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“We’re very encouraged by the Phase 2 data, which demonstrated a significant increase in median progression free survival, from approximately 10 to 16 months in patients receiving combination otlertuzumab/bendamustine therapy,” said
The publication, entitled, “Randomized Phase 2 Study of Otlertuzumab and Bendamustine Versus Bendamustine in Patients with Relapsed Chronic Lymphocytic Leukemia,” discusses the results of a multi-center Phase 2 clinical trial comparing the efficacy and safety of otlertuzumab in combination with bendamustine to bendamustine alone in patients with relapsed chronic lymphocytic leukemia (CLL). The data show an improved overall response rate and progression free survival with combination otlertuzumab/bendamustine therapy.
“While substantial advances in the treatment of CLL have been made over the last several years, there is still a significant unmet medical need for safe and effective new combination therapies to treat the many CLL patients that eventually will experience a relapse or discontinue therapy due to adverse events,” remarked Dr.
The data published in BJH suggest that combination therapy with otlertuzumab may improve outcomes for CLL patients. In previous studies Aptevo has shown that otlertuzumab in combination with rituximab, obintuzumab or idelalisib is clinically active and appears to have a good safety and tolerability profile. Based on this promising body of data, Aptevo is further exploring its utility in subgroups of CLL patients who have either (i) not achieved a complete response after one year of therapy with ibrutinib, or (ii) in patients who are developing a resistant clone to ibrutinib but have not yet experienced a clinical relapse.
About the Phase 2 Clinical Trial
A total of 65 patients participated in the study with 32 receiving a combination of otlertuzumab and bendamustine and 33 receiving bendamustine alone. The primary endpoint in the clinical trial was overall response rate (ORR), as measured by the 2008
Phase 2 Clinical Trial Results
The study demonstrated that otlertuzumab combined with bendamustine significantly increased overall response rate, which was 69% for the combination compared to 39% for bendamustine alone (p=0.025). In addition, the combination showed an improvement in median progression free survival, which was 15.9 months in the otlertuzumab/bendamustine combination treatment arm compared to 10.2 months in the bendamustine treatment arm (p=0.0192). Otlertuzumab in combination with bendamustine was generally well tolerated, although there was a higher incidence of pyrexia (34% vs. 12%) and neutropenia (59% vs. 39%) with the combination, however, this did not result in a higher incidence of severe (grade 3 or 4) infections.
The full publication in the
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Aptevo Therapeutics Stacey JurchisonSenior Director, Investor Relations and Corporate Communications 206-859-6628 JurchisonS@apvo.com