Data on the effect of sotoracib (AMG 510) on prolonging the survival of patients with advanced disease

In a phase II study of CodeBreaK 100 , patients with advanced KRAS who had previously received platinum-based chemotherapy and PD-1/PD-L1 inhibitors After patients with G12CmutationsNSCLC received sotoraxib, the median overall survival (OS) reaches 12.5 months, and the median progression-free survival (PFS) is about 6.8 months, the objective response rate (ORR) is 37.1% (including 3.2%complete response), and the disease control rate (DCR) is as high as 80.6%.

Paragraph 2: Long-term follow-up effects

In the study's two-year update, sotoraxib showed sustained efficacy and survival benefit: Median PFS was 6.3months,ORR improved to approximately41%, medianOS Still 12.5 months and 2 years OSrate reaches about32.5%, that is, nearly 1/3 patients survive for two years. Durable efficacy was also observed in certain molecularly characterized subgroups (e.g., STK11/KEAP1 co-mutations), suggesting that sotoraxib may confer significant long-term clinical benefit.

Multicenter real-world studies (such as German and US veterans cohorts) also support these results. In real-world scenarios, the ORR is approximately 34–39%, with a median of PFSis about5–6 months, and median OSis about9.8–12 months, the results are consistent with clinical trials. Although some patients have poor results due to combined gene mutations (such asKEAP1), the overall effect is still significantly better than traditional chemotherapy.

Overall, sotorasiib provides an effective targeted therapy option with prolonged survival for patients with advanced KRAS G12CmutatedNSCLC. Compared with traditional second-line chemotherapy, the median OS can be extended to 12.5 months, and about one-third of patients can remain alive for two years, which is of great significance to improving long-term prognosis. Especially for patients who have failed previous treatments, the drug shows durable efficacy and relatively controllable safety, making it an important therapeutic breakthrough for this subtype of patients.

Reference materials:https://www.drugs.com/