Phase I open-label study evaluating the safety, pharmacokinetics, and preliminary efficacy of ABBV-181 and rovalpituzumab tesirine (ROVA-T) in patients with small cell lung cancer

abstracts

Annals of Oncology

1748P

Phase I open-label study evaluating the safety, pharmacokinetics, and preliminary efficacy of ABBV-181 and rovalpituzumab tesirine (ROVA-T) in patients with small cell lung cancer

Background: ABBV-181 is a humanized anti-programmed cell death 1 (PD-1) monoclonal antibody with activity in solid tumors. ROVA-T is an immunoglobulin G1 antibody-drug conjugate targeting cell surface delta-like protein 3 (DLL3) incorporating the pyrrolobenzodiazepine-based DNA cross-linking agent SC-DR002, for which safety and activity in small cell lung cancer (SCLC) has been reported. This report summarizes data from SCLC patients (pts) treated with ABBV-181 and ROVA-T in study NCT03000257. Methods: Pts with previously treated SCLC received 2 doses of ROVA-T 0.3 mg/kg intravenously (IV) every 6 weeks (Q6W) and ABBV-181 375 mg IV Q3W to progression. Response was assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 and immune RECIST. Serial pharmacokinetic (PK) and pharmacodynamic (PD) samples were collected. Results: As of 5 April 2019, 31 pts were dosed.

Table: 1748P n (%) Median days on ABBV-181 treatment, range Doses of ROVA-T Grade (G) 1 adverse events (AEs) G  3 AEs ABBV-181-related G  3 AEs ROVA-T-related G  3 AEs AEs resulting in discontinuation of ABBV-181a,b / ROVA-Tc,d G5 AEse

58.5, 10–358.0 1: 15 (48.0); 2: 16 (52.0) 31 (100.0) 25 (80.6) 9 (29.0) 12 (38.7) 6 (19.4) / 3 (9.7) 2 (6.5)

a

Four (12.9%) ABBV-181-related, 1 each of immune-related hepatitis, colitis, general physical health deterioration, and peripheral sensory neuropathy. b One (3.2%) ROVA-T-related, of peripheral sensory neuropathy. c One (3.2%) ABBV-181-related, of general physical health deterioration. d One (3.2%) ROVA-T-related, of thrombocytopenia. e Unrelated to either ABBV-181 or ROVA-T (1 [3.2%] malignant neoplasm progression and 1 [3.2%] depressed level of consciousness)

The most frequent AEs of any grade included: fatigue, 12 pts (38.7%), decreased appetite and nausea, 9 pts each (29.0%). ABBV-181 and ROVA-T PK were not impacted by the combination regimen when compared with dose-normalized ABBV-181 PK or ROVA-T PK alone. PD-1 saturation on circulating CD4þ T cells, and increased Ki67þ CD8þ T cells and serum chemokine C-X-C ligand 9 (CXCL9)/CXCL10 were observed, consistent with previous ABBV-181 reports. In pts with 1 post-baseline assessment, investigator-assessed best overall response and objective response rates were 9/29 and 4/29 (including 1 complete response in each). Conclusions: The combination of ROVA-T and ABBV-181 has an adequate safety profile and preliminary efficacy, with no impact on the PK/PD characteristics of either

Volume 30 | Supplement 5 | October 2019

grant / Funding (institution), (Or consultation fees): Novartis; Honoraria (self), Research grant / Funding (institution), (Or consultation fees): Nanobiotix; Honoraria (self), Research grant / Funding (institution), (Or consultation fees): Pfizer; Honoraria (self), (Or consultation fees): Janssen-Cilag; Honoraria (self), (Or consultation fees): GLG Pharma; Honoraria (self), (Or consultation fees): PsiOxus Therapeutics; Honoraria (self), Research grant / Funding (institution), (Or consultation fees): Merck; Honoraria (self), (Or consultation fees): Medscape; Honoraria (self), Research grant / Funding (institution), (Or consultation fees): Bristol-Myers Squibb; Honoraria (self), (Or consultation fees): Gilead Sciences; Honoraria (self), (Or consultation fees): Seattle Genetics; Honoraria (self), (Or consultation fees): Pierre Fabre; Honoraria (self), Research grant / Funding (institution), (Or consultation fees): Boehringer Ingelheim; Honoraria (self), (Or consultation fees): Cerulean Pharma; Honoraria (self), (Or consultation fees): EUSA Pharma; Honoraria (self), (Or consultation fees): Gehrmann Consulting; Honoraria (self), Research grant / Funding (self), Research grant / Funding (institution), (Or consultation fees): AstraZenenca; Honoraria (self), (Or consultation fees): Roche; Honoraria (self), (Or consultation fees): Guidepoint; Honoraria (self), (Or consultation fees): Servier; Honoraria (self), (Or consultation fees): Celgene; Honoraria (self), Research grant / Funding (institution), (Or consultation fees): AbbVie; Honoraria (self), Research grant / Funding (institution), (Or consultation fees): amcure; Honoraria (self), (Or consultation fees): OncoDNA; Honoraria (self), (Or consultation fees): Alkermes; Leadership role, Full / Part-time employment: director clinical research, START Madrid (Program of Early Phase Clinical Drug Development in Oncology); Leadership role, Full / Part-time employment: director clinical research, HM Hospitals Group, Madrid; Leadership role: founder and president, non-for-profit Foundation INTHEOS (Investigational Therapeutics in Oncological Sciences); Leadership role: co-director, Methods in Clinical Cancer Research (MCCR) Workshop, Zeist, Netherlands (joint ECCO-AACR-EORTC-ESMO Workshop on MCCR); Shareholder / Stockholder / Stock options, Full / Part-time employment, (Or ownership): START; Shareholder / Stockholder / Stock options, (Or ownership): Oncoart Associated; Shareholder / Stockholder / Stock options, (Or ownership): International Cancer Consultants; Research grant / Funding (self): Novartis; Research grant / Funding (self), Research grant / Funding (institution): BeiGene; Research grant / Funding (institution): ACEO; Research grant / Funding (institution): Amgen; Research grant / Funding (institution): CytomX Therapeutics; Research grant / Funding (institution): GlaxoSmithKline; Research grant / Funding (institution): Genentech/Roche; Research grant / Funding (institution): H3 Biomedicine; Research grant / Funding (institution): Incyte; Research grant / Funding (institution): Janssen; Research grant / Funding (institution): Kura; Research grant / Funding (institution): Lilly; Research grant / Funding (institution): Loxo; Research grant / Funding (institution): Nektar Therapeutics; Research grant / Funding (institution): MacroGenics; Research grant / Funding (institution): Menarini; Research grant / Funding (institution): Merus; Research grant / Funding (institution): PharmaMar; Research grant / Funding (institution): Principia; Research grant / Funding (institution): PUMA; Research grant / Funding (institution): Sanofi; Research grant / Funding (institution): Taiho; Research grant / Funding (institution): Tesaro; Research grant / Funding (institution): Transgene; Research grant / Funding (institution): Takeda; Research grant / Funding (institution): Innovio; Research grant / Funding (institution): MSD; Research grant / Funding (institution), Non-remunerated activity/ies: PsiOxus; Research grant / Funding (institution): Seattle Genetics; Research grant / Funding (institution): Mersana; Research grant / Funding (institution): Daiichi; Research grant / Funding (institution): Nektar; Research grant / Funding (institution): Astellas; Research grant / Funding (institution): ORCA; Research grant / Funding (institution): Boston Therapeutics; Research grant / Funding (institution): Dynavax; Research grant / Funding (institution): Debiopharm; Research grant / Funding (institution): Regeneron; Research grant / Funding (institution): Millenium; Research grant / Funding (institution): Synthon; Research grant / Funding (institution): Spectrum; Research grant / Funding (institution): Rigontec; Non-remunerated activity/ies: Memberships for SEOM, EORTC, ESMO, and ASCO. A. Spira: Honoraria (self), Research grant / Funding (institution): CytomX Therapeutics; Honoraria (self): AstraZeneca/MedImmune; Honoraria (self): Merck; Advisory / Consultancy: Array BioPharma; Research grant / Funding (institution): Roche; Research grant / Funding (institution): AstraZeneca; Research grant / Funding (institution): Boehringer Ingelheim; Research grant / Funding (institution): Astellas Pharma; Research grant / Funding (institution): MedImmune; Research grant / Funding (institution): Novartis; Research grant / Funding (institution): NewLink Genetics; Research grant / Funding (institution): Incyte; Research grant / Funding (institution): AbbVie; Research grant / Funding (institution): Ignyta; Research grant / Funding (self), Research grant / Funding (institution): LAM Therapeutics; Research grant / Funding (institution): TrovaGene; Research grant / Funding (institution): Takeda; Research grant / Funding (institution): MacroGenics; Research grant / Funding (institution): Astex Pharmaceuticals; Research grant / Funding (institution): Bristol-Myers Squibb; Research grant / Funding (institution): Loxo; Research grant / Funding (institution): Arch. H. Prenen: Honoraria (self): Roche; Honoraria (self): Bayer; Honoraria (self): Amgen; Honoraria (self): Ipsen; Honoraria (self): Pfizer; Honoraria (self): Novartis; Honoraria (self): Sanofi; Honoraria (self): Merck; Honoraria (self): Vfor Pharma; Honoraria (self): Lilly. Y. Ohe: Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): AstraZeneca; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Chugai; Honoraria (self), Research grant / Funding (institution): Lilly; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): ONO; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Bristol-Myers Squibb; Honoraria (self): Boehringer Ingelheim; Honoraria (self): Bayer; Honoraria (self), Research grant / Funding (institution): Pfizer; Honoraria (self): MSD; Honoraria (self), Research grant / Funding (institution): Taiho; Advisory / Consultancy, Research grant / Funding (institution): Kyorin; Advisory / Consultancy: Celltrion; Advisory / Consultancy: Amgen; Research grant / Funding (institution): Dainippon Sumitomo; Research grant / Funding (institution): Novartis; Research grant / Funding (institution): Ignyta; Research grant / Funding (institution): Takeda; Research grant / Funding (institution): Kissei; Research grant / Funding (institution): Daiichi-Sankyo; Research grant / Funding (institution): Janssen. A. Gazzah: Research grant / Funding (self), Travel / Accommodation / Expenses, Non-remunerated activity/ies: Boehringer Ingelheim; Research grant / Funding (self), Travel / Accommodation / Expenses: Novartis; Research grant / Funding (self), Travel / Accommodation / Expenses, Nonremunerated activity/ies: Pfizer; Research grant / Funding (self), Travel / Accommodation / Expenses, Non-remunerated activity/ies: Roche; Advisory / Consultancy, Speaker Bureau / Expert testimony: Novartis; Research grant / Funding (self): Aduro Biotech; Research grant / Funding (self): Agios Pharmaceuticals; Research grant / Funding (self): Amgen; Research grant / Funding (self): argen x SE; Research grant / Funding (self): Arno Therapeutics; Research grant / Funding (self): Astex Pharmaceuticals; Research grant / Funding (self), Non-remunerated activity/ies: AstraZeneca; Research grant / Funding (self): Aveo; Research grant / Funding (self): Bayer; Research grant /

doi:10.1093/annonc/mdz264 | v715

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E. Calvo1, A. Spira2, H. Prenen3, Y. Ohe4, S. Rottey5, A. Gazzah6, M. Millward7, V. Moreno8, A. Italiano9, T. Alanko10, K. Yoh11, P.A. Cassier12, T. Seto13, D. Afar14, S. Englert15, P. Komarnitsky16, S. Lambert14, A. Parikh17, G. Vosganian14, B. Gao18 1 START Madrid - CIOCC, Centro Integral Oncologico Clara Campal, Hospital Madrid Norte Sanchinarro, Madrid, Spain, 2Oncology Program, Virginia Cancer Specialists, Fairfax, VA, USA, 3Oncology Department, University Hospital Antwerp, Edegem, Belgium, 4Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan, 5Department of Medical Oncology, Heymans Institute of Pharmacology, Ghent, Belgium, 6Department of Drug Development (DITEP), Gustave Roussy, Universite´ ParisSaclay, Villejuif, France, 7Early Phase Clinical Research, Linear Clinical Research, Perth, on Jime´nez Dıaz, Madrid, Australia, 8START Madrid - FJD, Hospital Universitario Fundaci Spain, 9Department of Medical Oncology, Institute Bergonie´, Bordeaux, France, 10 Department of Medical Oncology, Docrates Cancer Center, Helsinki, Finland, 11 Department of Thoracic Oncology, National Cancer Center Hospital East, Kashiwa, Japan, 12Department of Medical Oncology, Le´on Be´rard Cancer Center, Lyon, France, 13 Department of Thoracic Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan, 14Oncology Early Development, AbbVie Inc., Redwood City, CA, USA, 15Data and Statistical Sciences, AbbVie Inc., Ludwigshafen, Germany, 16Oncology Development, AbbVie Inc., North Chicago, IL, USA, 17Clinical Pharmacology and Pharmacometrics, AbbVie Inc., Redwood City, CA, USA, 18Medical Oncology, Blacktown and Westmead Hospitals, Sydney, Australia

agent. Additional follow-up is required to characterize safety, efficacy, and associations with PD-L1/DLL3 expression for this combination. Clinical trial identification: NCT03000257. Editorial acknowledgement: Oana Draghiciu, PhD, CMPP, from Aptitude Health, The Hague, The Netherlands; funded by AbbVie. Legal entity responsible for the study: AbbVie Inc. Funding: AbbVie Inc. Disclosure: E. Calvo: Honoraria (self), (Or consultation fees): Astellas; Honoraria (self), Research

abstracts

1749P

Activity of the novel Aurora kinase B inhibitor AZD2811 in biomarkerdefined models of small cell lung cancer

C.M. Della Corte1, L. Ajpacaja1, R.J. Cardnell1, C.M. Gay1, Q. Wang2, L. Shen2, K. Ramkumar1, A.C. Stewart1, Y-H. Fan1, C.A. Adelman3, J. Travers3, J. Wang2, J. Heymach4, L.A. Byers1 1 THNMO, MD Anderson Cancer Center, Houston, TX, USA, 2Bioinformatics & Computational Biology, MD Anderson Cancer Center, Houston, TX, USA, 3Drug Development Department, AstraZeneca, Cambridge, UK, 4Thoracic/Head & Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA Background: Aurora Kinases (AURK) regulate mitosis and are often upregulated in cancer. SCLC is characterized by TP53 and RB1 loss and frequent MYC amplification. Our group, and others, have proved that MYC-driven SCLC are vulnerable to AURKAinhibitors (AURKAi), but their use is limited by toxicity due to high AURKA expression. AURKB levels are variable in SCLC, making AURKB an attractive targeted therapeutic approach. A novel AURKBi, AZD2811NP (nanoparticle), is now being investigated in relapsed SCLC patients (NCT02579226). We hypothesize that molecularly defined subsets may be sensitive to AZD2811.

v716 | SCLC

Methods: We tested 50 human-derived SCLC cell lines with AZD2811 in 96 hour proliferation assays. To identify translatable biomarkers of response, we correlated IC50 values with genomic (WES), transcriptomic (RNASeq), and proteomic profiling (RPPA). Results: AZD2811 is active in a subset of SCLC cells: 13/30 (26%) have high sensitivity (IC50<30 nM, Cmax) and 7/30 (14%) intermediate (IC50¼30-100nM). Comparing protein expression, we found that cMYC (Fold change, FC:2.5; P ¼ 0.015) and Vimentin (FC:1.66; P ¼ 0.022) were top biomarkers of sensitivity, while high E-cadherin (FC:1.94; P ¼ 0.046) and BCL-2 (FC:1.86; P ¼ 0.032) associated with resistance. Interestingly, among the 13 highly sensitive cells, only 5 overexpress cMYC, highlighting that activity of AURKBi is not limited to MYC-driven SCLC. Indeed, among recently-described transcription factor defined subsets of SCLC, a majority of the NEUROD1-defined subset (cMYC enriched) were sensitive to AZD2811, as 25% of ASCL1- and 67% of POU2F-3-defined ones. These data suggest that the ASCL1 subset includes heterogeneous sub-groups that require further analysis to dissect their molecular features. Mutations in EP300, a Histone acetyltransferase that controls chromatin modification and transcription, also predict sensitivity. Conclusions: Our results show encouraging single agent in vitro activity of AZD2811 in SCLC cells, and suggest a novel biomarker-driven approach for combinations. Candidate biomarkers will be tested in samples from the ongoing clinical trial. The high BCL2 levels observed in resistant cells provide a rationale for exploring AURKB/BCL2-i combinations. Clinical trial identification: NCT02579226. Legal entity responsible for the study: The authors. Funding: AstraZeneca. Disclosure: C.A. Adelman: Full / Part-time employment: AstraZeneca. J. Travers: Full / Part-time employment: AstraZeneca. J. Heymach: Advisory / Consultancy, Research grant / Funding (self): AstraZeneca; Advisory / Consultancy, Licensing / Royalties: BioTree; Advisory / Consultancy: Boehringer Ingelheim; Advisory / Consultancy: Exelixis; Advisory / Consultancy: Genentech; Advisory / Consultancy: GSK; Advisory / Consultancy: Guardant Health; Advisory / Consultancy: Hengrui; Advisory / Consultancy: Lilly; Advisory / Consultancy: Novartis; Advisory / Consultancy, Research grant / Funding (self), Licensing / Royalties: Spectrum; Advisory / Consultancy: EMD Serono; Advisory / Consultancy: Synta; Research grant / Funding (self): Bayer; Research grant / Funding (self): GlaxoSmithKline. L.A. Byers: Advisory / Consultancy, Research grant / Funding (self): AstraZeneca; Advisory / Consultancy, Research grant / Funding (self): AbbVie; Advisory / Consultancy, Research grant / Funding (self): GenMab; Advisory / Consultancy: BergenBio; Advisory / Consultancy: Pharma Mar; Advisory / Consultancy: SA; Advisory / Consultancy, Research grant / Funding (self): Sierra Oncology; Research grant / Funding (self): Tolero Pharmaceuticals. All other authors have declared no conflicts of interest.

1750P

Multi-level proteomics identifies FABP5 as a primary chemoresistance mediator in extensive-stage small cell lung cancer

Y. Chen1, Y. Jin1, X. Shi2, M. Chen1 Zhe Jiang Key Laboratory of Radiation Oncology, Zhe Jiang Cancer Hospital, Hangzhou, China, 2Department of Medical Oncology, Zhe Jiang Cancer Hospital, Hang Zhou, China

1

Background: Small cell lung cancer (SCLC), a highly invasive neuroendocrine tumor, accounts for approximately 15% of all new diagnosed lung cancer. Primary disease is highly sensitive to chemotherapy as well as radiotherapy, recurrences occur quickly, and less effective to subsequent therapies than the initial chemotherapy, the response rate of second-line therapy topotecan is only 22%. Drug resistance, is the main reason for failure of SCLC chemotherapy. Here, we quantitatively analyzed the proteomes of Cisplatin/Etoposide-resistant and -sensitive ES-SCLC patients from minute amounts of formalin-fixed and paraffin-embedded (FFPE) tissues. FABP5 was identified to be related with primary chemosensitivity, and may be an important mediator of Cisplatin/ Etoposide-induced cell death. Methods: 51 tissue samples were collected from ES-SCLC patients who underwent Cisplatin and Etoposide chemotherapy in Zhe Jiang Cancer Hospital from January 2015 to November 2017. The 51 cases included 23 chemosensitive patients and 28 chemoresistant patients. System-wide quantitative proteomics approach was applied on the cohort of chemo-resistant and -sensitive tissues, and label free protein quantification was performed. Realtime-PCR was performed to assess the mRNA expression in H69 and multi-drug resistant H69AR cells. Results: A total of 4,485 proteins were identified and quantified, more than 50% proteins were 10-70KD, Proteins with a fold difference greater than 1.5 (up/down) and a P value (t test) less than 0.05 were considered differentially expressed proteins, few overall proteome changes across the two groups. Comparison of the two-group found that FABP5 was significantly decreased in drug-resistant patients. Consistent with the protein level in tumor tissues, FABP5 mRNA was down-regulated in H69AR cells. FABP5 expression strongly correlated with decreased disease-free survival and overall survival in ES-SCLC patients. Conclusions: These data revealed FABP5 may serve as a potential biomarker for primary chemoresistance and prognostic factor for patients with ES-SCLC, which need further research. Legal entity responsible for the study: Yamei Chen. Funding: National Natural Science Foundation of China (grant numbers 81672972). Disclosure: All authors have declared no conflicts of interest.

Volume 30 | Supplement 5 | October 2019

Downloaded from https://academic.oup.com/annonc/article-abstract/30/Supplement_5/mdz264.012/5577087 by guest on 17 October 2019

Funding (self): BBB Technologies BV; Research grant / Funding (self): BeiGene; Research grant / Funding (self): BioAlliance Pharma; Research grant / Funding (self): BioNTech AG; Research grant / Funding (self): Blueprint Medicines; Research grant / Funding (self), Non-remunerated activity/ies: Bristol-Myers Squibb; Research grant / Funding (self): Ca; Research grant / Funding (self): Celgene Corporation; Research grant / Funding (self): Chugai Pharmaceutical; Research grant / Funding (self): Clovis Oncology; Research grant / Funding (self): Daiichi Sankyo; Research grant / Funding (self): Debiopharm; Research grant / Funding (self): Eisai; Research grant / Funding (self): Exelixis; Research grant / Funding (self): Forma; Research grant / Funding (self): GamaMabs; Research grant / Funding (self): Genentech; Research grant / Funding (self): Gilead Sciences; Research grant / Funding (self): GalxoSmithKline; Research grant / Funding (self): Glenmark Pharmaceuticals; Research grant / Funding (self): H3 Biomedicine; Research grant / Funding (self): Hoffmann La Roche AG; Research grant / Funding (self): Incyte Corporation; Research grant / Funding (self): Innate Pharma; Research grant / Funding (self): Iris Servier; Research grant / Funding (self): Janssen; Research grant / Funding (self): Kura Oncology; Research grant / Funding (self): Kyowa Kirin Pharma; Research grant / Funding (self), Non-remunerated activity/ies: Lilly; Research grant / Funding (self): Loxo Oncology; Research grant / Funding (self): Lytix Biopharma; Research grant / Funding (self), Non-remunerated activity/ies: MedImmune; Research grant / Funding (self): Menarini Ricerche; Research grant / Funding (self): Merck Sharp & Dohme Chibret; Research grant / Funding (self): Merrimack Pharmaceuticals; Research grant / Funding (self): Merus; Research grant / Funding (self): Millennium Pharmaceuticals; Research grant / Funding (self): Nanobiotix; Research grant / Funding (self): Nektar Therapeutics; Research grant / Funding (self): Octimet Oncology NV; Research grant / Funding (self): OncoEthix; Research grant / Funding (self): OncoMed; Research grant / Funding (self): Oncopeptides; Research grant / Funding (self): Onyx Therapeutics; Research grant / Funding (self): Orion Pharma; Research grant / Funding (self): Oryzon Genomics; Research grant / Funding (self): PharmaMar; Research grant / Funding (self): Pierre Fabre; Research grant / Funding (self): Rigontec Gmbh; Research grant / Funding (self): Sanofi Aventis; Research grant / Funding (self): Sierra Oncology; Research grant / Funding (self): Taiho Pharma; Research grant / Funding (self): Tesaro; Research grant / Funding (self): Tioma Therapeutics; Research grant / Funding (self): Xencor; Research grant / Funding (self): Janssen Cilag; Research grant / Funding (self), Non-remunerated activity/ies: Merck; Research grant / Funding (self): Sanofi; Non-remunerated activity/ies: Bayer; Non-remunerated activity/ies: Johnson&Johnson; Non-remunerated activity/ies: NH TherAguix. M. Millward: Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Advisory / Consultancy, Travel / Accommodation / Expenses: Bristol-Myers Squibb; Advisory / Consultancy, Travel / Accommodation / Expenses: AstraZeneca; Advisory / Consultancy, Travel / Accommodation / Expenses: Merck Sharp & Dohme; Advisory / Consultancy: Novartis; Advisory / Consultancy: Boehringer Ingelheim; Advisory / Consultancy: Pfizer/EMD Serono. T. Alanko: Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Eli Lilly; Honoraria (self), Advisory / Consultancy: Roche; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Bayer; Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Bristol-Myers Squibb; Advisory / Consultancy, Travel / Accommodation / Expenses: Celgene; Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: MSD/Merck; Advisory / Consultancy: Nordic Drugs; Advisory / Consultancy, Travel / Accommodation / Expenses: Shire; Research grant / Funding (institution): AbbVie; Research grant / Funding (institution): Boehringer Ingelheim; Research grant / Funding (institution): Incyte; Research grant / Funding (institution), Travel / Accommodation / Expenses: Pfizer; Speaker Bureau / Expert testimony: Servier; Travel / Accommodation / Expenses: Roche. K. Yoh: Honoraria (self), Research grant / Funding (institution): AstraZeneca; Honoraria (self): Chigai Pharmaceutical; Research grant / Funding (institution): Lilly Japan; Research grant / Funding (institution): Pfizer; Research grant / Funding (institution): MSD. P.A. Cassier: Honoraria (self), Travel / Accommodation / Expenses: Amgen; Honoraria (self), Research grant / Funding (institution), (nonfinancial research support): AstraZeneca; Honoraria (self), Research grant / Funding (institution), Travel / Accommodation / Expenses: Novartis; Honoraria (self), Research grant / Funding (institution), Travel / Accommodation / Expenses: Roche; Research grant / Funding (institution): Celgene; Research grant / Funding (institution): Lilly; Research grant / Funding (institution), (non-financial research support): MSD. T. Seto: Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Bristol-Myers Squibb; Advisory / Consultancy, Research grant / Funding (institution): Chugai Pharmaceutical; Advisory / Consultancy, Research grant / Funding (institution): Eli Lilly Japan; Advisory / Consultancy, Research grant / Funding (institution): MSD; Advisory / Consultancy: Nippon Boehringer Ingelheim; Advisory / Consultancy, Research grant / Funding (institution): Novartis; Advisory / Consultancy, Research grant / Funding (institution): Pfizer Japan; Advisory / Consultancy: Taiho Pharmaceutical; Advisory / Consultancy, Research grant / Funding (institution): Takeda Pharmaceutical; Advisory / Consultancy: Thermo Fisher Scientific; Research grant / Funding (institution): Daiichi Sankyo; Research grant / Funding (institution): Loxo Oncology; Research grant / Funding (institution): Kissei Pharmaceutical. D. Afar: Full / Part-time employment, May own stock: AbbVie. S. Englert: Full / Part-time employment, May own stock: AbbVie Inc. P. Komarnitsky: Full / Part-time employment, May own stock: AbbVie Inc. S. Lambert: Full / Part-time employment, May own stock: AbbVie Inc. A. Parikh: Full / Part-time employment, May own stock: AbbVie Inc. G. Vosganian: Full / Part-time employment, May own stock: AbbVie Inc. .B. Gao: Advisory / Consultancy: Pfizer; Advisory / Consultancy: Merck Sharp & Dohme. All other authors have declared no conflicts of interest.

Annals of Oncology