Bristol-Myers Squibb (BMS) and Seattle Genetics have decided to expand their clinical collaboration and carry out a Stage III study evaluating a combination of BMS’ programmed cell loss of life 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). A global, open-label trial is projected to start this year and will evaluate Opdivo and Adcetris combination therapy with Adcetris monotherapy in patients with relapsed/refractory HL who are ineligible intended for or who have failed autologous stem cell transplantation.
Adcetris and Opdivo combination therapy is already getting evaluated in multiple Phase I/II studies afor a variety of HL and non-Hodgkin lymphoma indications including T-cell lymphomas, and B-cell malignancies including diffuse large B-cell lymphoma.
“ We are evaluating Adcetris in story combinations in order to identify optimal treatment regimens for individuals with CD30-expressing lymphomas, ” stated Jonathan Drachman, Meters. D., chief medical officer and evp for R and d at Seattle Genetics. “ We are pleased to expand this particular collaboration with Bristol-Myers Squibb to evaluate Adcetris compared to the mixture of Adcetris and Opdivo in a pivotal Phase III research in relapsed Hodgkin lymphoma. ”
“ Our collaboration with Seattle Genetics combines our encounter and understanding of Hodgkin lymphoma and a shared goal associated with 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 associated with Adcetris and Opdivo in patients with relapsed Hodgkin lymphoma. ”
BMS and Seattle’ t agreement to expand their clinical collaboration follows simply days after BMS inked separate deals with Advaxis with Array BioPharma to evaluate Opdivo and/or Yervoy ® (ipilumab) in combination with Advaxis’ ADXS-DUAL immunotherapy towards cervical cancer, and with Array’ s MEK inhibitor binimetinib against colorectal cancer.
Opdivo first accomplished regulatory approval, in Japan in 2014, for dealing with patients with unresectable melanoma. The drug has given that been approved in multiple geographies, including the U. H., either as monotherapy or in combination with Yervoy, for several tumor types.
Adcetris was first approved by FOOD AND DRUG ADMINISTRATION in 2011 for treating HL and is now standard associated with care for the HL indication, Seattle maintains. In May 2016 Opdivo was granted FDA accelerated approval for dealing with classical HL that has relapsed or progressed after autologous hematopoietic stem cell transplantation and subsequent Adcetris treatment.