Patients with Hodgkin’s lymphoma who failed to respond to autologous hematopoietic stem cell transplant (HSCT) may markedly benefit from Adcetris (brentuximab vedotin), according to end-of-study results of a Phase 2 clinical trial.
The study, “Five-year survival and durability results of brentuximab vedotin in patients with relapsed or refractory Hodgkin lymphoma,” published in the journal Blood, reports that Adcetris may control the disease in a subgroup of patients for more than five years, even without receiving any additional anti-cancer therapy.
“Hodgkin lymphoma is a very treatable malignancy that tends to show up more frequently in younger patients, and is often cured with chemotherapy and radiation programs,” Dr. Joseph M. Connors, MD, FRCPC, clinical professor of medicine at the University of British Columbia and clinical director of the Centre for Lymphoma Cancer at BC Cancer Agency, said in a press release.
“In about 20 percent of patients, it is not cured, and the disease will threaten their lives. Before [Adcetris] was developed, we hadn’t found a new agent that had much potency or effectiveness for these patients in several decades.”
Patients with Hodgkin’s lymphoma who relapse or progress after HSCT usually have poor outcomes.
Adcetris is an anti-CD30 antibody linked to a microtubule-disrupting agent that induces the death of lymphoma cells expressing the CD30 protein at their surface. In August 2015, it was approved by the U.S. Food and Drug Administration as a consolidation therapy for patients with classical Hodgkin’s lymphoma who are at high risk of relapse or progress following HSCT.
To assess the effects of Adcetris in these Hodgkin’s lymphoma patients, the researchers enrolled 102 patients who failed HSCT and were assigned intravenous Adcetris (1.8 mg/kg) every three weeks for up to 16 cycles.
Previous interim data from the Phase 2 study (NCT00848926) had demonstrated significant efficacy and three-year disease control in heavily pretreated relapsed or refractory Hodgkin’s lymphoma patients.
Now, researchers reported the five-year end-of-study results.
After a median follow-up of 35.1 months, the researchers observed a median overall survival (OS) of 40.5 months and a median progression-free survival (PFS) of 9.3 months. In addition, the estimated five-year OS was 41 percent and estimated five-year PFS was 22 percent.
Of the 34 patients who achieved a complete response to Adcetris, the estimated OS was 64 percent and PFS was 52 percent. Importantly, at the time of the study’s closure, 13 patients remained in remission, nine of whom did not receive additional anti-cancer therapy. The other four received consolidative allogeneic HSCT.
The most common adverse event was peripheral neurophathy with grade 1 or grade 2 symptoms. This was resolved or improved in 88 percent of patients experiencing those side effects.
“It’s striking to see that a fraction of patients sustained their complete responses,” Connors said. “It is not unreasonable to hope that some of those patients were cured by [Adcetris]. Before this agent came along, we didn’t have a way of doing that.”