The phase 1 trial of sotorasib, a KRASG12C inhibitor, demonstrated a favorable safety profile and preliminary antitumor activity in pts with advanced solid tumors harboring
Key eligibility criteria include
As of July 17, 2019, 40 pts with NSCLC (22 female [55.0%], median age: 68.0 years [range: 49-77]) were enrolled. Data cutoff date was March 25, 2020. 31 (77.5%) and 19 pts (47.5%) received ≥ 2 and 3 prior lines of therapy, respectively. Median follow-up was 10.2 (range: 8.3–19.0) months (mos). 3 pts (7.5%) had adverse events leading to discontinuation. There were no dose-limiting toxicities or fatal tx-related adverse events. Median PFS for all pts was 6.9 (range: 1.2–13.9) mos. ORR was 30% (95% Cl, 16.56–46.53). DOR ranged from 1.6 (+) to 12.7 mos, with 7 of 12 responders still in response at data cutoff. DCR was 92.5% (95% Cl, 79.61–98.43). 18 pts (45.0%) had progressive disease. At data cutoff, 10 pts (25.0%) were on study without disease progression, and 9 pts (22.5%) died. 18 pts (45.0%) (5 partial response (PR), 12 stable disease (SD), 1 progressive disease (PD)) had
In pts with heavily pretreated NSCLC, durable responses to sotorasib were seen, with the majority of pts achieving disease control leading to a median PFS of 6.9 months. The current limited dataset suggests that neither
NCT03600883.
Medical writing support was provided by Liz Leight (Amgen Inc.).
Amgen Inc.
Amgen Inc.
D.S. Hong: Research grant/Funding (institution), Non-remunerated activity/ies, Other: Bayer; Research grant/Funding (institution): Lilly; Research grant/Funding (institution): Genentech; Honoraria (self), Research grant/Funding (institution): Loxo; Research grant/Funding (institution): Pfizer; Research grant/Funding (institution): Amgen; Research grant/Funding (institution): Mirati; Research grant/Funding (institution): Ignyta; Research grant/Funding (institution): Merck; Research grant/Funding (institution): Daiichi Sanko; Research grant/Funding (institution): Eisai; Research grant/Funding (institution): Adaptimmune; Research grant/Funding (institution): AbbVie; Research grant/Funding (institution): AstraZeneca; Research grant/Funding (institution): BMS; Research grant/Funding (institution): Genmab; Research grant/Funding (institution): Infinity; Research grant/Funding (institution): Kite; Research grant/Funding (institution): Kyowa; Research grant/Funding (institution): MedImmune; Research grant/Funding (institution): Molecular Template; Research grant/Funding (institution): Novartis; Research grant/Funding (institution): Takeda; Honoraria (self): Mirna; Non-remunerated activity/ies, Other: Baxter; Non-remunerated activity/ies, Other: Guidepoint Global; Non-remunerated activity/ies, Other: Oncoresponse; Non-remunerated activity/ies, Other: Janssen; Non-remunerated activity/ies, Other: Molecular Match. Y-J. Bang: Advisory/Consultancy, Research grant/Funding (institution): AstraZeneca; Advisory/Consultancy, Research grant/Funding (institution): Novartis; Advisory/Consultancy, Research grant/Funding (institution): Genentech/Roche; Advisory/Consultancy, Research grant/Funding (institution): MSD; Advisory/Consultancy, Research grant/Funding (institution): Merck Serano; Advisory/Consultancy, Research grant/Funding (institution): Bayer; Advisory/Consultancy, Research grant/Funding (institution): BMS; Advisory/Consultancy, Research grant/Funding (institution): Eli Lilly; Advisory/Consultancy, Research grant/Funding (institution): Taiho; Advisory/Consultancy, Research grant/Funding (institution): Daiich-Sankyo; Advisory/Consultancy, Research grant/Funding (institution): Astellas; Advisory/Consultancy, Research grant/Funding (institution): BeiGene; Advisory/Consultancy, Research grant/Funding (institution): GreenCross; Advisory/Consultancy: Samyang Biopharm; Advisory/Consultancy: Hanmi; Advisory/Consultancy, Research grant/Funding (institution): Genexine; Research grant/Funding (institution): GSK; Research grant/Funding (institution): Pfizer; Research grant/Funding (institution): Boehringer Ingelheim; Research grant/Funding (institution): MacroGenics; Research grant/Funding (institution): Boston Biomedical; Research grant/Funding (institution): FivePrime; Research grant/Funding (institution): Curis; Research grant/Funding (institution): Takeda; Research grant/Funding (institution): Ono; Research grant/Funding (institution): CKD Pharma. F. Barlesi: Honoraria (self), Research grant/Funding (institution), Non-remunerated activity/ies, Principal Investigator for clinical trial: AstraZeneca; Honoraria (self), Research grant/Funding (institution): Bayer; Honoraria (self), Research grant/Funding (institution), Non-remunerated activity/ies, Principal Investigator for clinical trial: Bristol-Myers Squibb; Honoraria (self), Research grant/Funding (institution): Boehringer–Ingelheim; Honoraria (self), Research grant/Funding (institution): Eli Lilly Oncology; Honoraria (self), Research grant/Funding (institution), Non-remunerated activity/ies, Principal Investigator for clinical trial: F. Hoffmann–La Roche Ltd; Honoraria (self), Research grant/Funding (institution): Novartis; Honoraria (self), Research grant/Funding (institution), Non-remunerated activity/ies, Principal Investigator for clinical trial: Merck; Honoraria (self), Research grant/Funding (institution): MSD; Honoraria (self), Research grant/Funding (institution), Non-remunerated activity/ies, Principal Investigator for clinical trial: Pierre Fabre; Honoraria (self), Research grant/Funding (institution): Pfizer; Honoraria (self), Research grant/Funding (institution): Takeda; Research grant/Funding (institution): AbbVie; Research grant/Funding (institution): ACEA; Research grant/Funding (institution): Amgen; Research grant/Funding (institution): Eisai; Research grant/Funding (institution): Genentech; Research grant/Funding (institution): Ipsen; Research grant/Funding (institution): Ignyta; Research grant/Funding (institution): Innate Pharma; Research grant/Funding (institution): Loxo; Research grant/Funding (institution): MedImmune; Research grant/Funding (institution): Sanofi-Aventis .G.A. Durm: Research grant/Funding (institution): Merck; Research grant/Funding (institution): AstraZeneca; Research grant/Funding (institution): Bristol-Myers Squibb; Non-remunerated activity/ies: Amgen. G.S. Falchook: Honoraria (self): Wolters Kluwer; Advisory/Consultancy, Travel/Accommodation/Expenses: FujiFilm; Travel/Accommodation/Expenses: Bristol-Myers Squibb; Travel/Accommodation/Expenses: Sarah Cannon Research Institute; Speaker Bureau/Expert testimony: Total Health Conferencing; Research grant/Funding (institution): 3-V Biosciences; Research grant/Funding (institution): AbbVie; Research grant/Funding (institution): ADC Therapeutics; Research grant/Funding (institution): Aileron; Research grant/Funding (institution): American Society of Clinical Oncology; Research grant/Funding (institution): Amgen; Research grant/Funding (institution): ARMO; Research grant/Funding (institution): AstraZeneca; Research grant/Funding (institution): BeiGene; Research grant/Funding (institution): Bioatla; Research grant/Funding (institution): Biothera; Research grant/Funding (institution): Celldex; Research grant/Funding (institution): Celgene; Research grant/Funding (institution): Ciclomed; Speaker Bureau/Expert testimony: Rocky Mountain Oncology Society ; Research grant/Funding (institution): Curegenix; Research grant/Funding (institution): Curis; Research grant/Funding (institution): Cyteir; Research grant/Funding (institution): Daiichi; Research grant/Funding (institution): DelMar; Research grant/Funding (institution): eFFECTOR; Research grant/Funding (institution): Eli Lilly; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: EMD Serono; Research grant/Funding (institution): Epizyme, Exelixis, Fujifilm, Genmab, GlaxoSmithKline, Hutchison MediPharma, Ignyta, Incyte, Jacobio, Jounce, Kolltan, Loxo, MedImmune, Millennium, Merck, miRNA Therapeutics, National Institutes of Health, Novartis, OncoMed, Oncorus; Research grant/Funding (institution): Oncothyreon, Poseida, Precision Oncology, Prelude, Regeneron, Rgenix, Ribon, Strategia, Syndax, Taiho, Takeda, Tarveda, Tesaro, Tocagen, Turning Point Therapeutics, U.T. MD Anderson Cancer Center, Vegenics, Xencor. K. Park: Advisory/Consultancy: Amgen. J.H. Strickler: Advisory/Consultancy, Research grant/Funding (institution): Amgen. T.F. Burns: Advisory/Consultancy: Novartis; Advisory/Consultancy: Blueprint Medicine; Advisory/Consultancy: Thermo Fisher Scientific. J. Kim: Shareholder/Stockholder/Stock options, Full/Part-time employment: Amgen. A. Ang: Shareholder/Stockholder/Stock options, Full/Part-time employment: Amgen. J.R. Lipford: Shareholder/Stockholder/Stock options, Full/Part-time employment: Amgen. G. Ngarmchamnanrith: Shareholder/Stockholder/Stock options, Full/Part-time employment: Amgen. A. Anderson: Shareholder/Stockholder/Stock options, Full/Part-time employment: Amgen. B.T. Li: Advisory/Consultancy, Research grant/Funding (institution): Genentech/Roche; Advisory/Consultancy: Thermo Fisher Scientific; Advisory/Consultancy, Research grant/Funding (institution): Guardant Health; Advisory/Consultancy, Research grant/Funding (institution): Hengrui Therapeutics; Advisory/Consultancy: Mersana Therapeutics; Advisory/Consultancy, Research grant/Funding (institution): Eli Lilly; Travel/Accommodation/Expenses: Resolution Bioscience; Research grant/Funding (institution), Travel/Accommodation/Expenses: MORE Health; Research grant/Funding (institution): Amgen; Research grant/Funding (institution): Daiichi Sankyo; Research grant/Funding (institution): AstraZeneca; Research grant/Funding (institution): BioMedValley Discoveries; Research grant/Funding (institution): Illumina; Research grant/Funding (institution): GRAIL. All other authors have declared no conflicts of interest.