China’s National Medical Products Administration (NMPA) has granted approval for Innovent Biologics’ Kristen rat sarcoma (KRAS) G12C inhibitor, Dupert (fulzerasib), to treat advanced non-small cell lung cancer (NSCLC) in adults.
It is approved for NSCLC treatment in adults with the KRAS G12C mutation who have received a minimum of one systemic therapy.
Dupert is orally administered and targets the guanosine triphosphate/guanosine diphosphate exchange process by covalently and irreversibly modifying the KRAS G12C protein’s cysteine residue.
Preclinical studies have shown fulzerasib’s high selectivity towards G12C, effectively inhibiting downstream signalling pathways, leading to apoptosis [programmed cell death] and cell cycle arrest in tumour cells.
The approval of Dupert is grounded in the outcomes of a Phase II clinical study, which assessed the efficacy and safety of fulzerasib monotherapy in Chinese patients with advanced NSCLC and the KRAS G12C mutation.
As of 13 December 2023, the study had enrolled 116 evaluable subjects, demonstrating that fulzerasib was generally well-tolerated and exhibited promising antitumour activity.
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The Independent Radiology Review Committee (IRRC) confirmed an objective response rate (ORR) of 49.1% and a disease control rate of 90.5%. The median duration of response and overall survival has not yet been reached, with a median progression-free survival of 9.7 months.
In September 2021, Innovent entered an exclusive licence agreement with GenFleet Therapeutics for the development and commercialisation of fulzerasib in China, including mainland China, Hong Kong, Macau and Taiwan.
The therapy has received breakthrough therapy designation (BTD) from the Center for Drug Evaluation (CDE) of China’s NMPA twice, first in January 2023 for advanced NSCLC and again in May 2023 for advanced colorectal cancer with the KRAS G12C mutation.
Innovent senior vice-president Dr Hui Zhou stated: “Patients with advanced NSCLC harboring KRAS G12C mutations have limited treatment options, with traditional chemotherapy offering minimal benefits.
“We are excited that Dupert has become the first KRAS G12C inhibitor approved in China, marking the beginning of a new era in targeted therapy for KRAS mutations. As Innovent’s eleventh drug, Dupert further strengthens our robust oncology portfolio.”
