- Phase 3 trial of ifinatamab deruxtecan for metastatic castration-resistant prostate cancer (mCRPC) initiated.
- Trial compares ifinatamab deruxtecan to standard docetaxel treatment.
- Daiichi Sankyo (4568) and Merck (MRK, Financial) are jointly developing this investigational drug.
The IDeate-Prostate01 Phase 3 trial has begun, marking a significant step in testing ifinatamab deruxtecan, a potential first-in-class B7-H3 directed antibody drug conjugate (ADC), against the standard docetaxel regimen in patients with metastatic castration-resistant prostate cancer (mCRPC). This trial aims to evaluate the safety and efficacy of this investigational drug.
Ifinatamab deruxtecan, developed jointly by Daiichi Sankyo and Merck (MRK, Financial), targets patients who have shown disease progression despite prior androgen receptor pathway inhibitor treatments. The trial hopes to ascertain if ifinatamab deruxtecan can surpass current taxane-based chemotherapy, offering a new hope for patients facing poor prognosis with previously treated mCRPC.
The trial will enroll approximately 1,440 patients across various continents, focusing on two primary endpoints: overall survival and radiographic progression-free survival. Secondary endpoints include response rates and safety measures. This development follows promising results from earlier phase trials presented at the European Society of Medical Oncology (ESMO) Congresses, highlighting ifinatamab deruxtecan's potential in heavily pretreated mCRPC patients.
