China's First NDA for a KRAS G12C Inhibitor: Innovent Announces the National Medical Products Administration of China Has Accepted and Granted Priority Review Designation to the New Drug Application for IBI351
November 24 , 2023
By Innovent Biologics, 23 Nov, 2023, 19:38 ET

ROCKVILLE, Md. and SUZHOU, China, Nov. 23, 2023 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, metabolic, autoimmune, ophthalmology and other major diseases, announces that the New Drug Application (NDA) for IBI351 (KRAS G12C inhibitor) has been accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China and granted Priority Review designation[1], for the treatment of patients with advanced non-small cell lung cancer (NSCLC) harboring KRAS G12C mutation who have received at least one systemic therapy. It is China's first NDA for a KRAS G12C inhibitor and is anticipated to benefit more lung cancer patients harbouring KRAS G12C mutation after approval.

The NDA acceptance and Priority Review designation are based on the results from a single-arm registrational Phase 2 clinical study (NCT05005234) intended to evaluate the efficacy and safety of IBI351 monotherapy in advanced NSCLC patients harbouring KRAS G12C mutation who failed or were intolerant to the standard treatment in China. The results will be presented at the upcoming European Society for Medical Oncology (ESMO) Asia Congress 2023. 

Professor Yi-Long Wu from Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, stated: "KRAS mutation as the 'undruggable' target for decades has become one of the most popular direction for clinical development recently. Although FDA has approved KRAS G12C targeted drugs overseas, there's no drug approved in China. IBI351, as a novel, irreversible covalent inhibitor of KRAS G12C mutation, demonstrated favorable safety and promising efficacy in KRAS G12C mutated advanced NSCLC as monotherapy. We look forward to the NDA approval of this novel drug to benefit more NSCLC patients with KRAS G12C mutation soon."

Dr. Hui Zhou, Senior Vice President of Innovent, stated: "Median survival is poor for advanced NSCLC patients with KRAS G12C mutation who failed or intolerant to standard of care treatment, highlighting the need for more effective options. We are glad about the NDA acceptance of IBI351 and it could potentially become the first approved KRAS G12C inhibitor in China, which could bring more treatment options to NSCLC patients. We are also advancing clinical development of IBI351 as monotherapy and combination therapy for more solid tumors such as colorectal cancer and lung cancer to look for opportunities to benefit more patients."

Previously, the results of IBI351 from a Phase 1 clinical trial in patients with solid tumors were updated in an oral presentation at the 2023 American Association for Cancer Research Annual Meeting (AACR 2023).

-  As of February 10, 2023, of the 67 evaluable NSCLC patients, objective response rate (ORR) is 61.2% and disease control rate (DCR) is 92.5%.
-  Among 30 patients with NSCLC treated at 600mg BID (the recommended phase 2 dose), better efficacy signal was observed, with ORR 66.7% (confirmed ORR 53.3%) and DCR 96.7%. The median duration of response (DoR) was not reached yet, the 6-month DoR rate was 75.4% (95% CI, 39.8-91.7). The median progression free survival (PFS) was 8.2m (PFS events 46.7%), the 6-month and 9-month PFS rate were 58.9% (95% CI, 39.0-74.3) and 47.3% (95% CI, 26.1-65.8), respectively, with a median follow-up of 8.1 months, and the data is immature.
-  As of November 30 2022, IBI351 was well tolerated. No dose limiting toxicity (DLT) was reported and maximum tolerated dose (MTD) was not reached. Treatment-related adverse events (TRAEs) occurred in 94.0% (63/67) patients and the most common TRAEs were anemia, pruritus, transferase increased, asthenia, protein urine present and bilirubin increased. The majority of the TRAEs were grade 1-2 with 31.3% of patients reporting ≥grade 3 TRAEs. There were no TRAEs led to treatment discontinuation or death.

Innovent is also exploring the potential of IBI351 in combination therapy for previously-untreated advanced NSCLC patients with KRAS G12C mutation. Two Phase 1b studies of IBI351, in combination with cetuximab (ERBITUX®, EGFR inhibitor) and sintilimab (TYVYT®, PD-1 inhibitor) respectively, are currently ongoing.

Besides, IBI351 monotherapy also demonstrated excellent efficacy and safety in previously-treated advanced colorectal carcinoma (CRC) patients with KRAS G12C mutation, of which the preliminary results were presented at the American Society of Clinical Oncology (ASCO) 2023. In May 2023, IBI351 became China's first KRAS G12C inhibitor to receive NMPA Breakthrough Therapy Designation as monotherapy for CRC patients with KRAS G12C mutation who have received at least two systemic therapies.
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