It’s been more than three years since Bristol Myers Squibb’s powerhouse immuno-oncology combination treatment of Opdivo and Yervoy has scored a combined FDA approval.
But the duo could be on its way to a new endorsement based on a phase 3 trial that shows it can keep certain first-line colorectal cancer patients alive longer than chemotherapy.
An interim analysis of the CheckMate-8HW trial of patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) shows that the study met one of its two primary objectives as assessed by Blinded Independent Central Review (BICR), BMS said Thursday.
In the trial of 830 patients, who were split into three groups, Opdivo (nivolumab) plus Yervoy (ipilimumab) demonstrated “statistically significant and clinically meaningful improvement” in progression-free survival (PFS) compared to chemotherapy, the company said.
As for the other primary endpoint, assessing the combo versus Opdivo as a solo agent across all lines of therapy, the “study is ongoing,” said BMS.
Dana Walker, M.D., BMS’s global program lead, gastrointestinal and genitourinary cancers, pointed out in a release that the results are further evidence of the benefits of the combo in the indication which were previously shown in CheckMate-142. In that study, Opdivo and Yervoy showed durable anti-tumor activity in patients who had progressed after fluoropyrimidine-based combination chemotherapy.
“With these positive results from CheckMate-8HW, we have randomized data showing Opdivo plus Yervoy significantly improved PFS in the first-line setting,” Walker said.
The company plans to share the results with the scientific community at an upcoming medical conference and discuss them with health authorities.
After blood thinner Eliquis, which generated $11.8 billion in sales last year, Opdivo is BMS’s second best-selling drug, ringing up $8.2 billion in revenue last year, for a 10% increase over 2021. Yervoy was up 5% last year to $2.1 billion.
Both Opdivo and Yervoy were originally approved to treat melanoma, in 2014 and 2011 respectively. In combination, the treatments have been blessed in four other cancer types: renal cell carcinoma (2018), colorectal cancer (2018), mesothelioma (2020) and lung cancer (2020).