Bristol-Myers Squibb said Monday that its Phase 3 CheckMate -227 study met its co-primary endpoint of progression-free survival (PFS) with the Opdivo (nivolumab) plus Yervoy (ipilimumab) combination versus chemotherapy in first-line advanced non-small cell lung cancer (NSCLC).
This is designed for the patients whose tumors have high tumor mutation burden (TMB), regardless of PD-L1 expression.
According to the press release the company issued today, the same day when it reported good sales of Obdivo in 2017 and regulatory success with it, the study evaluated TMB with Foundation Medicine’s analytically validated assay FoundationOne CDx.
“TMB 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 TMB,” said Matthew D. Hellmann, study investigator and medical oncologist at Memorial Sloan Kettering Cancer Center.
He pointed out that the study showed the importance of TMB as in independent predictive biomarker that can identify a population of first-line NSCLC patients who may benefit from the nivolumab plus ipilimumab combination.
Giovanni Caforio, chairman and chief executive officer, Bristol-Myers Squibb, said that the data from the study should be a breakthrough in cancer research and a meaningful step forward in determining which first-line lung cancer patients may benefit most from the combination of Opdivo and Yervoy. “These findings attest to our deep understanding of cancer biology, leading translational medicine capabilities and commitment to developing new approaches for cancer patients,” he said.