Seattle Genetics, BMS Partner in Immuno-OncologyBy
Seattle Genetics, Inc. and Bristol-Myers Squibb have initiated a Phase I/II clinical trial of Seatlle Genetics’ antibody drug conjugate (ADC) Adcetris (brentuximab vedotin), in combination with Bristol-Myers Squibb’s immuno-oncology drug, Opdivo (nivolumab), for treating patients with CD30-expressing relapsed or refractory B-cell and T-cell non-Hodgkin lymphomas (NHL), including diffuse large B-cell lymphoma (DLBCL), peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL).
This is the second of two trials being conducted under a previously announced clinical trial collaboration agreement between Bristol-Myers Squibb Company and Seattle Genetics.
Adcetris is an ADC directed to CD30, a marker expressed on Hodgkin lymphoma (HL) and several types of NHL. It consists of an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics' proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells. CD30 is a member of the tumor necrosis factor receptor (TNFR) superfamily.
Adcetris is approved in the US for three indications: (1) regular approval for the treatment of patients with classical HL after failure of autologous hematopoietic stem cell transplantation (auto-HSCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates, (2) regular approval for the treatment of classical HL patients at high risk of relapse or progression as post-auto-HSCT consolidation, and (3) accelerated approval for the treatment of patients with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen.
Seattle Genetics and Takeda Pharmaceutical Company Limited are jointly developing Adcetris. Under the terms of the collaboration agreement, Seattle Genetics has US and Canadian commercialization rights and Takeda has rights to commercialize Adcetris in the rest of the world. Seattle Genetics and Takeda are funding joint development costs for Adcetris on a 50:50 basis, except in Japan where Takeda is solely responsible for development costs.
Opdivo is 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. Opdivo has regulatory approval in more than 40 countries including the United States, Japan, and the European Union. Bristol-Myers Squibb has a broad, global development program to study Opdivo in multiple tumor types consisting of more than 50 trials as a monotherapy or in combination with other therapies, in which more than 8,000 patients have been enrolled worldwide
Source: Bristol-Myers Squibb