MSD and Daiichi Sankyo have announced first subject dosing in the randomised IDeate-Prostate01 Phase III trial of ifinatamab deruxtecan (I-DXd) against docetaxel in individuals with metastatic castration-resistant prostate cancer (mCRPC).
I-DXd is a potential first-in-class B7-H3-directed antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being co-developed with MSD.
Go deeper with GlobalData
The open-label, multicentre, randomised trial assesses the ADC in mCRPC patients with progression of the disease during or post-treatment with an androgen receptor pathway inhibitor.
It aims to assess the efficacy and safety of 12mg/kg of I-DXd with docetaxel (75mg/m²) + corticosteroid.
The trial’s dual primary goals are radiographic progression-free survival and overall survival, with secondary endpoints including objective response rate and time to various progression metrics.
Around 1,440 subjects are expected to be enrolled in the IDeate-Prostate01 trial across regions, including Oceania, Europe, Asia, and North America.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataThe start of the trial follows the IDeate-PanTumor01 Phase I/II trial outcomes, which were presented at the European Society of Medical Oncology (ESMO) Congresses in 2022 and 2023.
These results showed encouraging responses in heavily pretreated mCRPC subjects.
Daiichi Sankyo therapeutic area oncology development head Mark Rutstein said: “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.”
Daiichi Sankyo and MSD’s partnership, which began in October 2023, encompasses the co-development and commercialisation of patritumab deruxtecan (HER3-DXd), raludotatug deruxtecan (R-DXd), and I-DXd.
Daiichi Sankyo retains exclusive rights in Japan and is solely responsible for manufacturing and supply.
Last August, the companies expanded their agreement to include the joint development and commercialisation of gocatamig worldwide, with MSD holding exclusive rights in Japan and taking charge of manufacturing and supply.
Furthermore, the companies announced last month the first subject dosing in the Phase III Ideate-Esophageal01 trial, assessing I-DXd in individuals with unresectable advanced or metastatic oesophageal squamous cell carcinoma (SCC).
ADC content on Pharmaceutical Technology (Or Clinical Trials Arena) is supported by Syngene. Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content.
