Chiatai Tianqing is conducting the "Randomized, controlled, double-blind, dual-simulation, multicenter Phase III clinical study to evaluate D1553 versus docetaxel for the treatment of locally advanced or metastatic non-small cell lung cancer with KRAS G12C mutation-positive lung cancer that has failed previous standard therapy (D1553-III-01)" nationwide. Recently, the project has completed the enrollment and successful dosing of the first subject.

Garsorasib is a novel targeted KRAS G12C mutation inhibitor, registered under the classification of chemical drug class 1, is the first self-developed KRAS G12C inhibitor in China that has entered the clinical trial stage, and is included in the breakthrough therapeutic varieties by the CDE. on December 29, 2023, the National Drug Administration (NMPA) has accepted Garsorasib's New Drug Marketing Application for the treatment of locally advanced or metastatic non-small cell lung cancer with disease progression or intolerable disease after prior first-line systemic therapy and with the presence of a KRAS G12C mutation confirmed by testing.

Updated results from a Phase 2 clinical trial of Garsorasib in patients with non-small cell lung cancer (NSCLC) with KRAS G12C mutations were presented in April 2024 at the American Cancer Society Annual Meeting (AACR). The study results showed that Garsorasib had an objective remission rate (ORR) of 50%, a disease control rate (DCR) of 89%, a median duration of remission (DOR) of 12.8 months, and a median progression-free survival (PFS) of 7.6 months. No new safety signals were identified in the study and most adverse events were well controlled. Also, there were no drug-related adverse events (TRAEs) that led to permanent discontinuation.

In NSCLC patients harboring the KRAS G12C mutation, Garsorasib showed a higher rate of tumor remission and a longer duration of remission; it was also well tolerated in terms of safety. Currently, the D1553-III-01 program is recruiting nationally as a Phase 3 confirmatory clinic for Garsorasib. Garsorasib is expected to be a promising treatment option for this patient population with unmet medical needs.

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