FDA Approves Chemotherapy Plus Immunotherapy Combination in First-Line Treatment of Resistant NSCLC
Posted: Friday, May 29, 2020
On May 26, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo) and ipilimumab (Yervoy) with platinum-doublet chemotherapy in the first-line treatment of patients with metastatic or recurrent non–small cell lung cancer (NSCLC), regardless of PD-L1 expression. Treatment eligibility also includes patients with squamous or nonsquamous disease who do not have EGFR or ALK genomic tumor aberrations.
The recommended doses are 360 mg of nivolumab and 1 mg/kg of ipilimumab with two cycles of platinum-doublet chemotherapy. This announcement expands on the May 15 FDA approval for nivolumab and ipilimumab as a first-line treatment of metastatic NSCLC, if tumors showed 1% or greater expression of PD-L1.
The FDA approval is based the open-label, multicenter, phase III CheckMate-9LA trial. The study evaluated the overall survival in patients receiving nivolumab and ipilimumab with two cycles of platinum-doublet chemotherapy (n = 361) versus four cycles of platinum-doublet chemotherapy (n = 358). All groups continued treatment until disease progression or toxicity for up to 2 years.
Patients receiving two cycles of chemotherapy had better overall survival than those who received four cycles (hazard ratio = 0.69; 96.71% confidence interval [CI] = 0.55–0.87; P = .0006). In addition, the median overall survival was 14.1 months (95% CI = 13.2–16.2 months) versus 10.7 months (95% CI = 9.5–12.5 months), respectively. After 1 year, 63% of patients administered nivolumab and ipilimumab with two cycles of chemotherapy were still alive, compared with 47% treated with four cycles of chemotherapy.
Serious adverse reactions seen in more than 2% of patients administered nivolumab and ipilimumab with chemotherapy included pneumonia, diarrhea, febrile neutropenia, anemia, acute kidney injury, musculoskeletal pain, dyspnea, pneumonitis, and respiratory failure. Common adverse reactions in more than 20% of patients involved fatigue, musculoskeletal pain, nausea, diarrhea, rash, decreased appetite, constipation, and pruritus.
