Trial Data Show Durable, Long-Term Survival with Nivolumab, Ipilimumab in Patients with Non-Small Cell Lung Cancer With PD-L1 Expression

Jill Murphy, Associate Editor

The safety profile for the combination treatment remained consistent with previously reported data in NSCLC and was deemed manageable with established protocols with no new safety signals identified.

Data from part 1 of the phase 3 CheckMate -227 trial indicates the long-term survival benefits of first-line treatment with nivolumab (Opdivo) plus ipilimumab (Yervoy) compared to chemotherapy in patients with advanced non-small cell lung cancer (NSCLC), regardless of programmed death-ligand 1 (PD-L1) expression level or histology, according to a press release from Bristol Myers Squibb.

Among patients with PD-L1 expression ≥1%, nivolumab's 4-year survival rate in combination with ipilimumab was 29% compared to 18% for chemotherapy. In a more in-depth analysis of patients with PD-L1 expression <1%, more than twice as many patients treated with nivolumab plus ipilimumab were alive at 4 years compared to chemotherapy.

The safety profile for the combination treatment remained consistent with previously reported data in NSCLC and was deemed manageable with established protocols with no new safety signals identified, according to the study authors.

“As clinicians, our aim in treating lung cancer is to extend the lives of patients with this disease, which remains the leading cause of cancer deaths,” said Luis G. Paz-Ares, MD, PhD, chair of the medical oncology department, in the press release. “In CheckMate -227, nivolumab plus ipilimumab continues to demonstrate durable overall survival as well as impressive duration of response after four years of follow-up. These data illustrate how much progress we have made in addressing advanced non-small cell lung cancer and reinforce the importance of this dual immunotherapy regimen among first-line options.”

In a more descriptive analysis of patients whose tumors express PD-L1, including those with PD-L1 expression ≥50%, the combination of nivolumab plus ipilimumab showed efficacy benefits relative to nivolumab monotherapy at 4 years, which indicates the efficacy of ipilimumab in improving long-term outcomes, according to the study.

In patients with PD-L1 expression ≥1%, 29% treated nivolumab plus ipilimumab were alive compared to 21% with nivolumab monotherapy. Conversely, in patients with high PD-L1 expression, 37% of the nivolumab plus ipilimumab cohort were alive compared to 26% for nivolumab monotherapy, according to the study.

“With each additional year of follow-up, we continue to see the sustained benefits of the Opdivo plus Yervoy combination, not only in lung cancer, but in several different tumor types. The four-year results from CheckMate -227, showing improved long-term outcomes with Opdivo plus Yervoy,are the most mature Phase 3 data for an immunotherapy combination in first-line advanced non-small cell lung cancer,” said Abderrahim Oukessou, MD, vice president, thoracic cancers development lead, Bristol Myers Squibb, in the press release.

“We thank the patients and investigators involved in the trial, who have made it possible to bring the proven benefit of dual immunotherapy to people living with non-small cell lung cancer around the world.”

REFERENCE

Four-Year Data from Phase 3 CheckMate -227 Trial Show Durable, Long-Term Survival with Opdivo(nivolumab) Plus Yervoy (ipilimumab) in Patients with Non-Small Cell Lung Cancer with PD-L1 Expression ≥1%. Bristol Myers Squibb. Published May 19, 2021. Accessed May 20, 2021. https://news.bms.com/news/details/2021/Four-Year-Data-from-Phase-3-CheckMate--227-Trial-Show-Durable-Long-Term-Survival-with-Opdivonivolumab-Plus-Yervoy-ipilimumab-in-Patients-with-Non-Small-Cell-Lung-Cancer-with-PD-L1-Expression-1/default.aspx