Takeda to present data from the ICLUSIG (ponatinib) Clinical Trial Program that Could Prove Practice-Changing for the Treatment of Chronic-Phase CML


TAKEDA Pharmaceutical Company Limited today announced that interim analysis data from the Phase 2 OPTIC (Optimizing Ponatinib Treatment In CML) trial will be presented during an oral session at the virtual 56th American Society of Clinical Oncology, ASCO, Annual Meeting and the 25th European Hematology Association (EHA) Annual Meeting.

The OPTIC trial is an ongoing, randomized, open-label study prospectively evaluating response-based dosing regimens of ICLUSIG, ponatinib, over a range of three starting doses (45-, 30-, or 15-mg) with the aim of optimizing its efficacy and safety in patients with chronic-phase chronic myeloid leukemia, CP-CML, who are resistant or intolerant to prior tyrosine kinase inhibitor, TKI, therapy.

With a median follow-up of approximately 21 months, data from the interim analysis of OPTIC show that the optimal benefit-risk profile for ICLUSIG in patients with CP-CML is achieved with a daily starting dose of 45-mg and, upon achieving ≤1% BCR-ABL1, dose reduction to 15-mg. This dosing regimen resulted in an adjudicated arterial occlusive event (AOE) rate of 5.3%.

“These data help revise our understanding of how to treat with ICLUSIG to optimize the benefit-risk in chronic-phase CML patients who are resistant or intolerant to prior TKIs – which was demonstrated in the 45-mg followed by dose reduction to 15-mg regimen – while maintaining a manageable safety profile,” said Jorge Cortes, MD, Georgia Cancer Center at Augusta University, and an OPTIC trial principal investigator.

“It is also important to note that clinical benefit was observed in all three starting doses in this population of patients who were resistant to multiple prior TKIs, and the majority had not demonstrated responses better than a complete hematological response to the immediate prior TKI.”

Takeda will be discussing these data with the U.S. Food and Drug Administration (FDA). The complete primary analysis of the OPTIC trial will be conducted and presented at a later date.

“ICLUSIG has been an effective treatment option for appropriate CML patients since its FDA approval in 2012,” said Christopher Arendt, Head, Oncology Therapeutic Area Unit, Takeda.

“These data provide additional context around the safety profile of ICLUSIG, a third-generation targeted inhibitor of BCR-ABL1, and may provide further guidance on how to reduce the risk of arterial occlusive events, a concern that we believe has limited patient access to ICLUSIG in the past. We are excited about the OPTIC findings, and we intend to submit these data to the U.S. FDA as quickly as possible as part of a supplemental New Drug Application.”

Interim Analysis (IA) of OPTIC: A Dose Ranging Study of Three Starting Doses of Ponatinib (PON).

Key findings, to be presented by Dr. Jorge Cortes, include:

  • By the interim analysis (IA; cutoff date of July 2019) with median follow-up time of approximately 21 months, 77% (n/N=216/282) of patients in the OPTIC trial were evaluable for the primary endpoint.
  • The OPTIC IA shows benefit of ponatinib in all three starting doses in a largely resistant population where the majority of patients (>60%) demonstrated a complete hematological response, CHR, or lower response to immediate prior therapy.
  • The maximum rates of ≤1% BCR-ABL1 IS at 12 months were achieved in the 45-mg/day starting dose cohort (38.7%), and responses were maintained with the dose reduction to 15-mg/day.
  • With the protocol-mandated dose reduction for response in the higher dose cohorts, 75% of patients in the 45-mg cohort and 88% of patients in the 30-mg cohort were Ferring and Igenomix collaborate to advance care in reproductive medicine, maternal health Ferring Pharmaceuticals and Igenomix today announced a two-year research collaboration aimed at the discovery of novel targets and disease mechanisms in infertility and pregnancy-related conditions, including preeclampsia, with the goal of developing innovative diagnostic and therapeutic strategies in these areas of high unmet need.

A new research hub will be created in Boston, bringing together scientists and expertise from both companies. The hub will focus on investigating molecular signatures, developing novel functional genomic systems and creating translational tools to study for embryo implantation, endometrial microbiome interaction and decidualization biology to drive innovative solutions for patients.

“Today, 1 in 6 couples worldwide are affected by fertility issues, with embryo implantation being a critical step to improving success rates in assisted reproduction technologies (ART) such as IVF. Furthermore, between 3 and 5% of all pregnancies are affected by preeclampsia, 1 a severe complication which increases the morbidity and mortality of both mother and baby, said Joan-Carles Arce, Senior Vice President of Reproductive Medicine and Maternal Health, Ferring.

Through this collaboration, we aim to advance diagnostic testing and the discovery of candidate drug targets in these areas of high unmet need and ultimately help more people build healthy families worldwide.”

“This new research hub will connect Igenomix’s unique diagnostic capabilities with Ferring’s deep therapeutic expertise, said Professor Carlos Simón, Head of Scientific Board of Igenomix Foundation and Project Lead for the new hub. We believe this collaboration will accelerate scientific findings and improve conception rates at a time when significant progress is needed in preimplantation science to help more women and families experience healthy pregnancies.”


About Fertility Issues

The World Health Organization defines infertility as a disease of the reproductive system defined by the failure to achieve a clinical pregnancy after 12 months or more of regular unprotected sexual intercourse.

Today, 1 in 6 couples worldwide are affected by fertility issues. Assisted Reproductive Technologies, ART, such as In Vitro Fertilisation (IVF) and Intracytoplasmic Sperm Injection (ICSI) can help couples who have problems.

– June 04, 2020 @ 18:20 GMT |

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