This is the first therapy combining a KRASG12C inhibitor and cetuximab granted with CTA approval to treat advanced patients with KRASG12C-mutant NSCLC (non-small cell lung cancer) in the first-line setting.
The Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) for IBI351 (GFH925) for the treatment of advanced non-small cell lung cancer patients with KRASG12C mutation that have received at least one prior line of systemic therapy.
This trial collaboration will mark the starting point of GenFleet's multi-regional clinical development in Europe. As we reach an increasing number of milestones in our globalization efforts, we believe our cooperation with Merck will strengthen GenFleet's competitive advantage with differentiated development strategy and efficiency
the preliminary safety and efficacy data from the Phase I study of GFH009 monotherapy for treatment of relapsed/refractory hematological malignancies will be shared at the 2002 Annual Meeting of the American Society of Hematology (ASH) in New Orleans, Louisiana, on December 12, 2022.
Through an open-label, multicenter study, GFH018 demonstrated a favorable safety/tolerability profile and preliminary efficacy signal among advanced solid tumor patients that failed to respond to prior standard therapies.
The trial will be conducted in patients with peripheral artery disease and with intermittent claudication at 15 research centers, including University of Colorado Anschutz Medical Campus.
One study is a phase Ib/II trial of GFH018 with PD-1 inhibitor treating patients with advanced solid tumors; the other study is a phase II trial of GFH018, PD-1 inhibitor with concurrent chemoradiotherapy treating patients with locally advanced & unresectable NSCLC. GenFleet has completed a phase I trial of GFH018 monotherapy treating solid tumors in early 2022, and the data will soon be published in relevant international medical conference.
GenFleet will fully design and execute a randomized Phase 2b clinical trial. GenFleet will be eligible to receive tiered percentage royalties on future Motixafortide sales, if approved.
