LBA4 Association of KRAS mutational status with response to pembrolizumab monotherapy given as first-line therapy for PD-L1-positive advanced non-squamous NSCLC in Keynote-042

Annals of Oncology

LBA4

Association of KRAS mutational status with response to pembrolizumab monotherapy given as first-line therapy for PD-L1-positive advanced non-squamous NSCLC in KEYNOTE-042

R.S. Herbst1, G. Lopes2, D.M. Kowalski3, K. Kasahara4, Y-L. Wu5, G. De Castro Jr.6, B.C. Cho7, H.Z. Turna8, R. Cristescu9, D. Aurora-Garg9, J. Lunceford9, J. Kobie9, M. Ayers9, M.C. Pietanza9, B. Piperdi9, T.S.K. Mok10 1 Medical Oncology, Yale University School of Medicine, New Haven, CT, USA, 2Cancer, Sylvester Comprehensive Cancer Center at the University of Miami, Miami, FL, USA, 3 Lung Cancer and Chest Tumours, Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Warsaw, Poland, 4Oncology, Kanazawa University Hospital, Kanazawa, Japan, 5Oncology, Guangdong Lung Cancer Institute, Guangdong, China, 6 Clinical Oncology, Instituto do C^ ancer do Estado de S~ ao Paulo, S~ ao Paulo, Brazil, 7 Medical Oncology, Yonsei Cancer Center, Seoul, Republic of Korea, 8Medical Oncology, Istanbul University - Cerrahpasa Medical Faculty, Istanbul, Turkey, 9Oncology, Merck & Co., Inc., Kenilworth, NJ, USA, 10Clinical Oncology, State Key Laboratory of South China, Chinese University of Hong Kong, Hong Kong, China Background: Somatic KRAS mutations are detected in approximately 15%-30% of lung adenocarcinomas, with regional variation, and are associated with poor prognosis. We explored the prevalence of KRAS mutations and their association with efficacy in

Volume 30 | Supplement 11 | December 2019

participants (pts) with non-squamous NSCLC enrolled in the KEYNOTE-042 study of pembrolizumab monotherapy vs platinum-based chemotherapy as first-line therapy for advanced PD-L1-positive (TPS 1%) NSCLC (NCT02220894). Methods: KRAS mutational status and tumor mutational burden (TMB) were assessed by whole-exome sequencing (WES) in pts with who had available tumor and matchednormal tissue. This exploratory analysis included descriptive analyses of the correlation between KRAS mutational status and shifts in distributions of TMB and PD-L1 expression and the association of KRAS and KRAS G12C status with efficacy. Results: Of the 782 pts with non-squamous histology, 301 (38%) were evaluable by WES and had matched tumor and normal DNA. KRAS mutations were identified in 69 (23%) pts, including 29 (10%) G12C carriers. Pts with vs without KRAS mutation tended to have higher PD-L1 TPS (median [IQR] 60% [10-95] vs 35% [10-80]) and TMB (median [IQR] 191 [129-288] vs 105 [56-226] mut/exome). Outcomes of pembrolizumab and of chemotherapy for pts with and without KRAS mutation and for KRAS G12C carriers are in the table. Of note, CIs were wide given the modest frequency of KRAS mutation and low frequency of KRAS G12C. Conclusion: Findings of this descriptive exploratory analysis suggest that pembrolizumab monotherapy should be considered as a standard first-line treatment option for PD-L1-positive advanced non-squamous NSCLC regardless of KRAS mutational status. These findings also suggest that a pembrolizumab-containing regimen is a clinically relevant comparator for studies of KRAS -targeted therapy given as first-line treatment of NSCLC. Clinical trial identification: KEYNOTE-042; NCT02220894. Editorial acknowledgement: Joanne Tomassini and Melanie Leiby, both of Merck & Co., Inc., Kenilworth, NJ, for writing support. Legal entity responsible for the study: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. Funding: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. Disclosure: R.S. Herbst: Advisory / Consultancy: Abbvie Pharmaceuticals; Advisory / Consultancy: ARMO Biosciences; Advisory / Consultancy, Research grant / Funding (self): AstraZeneca; Advisory / Consultancy: Biodesix; Advisory / Consultancy: Bristol-Myers Squibb; Advisory / Consultancy, Research grant / Funding (self): Eli Lilly and Company; Advisory / Consultancy: EMD Serrano; Advisory / Consultancy: Genentech/Roche; Advisory / Consultancy: Genmab; Advisory / Consultancy: Halozyme; Advisory / Consultancy: Heat Biologics; Advisory / Consultancy: Infinity Pharmaceuticals; Advisory / Consultancy: Loxo Oncology; Advisory / Consultancy, Research grant / Funding (self): Merck & Co., Inc., Kenilworth, NJ, USA; Advisory / Consultancy: Nektar; Advisory / Consultancy: Neon Therapeutics; Advisory / Consultancy: NextCure; Advisory / Consultancy: Novartis; Advisory / Consultancy: Pfizer; Advisory / Consultancy: Sanofi; Advisory / Consultancy: Seattle Genetics; Advisory / Consultancy: Shire PLC; Advisory / Consultancy: Spectrum Pharmaceuticals; Advisory / Consultancy: Symphogen; Advisory / Consultancy: Tesaro; Advisory / Consultancy: Tocagen; Officer / Board of Directors: Junshi Pharmaceuticals. G. Lopes: Research grant / Funding (institution): AstraZeneca; Research grant / Funding (institution): EMD Serono; Research grant / Funding (institution): Merck & Co., Inc.. D.M. Kowalski: Advisory / Consultancy, Research grant / Funding (institution): MSD; Advisory / Consultancy: Boehringer-Ingelheim; Advisory / Consultancy: Roche; Advisory / Consultancy: Pfizer; Advisory / Consultancy: BMS. K. Kasahara: Research grant / Funding (institution): MSD. Y-L. Wu: Advisory / Consultancy, Research grant / Funding (institution): Boehringer-Ingelheim; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Roche; Advisory / Consultancy, Research grant / Funding (institution): MSD; Honoraria (self), Advisory / Consultancy: AstraZeneca; Honoraria (self): Eli Lilly; Honoraria (self): Pierre Fabre; Honoraria (self): Pfizer; Honoraria (self): Sanofi. G. De Castro Jr.: Honoraria (self), Honoraria (institution), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Roche; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: AstraZeneca; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses: MSD; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: BMS; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Pfizer; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Merck Serono; Honoraria (self), Honoraria (institution), Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Boehringer-Ingelheim; Honoraria (self), Honoraria (institution): Novartis; Honoraria (institution): Amgen; Honoraria (institution): Astellas. B.C. Cho: Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): AstraZeneca; Honoraria (self), Advisory / Consultancy: Boehringer Ingelheim; Honoraria (self), Advisory / Consultancy: Roche; Speaker Bureau / Expert testimony: Bristol Myers Squibb; Speaker Bureau / Expert testimony, Research grant / Funding (institution): MSD; Speaker Bureau / Expert testimony, Research grant / Funding (institution): Novartis; Research grant / Funding (institution): Bayer; Research grant / Funding (institution): Yuhan. H.Z. Turna: Research grant / Funding (institution): MSD. R. Cristescu: Shareholder / Stockholder / Stock options, Full / Part-time employment: Merck Sharp & Dohme. D. Aurora-Garg: Shareholder / Stockholder / Stock options, Full / Part-time employment: Merck Sharp & Dohme. J. Lunceford: Shareholder / Stockholder / Stock options, Full / Part-time employment: Merck Sharp & Dohme. J. Kobie: Shareholder / Stockholder / Stock options, Full / Part-time employment: Merck Sharp & Dohme. M. Ayers: Shareholder / Stockholder / Stock options, Full / Part-time employment: Merck Sharp & Dohme. M.C. Pietanza: Shareholder / Stockholder / Stock options, Non-remunerated activity/ies: Merck Sharp & Dohme. B. Piperdi: Shareholder / Stockholder / Stock options, Full / Part-time employment: Merck Sharp & Dohme. T.S.K. Mok: Honoraria (self), Advisory / Consultancy, Leadership role, Research grant / Funding (institution): AstraZeneca; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Boehringer Ingelheim; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): BMS; Advisory / Consultancy, Research grant / Funding (institution): Clovis Oncology; Research grant / Funding (institution): Eisai; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): MSD; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Novartis; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Pfizer; Research grant / Funding (institution): Roche; Advisory / Consultancy, Research grant / Funding (institution): SFJ Pharmaceuticals; Research grant / Funding (institution): Taiho; Research grant / Funding (institution): Xcovery; Honoraria (self), Advisory / Consultancy: Roche/Genentech; Honoraria (self), Leadership role, Shareholder / Stockholder / Stock options: Hutchinson MedPharma; Honoraria (self): Janssen; Honoraria (self): Takeda; Honoraria (self): Fishawack Facilitate Ltd; Advisory /

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Research grant / Funding (self): Roche/Genentech; Research grant / Funding (self): CPO; Research grant / Funding (self): PUCRS; Research grant / Funding (self): LACOG; Research grant / Funding (self): GBECAM; Research grant / Funding (self): INCA-Brazil; Advisory / Consultancy: BoehringerIngelheim; Advisory / Consultancy: GSK; Advisory / Consultancy: EIsai; Advisory / Consultancy: Bayer. M. Morise: Research grant / Funding (self): F. Hoffmann-La Roche; Honoraria (self), Lecture fee: Eli Lilly; Honoraria (self), Research grant / Funding (self), Lecture fee, Principal investigator of contact clinical trial: Chugai; Honoraria (self), Research grant / Funding (self), Lecture fee. Principal investigator of contact clinical trial: Astra Zeneca; Honoraria (self), Lecture fee: Ono; Honoraria (self), Research grant / Funding (self), Lecture fee, Principal investigator of contact clinical trial: Pfizer; Honoraria (self), Lecture fee: MSD; Research grant / Funding (self), Principal investigator of contact clinical trial: Merk serono; Research grant / Funding (self), Principal investigator of contact clinical trial: Kissei; Research grant / Funding (self), Principal investigator of contact clinical trial: Taiho; Research grant / Funding (self), Principal investigator of contact clinical trial: Novartis; Research grant / Funding (self): Boehringer-ingelheim. E. Felip: Research grant / Funding (self): F. Hoffmann-La Roche; Advisory / Consultancy, Speaker Bureau / Expert testimony: Abbvie; Advisory / Consultancy, Speaker Bureau / Expert testimony: Astra Zeneca; Advisory / Consultancy: Bergenbio; Advisory / Consultancy: Blue Print Medicine; Advisory / Consultancy, Speaker Bureau / Expert testimony: Boehringer Ingelheim; Advisory / Consultancy, Speaker Bureau / Expert testimony: BMS; Advisory / Consultancy: Celgene; Advisory / Consultancy, Speaker Bureau / Expert testimony: Eli Lilly; Advisory / Consultancy: Guardant Health; Advisory / Consultancy: Janssen; Advisory / Consultancy, Speaker Bureau / Expert testimony: Medscape; Advisory / Consultancy, Speaker Bureau / Expert testimony: Merck KgaA; Advisory / Consultancy, Speaker Bureau / Expert testimony: Merck Sharp & Dohme; Advisory / Consultancy, Speaker Bureau / Expert testimony: Novartis; Advisory / Consultancy, Speaker Bureau / Expert testimony: Pfizer; Advisory / Consultancy: Prime Oncology; Advisory / Consultancy, Speaker Bureau / Expert testimony: Roche; Advisory / Consultancy: Samsung; Advisory / Consultancy, Speaker Bureau / Expert testimony: Takeda; Advisory / Consultancy: Touchtime. Z. Andric: Research grant / Funding (self): F. Hoffmann-La Roche. S. Geater: Research grant / Funding (self): F. Hoffmann-La Roche. M. Ozguroglu: Research grant / Funding (self): F. Hoffmann-La Roche.S. Mocci: Full / Part-time employment: Genentech, Inc. M. McCleland: Full / Part-time employment: Genentech, Inc.. W. Zou: Full / Part-time employment: Genentech, Inc.. I. Enquist: Full / Part-time employment: Genentech, Inc.. K. Komatsubara: Full / Part-time employment: Genentech, Inc.. Y. Deng: Full / Part-time employment: Genentech, Inc.. H. Kuriki: Full / Part-time employment: Genentech, Inc.. D.R. Spigel: Research grant / Funding (institution): F. Hoffmann-La Roche; Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Genetech/Roche; Advisory / Consultancy, Research grant / Funding (institution): Novartis; Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Celgene; Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Bristol-Myers Squibb; Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: AstraZeneca; Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Pfizer; Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Boehringer Ingelheim; Advisory / Consultancy, Research grant / Funding (institution): Abbvie; Advisory / Consultancy, Research grant / Funding (institution): Foundation Medicine; Advisory / Consultancy, Research grant / Funding (institution): GlaxoSmithKline; Advisory / Consultancy, Research grant / Funding (institution): Lilly; Advisory / Consultancy, Research grant / Funding (institution): Merck; Advisory / Consultancy: Moderna Therapeutics; Advisory / Consultancy, Research grant / Funding (institution): Nektar; Advisory / Consultancy, Research grant / Funding (institution): Takeda; Advisory / Consultancy, Research grant / Funding (institution): Amgen; Advisory / Consultancy: TRM Oncology; Advisory / Consultancy: Precision Oncology; Advisory / Consultancy: Evelo Therapeutics; Advisory / Consultancy: Illumina; Advisory / Consultancy: PharmaMar; Research grant / Funding (institution): University of Texas Southwestern Medical Center- Simmons Cancer Center; Research grant / Funding (institution): G1 Therapeutics; Research grant / Funding (institution): Neon Therapeutics; Research grant / Funding (institution): Celldex; Research grant / Funding (institution): Clovis Oncology; Research grant / Funding (institution): Daiichi Sankyo; Research grant / Funding (institution), Travel / Accommodation / Expenses: EMD Serono; Research grant / Funding (institution): Acerta Pharma; Research grant / Funding (institution): Oncogenex; Research grant / Funding (institution): Astellas Pharma; Research grant / Funding (institution): GRAIL; Research grant / Funding (institution): Transgene; Research grant / Funding (institution): Aeglea Biotherapeutics; Research grant / Funding (institution): Tesaro; Research grant / Funding (institution): Ipsen; Research grant / Funding (institution): ARMO BioSciences; Research grant / Funding (institution): Millennium; Travel / Accommodation / Expenses: Genzyme; Travel / Accommodation / Expenses: Intuitive Surgical; Travel / Accommodation / Expenses: Purdue Pharma; Travel / Accommodation / Expenses: Spectrum Pharmaceuticals; Travel / Accommodation / Expenses: Sysmex. J. Jassem: Research grant / Funding (self): F. Hoffmann-La Roche; Speaker Bureau / Expert testimony: Roche; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Pfizer; Advisory / Consultancy, Speaker Bureau / Expert testimony: Astra Zeneca; Advisory / Consultancy: BMS; Advisory / Consultancy: MSD; Advisory / Consultancy: Takeda; Travel / Accommodation / Expenses: Roche.

abstracts

abstracts

Annals of Oncology

Table: LBA4 With KRAS G12C Mutation

Without Any KRAS Mutation

Pembro Mono-therapy (N ¼ 30)

Pembro Mono-therapy (N ¼ 12)

Pembro Mono-therapy (N ¼ 127)

Chemo-therapy (N ¼ 39)

56.7 (37.4-74.5) 18.0 (7.5-33.5) 12 (8-NR) 6 (4-9) 0.51 (0.29-0.87) 28 (23-NR) 11 (7-25) 0.42 (0.22-0.81)

66.7 (34.9-90.1) 23.5 (6.8-49.9) 15 (10-NR) 6 (4-8) 0.27 (0.10-0.71) NR (23-NR) 8 (5-NR) 0.28 (0.09-0.86)

Consultancy: Eli Lilly; Advisory / Consultancy: Merck Serono; Advisory / Consultancy: ACEA Biosciences Inc.; Advisory / Consultancy: Celgene, Vertex, geneDecode, OncoGenex, Ignyta; Leadership role, Shareholder / Stockholder / Stock options: Sanomics Ltd; Advisory / Consultancy, Shareholder / Stockholder / Stock options: Cirina; Non-remunerated activity/ies, ASCO board of directors: ASCO; Non-remunerated activity/ies, track chair for ESMO 2019: ESMO.

LBA5

KRAS mutational status and efficacy in KEYNOTE-189: Pembrolizumab (pembro) plus chemotherapy (chemo) vs placebo plus chemo as firstline therapy for metastatic non-squamous NSCLC

S. Gadgeel1, D. Rodriguez-Abreu2, E. Felip3, E. Esteban4, G. Speranza5, M. Reck6, R. Hui7, M. Boyer8, E.B. Garon9, H. Horinouchi10, R. Cristescu11, D. Aurora-Garg11, J. Lunceford11, J. Kobie11, M. Ayers11, B. Piperdi11, M.C. Pietanza11, M.C. Garassino12 1 Oncology, Karmanos Cancer Institute (currently at University of Michigan), Detroit, MI, USA, 2Medical Oncology, Complejo Hospitalario Universitario Insular Materno-Infantil de Gran Canaria, Universidad de Las Palmas de Gran Canaria, Gran Canaria, Spain, 3 Medical Oncology Department, Vall d’Hebron University Hospital, Barcelona, Spain, 4 Medical Oncology, Hospital Universitario Central de Asturias, Oviedo, Spain, 5 Oncology, Centre Integre´ de Cance´rologie de la Monte´re´gie, Universite´ de Sherbrooke, Greenfield Park, QC, Canada, 6Thoracic Oncology, LungenClinic, Airway Research Center North, German Center for Lung Research, Grosshansdorf, Germany, 7Medical Oncology, Westmead Hospital and University of Sydney, Westmead, Australia, 8Medical Oncology, Chris O’Brien Lifehouse, Camperdown, Australia, 9Medicine; Division of Hematology/Oncology, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA, 10Oncology, National Cancer Center Hospital, Tokyo, Japan, 11Oncology, Merck & Co., Inc., Kenilworth, NJ, USA, 12Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy Background: KRAS mutations are observed in 25% of lung adenocarcinomas, with some studies suggesting it is a prognostic factor in NSCLC. We assessed the prevalence of KRAS mutations and their association with efficacy in an exploratory analysis of the KEYNOTE-189 study of pembrolizumab plus pemetrexed and platinum chemotherapy vs placebo plus chemotherapy as first-line therapy for metastatic non-squamous NSCLC (NCT02578680). Methods: Whole-exome sequencing (WES) was used to assess KRAS status and tumor mutational burden (TMB) in participants (pts) who had available tumor and matchednormal tissue. Descriptive analyses of the association of KRAS and KRAS G12C status with efficacy were included as part of this exploratory analysis, as was correlation between KRAS mutational status and shifts in TMB and PD-L1 expression distributions. Results: 289 (47%) of 616 pts had evaluable WES data from both tumor and normal DNA. 89 (31%) of 289 pts had KRAS mutation, including 37 (13%) G12C carriers. Pts with vs without KRAS mutations tended to have higher PD-L1 TPS (median [IQR] 30% [1-71] vs 5% [0-60]) and higher TMB (median [IQR] 204 [137-276] vs 141 [85252] mut/exome). Outcomes of pembrolizumab plus chemotherapy and of placebo plus chemotherapy in pts with and without KRAS mutation and in KRAS G12C carriers are summarized in the table. 95% CIs were wide given the modest frequency of KRAS mutation, particularly KRAS G12C, and the 2:1 randomization that resulted in small populations for placebo plus chemotherapy. Conclusion: Based on this descriptive exploratory analysis, pembrolizumab plus pemetrexed and a platinum should be a standard first-line treatment for pts with metastatic non-squamous NSCLC regardless of KRAS mutation status. Clinical trial identification: KEYNOTE-189, NCT02578680.

xi64 | Biomarker development

Chemo-therapy (N ¼ 17)

Chemo-therapy (N ¼ 105)

29.1 (21.4-37.9) 21.0 (13.6-30.0) 6 (4-7) 6 (6-8) 1.00 (0.75-1.34) 15 (12-24) 12 (11-18) 0.86 (0.63-1.18)

Editorial acknowledgement: Joanne Tomassini and Melanie Leiby, both of Merck & Co., Inc., Kenilworth, NJ, USA, for writing support. Legal entity responsible for the study: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. Funding: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. Disclosure: S. Gadgeel: Advisory / Consultancy: Boehringer-Ingelheim; Advisory / Consultancy: Xcovery; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Novocure; Advisory / Consultancy, Travel / Accommodation / Expenses: Genentech/Roche; Advisory / Consultancy: Takeda; Research grant / Funding (institution): Merck Sharp & Dohme; Advisory / Consultancy: Pharmamar. D. Rodriguez-Abreu: Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Roche; Honoraria (self), Speaker Bureau / Expert testimony: AstraZeneca; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: BMS; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: Boehringer Ingelheim; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses: MSD; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: Eli Lilly; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: Pfizer; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Novartis. E. Felip: Advisory / Consultancy: Boehringer Ingelheim; Advisory / Consultancy: Eli Lilly; Advisory / Consultancy: Pfizer; Advisory / Consultancy: Roche; Advisory / Consultancy, Research grant / Funding (institution): Merck Sharp & Dohme; Advisory / Consultancy: Abbvie; Honoraria (self), lecture fees: AstraZeneca; Honoraria (self), lecture fees: Bristol Myers Squibb; Honoraria (self), lecture fees: Novartis. E. Esteban: Travel / Accommodation / Expenses: Pfizer; Travel / Accommodation / Expenses: Roche; Travel / Accommodation / Expenses: AstraZeneca; Travel / Accommodation / Expenses: Novartis; Research grant / Funding (institution): MSD. G. Speranza: Research grant / Funding (institution): MSD. M. Reck: Honoraria (self), Advisory / Consultancy: Amgen; Honoraria (self), Advisory / Consultancy: AstraZeneca; Honoraria (self), Advisory / Consultancy: BMS; Honoraria (self), Advisory / Consultancy: Boehringer Ingelheim; Honoraria (self), Advisory / Consultancy: Celgene; Honoraria (self), Advisory / Consultancy: Merck ; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): MSD; Honoraria (self), Advisory / Consultancy: Eli LIlly; Honoraria (self), Advisory / Consultancy: Pfizer; Honoraria (self), Advisory / Consultancy: Abbvie; Honoraria (self), Advisory / Consultancy: Roche; Honoraria (self), Advisory / Consultancy: Novartis. R. Hui: Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): MSD; Honoraria (self), Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: BMS; Honoraria (self), Advisory / Consultancy: Novartis; Honoraria (self), Advisory / Consultancy: Roche; Advisory / Consultancy: Eli Lilly. M. Boyer: Honoraria (self), Honoraria (institution), Research grant / Funding (institution): AstraZeneca; Honoraria (institution), Research grant / Funding (institution): MSD; Honoraria (institution): Roche; Research grant / Funding (institution): Amgen; Research grant / Funding (institution): BMS; Research grant / Funding (institution): Novartis; Research grant / Funding (institution): Beigene; Research grant / Funding (institution): Ascentage Pharma; Research grant / Funding (institution): Pfizer; Research grant / Funding (institution): Roche/Genentech; Research grant / Funding (institution): Janssen. E.B. Garon: Honoraria (self): Dracen; Honoraria (self), Research grant / Funding (institution): EMD Serono; Honoraria (self), Research grant / Funding (institution): Novartis; Research grant / Funding (institution): AstraZeneca; Research grant / Funding (institution): BMS; Research grant / Funding (institution): Genentech; Research grant / Funding (institution): Eli Lilly; Research grant / Funding (institution): Dynavax; Research grant / Funding (institution): Iovance; Research grant / Funding (institution): Mirati; Research grant / Funding (institution): Neon; Research grant / Funding (institution): MSD. H. Horinouchi: Honoraria (self), Advisory / Consultancy: Eli LIlly; Honoraria (self), Research grant / Funding (institution): BMS; Honoraria (self), Research grant / Funding (institution): ONO; Honoraria (self), Advisory / Consultancy: AstraZeneca; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): MSD; Honoraria (self): Kyowa-Kirin; Honoraria (self): Taiho; Research grant / Funding (institution): Daiichi-Sankyo; Research grant / Funding (institution): Abbvie; Research grant / Funding (institution): Chugai/Roche; Research grant / Funding (institution): Genomic Health. R. Cristescu: Shareholder / Stockholder / Stock options, Full / Part-time employment: Merck Sharp & Dohme. D. Aurora-Garg: Shareholder / Stockholder / Stock options, Full / Part-time employment: Merck Sharp & Dohme. J. Lunceford: Shareholder / Stockholder / Stock options, Full / Part-time employment: Merck Sharp & Dohme. J. Kobie: Shareholder / Stockholder / Stock options, Full / Parttime employment: Merck Sharp & Dohme. M. Ayers: Shareholder / Stockholder / Stock options, Full / Part-time employment: Merck Sharp & Dohme. B. Piperdi: Shareholder / Stockholder / Stock options,

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ORR, % (95% CI) PFS, median, mo (95% CI) PFS, HR (95% CI) OS, median, mo (95% CI) OS, HR (95% CI)

With Any KRAS Mutation