Onco-Summaries: Daily Oncology Updates at a Glance

18/06/2025

The Phase 3 IDeate-Prostate01 trial of ifinatamab deruxtecan has been initiated in pretreated, metastatic CRPC patients (Ref)

• The first patient has been dosed in the Phase 3 IDeate-Prostate01/NCT06925737 trial evaluating Daiichi Sankyo and Merck & Co./MSD's ifinatamab deruxtecan (I-DXd; B7-H3 ADC) vs docetaxel in patients with metastatic castration-resistant prostate cancer (CRPC) with disease progression during or after treatment with an androgen receptor pathway inhibitor.

• This multicenter, open-label, randomized trial will enroll ~1,440 patients and evaluate OS and radiographic PFS as the primary endpoints

• Mark Rutstein, Head, Therapeutic Area Oncology Development, Daiichi Sankyo: “Despite the emergence of new therapies, the current treatment landscape for patients with metastatic castration-resistant prostate cancer is challenging, and there is a need for new treatments. Following the promising results seen in our earlier phase trial, IDeate-Prostate01 has been initiated to evaluate whether ifinatamab deruxtecan may replace standard taxane-based chemotherapy as a potential treatment strategy in patients with metastatic castration-resistant prostate cancer with disease progression during or after treatment with androgen receptor pathway inhibitors.”

  
  

• Marjorie Green, SVP and Head of Oncology, Global Clinical Development, Merck Research Laboratories: “IDeate-Prostate01 marks the initiation of the third pivotal trial in the ifinatamab deruxtecan development program and reinforces our commitment to addressing critical unmet needs for patients. Our continued progress in the exploration of this potential first-in-class B7-H3 antibody drug conjugate in collaboration with Daiichi Sankyo, speaks to our pursuit of novel science in the hopes of making a difference for patients in need of new options.”