Aptevo Therapeutics disclosed interim data from two clinical trials of its lead candidate mipletamig combined with venetoclax and azacitidine in newly diagnosed acute myeloid leukemia patients who are elderly or unfit for intensive chemotherapy.
The combination achieved a clinical benefit rate of 86% (CR/CRi/PR) among 28 evaluable patients, with a complete remission or CRi rate of 79%. No cases of cytokine release syndrome were observed. Fifty‑five percent of CR/CRi patients achieved measurable residual disease–negative status, and four patients progressed to allogeneic stem cell transplant.
The trials included patients with high‑risk genetic features such as TP53 mutations, underscoring mipletamig’s potential to address a population with limited options. The data reinforce Aptevo’s strategy to position mipletamig as a safer, more effective alternative to existing CD123‑targeted therapies.
Chief Medical Officer Dirk Huebner said the data “highlight the differentiated profile we believe is needed to advance treatment in frontline AML” and that the safety profile, including absence of CRS, supports integration with standard regimens. President and CEO Marvin White added that the results “reinforce our conviction that mipletamig may represent a differentiated approach with the potential to complement existing frontline therapies.”
Market reaction was muted, with investors focusing on the company’s path to commercialization and capital requirements rather than the clinical efficacy itself. Analysts noted that while the data are promising, Aptevo remains a clinical‑stage company with no product sales and significant cash burn, and the $60 million equity line of credit extends the runway to 2029.
The announcement follows earlier positive data from the RAINIER study and positions Aptevo to pursue regulatory approval and partnership opportunities. The company’s recent executive transition, with Marvin White moving to Executive Chair and Jeff Lamothe becoming President & CEO, signals a continued focus on advancing mipletamig through development.
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