FDA has granted accelerated approval to Lumakras (sotorasib) a RAS GTPase family inhibitor, for adult patients with KRAS G12C ‑mutated locally advanced or metastatic non-small cell lung cancer, as determined by an FDA ‑approved test, who have received at least one prior systemic therapy.
Lumakras is sponsored by Amgen.
FDA also approved the Qiagen therascreen KRAS RGQ PCR kit (tissue) and the Guardant360 CDx (plasma) as companion diagnostics for Lumakras.
If no mutation is detected in a plasma specimen, the tumor tissue should be tested.
Approval was based on CodeBreaK 100, a multicenter, single-arm, open label clinical trial (NCT03600883) which included patients with locally advanced or metastatic NSCLC with KRAS G12C mutations.
Efficacy was evaluated in 124 patients whose disease had progressed on or after at least one prior systemic therapy. Patients received sotorasib 960 mg orally daily until disease progression or unacceptable toxicity.
The main efficacy outcome measures were objective response rate (ORR) according to RECIST 1.1, as evaluated by blinded independent central review and response duration. The ORR was 36% (95% CI: 28%, 45%) with a median response duration of 10 months (range 1.3+, 11.1).
