NEW YORK – GenFleet Therapeutics on Wednesday said it received the European Medicines Agency's permission to test its KRAS inhibitor GFH925 with Eli Lilly's EGFR inhibitor Erbitux (cetuximab) as a front-line combination treatment in patients with KRAS G12C-mutant non-small cell lung cancer.
Shanghai-based GenFleet will conduct a multicenter Phase Ib/II trial led by Rafael Rosell, chief medical officer of the Dr Rosell Oncology Institute at Quirón Dexeus University Hospital in Barcelona. GenFleet will first open trial sites in Europe and then initiate a similar trial in China with its partner Innovent.
"The innovative and thoughtful idea of combining GFH925 with Erbitux will potentially pave the way for bringing KRAS inhibitors to treat NSCLC in the first-line setting," Rosell said in a statement. "The study is among the few combination trials that target the frontline treatment and is in [a] leading position when compared with other pharmaceutical companies."
In the US, the EGFR-inhibiting monoclonal antibody Erbitux is approved as a treatment for head and neck cancer, KRAS wild-type EGFR-expressing metastatic colorectal cancer, and in combination with Pfizer's BRAF inhibitor Braftovi (encorafenib) for BRAF V600E-mutated metastatic colorectal cancer.
GenFleet is also studying GFH925 by itself in a Phase I/II trial in patients with KRAS G12C-mutant advanced NSCLC and other solid tumors.
GenFleet is also developing a transforming growth factor-beta receptor 1 (TGF-β R1) inhibitor in solid tumors, a CDK9 inhibitor in blood cancers, and a CXCR4 inhibitor in pancreatic cancer.