Daiichi Sankyo and Merck Launch Phase II/III Clinical Trial of CDH6-Targeted ADC DS-6000a in China for Platinum-Resistant Ovarian, Primary Peritoneal, and Fallopian Tube Cancers
Daiichi-Sankyo
Pharmaceutical R&D Developer
MSD
Pharmaceutical R&D and Manufacturer
On March 7, according to the CDE Clinical Trial Registration Platform, Daiichi Sankyo CDH6 ADC DS-6000a A Phase II/III clinical trial has been initiated in China to treat patients with platinum-resistant, high-grade ovarian cancer, primary peritoneal cancer, or fallopian tube cancer (Registration Number:CTR20240778）。
Source: CDE Official Website
In December last year, Daiichi Sankyo had already registered the initiation of this clinical trial on ClinicalTrials.gov. This time, the part conducted in China has been launched. In February this year, the enrollment of the world's first subject was completed.
DS-6000a(R-Dxd/Raludotatug deruxtecan) is aTargeted CDH6 ADC: Interim analysis data from the Phase I clinical trial presented at the 2022 ASCO meeting showed preliminary promising efficacy in patients with advanced renal cell carcinoma and ovarian cancer.Among them,Latest Results of Monotherapy in Patients with Advanced Ovarian CancerAnnounced at the 2023 ESMO Congress.Results:
Among 50 patients with measurable ovarian cancer treated with DS-6000a (4.8 to 8.0 mg/kg), confirmed by investigator assessmentORR was 46%(95% CI: 32-61), with 1 CR, 22 PRs, and 4 unconfirmed responses observed. The DCR reached 98%. As of the data cutoff date on July 14, 2023, the median DOR was 11.2 months (95% CI: 3.0-NE), and the median PFS was 7.9 months (95% CI: 4.4-12.4).
In a subgroup of 42 patients with a relative baseline reduction in CA-125 (a biomarker used to evaluate whether ovarian cancer responds to treatment), a confirmed ORR of 55% (95% CI: 39–70) was observed. Tumor responses were observed in patients expressing CDH6.AnIn terms of sexuality,DS-6000a AnGender Characteristics and HistoryResearchThe reports are consistent.
Targeted CDH6 ADC Still in Niche Stage, according to the Insight database, currently globallyIn clinical stageAnd the research and development is in an active stateOnly 2 options.
In addition to Daiichi Sankyo's R-Dxd, another drug, CUSP06 (AMT-707), co-developed by OncoC4 and Puzhong Discovery, initiated a Phase I clinical trial in the United States in January this year (Registration Number:NCT06234423), and just yesterday announced the completion of dosing for the first subject;Clinical trial application in China was also granted implied permission last December (Application No.:CXSL2300719）。
In addition, Novartis previously developed HKT288. However, the study was terminated due to the nature (neurological AEs) and frequency of adverse events observed at low doses in Phase I trials, as well as the lack of clear efficacy.
Last October, MSDUp to USD 22 billion in totalIntroducing Daiichi Sankyo's three Dxd-ADC candidate drugs: HER3-DXd (U3-1402), I-DXd (DS-7300a), and R-DXd (DS-6000).Currently, the two companies are actively advancing the development progress of their respective products. HER3-DXd, which targets HER3, had its BLA application accepted by the FDA in December of last year; I-DXd, targeting B7-H3, initiated its first Phase III clinical trial in January this year for SCLC (Registration Number: NCT06203210).
