A combination of Adcetris (brentuximab vedotin) and dacarbazine chemotherapy may be a suitable option for frail, elderly patients with classical Hodgkin’s lymphoma who are ineligible for standard treatment, according to data from a long-term Phase 2 clinical trial.
Those findings will be discussed at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting June 1-5 in Chicago, Illinois.
The poster, “Long-term follow-up of brentuximab vedotin +/- dacarbazine as first line therapy in elderly patients with Hodgkin lymphoma,” will be presented by Jonathan Friedburg, MD, principal investigator of the study at University of Rochester Medical Center.
Adcetris, by Seattle Genetics, is an antibody-drug conjugate that targets CD30, a protein that is present in Hodgkin’s lymphoma cells. Adcetris contains a toxic molecule called monomethyl auristatin E, which leads to cell death upon specific release in cancer cells.
The medicine is approved in the U.S. for the treatment of certain classical Hodgkin’s lymphoma patients, including those at high risk of relapse or progression after autologous stem cell transplant consolidation, those who relapsed after stem cell transplant, and those with advanced disease who have not received any prior therapy.
A Phase 2 trial (NCT01716806) is now evaluating Adcetris, alone or in combination with chemotherapy, as a treatment for older patients with newly-diagnosed classical Hodgkin’s lymphoma.
The trial enrolled patients 60 or older who could not receive or had declined standard chemotherapy treatment. While 27 participants received Adcetris alone every three weeks, an additional 22 received Adcetris plus dacarbazine for 12 cycles, followed by Adcetris alone.
In 2015, results from this trial showed that 92% of patients responded to Adcetris alone. All of those receiving the combination responded. Complete tumor clearance was seen in 73% and 62% of patients, respectively.
Now, Seattle Genetics shows that after three years of treatment, 71% of patients receiving Adcetris alone were still alive, and 34% remained without signs of disease progression. For those who received the combination, the results were 90% and 52%, respectively.
A total of 43 patients experienced mild or moderate peripheral nerve cell damage, which usually manifests as weakness, numbness, and pain in the hands or feet. Only one patient experienced severe peripheral neuropathy. These symptoms were completely resolved in 14 patients, and 17 patients experienced partial resolution or improvement of the symptoms.
Collectively, the results show that Adcetris alone or in combination with dacarbazine has the potential “to induce long-term remissions for a subset of elderly Hodgkin’s lymphoma patients,” the researchers stated.
“These durable responses suggest that Adcetris plus dacarbazine may be an induction option for frail, elderly patients ineligible for standard chemotherapy,” they added.
The study is recruiting participants.