Sotorasib Approved for KRAS G12C NSCLC. First FDA approved treatment for KRAS-positive non small cell lung cancer.
The FDA has approved sotorasib for KRAS G12C NSCLC. Sotorasib is the first treatment for adult patients with non–small cell lung cancer whose tumors harbor KRAS G12C mutations and who have received at least 1 prior systemic therapy.
The Federal Drug Administration (FDA) has approved sotorasib (Lumakras) for KRAS-G12C NSCLC. Sotorasib is the first treatment for adult patients with non–small cell lung cancer whose tumors harbor KRAS G12C mutations and who have received at least 1 prior systemic therapy.1,2
The regulatory decision was based on data from the phase 2 CodeBreaK 100 trial (NCT03600883), which demonstrated that treatment with KRAS G12C inhibitor elicited an objective response rate of 36% (95% CI, 28%-45%) in patients with KRAS G12C–mutated NSCLC who had progressed following treatment with an immunotherapy and/or chemotherapy. The median duration of response (DOR) with the treatment was 10 months; 58% of patients experienced a DOR that was 6 months or longer. Notably, the disease control rate achieved with sotorasib was 81% (95% CI, 73%-87%).
Sotorasib approved for KRAS-G12C NSCLC as first treatment for KRAS.
“KRAS mutations have long been considered resistant to drug therapy, representing a true unmet need for patients with certain types of cancer,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, stated in a press release. “Today’s approval represents a significant step toward a future where more patients will have a personalized treatment approach.”
A total of 126 patients were enrolled to the phase 2 CodeBreaK 100 trial; 124 of these patients were determined to have centrally evaluable lesions per RECIST criteria at baseline.3 To be eligible for enrollment, they needed to have locally advanced or metastatic NSCLC with a KRAS G12C mutation assessed per central testing of tumor biopsies. Patients had to have progressed on prior standard therapies. Those who had active brain metastases were excluded.
In the trial, study participants received oral sotorasib at 960 mg until disease progression. Radiographic scans were done every 6 weeks up to week 48 and then once every 12 weeks thereafter.