In the trial, 150 patients out of 154 patients with early-stage disease showed a 98% overall response rate (ORR) and a 93% complete response rate at the end of the treatment
A Micrograph image of Hodgkin lymphoma. (Credit: Nephron from Wikimedia Commons)
Seagen has announced that its antibody-drug conjugate Adcetris (brentuximab vedotin) in combination with the PD-1 inhibitor nivolumab and standard chemotherapy agents doxorubicin and dacarbazine (AN+AD) was well-tolerated in Part C of a Phase 2 trial of patients with early-stage classical Hodgkin lymphoma (cHL).
Adcetris is an antibody-drug conjugate (ADC) made from a CD30-directed monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE).
In the trial, 150 patients out of 154 patients with early-stage disease showed a 98% overall response rate (ORR) and a 93% complete response rate at the end of the treatment.
The regimen was well-tolerated with fewer than half of patients developing primarily low-grade peripheral neuropathy and no cases of febrile neutropenia.
Seagen said that the immune-mediated adverse events observed to date are consistent with the individual safety profile of nivolumab.
The updated data findings from Part B of the study in patients with the advanced-stage disease showed a 95% 12-month progression-free survival (PFS) rate and 93% 18-month PFS rate, an ORR of 95% and a CR rate of 89% at the completion of the treatment.
Seagen chief medical officer and R&D president Roger Dansey said: “We are encouraged by the promising clinical outcomes of an Adcetris plus nivolumab combination with reduced chemotherapy as we seek to maximise efficacy and improve tolerability in both early- and late-stage classical Hodgkin lymphoma.”
Part C of the single-arm Phase 2 trial is an ongoing open-label, multiple-part, multicentre trial with the goal to assess two different brentuximab vedotin treatment combinations in patients with advanced and early-stage cHL.
The primary endpoint is the proportion of participants with complete responses at the end of treatment as per the Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC). The incidence of adverse events is defined as the secondary endpoint.
The Phase 2 data will be presented along with three-year results from a 1,500-patient Phase 3 trial from the German Hodgkin Study Group evaluating non-inferiority efficacy and potential for reduced toxicity of an Adcetris regimen (BrECADD) compared to the BEACOPP regimen.
The antibody-drug conjugate is approved for seven indications in the US and five indications in Europe, where Japan-based Takeda owns the commercialisation rights.