SOUTH SAN FRANCISCO (dpa-AFX) - Genentech, a member of Swiss drug major Roche Group (RHHBY) announced Sunday positive results from the randomized Phase II GO29365 study, which showed its investigational Polatuzumab Vedotin plus Bendamustine and Rituxan (BR) increased complete response rates.
The study compared polatuzumab vedotin in combination with bendamustine plus Rituxan (rituximab) (BR) against BR alone in people with relapsed or refractory diffuse large B-cell lymphoma or DLBCL who are not candidates for hematopoietic stem cell transplant.
The study met its primary endpoint, demonstrating that the addition of polatuzumab vedotin to BR increased complete response or CR rates from 15 percent to 40 percent at the end of treatment, as measured by positron emission tomography or PET and assessed by an independent review committee.
No unexpected safety signals were observed with the addition of polatuzumab vedotin to BR.
These data led to FDA Breakthrough Therapy and EMA PRIME (PRIority MEdicines) designations, the company noted.
The data was presented in a poster session on Sunday, December 10 at the 59th American Society of Hematology Annual Meeting.
Sandra Horning, chief medical officer and head of Global Product Development, said, 'As many as 40 percent of people with diffuse large B-cell lymphoma do not respond to initial therapy or experience the return of their disease, at which point their treatment options are limited and the prognosis is very poor. The promising efficacy observed for polatuzumab vedotin in this study supports its potential as a new treatment option for people previously treated for this aggressive blood cancer, and we look forward to discussing the results with health authorities.'
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