Opdivo is the first and only Immuno-Oncology agent to receive this FDA approval; this accelerated approval is based on tumor response rate and durability of response in these patients
PRINCETON, NJ, USA I September 22, 2017 I Bristol-Myers Squibb Company (NYSE:BMY) today announced the U.S. Food and Drug Administration (FDA) has approved Opdivo (nivolumab) injection for intravenous use for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. Approval for this indication has been granted under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.1 In the CheckMate -040 trial, 14.3%* (95% CI: 9.2-20.8; 22/154) of patients responded to treatment with Opdivo. The percentage of patients with a complete response was 1.9% (3/154) and the percentage of patients with a partial response was 12.3% (19/154).1 Among responders (n=22), responses ranged from 3.2 to 38.2+ months; 91% of those patients had responses of six months or longer and 55% had responses of 12 months or longer.1
Opdivo is associated with the following Warnings and Precautions including: immune-mediated pneumonitis, colitis, hepatitis, endocrinopathies, nephritis and renal dysfunction, skin adverse reactions, encephalitis, other adverse reactions; infusion reactions; and embryo-fetal toxicity.1 Please see the Important Safety Information section below.
“We are proud to bring the potential for clinically meaningful responses with Immuno-Oncology therapy to these advanced-stage HCC patients, who have had limited treatment options for years,” said Chris Boerner, president, U.S. Commercial, Bristol-Myers Squibb. “Today’s approval marks an important step toward our mission of delivering transformational medicines to treat conditions with a high unmet need.”
The burden of liver cancer in the U.S. is significant and is expected to increase in the decades to come.5,6 A recently-released American Cancer Society (ACS) report published in CA: A Cancer Journal for Clinicians notes that death rates for liver cancer are increasing at a faster pace than any other cancer, doubling since the mid-1980s.5
“Unfortunately, the majority of HCC patients are diagnosed with advanced-stage disease and are not candidates for potentially curative surgical interventions,” said Adrian M. Di Bisceglie, M.D., co-director, Saint Louis University Liver Center, Chief of Hepatology. “More options are needed for advanced-stage HCC patients who have failed prior systemic therapy.”
Hepatocellular carcinoma is often diagnosed in the advanced-stage where treatment options are limited and there is a high unmet need for patients who are intolerant to or who have progressed on sorafenib therapy.5,7,8
“In recent years, there has been growing interest in leveraging immuno-oncology knowledge and discoveries to add to the treatment options available for patients with advanced-stage liver cancer,” said Anthony B. El-Khoueiry, M.D., lead investigator and associate professor of clinical medicine and phase I program director at the Keck School of Medicine of University of Southern California (USC) and the USC Norris Comprehensive Cancer Center. “The approval of Opdivo provides us with an encouraging approach and a new treatment option for appropriate patients with HCC following prior systemic therapy.”
Approval Based on Notable Overall Response Rate and Duration of Response
CheckMate -040 included a Phase 1/2, open-label, multicenter study evaluating Opdivo in patients with HCC who progressed on or were intolerant to sorafenib.1,9 In this study, 154 patients received Opdivo 3 mg/kg administered intravenously every two weeks. The recommended dose is 240 milligrams administered as an intravenous infusion over 60 minutes every two weeks until disease progression or unacceptable toxicity.1 Efficacy outcome measures included confirmed overall response rate (as assessed by blinded independent central review using RECIST v1.1 and modified RECIST for HCC) and duration of response.1 The median age of patients participating in the study was 63 (range: 19-81), all patients had received prior sorafenib therapy and 19% of patients had received two or more prior systemic therapies.1 Patients were enrolled regardless of PD-L1 expression level and whether or not they were infected with active Hepatitis B virus (HBV) or active Hepatitis C virus (HCV).1,2 Data from CheckMate -040 were presented at the American Society of Clinical Oncology 2017 Annual Meeting in June.
In the CheckMate -040 trial, 14.3%* (95% CI: 9.2-20.8; 22/154) of patients responded to treatment with Opdivo. The percentage of patients with a complete response was 1.9% (3/154) and the percentage of patients with a partial response was 12.3% (19/154). Among responders (n=22), responses ranged from 3.2 to 38.2+ months; 91% of those patients had responses of six months or longer and 55% had responses of 12 months or longer.1 The median time to response was 2.8 months (range: 1.2-7.0).2 The overall response rate based on modified RECIST was 18.2% (95% CI: 12.4-25.2; 28/154). Complete response rate was 3.2% (5/154); partial response rate was 14.9% (23/154).1 Responses were observed across PD-L1 expression levels.2
“I advocate for others because I know firsthand the terrible toll cancers of the liver take on a patient and their loved ones. In my opinion, HCC is an example of a cancer where awareness is out of sync with the impact of the disease,” said Suzanne Lindley, Co-Founder, Yes! Beat Liver Tumors. “Today’s approval shines a light of awareness and hope on a disease with a high unmet medical need.”
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