Phase 3 Trial of ICLUSIG® (ponatinib) Met Primary Endpoint in Newly-Diagnosed Ph+ ALL, a Setting with No Targeted Treatments Approved in the US

  • The PhALLCON Study Is the First Global, Phase 3, Registrational, and Only Head-To-Head Clinical Trial Comparing Two TKIs in Frontline Ph+ ALL
  • Primary Endpoint Result Shows Superiority Compared to Imatinib as Assessed by MRD-Negative Complete Remission

OSAKA, Japan and CAMBRIDGE, MA, USA I November 17, 2022 I Takeda (TSE:4502/NYSE:TAK) today announced that the randomized, Phase 3 PhALLCON trial met its primary endpoint, demonstrating that adult patients with newly-diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) treated with ICLUSIG® (ponatinib) plus reduced-intensity chemotherapy achieved higher rates of minimal residual disease (MRD)-negative complete remission (CR) compared to imatinib. MRD-negativity is associated with improvement in long-term outcomes for patients, as reported in literature. ICLUSIG is the only pan-mutational and third-generation tyrosine kinase inhibitor (TKI), targeting BCR::ABL1 and all known single, treatment-resistant mutations, including the most resistant T315I mutation.

“Ph+ ALL is a fast-progressing disease with no targeted treatments currently approved in the frontline 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,” said Awny Farajallah, MD, Head of Global Medical Affairs Oncology at Takeda. “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.”

The PhALLCON study is a Phase 3 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. 

About Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL)

Ph+ ALL is a rare form of ALL that affects approximately 25% of adult ALL patients in the U.S. and is characterized by the presence of an abnormal gene, known as the Philadelphia chromosome. In patients who are Philadelphia chromosome-positive (Ph+), an abnormal chromosome is formed when pieces of chromosomes 9 and 22 switch with each other. This forms a longer chromosome 9 and a shorter chromosome 22, which leads to the development of BCR::ABL1 and is associated with Ph+ ALL.

About ICLUSIG® (ponatinib) tablets

ICLUSIG is a kinase inhibitor targeting BCR::ABL1, an abnormal tyrosine kinase that is expressed in CML and Ph+ ALL. ICLUSIG is a targeted cancer medicine developed using a computational and structure-based drug-design platform, specifically designed to inhibit the activity of BCR::ABL1 and its mutations. ICLUSIG inhibits native BCR::ABL1, as well as all BCR::ABL1 treatment-resistant mutations, including the most resistant T315I mutation. ICLUSIG received full approval from the FDA in November 2016. ICLUSIG is indicated for the treatment of adult patients with chronic-phase (CP) CML with resistance or intolerance to at least two prior kinase inhibitors, accelerated-phase (AP) or blast-phase (BP) CML or Ph+ ALL for whom no other kinase inhibitor is indicated, and T315I+ CML (CP, AP or BP) or T315I-positive Ph+ ALL. ICLUSIG is not indicated and is not recommended for the treatment of patients with newly diagnosed CP-CML.

Takeda’s Commitment to Oncology

Our core R&D mission is to deliver novel medicines to patients with cancer worldwide through our commitment to science, breakthrough innovation and passion for improving the lives of patients. Whether it’s with our hematology therapies, our robust pipeline, or solid tumor medicines, we aim to stay both innovative and competitive to bring patients the treatments they need. For more information, visit www.takedaoncology.com.

About Takeda

Takeda is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people’s lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries and regions. For more information, visit https://www.takeda.com.

SOURCE: Takeda Pharmaceutical Co

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