Combining the monoclonal antibody-drug conjugate Adcetris (brentuximab vedotin) with the chemotherapy drug Gemzar (gemcitabine) results in a high complete response rate in children and young adults with relapsed or refractory Hodgkin’s lymphoma.
The results come from a cooperative-group Phase 1/2 clinical trial, conducted by the Children’s Oncology Group. Dr. Kara Kelly, chair of pediatrics at Roswell Park Cancer Institute in Buffalo, New York, presented the poster, “Phase 2 trial of brentuximab vedotin and gemcitabine for pediatric and young adult patients with relapsed or refractory Hodgkin lymphoma (HL): A Children’s Oncology Group (COG) report,” at the recent American Society of Clinical Oncology (ASCO) 2017 Annual Meeting in Chicago.
The AHOD1221 Phase 1/2 study (NCT01780662) evaluated the side effects and ideal dose of Adcetris when given together with Gemzar, to assess how well the two compounds worked in treating Hodgkin’s lymphoma that has returned or does not respond to treatment. The study enrolled 42 children and young patients aged 13 months to 30 years.
After determining the recommended combination dose in Phase 1, the trial’s Phase 2 part assessed the complete response rate within four cycles of therapy as its primary endpoint. Secondary endpoints included treatment-related toxicity and overall response rate, or number of patients who responded to treatment.
The combo treatment led to a complete response rate exceeding that seen in patients receiving either Adcetris (34 percent) or Gemzar (9 percent) alone, according to researchers. This suggests that these two therapies together represent a highly active combination for refractory or relapsed Hodgkin’s lymphoma. Among the evaluable patients, 23 of them, or 58 percent, achieved complete response to the combination within four cycles, and six patients, 15 percent, had a partial response.
Researchers also discovered that combining Adcetris (produced by Takeda Oncology) with Gemzar (made by Eli Lilly) offers the advantage of avoiding agents associated with late treatment sequelae, or long-term organ damage.
“We found very high response rates to this treatment combination, which has the added benefit of having a much reduced risk of long-term organ damage compared to the highly toxic chemotherapy agents typically used for patients with relapsed Hodgkin lymphoma,” Kelly said in a press release. “We’re encouraged at the prospect that these findings, if confirmed in a Phase 3 study, might represent a new standard of care for one of our most common pediatric and young-adult cancers.”
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