A combination of Adcetris (brentuximab vedotin) and Opdivo (nivolumab) led to Hodgkin lymphoma diminishing in 85 percent of patients in a Phase 1/2 trial (NCT02572167), researchers reported.
Among them, 63 percent had a complete response, supporting the combo’s move to Phase 3 testing. The trial covered patients with relapsed or refractory classical Hodgkin lymphoma.
Seattle Genetics and Bristol-Myers Squibb presented interim trial results at the International Conference on Malignant Lymphoma in Lugano, Switzerland, June 14-17. The presentation was titled “Interim Results from a Phase 1/2 Study of Brentuximab Vedotin in Combination with Nivolumab in Patients with Relapsed or Refractory Hodgkin Lymphoma.”
Sixty-two patients took part in the trial. Fifty-nine were able to be evaluated at the time of the interim analysis.
“The phase 1/2 study combining the antibody-drug conjugate brentuximab vedotin with the PD-1 immune checkpoint inhibitor nivolumab is a promising investigational approach as it combines a targeted therapy with a therapy designed to activate the immune system, and the combination may have additive activity,” Dr. Alex Herrera, an assistant professor at City of Hope Hospital in Duarte, California, said in a press release.
“The interim results support further exploration of this novel regimen, free of traditional chemotherapy,” added Herrera, the lead trial investigator.
About half the group had lymphoma that had failed to respond to earlier treatment. The cancer of 55 percent had relapsed after an initial response to first-line treatment. The majority — 90 percent — were treated with the chemotherapy ABVD (Adriamycin, bleomycin, vinblastine, and dacarbazine).
Among the 59 patients assessed for a response, 85 percent responded. Sixty-three percent had a complete response and 22 percent a partial response. Five patients, or 8 percent, achieved a stable disease from the treatment. Four patients’ disease progressed.
Of the initially enrolled patients, four discontinued their treatment before completing the course, and one dropped out before receiving the first dose.
Sixty percent of those who completed treatment had a stem cell transplant, and 19 percent another kind of salvage therapy, or treatment that doctors administer after a first-line therapy fails.
“Since our first patient treated with the combination regimen, the data continue to demonstrate encouraging activity with an acceptable safety profile,” said Dr. Jonathan Drachman, chief medical officer of Seattle Genetics.
Researchers said the combo had an acceptable safety profile. Nausea was the most common side effect, seen in 56 percent of participants, followed by fatigue in 43 percent and infusion-related reactions in 36 percent. In addition, 31 percent experienced itch, 28 percent had headaches and 26 percent had diarrhea, rash, or vomiting. Severe adverse events occurred in five patients.
Drachman said researchers will begin recruiting Phase 3 trial participants soon.
“We look forward to further evaluation of Adcetris in combination with Opdivo for the treatment of relapsed Hodgkin lymphoma.” said Dr. Fouad Namouni, head of Oncology Development at Bristol-Myers Squibb.