Daiichi Sankyo Launches Global First Phase III Trial of B7-H3 ADC Ifinatamab Deruxtecan in Esophageal Squamous Cell Carcinoma
Daiichi-Sankyo
Pharmaceutical R&D Developer
Screenshot source:China Drug Clinical Trial Registration and Information Disclosure Platform
This is a multicenter, randomized, open-label Phase III study designed to evaluate Ifinatamab Deruxtecan versus investigator's choice of chemotherapy.（ICC）Compared withPreviously received platinum-based systemic therapy and immune checkpoint inhibitors（ICI）In subjects with advanced or metastatic ESCC that is unresectable and has progressed after treatmentEfficacy and safety,The primary endpoint is OS.。The trial involved a total of 171 institutions, with plans to enroll 153 participants in China and 510 internationally.
At the 2023 ESMO Congress, Daiichi Sankyo presentedI/II Phase Clinical Study of Ifinatamab Deruxtecan in Patients with Advanced Solid Tumors（NCT04145622）The positive results. As of January 31, 2023, the study enrolled a total of 28 patients with ESCC, with a median number of treatment lines being 4.Data show that the drug demonstrated controllable safety and favorable antitumor activity.ESCC PatientsORR was 21%,mDoR was 3.5 months, mPFS was 2.8 months, and mOS was 7.0 months.。
Screenshot source:Insight Database
Ifinatamab deruxtecan It is a potential first-in-class ADC targeting B7-H3. The drug is designed using Daiichi Sankyo's proprietary DXd ADC technology and consists of a humanized anti-B7-H3 IgG1 monoclonal antibody linked via a cleavable tetrapeptide linker to a topoisomerase I inhibitor payload.(A derivative of exatecan, DXd)Composed of connections.
In 2023,Daiichi Sankyo and MerckFor inclusion ofIncluding Ifinatamab Deruxtecan, 3 ADC drugs（Patritumab deruxtecan, Ifinatamab deruxtecan, and Raludotatug deruxtecan）To carry out global development and commercialization cooperation,Except for Japan,Daiichi Sankyo reserves exclusive rights in Japan.. In return, Daiichi-Sankyo will receive payments including upfront payments, ongoing payments, and milestone payments.$22 billion。
In January 2024, the drug was launched overseas for the first time.Small Cell Lung Cancer Phase III Clinical Trial, becomingThe World's First B7-H3 ADC to Enter Phase III Clinical Trials。
Insight database shows that, currently, there are no such cases worldwide. B7-H3 ADC Approved for Marketing, but AlreadyThere are 37 itemsB7-H3 ADC Pipeline(Only active status is counted)Under research, 3 products have entered Phase III clinical trials, respectively fromDaiichi Sankyo/Merck（Ifinatamab deruxtecan）、Hansoh Pharma（HS-20093）AndYilian Biologics（YL201）。
Screenshot source:Insight Database
