The first-line treatment of early-stage classical Hodgkin lymphoma (cHL) with the combination of brentuximab vedotin (BV) and nivolumab, doxorubicin, and dacarbazine resulted in promising results, with durable objective response rates (ORR). In addition, the rates of peripheral sensory neuropathy and febrile neutropenia were low, according to data presented at the International Conference on Malignant Lymphoma 2023.
The ongoing, phase 2 SGN35-027 Part C trial (ClinicalTrials.gov identifier: NCT03646123) treated 154 patients with VB plus nivolumab, doxorubicin, and dacarbazine. The primary endpoint was complete response (CR) rate at the end of the trial. Secondary endpoints included ORR, duration of response (DOR), and progression-free survival.
At baseline, the median age was 31, with the majority of patients younger than age 65. There were 89% of patients with stage II disease at diagnosis, with the remaining patients diagnosed with stage I. The ORR was 95%, with a CR of 90%. There were 4 patients who were not evaluable for efficacy at data cutoff.
Nearly all patients experienced a treatment-related adverse event (TRAE) of any grade, including 34% who developed a grade 3 or higher event. The most common TRAEs of any grade were nausea, peripheral sensory neuropathy, fatigue, and constipation. The most common grade 3 or higher events were neutropenia and alanine aminotransferase increase.
There were 22% of patents who experienced an immune-mediated adverse event of any grade. The most common grade 3 or higher immune-mediated event was alanine aminotransferase increase.
“BV plus nivolumab, 2 targeted agents with distinct and complementary mechanisms of action, in combination with AD, demonstrated promising activity and were well tolerated in the first-lien treatment of early-stage cHL,” the authors concluded.
Disclosures: This research was supported by Seagen Inc. through the joint financial support of Seagen Inc. and Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda pharmaceuticals Limited. Some study authors declared affiliations with biotech, pharmaceutical, or device companies. Please see the original reference for a full list of disclosures.
Abramson JS, Straus D, Bartlett NL, et al. Brentuximab vedotin, nivolumab, doxorubicin, and dacarbazine for early-stage classical Hodgkin lymphoma: updated results from an ongoing phase 2 study. ICML 2023. June 13-17, 2023. Abstract 254