Mitul Gandhi, MD, discusses key findings from part C of the phase 2 SGN35-027 trial in Hodgkin lymphoma.
Mitul Gandhi, MD, medical oncologist, hematologist, Virginia Cancer Specialists, discusses key findings from part C of the phase 2 SGN35-027 trial (NCT03646123; EudraCT 2020-004027-17) in Hodgkin lymphoma.
The multicenter, multiple part, single-arm study investigated the efficacy and safety of a novel combination of brentuximab vedotin (Adcetris), nivolumab (Opdivo), dacarbazine, and doxorubicin in patients across multiple stages of Hodgkin lymphoma, Gandhi begins. Part C specifically evaluated the effect of this regimen on response durability in patients with non-bulky stage I and II disease, he says. Of the 129 patients enrolled in Part C, 76 were evaluable for efficacy. The study’s primary efficacy end point was complete response (CR) rate at the end of treatment, while secondary end points included safety and tolerability, objective response rate, duration of response (DOR), duration of complete response (DOCR), and progression-free survival.
Both the checkpoint inhibitor nivolumab and anti-CD30 antibody-drug conjugate brentuximab vedotin have received FDA approval for patients with relapsed or refractory classical Hodgkin lymphoma, and are considered highly active and well-tolerated agents in this tumor type, Gandhi notes. The trial aimed to combine these therapies in a tapered-down, cytotoxic backbone that could be administered as an abbreviated course of chemotherapy, Gandhi explains.
According to interim efficacy data, the combination regimen elicited a strong overall CR rate of 91%, Gandhi continues. Moreover, the regimen was considered well tolerated, with 35% of patients experiencing grade 3 or higher treatment-related adverse effects (TRAEs). Additionally, no treatment-emergent AEs resulted in early treatment discontinuation. Most patients were able to achieve sustained remission within the short follow-up, Gandhi says.
The regimen’s safety profile was consistent with previously known signals for brentuximab vedotin and nivolumab. Peripheral neuropathy, a known AE of brentuximab vedotin, was one of the grade 3 treatment-related AEs (TRAEs) observed. Additionally, immune-mediated AEs such as hypothyroidism and hyperthyroidism, and cutaneous manifestations including rash, were identified, Gandhi concludes.