Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422), a China-based pharmaceutical company, has unveiled plans to present clinical trial data for two of its drugs at the upcoming American Society of Clinical Oncology (ASCO) annual meeting. The company will showcase a Phase I clinical trial for its RET inhibitor, KL590586, in advanced solid tumors with RET mutation, and a Phase II expansion study for SKB264, an antibody-drug conjugate (ADC) targeting trophoblast cell-surface antigen 2 (TROP2), in non-small cell lung cancer (NSCLC).
KL590586: A RET Inhibitor for Advanced Solid Tumors
KL590586 is a small-molecule RET inhibitor under development for the treatment of advanced solid tumors with RET fusion or mutation. As of December 30, 2022, the dosing phase of the Phase I dose escalation and expansion Phase I/II study has been completed, with no dose limiting toxicity observed and the maximum tolerable dose (MTD) not reached. The incidence of treatment-related adverse events (TRAEs) was 93.1%, with the majority being level 1 to 2 TRAEs. Preliminary efficacy results showed an overall objective response rate (ORR) of 64% in 69 evaluable patients, with the longest treatment time exceeding 11 months.
SKB264: An ADC Targeting TROP2 for NSCLC
In May 2022, Kelun Pharma entered into a USD 1.41 billion licensing agreement with Merck Sharp & Dohme Corp, granting the US major development and commercial rights to SKB264 for territories outside of Greater China. SKB264 has previously obtained breakthrough therapy designations for use in triple negative breast cancer and NSCLC in China. As of February 9, 2023, the median follow-up time for the I/II study data published in ASCO 2023 was 11.5 months. The ORR in 39 evaluable patients was 44%, the duration of response (DoR) was 9.3 months, and the 6-month DoR rate was 77%. The population with EGFR mutations and previous EGFR-TKI treatment failure had an ORR of 60%, a disease control rate (DCR) of 100%, a median progression-free survival (PFS) of 11.1 months, and a 9-month PFS of 66.7%. The ORR and DCR in EGFR wild-type individuals who had previously failed PD-1/PD-L1 antibody treatment were 26% and 89% respectively, and the median PFS was 5.3 months. The 9-month overall survival (OS) rate was 80.4%. The overall safety of SKB264 was good, with no discontinuations or deaths caused by TRAEs.-Fineline Info & Tech
