On December 29, 2023, China's National Drug Administration (NMPA) has formally accepted the New Drug Application (NDA) for Garsorasib tablets (D-1553 tablets, KRAS G12C inhibitor) 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. metastatic non-small cell lung cancer.

This NDA acceptance is primarily based on the results of a Phase II single-arm registrational clinical study (Study D1553-102, CDE Registry No. CTR20220745) conducted in China with Professor Lu Shun of Shanghai Chest Hospital as the principal investigator.

Previously, the results of the Phase I clinical study of D-1553 in KRAS G12C mutation-positive non-small cell lung cancer were selected for an oral presentation at the World Conference on Lung Cancer (WCLC) in August 2022 and published in April 2023 in the Journal of Thoracic Oncology1 .

The study results showed that as of September 12, 2022, of the 74 evaluable patients, 30 patients were assessed to be in partial remission (PR) and 38 to have stable disease (SD), with a confirmed objective remission rate (ORR) of 40.5% (95% CI: 29.3-52.6), disease control rate (DCR) of 91.9% (95% CI: 83.2-97.0 ), and a median progression-free survival (PFS) of 8.2 months;

In terms of safety, as of September 12, 2022, of the 79 patients treated, 75 patients (94.9%) reported treatment-related adverse events, the majority of which were Grade 1-2. 38.0% of patients experienced Grade 3 or 4 adverse events, with the majority of Grade 3 or 4 adverse events being manageable and controllable, and only one patient permanently discontinued due to an adverse event. D-1553 was well tolerated at all dose levels, demonstrating a favorable safety profile.

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