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FDA approves Opdivo in MSI-H or dMMR metastatic colorectal cancer

Fri, 08/18/2017 - 09:34
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Approval for this indication has been granted under accelerated approval based on overall response rate (ORR) and duration of response

The FDA has approved Bristol-Myers Squibb’s Opdivo (nivolumab) injection for intravenous use for the treatment of adult and paediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.

Approval for this indication has been granted under accelerated approval based on overall response rate (ORR) and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. The recommended dose is 240 milligrams administered as an intravenous infusion over 60 minutes every two weeks until disease progression or unacceptable toxicity.

“Patients with metastatic colorectal cancer who have dMMR or MSI-H tumors are less likely to respond to conventional chemotherapy,” said Dr Heinz-Josef Lenz, J Terrence Lanni Chair in Gastrointestinal Cancer Research, University of Southern California. “While the challenges of treating these patients have been significant, tumours characterized by these biomarkers are immunogenic. Therefore, advances in immunotherapy research are encouraging in presenting new treatment options for appropriate patients with MSI-H metastatic colorectal cancer.”

In the CheckMate -142 trial, among patients (53/74) who received prior treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, 28% (95% CI: 17-42; 15/53) responded to treatment with Opdivo. The percentage of patients with a complete response was 1.9% (1/53) and the percentage of patients with a partial response was 26% (14/53). Among these responders, the median duration of response was not reached (range: 2.8+-22.1+ months). Among all enrolled patients, 32% (95% CI: 22-44; 24/74) responded to treatment with Opdivo; 2.7% (2/74) experienced a complete response, 30% (22/74) experienced a partial response.

“As part of our commitment to address hard-to-treat cancers, with today’s approval, Opdivo provides a new treatment option for these patients who have historically faced a poor prognosis,” said Chris Boerner, president, US Commercial, Bristol-Myers Squibb. “This approval is one example of how our commitment to translational medicine and investigating predictive biomarkers may help us discover treatment approaches to address different patients’ unique needs.”

CheckMate -142 is a Phase 2, multicentre, open-label, single-arm study evaluating Opdivo in patients with locally determined dMMR or MSI-H mCRC whose disease had progressed during, after, or were intolerant to, prior treatment with fluoropyrimidine-, oxaliplatin-, or irinotecan-based chemotherapy. In this study, 74 patients received Opdivo 3mg/kg administered intravenously every two weeks. The recommended dose is 240 mg administered as an intravenous infusion over 60 minutes every two weeks until disease progression or unacceptable toxicity.

Across the 74 patients, 72% received prior treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. Efficacy outcome measures included independent radiographic review committee-assessed confirmed ORR per RECIST 1 and duration of response. More than half of patients (51%) had a BRAF (16%) or KRAS (35%) mutation.

In this trial, Opdivo demonstrated an ORR of 28% (95% CI: 17-42; 15/53) in patients who received prior treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, including a 1.9% complete response rate (1/53) and a 26% partial response rate (14/53). Median duration of response in these patients was not reached (range: 2.8+-22.1+ months).2 Among all enrolled patients, 32% (95% CI: 22-44; 24/74) responded to treatment with Opdivo, including a 2.7% complete response rate (2/74) and a 30% partial response rate (22/74). The median duration of response was not reached (range: 1.4+-26.5+ months).2 Data from CheckMate -142 were published in The Lancet Oncology in July.

“As the third most common type of cancer in the United States, our view is that colorectal cancer – particularly for those with dMMR or MSI-H metastatic disease – has been in need of new research and treatments.8The approval of Opdivo for appropriate patients with this disease gives the community more hope,” said Michael Sapienza, chief executive officer of the Colon Cancer Alliance.

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