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Immunotherapy-chemotherapy combination extends OS in advanced NSCLC
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The addition of nivolumab and low-dose ipilimumab to first-line chemotherapy significantly extended OS for patients with advanced non-small cell lung cancer, according to results of a prespecified interim analysis from the randomized phase 3 CheckMate -9LA trial.
Nivolumab (Opdivo, Bristol-Myers Squibb), a PD-1 immune checkpoint inhibitor, is approved for treatment of patients with a variety of malignancies, including NSCLC, melanoma, renal cell carcinoma, Hodgkin lymphoma, urothelial carcinoma, hepatocellular carcinoma, and head and neck squamous cell carcinoma. Ipilimumab (Yervoy, Bristol-Myers Squibb), a CTLA-4 inhibitor, is approved for treatment of unresectable or metastatic melanoma, as well as for adjuvant treatment of certain patients with cutaneous melanoma.
The open-label, multicenter CheckMate -9LA trial enrolled patients with advanced NSCLC regardless of PD-L1 expression or histology.
Patients in the experimental group received nivolumab dosed at 360 mg every 3 weeks plus ipilimumab dosed at 1 mg/kg every 6 weeks combined with two cycles of concomitant chemotherapy. Treatment with nivolumab and ipilimumab continued for up to 2 years, or until disease progression or unacceptable toxicity.
Patients in the control group received up to four cycles of chemotherapy, plus optional pemetrexed maintenance if eligible. Treatment continued until disease progression or unacceptable toxicity.
The study met its primary endpoint, demonstrating superior OS among patients in the intention-to-treat population assigned the nivolumab-ipilimumab regimen.
Secondary endpoints included PFS, overall response rate and efficacy according to prespecified biomarkers.
The safety profile of the experimental regimen appeared consistent with the known profiles of each component from other studies in first-line NSCLC.
“These results build on the benefit the combination of Opdivo plus Yervoy has previously shown in first-line melanoma, renal cell carcinoma and most recently lung cancer, and may provide a new therapeutic option for patients,” Fouad Namouni, MD, head of oncology development for Bristol-Myers Squibb, said in a company-issued press release.
Full data from CheckMate -9LA will be presented at an upcoming medical meeting and shared with regulatory authorities.