Sotorasib Scores Second-line Approval in Canada

Sotorasib Scores Second-line Approval in Canada

Industry News & Regulatory Approvals
Sep 24, 2021
Regulatory Approval

SEPTEMBER 14, 2021—Health Canada approved sotorasib for second-line treatment of patients with locally advanced or metastatic NSCLC and a KRAS G12C mutation. A Notice of Compliance with Conditions was granted based on the overall response rate and duration of response found in the phase II CodeBreak 100 trial. Continued approval is contingent on verification and description of clinical benefit in future confirmatory trials. 

The phase II CodeBreak 100 trial, the results of which were presented at the 2020 WCLC,  included 126 patients with locally advanced or metastatic NSCLC with KRAS G12C mutations. Patients had progressed on no more than three prior standard therapies; 81% of included patients had progressed on prior platinum-based chemotherapy and PD-L1 inhibitors. The primary endpoint was overall response rate as assessed by blinded independent central review. 

Sotorasib was administered at 960 mg once daily until disease progression. 

Of the 126 patients included, two did not have measurable disease at baseline per central radiology review and were excluded from the response assessment. Of the 124 patients, the overall response rate (ORR) was 37.1% including three patients with confirmed response and 43 with partial response. The disease control rate was 80.6%.

The median time to objective response was 1.4 months with a median duration of response of 10 months. Forty-three percent of responders remained on treatment without progression as of data cutoff. 

The most common adverse reactions (> 20%) were diarrhea, musculoskeletal pain, nausea, fatigue, hepatotoxicity, and cough. AEs resulted in discontinuation for 9% of patients.