Bristol Myers Squibb (NYSE: BMY) received regulatory approvals for Opdivo (nivolumab) in two new classical Hodgkin lymphoma indications. The FDA approved Opdivo combined with doxorubicin, vinblastine and dacarbazine (AVD) for adult and pediatric patients 12 years and older with previously untreated, Stage III or IV classical Hodgkin lymphoma. The European Commission approved Opdivo with brentuximab vedotin for children 5 years and older, adolescents, and adults up to 30 years with relapsed or refractory classical Hodgkin lymphoma after one prior therapy line.

The U.S. approval stems from the Phase 3 SWOG 1826 study, which demonstrated a 58% reduction in disease progression or death risk compared to standard care. The trial showed statistically significant improvement in progression-free survival with median follow-up of 13.7 months. After 36.7 months median follow-up, median overall survival had not been reached in either treatment arm, with 26 total deaths: 9 in the Opdivo-AVD arm and 17 in the control arm.

The EU approval relies on the Phase 2 CheckMate-744 study evaluating Opdivo with brentuximab vedotin in children, adolescents, and young adults with relapsed or refractory classical Hodgkin lymphoma. Data presented at the 2023 American Society of Clinical Oncology Annual Meeting showed high complete metabolic response rates in this population.

Classical Hodgkin lymphoma accounts for 95% of Hodgkin lymphoma cases and is most commonly diagnosed in early adulthood and late adulthood. Despite treatment advances, advanced-stage Hodgkin lymphoma carries substantial relapse risk.

In the SWOG 1826 safety profile, serious adverse reactions occurred in 39% of patients receiving Opdivo with AVD. The most frequent serious adverse reactions included peripheral neuropathy (41%), neutropenia (7%), pyrexia (7%), febrile neutropenia (6%), and nausea (6%). Fatal adverse reactions occurred in three patients from sepsis.