respectively. Fewer pts discontinued therapy in cohort A (71%) vs B and C (each 100%), mainly for progressive disease (53%, 75%, and 67%, respectively). ORR in cohort A was 35.5% (95% CI, 26.5%–45.4%), with 3 complete responses; median (m) DOR was 7.5 (95% CI, 5.7–14.5) months (mo), DCR was 82% (95% CI, 74%–89%), mPFS and mOS were 6.9 (95% CI, 6.2–9.6) and 21.1 (14.8–not reached) mo (OS not mature at cutoff). In cohorts B and C, no patient achieved a response. Overall, most common adverse events (AEs) were hyperphosphatemia (60%; grade 3, 0%), alopecia (49%; 0%), diarrhea (47%; 3%), fatigue (42%; 5%), nail toxicities (42%; 2%), and dysgeusia (40%; 0%). Hyperphosphatemia was managed with diet modifications, phosphate binders, if needed; diuretics or dose reductions/interruptions. Discontinuation, dose reduction and interruption due to AEs occurred in 9%, 14% and 42% of patients, respectively. Conclusions: These data support pemigatinib as a potential treatment option for previously treated pts with CCA harboring FGFR2 gene rearrangements/fusions. Clinical trial identification: EudraCT: 2016-002422-36. Editorial acknowledgement: Editorial assistance was provided by Envision Pharma Group (Philadelphia, PA) and funded by Incyte Corporation. Legal entity responsible for the study: Incyte Corporation. Funding: Incyte Corporation. Disclosure: A. Vogel: Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Incyte; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: AstraZeneca; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Roche; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Lilly; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Bayer; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Medac; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Delcath; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Shire. V. Sahai: Research grant / Funding (institution): Agios; Research grant / Funding (institution): BristolMyers Squibb; Research grant / Funding (institution): Celgene; Research grant / Funding (institution): Clovis; Research grant / Funding (institution): Debiopharm; Research grant / Funding (institution): Fibrogen; Advisory / Consultancy, Research grant / Funding (institution): Incyte; Advisory / Consultancy, Research grant / Funding (institution): Ipsen; Research grant / Funding (institution): Merck; Research grant / Funding (institution): NCI; Research grant / Funding (institution): Rafael; Advisory / Consultancy: Halozyme; Advisory / Consultancy: QED; Advisory / Consultancy: NewLink Genetics. A. Hollebecque: Advisory / Consultancy, Travel / Accommodation / Expenses, Non-remunerated activity/ies: Amgen; Advisory / Consultancy: Spectrum Pharmaceuticals; Advisory / Consultancy, Travel / Accommodation / Expenses: Lilly; Advisory / Consultancy, Travel / Accommodation / Expenses: Debiopharm; Travel / Accommodation / Expenses: Servier; Travel / Accommodation / Expenses: Incyte; Non-remunerated activity/ies: Bayer; Non-remunerated activity/ ies: EISAI; Research grant / Funding (institution): Astrazeneca; Research grant / Funding (institution): BMS; Research grant / Funding (institution): Boehringer Ingelheim; Research grant / Funding

v876 | Gastrointestinal tumours, non-colorectal

(institution): Janssen Cilag; Research grant / Funding (institution): Merck; Research grant / Funding (institution): Novartis; Research grant / Funding (institution): Pfizer; Research grant / Funding (institution): Roche; Research grant / Funding (institution): Sanofi. D. Melisi: Advisory / Consultancy, Research grant / Funding (institution): Shire; Advisory / Consultancy, Research grant / Funding (institution): Incyte; Advisory / Consultancy, Research grant / Funding (institution): Evotec; Research grant / Funding (institution): Celgene; Advisory / Consultancy: Eli Lilly; Advisory / Consultancy: Baxter. R. Al-Rajabi: Research grant / Funding (institution): Incyte. A.S. Paulson: Advisory / Consultancy: AAA; Advisory / Consultancy, Research grant / Funding (institution): Taiho; Advisory / Consultancy: Ipsen; Advisory / Consultancy, Research grant / Funding (institution): BMS; Advisory / Consultancy: Eisai; Advisory / Consultancy: Amgen; Shareholder / Stockholder / Stock options: Aptose; Shareholder / Stockholder / Stock options: Seattle Genetics; Shareholder / Stockholder / Stock options: Immunomedics; Research grant / Funding (institution): Incyte; Research grant / Funding (institution): Exelixis. M.J. Borad: Research grant / Funding (institution): Senhwa Pharmaceuticals, Adaptimmune, Agios Pharmaceuticals, Halozyme Pharmaceuticals, Celgene Pharmaceuticals, EMD Merck Serono, Toray, Dicerna, Taiho Pharmaceuticals, Sun Biopharma, Isis Pharmaceuticals, Redhill Pharmaceuticals, Boston Biomed, Basilea, I; Honoraria (self): Exelixis, G1 Therapeutics, Immunonative Therapies, Western Oncolytics, Lynx Group, Inspyr Therapeutics, ADC Therapeutics; Shareholder / Stockholder / Stock options: OncBioMune Pharmaceuticals, Intercept, AVEO; Travel / Accommodation / Expenses: AstraZeneca. A.G. Murphy: Research grant / Funding (institution): BMS. D. Oh: Research grant / Funding (institution): Array; Research grant / Funding (institution): Eli Lilly; Advisory / Consultancy, Research grant / Funding (institution): AstraZeneca; Advisory / Consultancy, Research grant / Funding (institution): Novartis; Advisory / Consultancy: Merck Serono; Advisory / Consultancy: Bayer; Advisory / Consultancy: Taiho; Advisory / Consultancy: ASLAN; Advisory / Consultancy: Halozyme; Advisory / Consultancy: Zymeworks. E. Dotan: Honoraria (self): Boston Medical; Honoraria (self): Armo; Research grant / Funding (institution): Pfizer; Research grant / Funding (institution): Lilly. D.V. Catenacci: Honoraria (self), Advisory / Consultancy: Merck; Honoraria (self), Advisory / Consultancy: BMS; Honoraria (self), Advisory / Consultancy: Five Prime; Honoraria (self), Advisory / Consultancy: Astellas; Honoraria (self), Advisory / Consultancy: Taiho; Honoraria (self), Advisory / Consultancy: Lilly; Honoraria (self), Advisory / Consultancy: Genentech/Roche; Honoraria (self), Advisory / Consultancy: Gritstone; Honoraria (self), Advisory / Consultancy: Foundation Medicine; Honoraria (self), Advisory / Consultancy: Tempus; Honoraria (self), Advisory / Consultancy: Guardant Health. E. Van Cutsem: Advisory / Consultancy: Astellas; Advisory / Consultancy: Astrazeneca; Advisory / Consultancy, Research grant / Funding (institution): Bayer; Advisory / Consultancy, Research grant / Funding (institution): Bristol-Myers Squibb; Advisory / Consultancy, Research grant / Funding (institution): Celgene; Advisory / Consultancy: Incyte; Advisory / Consultancy, Research grant / Funding (institution): Lilly; Advisory / Consultancy, Research grant / Funding (institution): Merck Sharp & Dohme; Advisory / Consultancy, Research grant / Funding (institution): Merck KGaA; Advisory / Consultancy, Research grant / Funding (institution): Novartis; Advisory / Consultancy, Research grant / Funding (institution): Roche; Advisory / Consultancy, Research grant / Funding (institution): Servier; Research grant / Funding (institution): Amgen; Research grant / Funding (institution): Boehringer Ingelheim; Research grant / Funding (institution): Ipsen. C.F. Lihou: Shareholder / Stockholder / Stock options, Full / Part-time employment: Incyte Corporation. H. Zhen: Shareholder / Stockholder / Stock options, Full / Part-time employment: Incyte Corporation. L. Fe´liz: Shareholder / Stockholder / Stock options, Full / Part-time employment: Incyte Corporation. G.K. Abou-Alfa: Research grant / Funding (institution): ActaBiologica, Agios, Array, AstraZeneca, Bayer, Beigene, BMS, Casi, Celgene, Exelixis, Genentech, Halozyme, Incyte, Lilly, Mabvax, Novartis, OncoQuest, Polaris Puma, QED, Roche; Advisory / Consultancy: 3DMedcare, Agios, Alignmed, Amgen, Antengene, Aptus, Aslan, Astellas, AstraZeneca, Bayer, Beigene, Bioline, BMS, Boston Scientifc, Bridgebio, Carsgen, Celgene, Casi, Cipla, CytomX, Daiichi, Debio, Delcath, Eisai, Exelixis, Genoscience, Halozyme, Hengrui. All other authors have declared no conflicts of interest.

LBA41

Phase III randomized study of neoadjuvant chemotherapy (CT) with docetaxel(D), oxaliplatin(O) and S-1(S) (DOS) followed by surgery and adjuvant S-1, vs surgery and adjuvant S-1, for resectable advanced gastric cancer (GC) (PRODIGY)

Y-K. Kang1, J.H. Yook2, Y-K. Park3, Y-W. Kim4, J. Kim5, M-H. Ryu6, S.Y. Rha7, I-J. Chung8, I-H. Kim9, S.C. Oh10, C-H. Yoo11, J-H. Choi12, D.Y. Zang13, G. Kim14, Y. Lee15, S-H. Noh16 1 Oncology Department, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea, 2Department of Surgery, Asan Medical Center, University of Ulsan, Seoul, Republic of Korea, 3Department of Surgery, Chonnam National University Hwasun Hospital, Gwangju, Republic of Korea, 4Stomach Cancer, National Cancer Center, Goyang, Republic of Korea, 5Department of Hemato-Oncology, Keimyung University Dongsan Medical Center, Daegu, Republic of Korea, 6Department of Oncology, Asan Medical Center, University of Ulsan, Seoul, Republic of Korea, 7Medical Oncology, Yonsei University, Seoul, Republic of Korea, 8Medical Oncology, Chonnam National University Hwasun Hospital, Jeonnam, Republic of Korea, 9Department of Internal Medicine, Seoul St. Mary’s Hospital, Seoul, Republic of Korea, 10Department of Internal Medicine, Korea University Guro Hospital, Seoul, Republic of Korea, 11 Department of Surgery, Kangbuk Samsung Hospital, Seoul, Republic of Korea, 12 Hematology-Oncology, Ajou University School of Medicine, Suwon, Republic of Korea, 13 Department of Internal Medicine, Hallym University Sacred Heart Hospital, Anyang, Republic of Korea, 14Sanofi Korea, Seoul, Republic of Korea, 15R&D Clinical Study Unit, Sanofi Korea, Seoul, Republic of Korea, 16Department of Surgery, Yonsei Cancer Center, Yonsei University Health System, Seoul, Republic of Korea Background: Adjuvant CT after D2 gastrectomy is standard therapy for resectable advanced GC in Asia. We investigated whether added neoadjuvant (NA) CT can further improve outcomes. Methods: 530 pts with newly diagnosed locally advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma (cT2,3/N[þ]M0 or cT4/N[any]M0, AJCC 7th ed), ECOG PS 0-1, were randomized 1:1 to NA DOS then surgery and adjuvant S-1 (CSC; n ¼ 266), or surgery and adjuvant S-1 (SC; n ¼ 264). NA CT was D 50mg/m2 iv and O 100mg/m2 iv on day 1, S 40mg/m2 twice po on days 1–14 every 3 weeks for 3 cycles. Standard surgery was D2 gastrectomy. Adjuvant CT was S 40mg/m2 twice po on days 1–28 every 6 weeks for 8 cycles. Primary endpoint: 3-year progression free survival (PFS) in full analysis set (FAS).

Volume 30 | Supplement 5 | October 2019

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A. Vogel1, V. Sahai2, A. Hollebecque3, G. Vaccaro4, D. Melisi5, R. Al-Rajabi6, A.S. Paulson7, M.J. Borad8, D. Gallinson9, A.G. Murphy10, D-Y. Oh11, E. Dotan12, D.V. Catenacci13, E. Van Cutsem14, C.F. Lihou15, H. Zhen16, L. Fe´liz15, G.K. Abou-Alfa17 1 Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany, 2Division of Hematology and Oncology, Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA, 3Department of Adult Medicine, Gustave Roussy, Villejuif, France, 4Hematology Oncology, Providence Cancer Center Oncology and Hematology Care Clinic, Portland, OR, USA, 5Digestive Molecular Clinical Oncology Research Unit, Department of Medicine, Universit a degli Studi di Verona, Verona, Italy, 6Department of Internal Medicine, Division of Hematology/ Oncology, University of Kansas Cancer Center, Kansas City, KS, USA, 7Baylor Charles A. Sammons Cancer Center, Baylor University Medical Center, Dallas, TX, USA, 8 Department of Internal Medicine, Mayo Clinic Cancer Center, Scottsdale, AZ, USA, 9 Department of Hematology/Oncology, Morristown Memorial Hospital, Carol Cancer Center, Morristown, NJ, USA, 10Department of Oncology, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA, 11Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea, 12Department of Hematology/Oncology, Fox Chase Cancer Center, Philadelphia, PA, USA, 13Department of Medicine, University of Chicago, Chicago, IL, USA, 14Department of Digestive Oncology, University Hospitals Leuven and KU Leuven, Leuven, Belgium, 15Clinical Development, Incyte Corporation, Wilmington, DE, USA, 16Biostatistics, Incyte Corporation, Wilmington, DE, USA, 17Department of Medicine, Memorial SloanKettering Cancer Center, New York, NY, USA

Annals of Oncology