Nivolumab plus ipilimumab combination improved overall survival, with 21% of individuals with metastatic non–small cell lung cancer treated with the combination and 2 cycles of chemotherapy alive compared to 16% with chemotherapy alone.
The 4-year follow-up results of the phase 3 CheckMate -9LA trial demonstrated long-term survival benefits with nivolumab (Opdivo; Bristol Myers Squibb) combined with ipilimumab (Yervoy; Bristol Myers Squibb) and 2 cycles of chemotherapy compared to 4 cycles of chemotherapy alone in previously untreated individuals with metastatic non–small cell lung cancer (NSCLC), according to data presented at the 2023 American Society of Clinical Oncology Annual Meeting (ASCO).
The combination was found to improve overall survival (OS), the primary endpoint of the study, with 21% of individuals administered the combination and 2 cycles of chemotherapy alive compared to 16% of patients administered chemotherapy alone at 4 years.
“The durable results seen with nivolumab plus ipilimumab with chemotherapy over 4 years, especially in patients typically facing a poor prognosis, demonstrate the sustained benefits of combining dual immunotherapy with limited chemotherapy for patients with advanced or metastatic [NSCLC,] which remains an incredibly challenging disease to treat,” David Carbone, MD, PhD, director of the Thoracic Oncology Center at The Ohio State University Comprehensive Cancer Center, said in a statement. “The data in patients with tumor PD-L1 expression <1% and squamous histology are particularly encouraging, as they show that the combination therapy continues to reduce the risk of death by approximately one-third compared to chemotherapy alone 4 years following treatment in patient groups historically facing the worst outcomes.”
There was a minimum follow-up of 47.9 months in which the combination and 2 cycles of chemotherapy maintained meaningful benefits across secondary endpoints and key subgroups of patients. Investigators noted that the benefits were more pronounced within individuals who had tumor PD-L1 expression less than 1% and squamous histology, which is a subgroup of patients with a high unmet need.
Individuals with tumor PD-L1 expression of less than 1% had an OS of 23% with the combination therapy compared to 13% for chemotherapy alone. Investigators said this represents a 34% reduction in the risk of death.
For those with squamous histology, 20% of individuals administered the combination were alive at 4 years compared to 10% of individuals who received chemotherapy alone, representing an overall reduction in the risk of death by 36%.
“Cancer treatment is never a one-size-fits-all approach given that patients with thoracic cancers like [NSCLC] have diverse sets of needs. We are committed to researching solutions that work for more patients and can potentially help improve outcomes and fill areas of high unmet need,” said Abderrahim Oukessou, MD, vice president of Thoracic Cancers Development Lead at Bristol Myers Squibb, in the statement. “Our data in lung cancer at ASCO 2023 add to the growing body of evidence supporting the potential of our medicines to improve long-term outcomes for patients in both advanced settings and earlier stages of disease, as well as difficult-to-treat patient groups requiring personalized approaches to treatment. The CheckMate -9LA results, which demonstrate sustained efficacy benefits over four years with a nivolumab-based combination, further reinforce our promise to deliver durable options to more patients across varying stages and types of cancer.”
There were no new safety signals observed with the combination in the extended follow-up of the trial. Furthermore, the combination has shown significant improvements in OS in 6 other phase 3 clinical trials, representing 5 tumors to date, including metastatic NSCLC, metastatic melanoma, advanced renal cell carcinoma, malignant pleural mesothelioma, and esophageal squamous cell carcinoma.
Four-year oucomes from phase 3 CheckMate -9LA trial show durable, long-term survival with Opdivo (nivolumab) plus Yervoy (ipilimumab) with two cycles of chemotherapy for patients with metastatic non–small cell lung cancer. News release. Bristol Myers Squibb. June 4, 2023. Accessed June 5, 2023. https://news.bms.com/news/corporate-financial/2023/Four-Year-Outcomes-from-Phase-3-CheckMate--9LA-Trial-Show-Durable-Long-Term-Survival-with-Opdivo-nivolumab-Plus-Yervoy-ipilimumab-with-Two-Cycles-of-Chemotherapy-for-Patients-with-Metastatic-Non-Small-Cell-Lung-Cancer/default.aspx