The FDA has awarded a priority review for Bristol-Myers Squibb’s checkpoint inhibitor Opdivo as a second-line treatment for colorectal cancer, setting up a potential approval in early-August.
BMS is seeking approval for Opdivo (nivolumab) in patients with two specific biomarkers metastatic colorectal cancer who have already been treated first-line with chemotherapy. The biomarkers – mismatch repair deficiency (dMMR) or microsatellite instability high (MSI-H) – occur in around 15% and 5% respectively of the 134,000 new cases of colorectal cancer diagnosed in the US every year.
“These patients have a distinct unmet need, as they are less likely to benefit from conventional chemotherapy and have a shorter overall survival than patients with metastatic colorectal cancer without these biomarkers,” commented BMS’ gastrointestinal oncology lead Ian Waxman.
“We look forward to working with the FDA towards the goal of providing a new treatment option for patients with metastatic colorectal cancer defined by dMMR or MSI-H biomarkers.”
The submission was based on data from the ongoing phase II CheckMate -142 trial evaluating Opdivo in patients with dMMR or MSI-H colorectal cancer, which was first presented at the American Society of Clinical Oncology (ASCO) meeting last year. Follow-up data reported in February showed that after a median follow-up of more than seven months, 74% of these heavily pre-treated patients were still alive, with half of patients progression-free at 12 months.
The results – which also included an objective response rate of 31% and disease stabilization in 69% of patients – have led to suggestions that Opdivo could become a new standard of care for this indication, according to an ASCO Post report.
The news adds to a stream of positive developments for BMS’ PD-1 inhibitor of late as it tries to put the drug back on course after last year’s disappointing results in first-line non-small cell lung cancer (NSCLC).
Opdivo has just picked up a positive opinion in Europe for head and neck cancer, which showed a positive effect on survival in combination with BMS’ Yervoy (ipilimumab) in patients with untreated advanced melanoma, and strong five-year survival data when given second-line for advanced NSCLC.
For good measure, BMS has also signed an expanded agreement for combination studies of Opdivo with Incyte’s IDO1 inhibitor epacadostat, including phase III pivotal trials in first-line NSCLC and first-line head and neck cancer due to start next year. Rival Merck & Co – which sells PD-1 inhibitor Keytruda (pembrolizumab) and stands to gain the most from Opdivo’s first-line NSCLC miss – also signed a wide-ranging deal with Incyte to pair their drugs as initial therapy for a range of tumour types.
There was one setback this week however, that shows once again – despite their promise – all will not be plain sailing for immuno-oncology drugs. Opdivo failed to improve survival compared to Roche’s Avastin (bevacizumab) in glioblastoma multiforme, a hard-to-treat form of brain cancer.