On June 13, 2022 InventisBio reported that the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) of China has granted Breakthrough Therapy Designation (BTD) to KRAS G12C inhibitor, D-1553, (Press release, InventisBio, JUN 13, 2022, View Source [SID1234633495]).

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InventisBio launched an international multi-center clinical study of D-1553 in October 2020, with several trials carried out since in non-small cell lung cancer (NSCLC), colorectal cancer, and others.

In preclinical studies, D-1553 has demonstrated tumor inhibitory effect, noted the company.

Specifically in NSCLC harboring KRAS G12C mutation, D-1553 led to patients achieving an objective response rate (ORR) of 40.4%, with a disease control rate of 90.4%, according to InventisBio at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in April 2022.

D-1553 has become China’s first homegrown breakthrough drug for the treatment of KRAS G12C mutant tumors.