FDA approves immunotherapy combination for first-line treatment of metastatic NSCLC

Issue: June 10, 2020

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The FDA approved nivolumab plus ipilimumab for first-line treatment of certain patients with metastatic non-small cell lung cancer.

The approval applies to use of the agents for patients whose tumors express PD-L1 (1% or greater) as determined by an FDA-approved test, and who have no EGFR or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.

“Metastatic lung cancer is a complex and challenging disease. Patients impacted by metastatic NSCLC have been closely watching advances in the field of immunotherapy for additional treatment options that have the potential to significantly extend their lives,” Bonnie J. Addario, co-founder and chair of GO2 Foundation, said in a press release. “The fact that certain previously untreated patients now have access to a combination immunotherapy that is chemotherapy-free and has shown a continued survival benefit with more than 3 years of follow-up is an important step in the treatment of the disease.”

Nivolumab (Opdivo, Bristol-Myers Squibb) is an anti-PD-1 antibody. Ipilimumab (Yervoy, Bristol-Myers Squibb) is an anti-CTLA-4 antibody.

The FDA based the approval on results of the randomized CheckMate -227 trial, which included patients with metastatic or recurrent NSCLC who received no prior anticancer therapy.

One part of the open-label trial included 793 patients with PD-L1 tumor expression of 1% or greater.

Researchers randomly assigned 396 patients to nivolumab dosed at 3 mg/kg every 2 weeks plus ipilimumab dosed at 1 mg/kg every 6 weeks. The other 397 patients received platinum-doublet chemotherapy.

Minimum follow-up was 29.3 months.

Results showed significantly longer median OS in the nivolumab-ipilimumab group (17.1 months vs. 14.9 months; HR = 0.79; 95% CI, 0.67-0.94). A higher percentage of patients assigned the combination vs. chemotherapy remained alive at 1 year (63% vs. 56%), 2 years (40% vs. 33%) and 3 years (33% vs. 22%).

The combination also appeared associated with a higher confirmed overall response rate by blinded independent central review (36% vs. 30%) and longer median response duration (23.2 months vs. 6.2 months).

Matthew D. Hellmann

“Patients with metastatic lung cancer remain in need of new treatment options that may provide durable responses,” Matthew D. Hellmann, MD, a researcher on the CheckMate -227 trial and medical oncologist at Memorial Sloan Kettering Cancer Center, said in a Bristol-Myers Squibb-issued press release. “The results from the CheckMate -227 trial show that a dual immunotherapy approach offers a chance at long-term survival for appropriate patients with metastatic NSCLC.”

The most common adverse reactions among patients assigned the nivolumab-ipilimumab combination included fatigue, rash, decreased appetite, musculoskeletal pain, diarrhea/colitis, dyspnea, cough, pruritus, nausea and hepatitis.

The FDA previously granted priority review to the nivolumab-ipilimumab combination for this indication.

The agency also approved PD-L1 IHC 28-8 pharmDx (Agilent Technologies Inc.), an qualitative immunohistochemistry assay, as a companion diagnostic device to guide selection of patients with NSCLC who are appropriate for treatment with the nivolumab-ipilimumab combination.