Bristol Myers Squibb’s Opdivo plus Yervoy, as well as Pfizer’s Braftovi, have each shown strong Phase III performances that could position them as new standards of care in certain subtypes of metastatic colorectal cancer.
Bristol Myers Squibb and Pfizer unveiled new late-stage data at the recently concluded 2025 American Society of Clinical Oncology Gastrointestinal Cancer Symposium in San Francisco, establishing their respective cancer therapies as potentially new standards of care in specific colorectal cancer subtypes.
In the Phase III CheckMate -8HW trial, BMS’s PD-1 inhibitor Opdivo (nivolumab), when combined with the company’s anti-CTLA4 antibody Yervoy (ipilimumab), achieved a strong progression-free survival (PFS) benefit in patients with microsatellite instability-high/mismatch repair-deficient (MSI-H/dMMR) metastatic colorectal cancer (mCRC).
After a median follow-up of 47 months, the Opdivo combo reduced the risk of death or disease progression by 38% versus Opdivo monotherapy, an effect with a p-value of 0.0003, according to BMS’s Saturday news release.
Overall response rate (ORR), a key secondary endpoint, was also significantly higher in patients treated with Opdivo plus Yervoy. The combination treatment resulted in a 71% ORR as opposed to 58% in those given Opdivo alone.
As for safety, 22% of those in the combo arm developed grade 3 or 4 treatment-related adverse events, whereas such toxicities were reported in 14% of those on Opdivo monotherapy. Still, BMS maintained that the safety profile for the Opdivo-Yervoy regimen was consistent with what had been previously established, with no new signals of concern detected.
Of note, the PFS benefits of Opdivo plus Yervoy remained significant “across all lines of therapy, including first-line,” according to the pharma’s news release.
For Thierry Andre, head of the Medical Oncology department at Sorbonne University, these latest findings “confirm nivolumab plus ipilimumab as a new standard treatment for people living with metastatic colorectal cancer.” Thierry has disclosed receiving honoraria from BMS, as well as having acted as a consultant or advisor to the company.
Also at ASCO GI 2025, Pfizer announced Monday that its oral kinase inhibitor Braftovi (encorafenib), when used with cetuximab and the mFOLFOX6 chemotherapy regimen, results in significant ORR improvements in mCRC patients with the V600E mutation in the BRAF gene.
The Braftovi combo yielded a 60.9% ORR, versus 40% in counterparts who were given chemotherapy with or without bevacizumab. The treatment difference was statistically significant, with a p-value of 0.0008, according to Pfizer. At the time of the readout, median duration of response was 13.9 months in the Braftovi arm, as compared with 11.1 months in control comparators.
Overall survival data were still immature, though Pfizer detected a trend in favor of the Braftovi combo. As for safety, the study found that the adverse event profile of the combination therapy was consistent with the known side effects of each respective agent. Serious adverse events were approximately balanced between the treatment groups.
Scott Kopetz, deputy chair of Gastrointestinal Medical Oncology at The University of Texas MD Anderson Cancer Center, in a statement said that these latest findings potentially position the Braftovi regimen as “the new standard of care for people with BRAF V600E-mutant metastatic colorectal cancer, for whom long-term disease control is critical.” Kopetz is a co-principal investigator of the Pfizer study and has consulted for the pharma.
