CheckMate-227 met its primary endpoint of improved PFS with nivolumab plus ipilimumab compared with chemotherapy for the first-line treatment of patients with non-small cell lung cancer with high tumor mutation burden, according to a press release issued by Bristol-Myers Squibb.
Nivolumab (Opdivo, Bristol-Myers Squibb) — a PD-1 immune checkpoint inhibitor — in combination with ipilimumab (Yervoy, Bristol-Myers Squibb) marked the first immuno-oncology combination to receive approval for metastatic melanoma.
CheckMate-227 is a phase 3 trial that assessed nivolumab-based treatments compared with platinum-doublet chemotherapy among more than 2,500 patients with nonsquamous and squamous NSCLC.
This trial update reflects parts 1a and 1b of the trial, which assessed nivolumab plus ipilimumab among patients whose tumors did and did not express PD-L1.
Results showed superior PFS for nivolumab plus ipilimumab compared with chemotherapy among patients whose tumors have high tumor mutation burden — defined as at least 10 mutations/megabase as assessed by FoundationOne CDx (Foundation Medicine) — regardless of PD-L1 expression.
“[Tumor mutation burden] has emerged as an important biomarker for the activity of immunotherapy. For the first time, this phase 3 study shows superior PFS with first-line combination immunotherapy in a predefined population of NSCLC patients with high [tumor mutation burden],” Matthew D. Hellmann, MD, medical oncologist at Memorial Sloan Kettering Cancer Center, said in the press release. “CheckMate-227 showed that [tumor mutation burden] is an important, independent predictive biomarker that can identify a population of first-line NSCLC patients who may benefit from the nivolumab plus ipilimumab combination.”
Researchers will continue to assess for OS — the second co-primary endpoint.
Results will be presented at an upcoming meeting.
The safety profile appeared consistent with previous findings.
“We believe these data from CheckMate-227 are a breakthrough in cancer research and a meaningful step forward in determining which [patients with first-line lung cancer] may benefit most from the combination of Opdivo and Yervoy,” Giovanni Caforio, MD, chairman and CEO at Bristol-Myers Squibb, said in the release.