Bristol-Myers Squibb has revealed promising data from its ongoing Phase 3 study investigating the efficacy of Opdivo (nivolumab) in combination with Yervoy (ipilimumab) compared to chemotherapy in the first-line treatment of advanced non-small-cell lung cancer (NSCLC) in patients whose cancers have a high tumour mutation burden (TMB), regardless of PD-L1 expression.

The New York City-based company confirmed that the drug combination met its co-primary endpoint of progression-free survival. The study comprises 2,500 patients randomised across non-squamous and squamous histologies, with around 45% of the TMB evaluable participants possessing a high (>10 mut/mb) TMB score.

Full results are due to be unveiled at a future medical event. The study is ongoing as the company seeks to assess its second primary endpoint of overall survival in patients whose tumours express PD-L1.

“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,” commented Matthew D Hellmann, study investigator and Medical Oncologist at Memorial Sloan Kettering Cancer Center. “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.”

Giovanni Caforio, Chairman and Chief Executive Officer at Bristol-Myers Squibb, added: “We believe these data from CheckMate -227 are 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.”