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Bristol, Seattle Genetics redo pact to back Phase 3 of lymphoma combo med

June 3, 2017

Six months after touting positive data from a Phase I/II combination study of Opdivo and Adcetris in patients with relapsed or refractory classical Hodgkin lymphoma at the American Society of Hematology, Bristol-Myers Squibb (BMY) and Seattle Genetics (SGEN) are plowing forward into a Phase III trial.

This morning, BMS and Seattle Genetics announced the two companies will evaluate the combination of Seattle Genetics’ Adcetris and BMS’ PD-1 inhibitor Opdivo against Adcetris alone. ADCETRIS is an ADC directed to CD30, a defining marker of classical HL, which combines the targeting ability of a monoclonal antibody with the potency of a cell-killing agent. Opdivo is a human programmed death receptor-1 (PD-1) blocking antibody that binds to the PD-1 receptor expressed on activated T-cells and other immune cells. In December, the companies showed data that 90 percent of the small patient population showed an objective response rate.

The two companies said the study is expected to begin later this year. The Phase III trial will be a randomized, open-label study in classical HL patients with relapsed/refractory disease who are ineligible for autologous stem cell transplant (ASCT) or after failure of ASCT, the companies said.

Jonathan Drachman, chief medical officer at Seattle Genetics, said the goal of pairing Adcetris with Opdivo is to “identify optimal treatment regimens for patients with CD30-expressing lymphomas.” Drachman added that Adcetris, which was approved by the Food and Drug Administration in 2011, has become the standard of care for relapsed Hodgkin lymphoma, with more than 20,000 patients treated.

“Clinical collaborations enable our pursuit of innovative combinations of therapies that may offer the potential of improved outcomes for patients with difficult to treat cancers,” Fouad Namouni, head of oncology development at Bristol-Myers Squibb, said in a statement.

BMS’ Opdivo (nivolumab) is Bristol-Myers PD-1 immune checkpoint inhibitor. It was the first PD-1 inhibitor to receive regulatory approval, but over the past year has run into some trouble, including a failed Phase III trial as a monotherapy for a “broad patient population” in patients with previously untreated advanced non-small cell lung cancer. Strong sales of Opdivo, along with BMS’ other cancer drugs, propelled the company to a stronger-than-expected first quarter.

This is not the only combination trial of Opdivo and Adcetris the two companies are running. The combination is also being explored in several ongoing Phase I/II trials, which include studies of patients with relapsed or refractory Hodgkin lymphoma and CD30-expressing relapsed or refractory non-Hodgkin lymphomas, including T-cell lymphomas, diffuse large B-cell lymphoma (DLBCL), and other rare subtypes of B-cell malignancies, such as mediastinal B-cell lymphoma and mediastinal gray zone lymphoma. In addition, the Adcetris and Opdivo combination is being evaluated for older HL patients and relapsed/refractory classical HL for children, adolescents and young adults. The potential successes of the drug combinations could prove to be strong revenue drivers for both companies.

Classical Hodgkin lymphoma is the most common type of HL, accounting for 95 percent of cases. Classical HL is distinguished from other lymphomas by the characteristic presence of CD30-positive Reed-Sternberg cells. According to the American Cancer Society, more than 8,000 cases of HL will be diagnosed in the United States during 2017 and approximately 1,000 will die from the disease.

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