Aptevo Therapeutics (APVO) Announces Positive Phase 2 Data for Otlertuzumab

December 16, 2016 9:09 AM

Aptevo Therapeutics Inc. (Nasdaq: APVO) announced the publication of positive data from a Phase 2 clinical trial evaluating its proprietary humanized monospecific anti-CD37 protein therapeutic, otlertuzumab. The results were recently published in the British Journal of Haematology (BJH).

“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 Marvin L. White, President and Chief Executive Officer. “These data, coupled with additional results from ongoing studies of otlertuzumab used in combination with current CLL therapies should help position otlertuzumab for a potential partnership to advance into Phase 3 clinical development.”

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. Scott Stromatt, Chief Medical Officer for Aptevo. “These latest data show the combination of otlertuzumab and bendamustine is well tolerated and significantly increases the response rate and PFS in patients with relapsed or refractory CLL. Consequently we are now exploring the utility of otlertuzumab in combination with additional CLL therapies to evaluate clinical benefit in distinct CLL patient subgroups.”

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.


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