News from the FDA/CDC

Frontline nivo-ipi plus chemo approved for metastatic NSCLC


The Food and Drug Administration has approved the combination of nivolumab (Opdivo), ipilimumab (Yervoy), and two cycles of platinum-doublet chemotherapy as frontline treatment for patients with metastatic or recurrent non–small cell lung cancer (NSCLC) who have no EGFR or ALK genomic tumor aberrations.

The FDA collaborated with the Australian Therapeutic Goods Administration, Health Canada, and Singapore’s Health Sciences Authority on the review that led to this approval, as part of Project Orbis. The FDA approved the application 2 months ahead of schedule.

The combination chemotherapy was investigated in the CHECKMATE-9LA trial (NCT03215706), which enrolled patients with metastatic or recurrent NSCLC.

Patients were randomized to receive nivolumab plus ipilimumab and two cycles of platinum-doublet chemotherapy (n = 361) or platinum-doublet chemotherapy for four cycles (n = 358).

There was a significant overall survival benefit in the nivolumab-ipilimumab arm, compared with the chemotherapy-only arm. The median overall survival was 14.1 months and 10.7 months, respectively (hazard ratio, 0.69; P = .0006).

The median progression-free survival was 6.8 months in the nivolumab-ipilimumab arm and 5 months in the chemotherapy-only arm (HR, 0.70; P = .0001). The overall response rate was 38% and 25%, respectively (P = .0003).

The most common adverse events in the nivolumab-ipilimumab arm, which occurred in at least 20% of patients, were fatigue, musculoskeletal pain, nausea, diarrhea, rash, decreased appetite, constipation, and pruritus.

Serious adverse events occurred in 57% of patients in the nivolumab-ipilimumab arm. Fatal adverse events occurred in seven patients (2%) in that arm. Fatal events were hepatic toxicity, acute renal failure, sepsis, pneumonitis, diarrhea with hypokalemia, and massive hemoptysis in the setting of thrombocytopenia.

For more details, see the full prescribing information for nivolumab or ipilimumab. Nivolumab and ipilimumab are both products of Bristol-Myers Squibb.

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