GenFleet Therapeutics, a leading biotechnology company specializing in advanced therapies for oncology and immunology, has received approval from the US Food and Drug Administration (FDA) to commence clinical trials for GFH925, a KRAS G12C inhibitor, in treating refractory metastatic colorectal cancer (CRC) patients. This marks the initiation of the first phase III trial worldwide focusing on KRAS G12C inhibitor monotherapy for CRC patients. GFH925 has previously been granted Breakthrough Therapy Designation (BTD) by China's National Medical Products Administration (NMPA) for advanced CRC and non-small cell lung cancer (NSCLC) patients with G12C mutation.

The trial, designated as GFH925X0301, will enroll refractory metastatic CRC patients harboring KRAS G12C mutation who have experienced progression after at least two prior lines of therapies or who are intolerant to the last treatment. The primary objective of the study is to compare the efficacy of GFH925 with the current standard of care.

A comprehensive analysis from two phase I studies, presented at ESMO Asia 2023, showcased the efficacy of GFH925 monotherapy for CRC, demonstrating superior outcomes, including objective response rate and median progression-free survival, compared to other single-agent KRAS G12C inhibitors. Notably, its performance was comparable to combination regimens involving other G12C inhibitors with anti-EGFR antibodies.

Dr. Yu Wang, Chief Medical Officer of GenFleet, expressed gratitude for the FDA's acknowledgment of GFH925's efficacy and safety profile. He emphasized the significance of the approval for the proposed trial design, underscoring the potential of GFH925 monotherapy in CRC treatment. This development marks a crucial advancement in GFH925's journey towards potential frontline treatment for CRC.

Furthermore, ongoing studies are evaluating GFH925 in combination with cetuximab in Europe for treating advanced NSCLC in the first-line setting. Preliminary data analysis from this combination study has been selected for oral presentation during the 2024 ASCO annual meeting, reflecting GenFleet's strategic approach to global development and its commitment to advancing RAS-targeted therapies.

According to the GLOBOCAN 2022 report, CRC remains a significant global health concern, with a high incidence and mortality rate. Approximately 40% of CRC patients carry KRAS mutations, highlighting the relevance of targeted therapies like GFH925. The presence of KRAS mutation in CRC is associated with advanced disease and poorer outcomes, underscoring the urgent need for innovative treatment options.

GFH925's unique mechanism as a KRAS G12C inhibitor offers promise in addressing the unmet clinical needs of CRC patients and holds vast market potential. Its selective targeting of the G12C mutation subset signifies a leap forward in precision medicine for cancer treatment. Through its global development efforts, GenFleet is poised to make significant contributions to the field of oncology, driven by a deep understanding of biological pathways and a commitment to improving patient outcomes.

 

Source: prnewswire.com

Report Abuse