7MO - Sotorasib in <italic>KRAS</italic> G12C–mutated advanced non-small cell lung cancer (aNSCLC): Overall survival (OS) data from the global expanded access program (EAP study-436)

Background

Amgen study 20190436 (study-436) is a global protocol under the sotorasib EAP which allowed compassionate use of sotorasib, a first-in-class KRAS G12C inhibitor, in previously treated patients (pts) with KRAS G12C-mutated aNSCLC. The median real-world progression-free survival previously reported in study-436 was 6.7 (95% CI, 4.6–8.3) months. Here we present the median OS data from study-436.

Methods

Pts, including those with Eastern Cooperative Oncology Group performance status (ECOG PS) 2, a history of CNS metastases, additional co-morbidities, and who had exhausted other treatment options, were enrolled in 6 countries (USA, ARG, BRA, ISR, SAU, TWN) across 49 centers. The primary endpoint assessed the safety of oral sotorasib 960 mg once daily. Median OS, a key secondary endpoint, was estimated based on the time from the start of sotorasib treatment until death due to any cause.

Results

A total of 147 pts received sotorasib. At baseline, pts had received a median of 2 (range, 0–8) prior lines of anticancer therapy, 37 (25%) pts had ECOG PS 2, and 48 (33%) had a history of CNS metastases. With a median follow-up of 13.6 (95% CI, 11.1–14.6) months, the median OS was 9.5 (95% CI, 8.6–12.0) months. Among the subgroups, the median OS was numerically longer in pts with ECOG PS 0 or 1 vs ECOG PS 2; with up to 2 vs > 2 prior lines of anticancer therapies; and in pts with former vs current smoking history (table). The median OS was numerically similar between patients with vs without a history of CNS metastases.

Data cut-off date: November 8, 2022.

Conclusions

In the first report of survival in an EAP pt population treated with sotorasib, the median OS was similar to that observed in trials. The difference in median OS was minimal in pts with or without a history of CNS metastases at baseline.

Clinical trial identification

NCT04667234.

Editorial acknowledgement

Medical writing assistance was provided by Liz Leight, an employee of Amgen Inc., and Advait A. Joshi of Cactus LifeSciences (part of Cactus Communications), which was funded by Amgen, Inc.

Legal entity responsible for the study

Amgen Inc.

Funding

Amgen Inc.

Disclosure

S. Novello: Financial Interests, Personal, Speaker's Bureau: AstraZeneca, Amgen Inc., Boehringer Ingelheim, MSD, Eli Lilly, Takeda, Pfizer, Roche, Novartis, Sanofi, GSK. J.P. Stevenson: Financial Interests, Personal, Advisory Board: BeiGene, Novartis, Medtronic, Trizell Inc; Financial Interests, Institutional, Research Grant: Merck, EMD Serono, Amgen. W. Petty: Financial Interests, Personal, Other, Consultancy role: Mirati. I. Morbeck: Financial Interests, Personal, Other, Honoraria: Astellas Pharma, Bayer, Janssen Oncology; Financial Interests, Personal, Advisory Role: AstraZeneca, BMS Brazil, Ipsen, Janssen Oncology, MSD Oncology; Financial Interests, Personal, Speaker's Bureau: MSD Oncology; Financial Interests, Personal, Research Grant: Astellas Pharma; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: AstraZeneca. A. Zer: Financial Interests, Personal, Stocks/Shares: Nixio; Financial Interests, Personal, Other, Honoraria: AstraZeneca, Bristol Myers Squibb, MSD, Novartis, Roche, Takeda; Financial Interests, Personal, Advisory Role: Boehringer Ingelheim, Eli Lilly, MSD, Oncotest/Rhenium, Roche; Financial Interests, Institutional, Research Grant: Bristol Myers Squibb; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: AstraZeneca, MSD, Roche. J.R. Bauman: Financial Interests, Personal, Advisory Board: Kura, Janssen, Pfizer, Blueprint Medicine, Eli Lilly, Merck, Mirati, Turning Point Therapeutics, BeiGene. C. Xia: Financial Interests, Personal, Full or part-time Employment: Amgen Inc.; Financial Interests, Personal, Stocks/Shares: Amgen Inc. A. Meloni: Financial Interests, Personal, Full or part-time Employment: Amgen Inc.; Financial Interests, Personal, Stocks/Shares: Amgen Inc. T. Varrieur: Financial Interests, Personal, Full or part-time Employment: Amgen Inc.; Financial Interests, Personal, Stocks/Shares: Amgen Inc. M. Awad: Financial Interests, Personal, Other, Consultancy role: Genentech, Bristol Myers Squibb, Merck, AstraZeneca, Maverick, Blueprint Medicine, Syndax, Ariad, Nektar, ArcherDX, Mirati, NextCure, Novartis, EMD Serono; Financial Interests, Institutional, Research Grant: AstraZeneca, Eli Lilly, Genentech, Bristol Myers Squibb. All other authors have declared no conflicts of interest.