Trial of ponatinib regimen for ALL subset meets primary endpoint
The addition of ponatinib to chemotherapy increased the minimal residual disease-negative complete remission rate for certain adults with acute lymphoblastic leukemia, according to the agent’s manufacturer.
Ponatinib (Iclusig, Takeda) is a tyrosine kinase inhibitor that targets BCR-ABL1, which is expressed in chronic myeloid leukemia and Philadelphia chromosome-positive ALL.
The randomized phase 3 PhALLCON trial evaluated the efficacy and safety of reduced-intensity chemotherapy plus either ponatinib or imatinib as a front-line therapy for adults with newly diagnosed Ph+ALL.
The open-label, multicenter trial met its primary endpoint, with results showing a higher rate of minimal residual disease-negative complete remission in the ponatinib group.
“Ph+ALL is a fast-progressing disease with no targeted treatments currently approved in the front-line [setting] for patients in the U.S. There is an urgent need for an effective treatment that can suppress the development of difficult-to-treat mutations, which are associated with poor long-term outcomes,” Awny Farajallah, MD, head of global medical affairs for oncology at Takeda, said in a company-issued press release. “We are excited to see how Iclusig may be able to address this gap in care for these patients and look forward to sharing the results.”
Researchers observed no new safety signals with ponatinib in the PhALLCON trial.
The most common adverse reactions reported among ponatinib-treated patients include rash and related conditions, arthralgia, abdominal pain, headache, constipation, dry skin, hypertension, fatigue, fluid retention and edema, pyrexia, nausea, pancreatitis/lipase elevation, hemorrhage, anemia, hepatic dysfunction and arterial occlusive events.
The most common grade 3 or grade 4 laboratory abnormalities include decreased platelet count neutrophil cell count and white blood cell count.
Complete data from PhALLCON will be discussed with regulatory agencies and shared at a scientific meeting, according to the press release.