Bristol Myers Squibb announced that Opdivo (nivolumab) has received two new approvals for classical Hodgkin lymphoma (cHL) in the United States and the European Union. In the U.S., the Food and Drug Administration approved Opdivo in combination with doxorubicin, vinblastine and dacarbazine (AVD) for adult and pediatric patients 12 years and older with previously untreated Stage III or IV cHL. In the EU, the European Commission approved Opdivo in combination with brentuximab vedotin for children 5 years and older, adolescents, and adults up to 30 years of age with relapsed or refractory cHL after one prior line of therapy.
According to the company, the U.S. approval establishes Opdivo plus AVD as an immunotherapy-based combination option for patients with advanced, previously untreated cHL. The U.S. decision is based on the Phase 3 SWOG 1826 (CA2098UT) study, which evaluated Opdivo in combination with AVD in adult and pediatric patients 12 years and older with previously untreated Stage III or IV disease. A submission based on the SWOG 1826 data is also under review by the European Medicines Agency.
The EU approval is supported by results from the Phase 2 CheckMate -744 (CA209744) study, which evaluated Opdivo in combination with brentuximab vedotin in children, adolescents, and young adults up to age 30 with relapsed or refractory cHL after one prior line of therapy. With this decision, Opdivo plus brentuximab vedotin becomes an immunotherapy combination option for certain patients in Europe whose disease has returned or not responded to earlier treatment.
In the SWOG 1826 trial, Opdivo plus AVD demonstrated a 58% reduction in the risk of disease progression or death compared with brentuximab vedotin plus AVD, with a hazard ratio of 0.42 (95% confidence interval 0.27–0.67; p≤0.0001). The study met its primary endpoint, showing a statistically significant improvement in progression-free survival with Opdivo plus AVD after a median follow-up of 13.7 months in the intention-to-treat population. After a median follow-up of 36.7 months, median overall survival had not been reached in either treatment arm, with 9 deaths (1.8%) reported in the Opdivo plus AVD arm and 17 deaths (3.4%) in the brentuximab vedotin plus AVD arm.
Bristol Myers Squibb noted that these new approvals expand treatment options for both newly diagnosed patients with advanced cHL and for younger patients in Europe with relapsed or refractory disease. The company also highlighted that Opdivo and Yervoy carry warnings and precautions for severe and potentially fatal immune-mediated adverse reactions, infusion-related reactions, complications following allogeneic hematopoietic stem cell transplantation, embryo-fetal toxicity, and increased mortality in patients with multiple myeloma when Opdivo is added to a thalidomide analogue and dexamethasone, which is not recommended outside controlled clinical trials.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox!
Sign up now!