Aptevo Therapeutics Says Two Additional Patients In Early-Stage Leukemia Trial Achieve Remission Within 30 Days of Treatment

On Thursday, Aptevo Therapeutics APVO announced two additional frontline Acute Myeloid Leukemia (AML) patients have achieved remission within 30 days of treatment in the RAINIER dose optimization trial of mipletamig in combination with standard of care for patients unfit for intensive chemotherapy.

9 of 10 frontline patients across two trials achieved remission when receiving the triplet combination of mipletamig + venetoclax + azacitidine (ven/aza).

Notably, no cytokine release syndrome (CRS) has been reported in the RAINIER trial to date.

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The data builds on previously reported favorable outcomes from RAINIER’s Cohort 1 and the completed dose expansion trial where 100% of frontline patients achieved remission.

Together with the addition of these interim Cohort 2 results, mipletamig has achieved a compelling overall remission rate of 90% among frontline patients, outperforming the doublet remission rate from a venetoclax + azacitidine-only study of 66%.

Additionally, the frontline patient triplet therapy complete remission (CR) rate of 70% outperforms the CR rate from a venetoclax + azacitidine only study of 36% (Viale-A Pivotal trial).

Thus far, all RAINIER patients who achieved remission remain in remission.

Cohort 2 will include six patients dosed at the 18mcg level, the same dose used in combination with ven/aza in the completed expansion trial.

Three patients evaluable for efficacy achieved the following outcomes:

• Two patients achieved remission within 30 days of being dosed.
• One patient progressed after the first cycle and passed away for reasons unrelated to study drugs.
• Cohort 2 enrollment is nearing completion.

In December 2024, Aptevo Therapeutics announced that 100% of patients achieved remission within 30 days in Cohort 1 of the RAINIER frontline acute myeloid leukemia (AML) Phase 1b trial, including two patients who experienced complete remission with minimal residual disease (MRD)-negative status (100% elimination of cancer cells).

Price Action: APVO stock is 2.66% at $2.70 at the last check Thursday.

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