Sun Sep 15 13:40:11 UTC 2024: ## Promising Early Results for CLDN6-Targeted ADC DS-9606 in Advanced Solid Tumors
**TOKYO & BASKING RIDGE, N.J., September 15, 2024** – Initial results from a Phase 1 clinical trial of DS-9606, an investigational antibody drug conjugate (ADC) targeting Claudin-6 (CLDN6), show encouraging early signs of clinical activity in patients with advanced solid tumors. These findings were presented at the 2024 European Society for Medical Oncology (#ESMO24) conference.
DS-9606, developed by Daiichi Sankyo, is a modified pyrrolobenzodiazepine (PBD) ADC that specifically targets CLDN6, a protein found in various cancer types, including endometrial, ovarian, and gastric cancers, as well as germ cell tumors (GCT) and non-small cell lung cancer (NSCLC). High levels of CLDN6 have been linked to a poorer prognosis in these cancers, making it a promising target for treatment.
The Phase 1 trial enrolled 53 heavily pre-treated patients with various advanced solid tumors. The safety and tolerability of DS-9606 were evaluated at increasing dose levels, with no dose-limiting toxicities observed. The most common side effects were generally mild and manageable, with the majority of patients experiencing nausea, fatigue, and anemia.
Encouraging preliminary efficacy results were observed in patients receiving doses greater than or equal to 0.072 mg/kg, with four confirmed objective responses, including two in patients with GCT, one in a patient with gastric/esophageal cancer, and one in a patient with NSCLC. In the GCT patients, the two with confirmed objective responses remained on treatment for over six months, and five experienced significant reductions in alpha-fetoprotein and human chorionic gonadotropin tumor markers.
“These initial results of DS-9606 are encouraging, particularly those observed in germ cell tumors, which are known to express CLDN6 and where the majority of patients experienced a reduction in tumor markers,” commented Dr. Manish R. Patel, Director of Drug Development at Florida Cancer Specialists and Sarah Cannon Research Institute.
Enrollment continues in the Phase 1 trial to determine the optimal dose for expansion and further assess the response of various advanced solid tumors to DS-9606.
“While these results provide preliminary proof-of-concept for DS-9606, further clinical evaluation is warranted across different tumor types that are known to express CLDN6,” said Dr. Ken Takeshita, Global Head of R&D at Daiichi Sankyo. “We continue to apply our science and technology expertise to DS-9606, which has been developed from our second antibody drug conjugate platform in order to create potentially new and innovative treatments for certain patients with cancer.”
These early findings suggest that DS-9606 may hold promise as a new treatment option for patients with advanced solid tumors expressing CLDN6. Further clinical evaluation is needed to confirm these findings and determine the full therapeutic potential of this novel ADC.
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