What is the clinical efficacy of adagrasib in the treatment of non-small cell lung cancer?

Adagrasiib is indicated for the treatment of adults with locally advanced or metastatic non-small cell lung cancer with a KRAS G12C mutation as determined by an FDA-approved test who have received at least one prior systemic therapy.

This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent on verification and description of clinical benefit in confirmatory trials.

Accelerated approval is based on The Phase 2 registration cohort of the KRYSTAL-1 study, which evaluated oral adagrasiib 600 mg capsules twice daily in 116 patients with KRAS G12C-mutant advanced NSCLC who had previously been treated with a platinum-based regimen and immunotherapy. The primary efficacy endpoints were ORR and DOR determined by blinded independent central review (BICR) assessment according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1).

The trial showed The ORR was 43%, with 80% of patients achieving disease control. Median DOR was 8.5 months. In a pooled efficacy analysis (n=132), including the Phase 1/1b NSCLC and registrational Phase 2 NSCLC cohorts from the KRYSTAL-1 study, evaluating adalacil as a single agent in 600 mg capsules taken orally twice daily, adalacil showed an ORR of 44%, a disease control rate of 81%, a median DOR of 12.5 months, and a median overall survival of 12.5 months, based on blinded independent central review. 14.1 months.

In summary, adagrasib has demonstrated significant efficacy in the treatment of non-small cell lung cancer, including high objective response rate, disease control rate, and prolonged survival. These data provide strong support for the clinical application of adagrasib. However, patients still need to pay attention to possible adverse reactions when using it and conduct reasonable treatment under the guidance of a doctor.