Seagen has announced new efficacy and safety data from part C of the Phase II SGN35-027 trial of ADCETRIS (brentuximab vedotin) plus PD-1 inhibitor nivolumab, as well as doxorubicin and dacarbazine (AN+AD) chemotherapy, as a frontline treatment for early-stage classical Hodgkin lymphoma (cHL) patients.
Among the 154 patients with early-stage disease in part C of the single-arm trial, 150 were included for efficacy evaluation.
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The assessment showed that ADCETRIS (brentuximab vedotin), in combination with the new immunotherapy, delivered an overall response rate (ORR) of 98% in the trial participants.
A 93% complete response (CR) rate in participants was also reported.
The most common treatment-related, treatment-emergent adverse events (TRAEs) of any grade that occurred in more than 30% of patients were nausea, peripheral sensory neuropathy, and fatigue.
Further evaluation showed low grade peripheral sensory neuropathy, with no cases of febrile neutropenia.
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By GlobalDataImmune-mediated adverse events (AEs) reported so far are consistent with the specific safety profile of nivolumab.
No grade five AEs were reported during the evaluation.
The ongoing, open-label, multiple part, multicentre SGN35-027 trial features parts A, B, and C.
Part A is examining the combination of brentuximab vedotin and doxorubicin, vinblastine, and dacarbazine (A+AVD) with primary granulocyte-colony stimulating factor (G-CSF) prophylaxis.
Parts B and C are investigating brentuximab vedotin plus nivolumab, doxorubicin, and dacarbazine (AN+AD), respectively, as a first-line treatment in patients with advanced and early-stage disease.
Massachusetts General Hospital Jon and Jo Ann Hagler Center for Lymphoma director and the trial’s principal investigator Jeremy Abramson said: “With teens and young adults primarily impacted by Hodgkin lymphoma, our goal is to develop curative treatments that improve survival while also reducing toxicity.
“The targeted agents of brentuximab vedotin and nivolumab have distinct mechanisms of action and demonstrated promising activity and safety in this early study; the omission of bleomycin and vinblastine chemotherapy likely contributed to the absence of certain adverse events.”
