Bristol-Myers Squibb releases mixed results on Opdivo from late-stage CheckMate -227 study in NSCLC

Bristol-Myers Squibb on Wednesday unveiled data from Part 2 of the Phase III CheckMate -227 study, which showed that Opdivo (nivolumab) in combination with chemotherapy missed the primary endpoint of overall survival (OS) in patients with first-line non-squamous non-small-cell lung cancer (NSCLC), regardless of PD-L1 status. In the study, the combination regimen was associated with a median OS of 18.83 months, versus 15.57 months for chemotherapy, while the landmark one-year OS rates in these groups were 67.3% and 59.2%, respectively.  

"While this is not the outcome we had hoped for, the Opdivo plus chemotherapy one-year landmark overall survival in the non-squamous population was consistent with the experimental arms in previously-reported trials of [immuno-oncology]/chemotherapy combination regimens," remarked Fouad Namouni, head of oncology development at Bristol-Myers Squibb.  

Meanwhile, an exploratory analysis of patients with first-line squamous NSCLC indicated that the median OS was 18.27 months for Opdivo plus chemotherapy, compared with 11.96 months for chemotherapy alone. Bristol-Myers Squibb noted that no new safety signals were observed, adding that it plans to disclose complete findings from the study at a future research conference.  

However, the drugmaker also announced on Wednesday that Part 1a of the late-stage CheckMate -227 study met its co-primary endpoint, noting that in the study, Opdivo in combination with Yervoy (ipilimumab) was shown to significantly prolong OS versus chemotherapy in patients with NSCLC whose tumours express PD-L1 of at least 1%. 

Last year, Bristol-Myers Squibb reported that the combination of Opdivo and Yervoy regimen reduced the risk of death or disease progression by 42% versus chemotherapy in first-line advanced NSCLC patients whose tumours have high tumour mutation burden (TMB). 

"CheckMate-227 is the first Phase III trial to demonstrate that patients with lung cancer can achieve superior [OS] with a dual immunotherapy combination versus chemotherapy," noted Namouni. 

The study results come after Bristol-Myers Squibb withdrew its filing in the US seeking approval of Opdivo plus Yervoy for the treatment of certain patients with first-line advanced NSCLC in January. 

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