Bristol-Myers Squibb (BMS) and Seattle Genetics have agreed to expand their clinical collaboration and carry out a Phase III study evaluating a combination of BMS’ programmed cell death protein 1 (PD-1) checkpoint inhibitor Opdivo® (nivolumab) with Seattle’s antibody–drug conjugate (ADC) Adcetris® (brentuximab vedotin) in patients with classical Hodgkin lymphoma (HL). The global, open-label trial is projected to start this year and will compare Opdivo and Adcetris combination therapy with Adcetris monotherapy in patients with relapsed/refractory HL who are ineligible for or who have failed autologous stem cell transplantation.
Adcetris and Opdivo combination therapy is already being evaluated in multiple Phase I/II studies for a range of HL and non-HL indications, including T-cell lymphomas, and B-cell malignancies, including diffuse large B-cell lymphoma.
“We are evaluating Adcetris in novel combinations in order to identify optimal treatment regimens for patients with CD30-expressing lymphomas,” stated Jonathan Drachman, M.D., CMO and evp for R&D at Seattle Genetics. “We are pleased to expand this collaboration with Bristol-Myers Squibb to evaluate Adcetris compared to the combination of Adcetris and Opdivo in a pivotal Phase III study in relapsed HL.”
“Our collaboration with Seattle Genetics combines our experience and understanding of HL and a shared goal of providing patients with additional treatment options,” added Fouad Namouni, M.D., head of oncology development at BMS. “We look forward to initiating our registrational study of Adcetris and Opdivo in patients with relapsed Hodgkin lymphoma.”
BMS and Seattle’s agreement to expand their clinical collaboration follows just days after BMS inked separate deals with Advaxis and with Array BioPharma to evaluate Opdivo and/or Yervoy® (ipilumab) in combination with Advaxis’ ADXS-DUAL immunotherapy against cervical cancer, and with Array’s MEK inhibitor binimetinib against colorectal cancer.
Opdivo first achieved regulatory approval in Japan in 2014 for treating patients with unresectable melanoma. The drug has since been approved in multiple geographies, including the U.S., either as monotherapy or in combination with Yervoy for multiple tumor types.
Adcetris was first approved by the FDA in 2011 for treating HL and is now standard of care for the HL indication, Seattle maintains. In May 2016, Opdivo was granted FDA accelerated approval for treating classical HL that has relapsed or progressed after autologous hematopoietic stem cell transplantation and subsequent Adcetris therapy.