- An open-label trial with 59 patients heavily pretreated for NSCLC shows a favorable safety profile for sotorasib and a disease control rate of 88.1%.
Why this matters
- Preliminary antitumor activity was shown in a phase 1 trial of sotorasib in patients with advanced tumors harboring KRAS p.G12C-mutations.
- Sotorasib (formerly AMG 510) is a first-in-class, oral specific KRAS p.G12C inhibitor.
- This mutation is found in 13% of NSCLC cases, and there is currently no approved therapy for these.
- The phase 1, multicenter, open-label trial CodeBreaK 100 enrolled 129 patients with various types of cancer.
- Data were presented for 59 of them (median age, 68 years; 90% smokers) with advanced NSCLC and prior systemic treatment (77.5% 2 or more lines; 47.5% 3 lines of therapy).
- Median follow-up 11.7 months; 3 discontinuations because of adverse events.
- Funding: Amgen Inc.
- No dose-limiting toxicities or fatalities because of treatment.
- 18.6% with grade 3 or 4 adverse events.
- Any tumor shrinkage by week 6: 71.2%.
- Objective response rate: 32.2%.
- Disease control rate: 88.1%.
- Median PFS for all patients: 6.3 months.
- Median duration of response: 10.9 months.
- No significant association with expression of either KRAS p.G12C or PD-1.
- Limited dataset at cutoff (June 1, 2020).
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