Takeda and Seattle Genetics to Present Positive Data from Phase 3 ECHELON-1 Clinical Trial Evaluating ADCETRIS® (brentuximab vedotin) in Frontline Advanced Hodgkin Lymphoma

Takeda Pharmaceutical Company Limited & Seattle Genetics, Inc. have announced that data from the Phase 3 ECHELON-1 clinical trial evaluating ADCETRIS (brentuximab vedotin) as part of a frontline combination chemotherapy regimen in untreated advanced classical Hodgkin lymphoma will be presented in the Plenary Scientific Session at the 59^th American Society of Hematology (ASH) annual meeting.

The data were also simultaneously published online  in the New England Journal of Medicine and will be published in the print edition on January 25, 2018. Topline data were reported in June 2017 demonstrating the ECHELON-1 trial met its primary endpoint of a statistically significant improvement in modified progression-free survival (modified PFS) per Independent Review Facility (IRF) versus the control arm. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical Hodgkin lymphoma. ADCETRIS is currently not approved as a frontline therapy for Hodgkin lymphoma.

“For patients with advanced stage Hodgkin lymphoma, approximately one in three do not achieve long-term remission after standard frontline therapy, which is why the results of ECHELON-1 could be important to this group of patients,” said Jesús Gomez Navarro, M.D., Vice President, Head of Oncology Clinical Research and Development, Takeda. “The trial demonstrated that combination treatment with ADCETRIS resulted in a statistically significant improvement in modified progression-free survival versus the control arm. For patients treated with ADCETRIS+AVD, there was a 23 percent reduction in the occurrence of an event, defined as progression, death or need for subsequent anti-cancer therapy for patients not in a complete response, compared to those who were treated with ABVD. We are excited about these clinical trial results and the potential impact ADCETRIS may have in the treatment of patients with advanced stage Hodgkin lymphoma if approved by health authorities for frontline use.”

“The standard of care in the treatment of Hodgkin lymphoma has not changed over the last several decades and there remains an unmet need for additional regimens in frontline treatment. Current regimens include bleomycin, which is known to be associated with unpredictable and potentially fatal pulmonary toxicity,” said Joseph M. Connors, M.D., FRCPC, Clinical Director, Center for Lymphoid Cancer at BC Cancer in Vancouver, Canada. “Increasing the durable response rate with a frontline therapy that also removes bleomycin from the regimen, represents a major step forward for the Hodgkin lymphoma community. Reducing the risk of relapse, is an important concern for patients and their physicians. In the trial, 33 percent fewer patients treated in the ADCETRIS containing regimen required subsequent salvage chemotherapy or high dose chemotherapy and transplant compared to the patients treated with ABVD. Lastly, the safety profile of ADCETRIS+AVD in the trial was generally consistent with that known for the single-agent components of the regimen.”

“The ECHELON-1 Phase 3 clinical trial results were selected by ASH as one of only six abstracts to be featured in the Plenary Scientific Session, and the data were also published simultaneously today in the New England Journal of Medicine. This study represents a bold effort that began more than five years ago to improve upon the current standard of care regimen that has not significantly changed in more than four decades. We’d like to thank the many patients and physicians who participated in this landmark trial,” said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. “These data demonstrate statistically superior activity of an ADCETRIS-containing regimen over ABVD, the current standard of care, including the primary endpoint of modified PFS per IRF, and secondary endpoints trended in favor of the ADCETRIS-containing regimen as well. Importantly, patients treated with the ADCETRIS-containing regimen required fewer subsequent therapies after frontline treatment. The results of the ECHELON-1 study supported FDA Breakthrough Therapy Designation for ADCETRIS in combination with chemotherapy for frontline advanced classical Hodgkin lymphoma, and we recently submitted a supplemental Biologics License Application to the FDA. Our goal is to make this regimen available to patients in the U.S. with advanced Hodgkin lymphoma in the first half of 2018.”

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