Pharma Focus Asia

Innovent Announces Acceptance and Priority Review Designation for IBI351 New Drug Application by China's National Medical Products Administration

Friday, November 24, 2023

Innovent Biologics, Inc. (HKEX: 01801) has made a significant announcement regarding the acceptance of the New Drug Application (NDA) for IBI351, a KRAS G12C inhibitor, by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China. This NDA has been given Priority Review designation, marking a historic moment as it is China's first NDA for a KRAS G12C inhibitor. IBI351 is designed for the treatment of patients with advanced non-small cell lung cancer (NSCLC) who carry the KRAS G12C mutation and have undergone at least one systemic therapy.

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

Professor Yi-Long Wu from Guangdong Lung Cancer Institute highlighted the importance of IBI351 as a novel KRAS G12C inhibitor, emphasizing its favorable safety profile and promising efficacy in treating advanced NSCLC with this mutation. Dr. Hui Zhou, Senior Vice President of Innovent, stressed the critical need for more effective treatment options for advanced NSCLC patients with KRAS G12C mutation and expressed optimism about IBI351 potentially becoming the first approved KRAS G12C inhibitor in China.

The Phase 1 clinical trial results of IBI351 in patients with solid tumors, presented at the 2023 American Association for Cancer Research Annual Meeting, demonstrated an objective response rate (ORR) of 2% and a disease control rate (DCR) of 92.5% among evaluable NSCLC patients. The 600mg BID dose, recommended for Phase 2, showed improved efficacy with an ORR of 66.7% and a DCR of 96.7%. IBI351 was well-tolerated, with no dose-limiting toxicity reported.

In addition to its application in NSCLC, Innovent is 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 and sintilimab, are currently ongoing.

IBI351 has also demonstrated efficacy and safety in previously treated advanced colorectal carcinoma (CRC) patients with KRAS G12C mutation. In May 2023, it received NMPA Breakthrough Therapy Designation for monotherapy in CRC patients who have undergone at least two systemic therapies.

Lung cancer, especially NSCLC, is a prevalent and life-threatening malignancy worldwide, and KRAS mutations are common driver gene mutations in NSCLC. Patients with advanced NSCLC and KRAS G12C mutations face limited treatment options after standard first-line therapy, making IBI351 a potentially significant advancement in addressing this unmet medical need.

IBI351 is an orally active, potent KRAS G12C inhibitor designed to target the GTP/GDP exchange, a crucial step in pathway activation, by irreversibly modifying the cysteine residue of KRAS G12C protein. Its high selectivity towards G12C and effectiveness in inhibiting downstream signaling pathways make it a promising candidate for treating various cancers.

In collaboration with GenFleet Therapeutics, Innovent entered into an exclusive license agreement for the development and commercialization of IBI351 in China, with additional option-in rights for global development and commercialization. The drug has received Breakthrough Therapy Designation for advanced NSCLC and CRC from the CDE of China’s NMPA.

The acceptance and Priority Review designation of the NDA for IBI351 underscore its potential as an innovative and much-needed therapeutic option for patients with advanced NSCLC harboring KRAS G12C mutation, reinforcing Innovent's commitment to advancing cancer treatment options.



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