Dr Vale on Efficacy Data for Blinatumomab Plus Ponatinib in Ph+ B-ALL

“It is vitally important to achieve deep and durable responses [in patients with Ph+ B-ALL] without the risks of allogeneic stem cell transplants whenever possible.”

Colin Vale, MD, an assistant professor in the Department of Hematology and Medical Oncology at the Emory University School of Medicine, discussed long-term efficacy data from a phase 2 trial (NCT03263572) evaluating blinatumomab (Blincyto) in combination with ponatinib (Iclusig) for patients with Philadelphia chromosome (Ph)-positive B-cell acute lymphoblastic leukemia (B-ALL). Additionally, Vale explained why achieving remission while simultaneously avoiding allogeneic stem cell transplant (allo-SCT) is important for patients with Ph-positive B-ALL.

Vale began by highlighting the most important takeaways from the data that was presented, like how many patients achieved long-term remission and minimal residual disease (MRD) per next-generation sequencing. Updated findings presented at the 2025 ASH Annual Meeting and Exposition at a median follow-up of 3 years showed that evaluable patients (n = 65) achieved an overall remission rate of 96%, including a complete remission (CR) rate of 95%. In evaluable patients (n = 67), the overall MRD-negativity rate was 95%, with a median time to MRD negativity of 2.8 months (range, 0.8-51). The median event-free survival (EFS) and overall survival (OS) were both not reached, Vale added. The 3-year EFS and OS rates were 79% and 89%, respectively.

Positive results for remission and MRD suggest the ability of blinatumomab plus ponatinib to draw deep, durable remissions, Vale noted.. Moreover, differing white blood cell (WBC) counts among patients influenced the risk of long-term relapse, Vale added. In patients with a WBC count of at least 70 at baseline, the 3-year cumulative incidence of relapse rate was 31% compared with 6.7% for those with a WBC count below 70 (P = .005).

Vale then moved into a conversation about why treatments that enable patients to achieve durable remissions without procedures like allo-SCT is crucial. Vale mentioned that 70 of 88 patients patients from the trial remain in CR without allo-SCT. While acknowledging the curative potential of allo-SCT, Vale explained the procedure also exposes patients to risks such as infectious complications, graft-vs-host disease (GVHD), relapse, and impairments to quality of life. Vale clarified that despite improving interventions to these risks like conditioning regimens, GVHD prophylaxis and treatment, and post-transplant care, the risks of allo-SCT persist. Due to these persisting risks, Vale concluded by stressing the importance of achieving remission without the procedure whenever possible for patients.