Innovent Biologics has announced that China's National Medical Products Administration’s (NMPA) Center for Drug Evaluation (CDE) has granted breakthrough therapy designation (BTD) for IBI351 (GFH925).
BTD for IBI351 (GFH925) has been granted to treat advanced non-small cell lung cancer (NSCLC) patients with KRASG12C mutation who have undergone at least one prior line of systemic therapy.
The NMPA BTD for IBI351 has been granted based on the results from a Phase I/II trial.
This trial aims to analyse the safety, tolerability and efficacy of IBI351 monotherapy in patients suffering with advanced solid tumors who failed or are intolerant to standard of care (SOC) treatment.
The latest results of IBI351 from the Phase I study were presented at the 2022 Chinese Society of Clinical Oncology (CSCO) Annual Meeting.
IBI351 monotherapy has shown favourable safety and tolerability and promising antitumor activity.
Meanwhile, the single-arm registrational trial of IBI351 monotherapy in prior treated advanced non-small cell lung cancer patients with KRASG12C mutation is ongoing.
Updated study results will be published at an upcoming medical conference this year.
Innovent senior vice president Dr. Hui Zhou said: “We are glad to see the NMPA grants Breakthrough Therapy Designation based on the results of Phase I data of IBI351.
“KRASG12C mutated NSCLC patients have limited treatment options. IBI351 demonstrated encouraging efficacy and safety data in Phase I study.
“A single arm registrational trial of IBI351 monotherapy in previously-treated advanced NSCLC is ongoing. We are working to advance into late stage clinical development to explore the potential of IBI351 as monotherapy and in combo-therapy.”
GFH925, discovered by GenFleet Therapeutics, is a novel, orally active, potent KRASG12C inhibitor designed to effectively target the GTP/GDP exchange, an important step in pathway activation, by altering the cysteine residue of KRASG12C protein covalently and irreversibly.
Innovent and GenFleet Therapeutics signed an exclusive license agreement in September 2021 for the development and commercialisation of IBI351 in China with further option-in rights for global development and commercialisation.