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news.Emergent BioSolutions has started a Phase 1b/2 study (16011) to evaluate TRU-016 in conjunction with rituximab and bendamustine in patients with relapsed indolent non-Hodgkin's B-cell lymphomas, as well as small lymphocytic lymphoma, follicular lymphoma, and marginal zone lymphoma.
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Developed under the collaboration with Abbott, TRU-016 is a CD37-directed Small Modular ImmunoPharmaceutical protein therapeutic in development as a treatment for B-cell malignancies.
The company expects to recruit around 88 patients in both the trials in patients with relapsed indolent B-cell lymphoma, and who have failed prior treatments.
The Phase 1b portion of the study aims to establish the Phase 2 dose of TRU-016 given in combination with rituximab and bendamustine.
However, the Phase 2 portion will be an expansion study of approximately 76 additional patients to examine the safety and efficacy of TRU-016 in combination with 375mg/m2 of rituximab and 90 mg/m2 of bendamustine, versus bendamustine and rituximab.
Emergent Clinical Research vice president and chief medical officer Scott Stromatt said the preclinical studies show that when used together, TRU-016 and bendamustine resulted in increased anti-tumor activity beyond results achieved when either drug was administered alone.
"Based on these data, as well as data from our ongoing clinical studies of TRU-016 for chronic lymphocytic leukemia, we believe that TRU-016 in combination with bendamustine and rituximab could produce meaningful results in patients with indolent NHL," Stromatt said.