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news.Teva Pharmaceutical Industries and CureTech's Phase II study of CT-011 met primary endpoint of improved progression-free survival (PFS) in patients who are suffering from Diffuse Large B Cell Lymphoma (DLBCL) following autologous stem cell transplantation.
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CT-011, an experimental anti-PD-1 monoclonal antibody, has also achieved secondary endpoint of overall survival (OS) in the Phase II trial.
Initial analysis demonstrated that 70% of the patients treated with CT-011 were progression-free at the end of the follow-up period, as compared to only 47% in the historical control.
Furthermore, 84% of the patients treated with CT-011 were alive by the end of the follow-up period, compared to only 62% in the historical control.
CureTech CEO Michael Schickler said following the final results, the company will be ready to commence Phase III regulatory studies for the high unmet need in this severe indication.
Teva Innovative Ventures head Aharon Schwartz said when they expanded their collaboration with CureTech in 2008, they did so with the intention of building on CT-011’s success up to that point, and they are pleased with the Phase II data.