KEY TAKEAWAYS
- The Amgen study-436 presented median OS data for sotorasib EAP protocol in previously treated pts with KRAS G12C-mutated aNSCLC.
- The primary endpoint was assessing the safety of oral sotorasib 960 mg once daily in KRAS G12C-mutated aNSCLC.
- Initial results of sotorasib treatment on EAP patients showed comparable median OS to previous trials, with only a slight variance in patients with CNS metastases at baseline.
The study was conducted at 49 centers across six countries (USA, ARG, BRA, ISR, SAU, TWN) and enrolled patients (pts) with diverse medical conditions, 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. The primary objective was assessing the safety of oral sotorasib 960 mg once daily in KRAS G12C-mutated advanced non-small cell lung cancer (aNSCLC). The secondary aim was to estimate the median OS based on the time from the onset of sotorasib medicine until demise for any reason.
A total of 147 pts were given sotorasib in this study. Before this treatment, the pts had undergone a median of 2 (ranging from 0 to 8) sequences of anticancer therapies. Of the patients, 25% (n=37) had an ECOG PS of 2, while 33% (n=48) had a history of CNS metastases. The median follow-up was 13.6 (95% CI, 11.1–14.6) months, and the median OS was 9.5 (95% CI, 8.6–12.0.
The study showed that patients with ECOG PS 0 or 1, with up to 2 prior lines of anticancer treatments, and with former smoking history had a longer median OS compared to those with ECOG PS 2, more than two previous lines of anticancer therapies, and recent smoking history(refer table). However, the median OS was the same for patients with or without a history of CNS metastases.
Sotorasib’s initial report showed promising results in treating EAP patients, with comparable median OS and no significant difference for patients with or without a history of CNS metastases.
Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT04667234
Maimon, N., Stevenson, J.P., Petty, W., Ferreira, C.G.M., Morbeck, I., Zer, A., Bauman, J.R., Kalmadi, S., Xia, C., Meloni, A., Varrieur, T., Awad, M. Journal of Thoracic Oncology (2023).
