Bristol Myers Squibb announced that Opdivo (nivolumab) 3 mg/kg plus Yervoy (ipilimumab) 1 mg/kg (injections for intravenous use) was approved by the FDA for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 ( greater than 1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.
This approval is based on Part 1a of the Phase III CheckMate -227 trial in which Opdivo + Yervoy (n=396) demonstrated superior overall survival (OS) versus chemotherapy (n=397) (hazard ratio [HR] 0.79; 95% confidence interval [CI]: 0.67 to 0.94; P=0.0066) regardless of tumor histology with a minimum follow up of 29.3 months. The median OS was 17.1 months (95% CI: 15.0 to 20.1) versus 14.9 months (95% CI: 12.7 to 16.7). In the trial, 63% of patients treated with Opdivo + Yervoy and 56% treated with chemotherapy were alive at one year, and 40% and 33% at two years, respectively. At three years (median 43.1 months follow up), 33% of patients treated with Opdivo + Yervoy and 22% of those treated with chemotherapy were still alive. As assessed by Blinded Independent Central Review (BICR), the confirmed overall response rate (ORR) with a minimum follow up of 28.3 months was 36% (142/396, 95% CI: 31 to 41) with Opdivo + Yervoy (5.8% complete response [CR] and 30.1% partial response [PR]) and 30% (119/397, 95% CI: 26 to 35) with chemotherapy (1.8% CR and 28.2% PR). Among patients who responded, the median duration of response (DOR) was 23.2 months (95% CI: 15.2 to 32.2) for patients treated with Opdivo + Yervoy and 6.2 months (95% CI: 5.6 to 7.4) for chemotherapy. ORR and DOR were pre-specified descriptive analyses.