The Phase III CheckMate-227 trial evaluating the combination of nivolumab plus low-dose ipilimumab has met the co-primary endpoint of overall survival (OS), demonstrating a superior benefit versus chemotherapy in first-line non-small cell lung cancer (NSCLC) patients whose tumours express PD-L1 ≥1 percent.
The safety profile was consistent with previously reported findings in first-line NSCLC for the nivolumab 3 mg/kg every two weeks and low-dose ipilimumab (1 mg/kg) every six weeks combination schedule.
These data establish nivolumab and ipilimumab as the first dual immuno-oncology (I-O) combination to reach its primary endpoint in NSCLC and is the third tumour type in which nivolumab and ipilimumab has demonstrated an improvement in overall survival.
In an exploratory analysis of patients whose tumours do not express PD-L1, a survival benefit was also observed with nivolumab plus low-dose ipilimumab versus chemotherapy.
“We are delighted with the results from Part 1a of CheckMate-227, the first trial to show that a dual immunotherapy combination could help patients with non-small cell lung cancer live longer versus chemotherapy,” said Faisal Mehmud, UK Country Medical Director, Bristol-Myers Squibb. “These results not only demonstrate the potential of nivolumab and ipilimumab in treating patients with non- small cell lung cancer but, if licensed, will add the potential for a further chemotherapy sparing regimen for patients.”
Lung cancer is the most common cause of cancer death in the UK and accounts for 21 percent of all cancer deaths.
NSCLC accounts for nearly 90 percent of all lung cancer cases.
There are around 47,200 new lung cancer cases diagnosed in the UK every year and around three-quarters of lung cancer cases are diagnosed at a late stage in England.
It was also announced that Part 2 of the CheckMate-227 trial (evaluating nivolumab plus chemotherapy), did not meet the pre-specified primary endpoint of OS versus chemotherapy in patients with non-squamous histology, regardless of PD-L1 status.
Expert commentary from ecancer contributor and board member Dr Bishal Gyawali, Queen's University, Ontario, Canada:
"I don't think these results will salvage the role of nivolumab in first line NSCLC. Last year, they tried to convince us TMB is the biomarker to predict response to nivolumab-ipilimumab combination, irrespective of PDL1 status. Currently, they are claiming success for the combo for patients with PDL1>=1%. Nivolumab plus chemo combination has apparently failed (part 2 of CheckMate-227). Full publication is not out yet, but I am not overly enthusiastic about these results because first, they don't seem to be sure of the best biomarker and second, we already have solid OS results from pembrolizumab in this setting. So changing treatment choice to nivolumab-ipilimumab combo will need more robust data than this to convince the oncologists."
Source: Bristol Myers-Squibb