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FDA Approves Nivolumab–Ipilimumab Combo for First-Line Treatment of Metastatic NSCLC

On May 15, 2020, the FDA approved nivolumab (Opdivo; Bristol-Myers Squibb) plus ipilimumab (Yervoy; Bristol-Myers Squibb) for the first-line treatment of patients with metastatic non–small-cell lung cancer (NSCLC) with tumors expressing PD-L1 (≥1%), as determined by an FDA-approved test, and with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. The application for this approval was granted priority review by the FDA.

On this date, the FDA also approved a companion diagnostic device, the PD-L1 IHC 28-8 pharmDx (Agilent Technologies), that selects patients with NSCLC suitable for treatment with nivolumab plus ipilimumab.

This approval was based on efficacy data from the open-label CHECKMATE-227 clinical trial of treatment-naïve patients with metastatic or recurrent NSCLC. In Part 1a of the trial, a total of 793 patients with tumors expressing PD-L1 ≥1% were randomized to receive nivolumab plus ipilimumab (n = 396) or platinum-doublet chemotherapy (n = 397).

Compared with recipients of platinum-doublet chemotherapy, patients with PD-L1 tumor expression ≥1% given nivolumab plus ipilimumab had a statistically significant improvement in overall survival (OS). The median OS was 14.9 (95% CI, 12.7-16.7) versus 17.1 months (95% CI, 15-20.1), respectively (hazard ratio [HR], 0.79; 95% CI, 0.67-0.94; P = .0066).

Findings also showed that patients in the nivolumab plus ipilimumab arm and platinum-doublet chemotherapy arm had a median progression-free survival of 5.1 months (95% CI, 4.1-6.3) and 5.6 months (95% CI, 4.6-5.8), respectively (HR, 0.82; 95% CI, 0.69-0.97).

The confirmed overall response rate for these arms was 36% (95% CI, 31-41) and 30% (95% CI, 26-35), respectively, and the median duration of response was 23.2 months and 6.2 months, respectively.

The most frequently reported (≥20%) adverse reactions associated with nivolumab plus ipilimumab use in CHECKMATE-227 were fatigue, rash, decreased appetite, musculoskeletal pain, diarrhea/colitis, dyspnea, cough, pruritis, nausea, and hepatitis.—Hina Porcelli

Source: US Food and Drug Administration. FDA approves nivolumab plus ipilimumab for first-line mNSCLC (PD-L1 tumor expression ≥1%). May 15, 2020. www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-nivolumab-plus-ipilimumab-first-line-mnsclc-pd-l1-tumor-expression-1. Accessed May 15, 2020.

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