Street Calls of the Week
Investing.com -- Aptevo Therapeutics (NASDAQ:APVO) stock surged 57% Tuesday after the clinical-stage biotechnology company announced a 100% remission rate in Cohort 3 of its Phase 1b/2 RAINIER trial for acute myeloid leukemia (AML).
The trial is evaluating mipletamig, Aptevo’s CD123 x CD3 bispecific antibody, in combination with venetoclax and azacitidine for newly diagnosed AML patients unfit for intensive chemotherapy. The company reported that no dose-limiting toxicities or cytokine release syndrome have been observed in the trial.
The complete remission rate achieved at the highest dose level tested so far demonstrates mipletamig’s potential to improve frontline treatment options for AML patients. Additionally, 40% of patients treated have achieved minimal residual disease (MRD)-negative status, a marker associated with improved overall outcomes.
"Cohort 3 demonstrates the kind of progress that changes expectations for frontline AML therapy," said Marvin White, President and CEO of Aptevo. "Delivering a 100% remission rate reinforces our conviction that mipletamig is more than an active agent—it’s a differentiated medicine designed to integrate with the venetoclax and azacitidine backbone and elevate outcomes for patients who have had too few options for too long."
The company noted that frontline AML represents a multibillion-dollar global market where current standard treatments achieve lower remission rates than those observed in the RAINIER trial.
Aptevo reported that Cohort 3 enrollment is complete and Cohort 4 is actively enrolling patients at the next dose level. The company expects to present current findings at a major medical conference in the fourth quarter.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.