Profile Response Detail

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Molecular Profile	Indication/Tumor Type	Response Type	Therapy Name	Approval Status	Evidence Type	Efficacy Evidence	References
RET mutant	Advanced Solid Tumor	predicted - sensitive	EP0031	Phase I	Actionable	In a Phase I trial, EP0031 therapy led to durable responses in RET-mutant advanced solid tumor patients previously treated with a selective RET inhibitor (n=25), including 5 partial responses (PR) and 6 with stable disease (SD) in non-small cell lung cancer patients (n=15), 2 PRs and 2 with SD in medullary thyroid carcinoma patients (n=7), and SD in 1 pancreatic cancer patient, and 1 patient with papillary thyroid carcinoma was stable for 9 months (J Clin Oncol 2025 43: 16_suppl, 8598; NCT05443126).	detail...
RET mutant	Advanced Solid Tumor	predicted - sensitive	EP0031	Phase Ib/II	Actionable	In a Phase I/II trial (KL400-I/II-01), EP0031 treatment was well tolerated and demonstrated preliminary activity in patients with advanced solid tumors harboring mutations in RET, resulting in an objective response rate of 64%, with responses being observed in patients with non-small cell lung cancer, medullary thyroid cancer and pancreatic cancer (J Clin Oncol 41, 2023 (suppl 16; abstr 3007); NCT05265091).	detail...

PubMed Id	Reference Title	Details
	A phase I study of KL590586, a next-generation selective RET inhibitor, in patients with RET-altered solid tumors.	Full reference...
	Final results of a phase 1 study of EP0031, a next generation selective RET inhibitor (SRI) in patients with SRI naïve or pretreated advanced RET-altered tumors.	Full reference...