BMS immunotherapy combo approved in new colorectal use
Bristol-Myers Squibb’s Opdivo and Yervoy has become the first approved immunotherapy combination option for a group of patients with advanced colorectal cancer.
The FDA approved the combination for patients aged 12 years and older with microsatellite instability high (MSI-H) or mismatch repair deficient metastatic colorectal cancer.
This if the first combination therapy approved for this patient group – but they are also eligible for treatment with Merck & Co’s PD-1 immunotherapy rival, Keytruda (pembrolizumab), which has a indication covering all MSI-high or mismatch repair deficient cancers.
Patients must also have disease that has progressed following treatment with fluoropyrimidine, oxaliplatin, and irinotecan.
This accelerated approval following a fast six-month review was based on overall response rate and duration of response data.
BMS will have to supply confirmatory late-stage trial data to maintain the licence in this indication in the long term.
The approval was based on data from the ongoing phase 2 CheckMate-142 study where a cohort of patients with this form of the disease was treated with the combination of Opdivo (nivolumab) and Yervoy (ipilumab).
In the 82 patients treated who had previous chemotherapy, 38 (46%) responded to treatment as assessed by an independent committee.
The percentage of patients with a complete response – defined as no trace of a tumour or sign of disease, was 3.7%, and 43% were partial responders.
Among the 38 responders, median duration of response (DOR) was not reached, 89% had responses of six months or longer, and 21% had responses of 12 months or longer. The trial is ongoing.
Among all 119 enrolled patients, 49% responded to treatment with Opdivo and Yervoy; 4.2% experienced a complete response, while 45% experienced a partial response.
Among these 58 responders, the median DOR was not reached, 83% of those patients had responses of six months or longer, and 19% had responses of 12 months or longer.
In the combination cohort, 51 of 58 responders were ongoing at the time of database lock; 78% of these ongoing responders had not reached 12 months of follow-up from the date of onset of response.
Principal investigator, Heinz-Josef Lenz, Terrence Lanni Chair in Gastrointestinal Cancer Research, Keck School of Medicine of University of Southern California, said: “Metastatic colorectal cancers with dMMR or MSI-H biomarkers can be difficult to treat and some patients may need additional options.”
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