FDA Approves Nivolumab and Ipilimumab Plus Chemotherapy for mNSCLC
On May 26, 2020, the FDA approved the combination of nivolumab (Opdivo; Brystol-Myers Squibb) and ipilimumab (Yervoy; Bristol-Myers Squibb) along with 2 cycles of platinum-doublet chemotherapy for the frontline treatment of metastatic or relapsed non–small-cell lung cancer (NSCLC), without epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutations.
This approval is based on efficacy results from the CHECKMATE-9LA trial, which randomized patients metastatic or relapsed NSCLC to either nivolumab plus ipilimumab with 2 cycles of platinum-doublet chemotherapy (n = 361) or platinum-doublet chemotherapy alone for 4 cycles (n = 358).
Median overall survival (OS) was 14.1 months (95% CI, 13.2-16.2) in the nivolumab plus ipilimumab arm compared to 10.7 months (95% CI, 9.5-12.5) with chemotherapy alone (HR, 0.69; 96.71% CI, 0.55-0.87). Median progression-free survival (PFS) per blinded independent central review (BICR) was 6.8 months (95% CI, 5.6-7.7) and 5 months (95% CI, 4.3-5.6), respectively (HR 0.70; 95% CI, 0.57-0.86).
Additionally, confirmed overall response rate (ORR) was 38% (95% CI, 33-43) in the nivolumab plus ipilimumab arm and 25% (95% CI, 21-30) in the chemotherapy alone arm. Median response duration was 10 months and 5.1 months in each arm, respectively.
The most common adverse events (≥20%) with nivolumab plus ipilimumab and platinum-doublet chemotherapy were fatigue, musculoskeletal pain, nausea, diarrhea, rash, decreased appetite, constipation, and pruritus.—Janelle Bradley
Source: US Food and Drug Administration. FDA approves nivolumab plus ipilimumab and chemotherapy for first-line treatment of metastatic NSCLC. May 26, 2020. https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-nivolumab-plus-ipilimumab-and-chemotherapy-first-line-treatment-metastatic-nsclc. Accessed May 27, 2020.
