Seattle Genetics and BMS announce initiation of Phase I/II clinical trial of Adcetris in combination with Opdivo in relapsed or refractory non-Hodgkin lymphoma

Second of two planned trials combining Adcetris and Opdivo under clinical collaboration agreement.

This is the second of two trials being conducted under a previously announced clinical trial collaboration agreement between BMS and Seattle Genetics. Adcetris is an antibody-drug conjugate (ADC) directed to CD30, a marker expressed on Hodgkin lymphoma (HL) and several types of NHL, which combines the targeting ability of a monoclonal antibody with a highly potent cell-killing agent. Recent preclinical data suggest that Adcetris causes immunogenic cell death of tumor cells, providing rationale for combination with Opdivo, a human antibody that targets and inhibits the programmed death receptor-1 (PD-1), resulting in T-cell activation. Opdivo is part of a new class of cancer immunotherapy treatments known as checkpoint inhibitors, which are designed to harness the body’s own immune system in fighting cancer by targeting distinct regulatory components of the immune system.

“This is the second corporate-sponsored clinical trial to evaluate Adcetris combined with a checkpoint inhibitor to determine if the combination can improve patient outcomes,” said Jonathan Drachman, Chief Medical Officer and Executive Vice President, Research and Development at Seattle Genetics. “This study is a part of a broad development program that includes more than 70 ongoing clinical trials evaluating Adcetris in multiple lines of therapy for Hodgkin and non-Hodgkin lymphoma and as part of novel combinations that could result in improved clinical benefit with manageable safety profiles. Our goal is to establish Adcetris as the foundation of care for CD30-expressing lymphomas.”

The Phase I/II open-label, multi-center, clinical trial is designed to evaluate the safety, tolerability and antitumor activity of Adcetris in combination with Opdivo in patients with relapsed or refractory CD30-expressing NHL. The study will consist of a Phase I dose evaluation portion followed by a single-arm Phase II portion that will expand enrollment to treat disease-specific cohorts with relapsed or refractory DLBCL, PTCL or CTCL at the recommended dose level and treatment schedule. The primary endpoints are safety, tolerability and objective response rate of the combination of Adcetris with Opdivo. The secondary endpoints include duration of response, complete response rate with the combination regimen, duration of complete response, progression-free survival and overall survival. The trial is being conducted at multiple centers in the US, Canada and Europe and is designed to enroll approximately 120 patients.

“BMS continues to strengthen its industry-leading development program for Opdivo and its rapidly expanding hematology portfolio,” said Michael Giordano, senior vice president, Head of Development, Oncology, BMS. “We are pleased to collaborate with Seattle Genetics on clinical research that focuses on novel combination regimens in areas of serious unmet need.”

In addition to the two ongoing Opdivo combination trials under the collaboration with BMS, Adcetris is being evaluated in more than 70 ongoing clinical trials including the ECHELON-1 Phase III trial in frontline HL, the ECHELON-2 PhaseIII trial in frontline mature T-cell lymphoma and the ALCANZA Phase III trial in CTCL. Opdivo is being evaluated either as monotherapy or in combination with other therapies in some of the hardest-to-treat hematologic cancers, including multiple myeloma, chronic myelogenous leukemia, and Hodgkin and non-Hodgkin lymphomas including follicular and DLBCL. Opdivo has Breakthrough Therapy designation for the treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant and brentuximab vedotin.

Adcetris is not currently approved for frontline treatment or for the treatment of NHL other than relapsed systemic anaplastic large cell lymphoma (sALCL). Opdivo is not currently approved for the treatment of lymphoma.