Roche's Gazvya edges Rituxan in Phase 3
- Roche's cancer drug Gazyva (obinutuzumab) slightly edged out the Swiss giant's aging Rituxan (rituximab) in extending overall survival rates among patients with previously untreated follicular lymphoma, according to updated trial results presented Monday.
- The GALLIUM study showed Gazyva reduced the risk of disease worsening or death (progression-free survival) by 34% compared to Rituxan, meeting its primary endpoint, the company said.
- But the overall survival rate at 3 years for those patients treated with Gazyva — 94% — was only slightly better than the 92.1% rate seen in the Rituxan arm. And Gazyva led to more frequent occurrence of Grade 3 or higher adverse events, raising some concerns about Gazyva's profile.
Roche hopes Gazyva can take the place of Rituxan, which will soon face greater competition from biosimilars. Sales have seen modest growth through the first three quarters of 2016, totaling $142 million so far.
Continued expansion of Gazyva's indication is a key part of Roche's growth plans. The Swiss pharma had announced Gazyva met its progression-free survival endpoint in GALLIUM this past May, but detailed results were presented at the annual meeting of the American Society of Hematology.
At first glance, the results give Gazyva an edge over Rituxan, but the drug only marginally increased survival over the long term. With a riskier safety profile, the competitive edge of Gazyva might be lessened.
Gazyva failed a Phase 3 trial in diffuse large B-cell lymphoma earlier this year as well.
Follicular lymphoma is the most common slow-growing form of non-Hodgkin’s lymphoma (NHL), making up around one in five of all cases of the disease. Over 14,000 new cases of follicular lymphoma are identified each year in the U.S. Patients often go through cycles of remission and relapse, but the overall disease is thought to be incurable.
Gazyva targets CD20, a protein found on B-cells, and has received regulatory approvals in chronic lymphocytic leukemia and in second-line treatment of follicular lymphoma.
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