Bristol-Myers Squibb announced that the Food and Drug Administration (FDA) has approved Opdivo (nivolumab) for the treatment of patients aged ≥12 years with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) that has progressed after treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. 

In the Phase 2, multicenter, open-label, single-arm CheckMate -142 trial (n=74), qualified patients received Opdivo 3mg/kg intravenously (IV) every 2 weeks. The outcome measures included independent radiographic review committee-assessed confirmed overall response rate (ORR) and duration of response. 

The data showed 28% of patients who received prior treatment with a fluoropyrimidine, oxaliplatin, and irinotecan responded to Opdivo. Of these, complete response was seen in 1.9% and partial response was seen in 26%. The median duration of response was not reached among the responders (range 2.8–22.1 months). Overall, 32% of all study patients responded to Opdivo with complete response seen in 2.7% and partial response in 30%.

Related Articles

 

The FDA’s accelerated approval was based on ORR and duration of response. Continued approval may depend on verification and description of clinical benefit in confirmatory trials. 


Continue Reading

Opdivo, a programmed death receptor-1 (PD-1) blocking antibody, is already indicated for the treatment of various cancers, including melanoma, non-small cell lung cancer, renal cell carcinoma, classical Hodgkin lymphoma, head and neck squamous cell carcinoma, and urothelial carcinoma. It is available as 40mg/4mL and 100mg/10mL strength solutions in single-dose vials.

For more information call (800) 721-5072 or visit Opdivo.com.