Phase III trial sees Iclusig besting Glivec in newly-diagnosed frontline Ph+ ALL

Japanese drug major Takeda (TYO: 4502) today revealed that the Phase III PhALLCON trial of Iclusig (ponatinib) for adult patients with newly-diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) met its primary efficacy endpoint in the frontline setting.

The first-of-its kind study demonstrated that adult patients with newly-diagnosed Ph+ ALL treated with Iclusig plus reduced-intensity chemotherapy achieved higher rates of minimal residual disease (MRD)-negative complete remission (CR) compared to Novartis’ (NOVN: VX) Glivec/Gleevec (imatinib).

The PhALLCON study is a Phase III randomized, international, open-label multicenter trial evaluating the efficacy and safety of Iclusig versus imatinib in combination with reduced-intensity chemotherapy as a frontline therapy for adult patients with newly diagnosed Ph+ ALL. In the trial, no new safety signals were observed. Data from this trial will be discussed with regulatory agencies and shared with the scientific community in the future.