Results of Bristol-Myers Squibb’s highly anticipated CheckMate-227 study was revealed yesterday, and data showed that its cancer drug duo passed its co-primary endpoint with flying colours.
The phase III trial evaluated PD-1 inhibitor Opdivo (nivolumab) with CTLA4 blocker Yervoy (ipilimumab) on its safety and efficacy in first-line advanced non-small cell lung cancer (NSCLC) patients whose tumours have a high tumour mutation burden (TMB).
The safety profile of the two BMS drugs was found to be consistent with previously reported findings in first-line NSCLC for the combination schedule of Opdivo at 3mg every two weeks and Yervoy at 1mg every six weeks.
Pitted against chemotherapy however, the same dosing schedule for the combination showed superior progression free survival versus chemotherapy alone, which was one of BMS’ primary endpoints.
Although there has been no official word on results from its additional primary endpoint, which is the overall survival rate in NSCLC patients whose tumours express PD-L1, BMS seem confident in its findings.
Giovanni Caforio, chairman and chief executive officer of BMS, said: “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 had a completely different result from CheckMate-026 – a similar phase III trial that happened two years back – which saw Opdivo embarrassingly flop against both chemotherapy and Merck & Co’s blockbuster Keytruda (pembrolizumab) in NSCLC patients.
If the combo is approved however, the US pharma firm could be put in a strong position to take on Keytruda, which is already dominating the cancer immunotherapies market.
Although BMS has initially focussed on this combination, CheckMate-227 is also evaluating Opdivo plus chemotherapy versus chemotherapy alone in a broad population, which could bring about some interesting results for the pharma group.