The European Commission has approved the immunotherapy agent Opdivo (nivolumab) for the treatment of adult patients with relapsed or refractory classical Hodgkin’s lymphoma (cHL) following autologous stem cell transplant (ASCT) and treatment with Adcetris (brentuximab vendotin).
Opdivo was already approved by the European Medicines Agency to treat patients with advanced melanoma, non-small cell lung cancer, or advanced renal cell carcinoma. With this approval, Opdivo has become the first PD-1 inhibitor to be approved in the European Union for a hematological cancer.
“We’re incredibly proud of this approval for Opdivo and what it means for adult patients with relapsed or refractory classical Hodgkin lymphoma after autologous stem cell transplant and treatment with brentuximab vedotin, as it marks the first and only PD-1 inhibitor approved for a hematologic malignancy in the EU,” Emmanuel Blin, senior vice president and chief strategy officer, Bristol-Myers Squibb, said in a press release. “This also is Bristol-Myers Squibb’s second Immuno-Oncology agent approved for a blood cancer in the EU within just six months.”
The approval was based on integrated data from the Phase 2 CheckMate 205 (NCT02181738) and the Phase 1 CheckMate 039 trials, which assessed the safety and efficacy of Opdivo in patients with relapsed or refractory cHL after undergoing ASCT and Adcetris treatment.
In the group of patients assessed for efficacy, the objective response rate was 66%, including 6% with complete responses and 60% with partial responses. In addition, 23 percent of patients achieved stable disease after Opdivo treatment. Among responders, the median time to response was two months, and response was maintained for a median of 13.1 months. One-year progression free survival rate was 57%.
A post-hoc analysis found that 37 of the 80 patients in cohort B of CheckMate 205 had not responded to prior treatment with Adcetris, but with Opdivo showed an objective response rate of 59.5% and a median duration of response of 13.14 months.
Among the 263 patients assessed for safety, 21 percent had serious adverse events, including infusion-related reactions, liquid in the lungs, pneumonia, fever, rash, and pneumonitis. The most common adverse events, reported in more than 20 percent of patients, included fatigue, infection of the upper respiratory tract, fever, diarrhea, and cough.
“As a practicing hematologist, I have experienced the challenge of managing classical Hodgkin lymphoma and the need among previously treated patients,” said Andreas Engert, MD, lead investigator and professor of Internal Medicine, Hematology and Oncology, University Hospital of Cologne, Cologne, Germany. “It is incredibly exciting that with today’s approval of Opdivo for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma after autologous stem cell transplant and treatment with brentuximab vedotin in the EU, we now have an entirely new treatment approach that has shown impressive response rates and durability of response in this difficult-to-treat population.”
The U.S. Food and Drug Administration (FDA) gave “accelerated approval” to Opdivo’s use in the same group of classical Hodgkin’s lymphoma patients in May. In the U.S., Opdivo is also approved to treat advanced melanoma, advanced non-small cell lung cancer, advanced renal cell carcinoma, and advanced squamous cell carcinoma of the head and neck.