The US Food and Drug Administration (FDA) has approved Opdivo (nivolumab) with doxorubicin, vinblastine, and dacarbazine (AVD) for adult and pediatric patients 12 years and older with previously untreated, Stage 3 or 4 classical Hodgkin lymphoma (cHL). The approval also includes indications for adults with relapsed or refractory cHL after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin or after three or more lines of systemic therapy that includes autologous HSCT.
cHL is a heterogeneous group of malignant lymphoid neoplasms of B-cell origin characterized histologically by the presence of Hodgkin and Reed-Sternberg (HRS) cells in the vast majority of cases. The onset of cHL occurs most frequently in young adults and usually begins with the painless swelling of a lymph node in the upper body. HL can spread to multiple lymph node regions or lymphoid structures and is associated with systemic symptoms, such as weight loss, fevers, and night sweats.
Efficacy of nivolumab in combination with AVD was evaluated in Study CA209-8UT (NCT03907488), a randomized, open-label, multicenter trial in patients 12 years and older with previously untreated, Stage 3 and 4 cHL. A total of 994 patients were randomized to receive either nivolumab plus AVD or brentuximab vedotin plus AVD for 6 cycles.
The primary efficacy outcome measure was progression-free survival (PFS). The study demonstrated superiority of PFS in the nivolumab plus AVD arm, with a hazard ratio of 0.42. The median PFS was not reached in either arm, after a median follow-up of 13.7 months. After a median follow-up of 36.7 months, there were 1.8% deaths in the nivolumab plus AVD arm and 3.4% in the brentuximab vedotin plus AVD arm. In the nivolumab plus AVD arm, serious adverse reactions occurred in 39% and immune-mediated adverse reactions occurred in 9% of patients.
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To learn more about cHL and other cancers, visit https://checkrare.com/diseases/cancers/