The US Food and Drug Administration (FDA) has granted approval for GenFleet Therapeutics’ Phase III clinical trial of GFH925, a KRAS G12C inhibitor, for the treatment of patients with refractory metastatic colorectal cancer (CRC).

This marks the first Phase III trial of KRAS G12C inhibitor monotherapy targeting CRC patients globally.

GFH925 was the first G12C inhibitor that received breakthrough therapy designation (BTD) from China’s National Medical Products Administration for previously treated CRC.

It also received BTD and new drug application acceptance with Priority Review Designation by NMPA for earlier treated advanced non-small cell lung cancer (NSCLC)patients with G12C mutation.

The primary endpoint of the trial is to evaluate the efficacy of GFH925 compared to the current standard of care for refractory metastatic CRC patients harbouring KRAS G12C mutation who have progressed after at least two prior lines of therapies or are intolerant to the last treatment.

A pooled analysis from two Phase I studies showcased GFH925 monotherapy for CRC showed superior efficacy – objective response rate and median progression-free survival –to other single-agent KRAS G12C inhibitors.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Furthermore, GFH925 monotherapy was comparable to the combination regimens of other G12C inhibitors with anti-EGFR antibodies.

These findings were presented at ESMO Asia 2023.

GenFleet chief medical official Yu Wang said: “We appreciate the FDA’s recognition of GFH925’s efficacy and safety profile, as this is our first global Phase III monotherapy study in treating advanced-stage CRC.

“We believe the approval of our proposed trial design highlights the potential of GFH925 monotherapy in this indication, thus bringing more therapeutic options and clinical benefits to the patients.

“Additionally, the study of GFH925 in combination with cetuximab is ongoing in Europe treating advanced NSCLC in the first-line setting and the Phase II trial has completed the enrollment; the preliminary data analysis of this combination study, accepted as a late-breaking abstract, has been selected for oral presentation during the 2024 ASCO annual meeting.”

GFH925 has shown promising results in two Phase I trials, with a 45.8% confirmed objective response rate and a median progression-free survival of 7.6 months for patients receiving a 600mg BID dose.

The RAS protein family, which includes KRAS, HRAS, and NRAS, is frequently mutated in various cancers, with KRAS mutations found nearly in 90% of pancreatic cancer, 30% to 40% of colon cancer, and 15% to 20% of lung cancer.

Last month, GenFleet and BeiGene Switzerland signed a clinical trial collaboration and supply agreement to start a combination study of GFH009 (CDK9 inhibitor) and BRUKINSA (zanubrutinib, BTK inhibitor) in a multicentre Phase Ib/II trial treating diffuse large B cell lymphoma (DLBCL).