ATNM - Actinium jumps 13% as late-stage trial for leukemia candidate meets main goal

Actinium Pharmaceuticals ( NYSE: ATNM ) added ~13% pre-market Monday after announcing its pivotal Phase 3 trial for lead candidate Iomab-B reached the primary endpoint in active relapsed or refractory acute myeloid leukemia (r/r AML).

The 153-patient SIERRA trial was designed to evaluate Iomab-B against the physician's choice of salvage therapy, such as chemotherapies reflecting the current standard of care for r/r AML.

All patients who received the therapeutic dose of Iomab-B also had access to bone marrow transplant (BMT).

According to the company, following initial complete remission after BMT, Iomab-B met the primary endpoint of durable complete remission (dCR) of six months with a high statistical significance (p<0.0001).

In the Iomab-B arm, 22% of patients achieved dCR, while no patient in the control arm reached dCR. Patients who reached 6-month dCR did not achieve median OS but indicated 92% of 1-year survival and 60% of 2-year survival.

Actinium ( ATNM ) also said the Iomab-B arm showed a "significant improvement" in the secondary endpoint of event-free survival (EFS), with a 78% decline in the probability of an event (Hazard Ratio=0.22, p<0.0001).

The study drug was well tolerated with a favorable safety profile. The sepsis events in the active arm stood at ~6% compared to ~29% in the control arm. Other treatment-related adverse events were also lower in the Iomab-B arm.

In his recent take on Actinium ( ATNM ), Seeking Alpha contributor Bret Jensen focused on Iomab-B development.

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