Bristol Myers Squibb (BMS) has shared promising results from a late-stage study of its dual immunotherapy combination in metastatic colorectal cancer (CRC).
The ongoing phase 3 CheckMate-8HW trial has been evaluating Opdivo (nivolumab) plus Yervoy (ipilimumab) against Opdivo alone across all lines of therapy, including the front-line, in patients with microsatellite instability-high or mismatch repair-deficient (MSI-H/dMMR) metastatic CRC.
Results presented at this year’s American Society of Clinical Oncology Gastrointestinal Cancers Symposium showed that Opdivo plus Yervoy was associated with a statistically significant and clinically meaningful 38% reduction in the risk of disease progression or death compared to Opdivo monotherapy at a median follow up of 47 months.
Overall response rate was also significantly higher with Opdivo plus Yervoy compared to Opdivo alone, at 71% versus 58%, and the safety of the combination was consistent with previously reported data.
More than 154,000 cases of CRC, which develops in the colon or the rectum, are expected to be diagnosed in the US in 2025.
Up to 7% of patients with metastatic disease have dMMR or MSI-H tumours and, as a result, are less likely to benefit from conventional chemotherapy and typically face a poor prognosis.
Opdivo plus Yervoy-based combinations already hold approvals for a range of indications, including for patients with MSI-H/dMMR metastatic CRC that has progressed following treatment with a fluoropyrimidine, oxaliplatin and irinotecan.
Previous results reported from CheckMate-8HW showed that Opdivo plus Yervoy reduced the risk of disease progression or death by 79% compared to investigator’s choice of chemotherapy.
Commenting on the latest results for the combination, Dana Walker, vice president, global programme lead, late development, oncology, BMS, said: “The benefit of dual inhibition of PD-1 and CTLA-4 has been well established in phase 3 trials of Opdivo plus Yervoy across a broad range of tumour types, including in MSI-H/dMMR metastatic CRC compared to chemotherapy.
“The results from this analysis of the CheckMate-8HW trial answer affirmatively an important question about whether dual immunotherapy with Opdivo plus Yervoy can also improve outcomes for patients with MSI-H/dMMR metastatic CRC compared with Opdivo alone.”