Tanja Obradovic: Can We Expect Rapid Arrival to the Bedside of the First in Class B7-H3-Directed Antibody Drug Conjugate?
Tanja Obradovic, Oncology Medical Strategy Advisor at Mercurial AI, shared a post on Linkedin:
“Can we expect rapid arrival to the bedside of the first in class B7-H3-directed antibody drug conjugate (ADC)?
Late-stage clinical portfolio of ifinatamab deruxtecan (I-DXd), a potentially first in class B7-H3-directed antibody drug conjugate (ADC), is rapidly expanding as Merck and Daiichi Sankyo announce first patient dosing in recently opened IDeate-Prostate01 Phase III trial (NCT06925737). Trial has dual primary goals of radiographic progression-free survival and overall survival and it will evaluate efficacy and safety of I-DXd (12mg/kg) vs docetaxel (75mg/m²) + corticosteroid in patients with metastatic castration-resistant prostate cancer (mCRPC).
This Phase III is joining two other Phase III ongoing trials of ifinatamab deruxtecan. Mid last year Phase III of I-DXd versus physician’s choice in patients with relapsed small cell lung cancer (SCLC) (IDeate-Lung02, NCT06203210) started while last month first patient was dosed in Phase III Ideate-Esophageal01 trial (NCT06644781), evaluating I-DXd in patients with unresectable advanced or metastatic oesophageal squamous cell carcinoma (SCC).
Important to point is strategic approach in program development as early signals guiding indication choices that enabled rapid expansion into Phase III trials are evaluated in Phase Ib/II IDeate-PanTumor02 trial (NCT06330064). IDeate-PanTumor02 trial may yield additional tumor indication signals sufficient for starting Phase III. In terms of specific indication plans and possible relevant future combinations, as of now Phase 1/2, umbrella sub-study is ongoing to evaluate safety and efficacy of I-DXd in combinations in patients mCRPC) (IDeate-Prostate02, NCT06863272).”
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