Bristol-Myers Squibb Company today said that new data from a cohort of the phase 2 CheckMate -142 test of the combination of Opdivo and Yervoy show benefits for patients with certain metastatic colorectal cancer (mCRC).
The trial is being conducted for the previously treated patients with dMMR or MSI-H metastatic colorectal cancer.
With a median of 13.4 months of follow-up, the primary endpoint of objective response rate (ORR) per investigator assessment was 55% (95% CI: 45.2 to 63.8). Responses were durable, with median duration of response not yet reached and 94% of responses ongoing at time of data cutoff. The overall survival (OS) rate at one year was 85% (95% CI: 77.0 to 90.2), and median OS was not yet reached. Grade 3-4 treatment-related adverse events (TRAEs) occurred in 32% of patients receiving the Opdivo plus Yervoy combination. Patients received mCRC combination dosing of Opdivo (3 mg/kg) plus Yervoy (1 mg/kg) every three weeks for four doses, followed by Opdivo (3 mg/kg) every two weeks until disease progression, death or unacceptable toxicity.
“These results demonstrate that Opdivo plus Yervoy provide durable clinical benefit in patients with dMMR or MSI-H metastatic colorectal cancer,” said Thierry André, M.D., Head of the Medical Oncology Department in St. Antoine Hospital, Assistance Publique Hôpitaux de Paris. “The combination of Opdivo and Yervoy may represent an important advance for these distinct biomarker-defined patients, who historically have poorer outcomes compared to metastatic colorectal cancer patients whose tumors are mismatch repair proficient or microsatellite stable.”
Ian M. Waxman, M.D., development lead, Gastrointestinal Cancers, Bristol-Myers Squibb, said. “The Opdivo and Yervoy combination has demonstrated efficacy across tumors in a broad range of patients, and we are very encouraged to see that the complementary effect of this combination has the potential to increase anti-tumor activity in patients with dMMR or MSI-H metastatic colorectal cancer. We are continuing to increase our understanding of the benefit of Immuno-Oncology based combinations and look forward to further evaluating the potential of our immunotherapy treatments in colorectal cancer patients.”