Phase 3 CheckMate-227 Trial Met Co-Primary Endpoint of PFS in NSCLC

This week, drug maker Bristol-Myers Squibb announced in a press release that the ongoing Phase 3 Checkmate-227 trial met its co-primary endpoint of progression-free survival (PFS) with Opdivo plus Yervoy combination versus chemotherapy in first-line advanced non-small cell lung cancer (NSCLC) patients whose tumors have high levels of an emerging biomarker called tumor mutation burden (TMB).

The CheckMate-227 trial is an open-label phase 3 trial comprised of over 2500 patients.In the study, TMB was evaluated using Foundation Medicine’s analytically validated assay Foundation One CDx, and the safety profile was consistent with previously reported findings in first-line NSCLC for the combination schedule of Opdivo (3 mg/kg) every two weeks and low-dose Yervoy (1 mg/kg) every six weeks.

“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, MD, study investigator and medical oncologist at Memorial Sloan Kettering Cancer Center in a statement. “CheckMate -227 showed that TMB 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.”

The chairman and chief executive officer of Bristol-Myers Squibb, Giovanni Caforio, MD, added that the results from CheckMate-227 are a breakthrough in cancer research.

"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.