Clinical Outcomes of Tinengotinib for Cholangiocarcinoma Published in The Lancet
TransThera Sciences Inc. has recently made headlines with the publication of clinical study results for their drug tinengotinib, highlighted in The Lancet Gastroenterology and Hepatology. This Phase 2 trial focuses on patients battling Cholangiocarcinoma (CCA), a rare and aggressive cancer affecting the bile ducts. The troubling aspect of CCA is its tendency to be driven by genomic alterations such as FGFR2 fusions, which can often be treated with FGFR inhibitors. However, resistance to these medications is a frequent challenge, necessitating the exploration of new therapeutic options.
In this comprehensive study, patients diagnosed with FGFR2 fusion-positive CCA who experienced primary resistance or acquired resistance to prior FGFR inhibitor therapy were enrolled, alongside individuals with other FGFR alterations or wild-type tumors. The results revealed that tinengotinib exhibited substantial clinical activity in patients with FGFR2 fusion-positive CCA who had resistance to previously approved FGFR inhibitors.
Dr. Milind Javle, a noted expert from The University of Texas MD Anderson Cancer Center and the corresponding author of the publication, emphasized the urgent need for next-generation FGFR inhibitors. He remarked, "While we currently have two FDA-approved therapies that target FGFR2 fusions in CCA, the issue of resistance presents a significant hurdle in treatment. Tinengotinib's design as a multi-kinase FGFR inhibitor positions it uniquely to tackle both FGFR and other compensatory pathways known to contribute to resistance. The findings of this Phase 2 study indicate durable responses and meaningful clinical benefits, making a Phase 3 registration study a logical next step."
The Chief Medical Officer of TransThera, Dr. Jean Fan, echoed Dr. Javle's sentiments, expressing pride in the recognition that came from the publication in such a prestigious journal. She noted that the study provided vital insights into treatment strategies for patients facing CCA that has resisted chemotherapy and FGFR inhibitors. Dr. Fan reaffirmed TransThera’s commitment to advancing global enrollment in clinical trials and offering new treatment options for patients suffering from metastatic cholangiocarcinoma.
Tinengotinib, an internally developed, multi-kinase inhibitor, fights against tumors by targeting key pathways, including FGFRs and VEGFRs, along with other proteins involved in cell division. Ongoing trials in both the US and China are shedding light on tinengotinib’s potential efficacy across various solid tumors. The drug has received Orphan Drug and Fast Track Designations from the FDA for CCA treatment and has also been recognized with Breakthrough Therapy Designation in China. Additionally, the European Medicines Agency has granted Orphan Drug Designation for biliary tract cancer, showcasing tinengotinib’s prominence in oncological research and treatment.
TransThera is a biopharmaceutical firm concentrating on innovative therapies targeting oncology, inflammation, and metabolic disorders. Through meticulous research in translational medicine, the company aims to bring forth novel drug candidates aimed at addressing critical clinical needs worldwide. With the promising discoveries surrounding tinengotinib, TransThera strives to remain at the forefront of developments in cancer treatment, emphasizing their commitment to global health advancements. For further information on their initiatives, interested parties can visit www.transthera.com.
In this comprehensive study, patients diagnosed with FGFR2 fusion-positive CCA who experienced primary resistance or acquired resistance to prior FGFR inhibitor therapy were enrolled, alongside individuals with other FGFR alterations or wild-type tumors. The results revealed that tinengotinib exhibited substantial clinical activity in patients with FGFR2 fusion-positive CCA who had resistance to previously approved FGFR inhibitors.
Dr. Milind Javle, a noted expert from The University of Texas MD Anderson Cancer Center and the corresponding author of the publication, emphasized the urgent need for next-generation FGFR inhibitors. He remarked, "While we currently have two FDA-approved therapies that target FGFR2 fusions in CCA, the issue of resistance presents a significant hurdle in treatment. Tinengotinib's design as a multi-kinase FGFR inhibitor positions it uniquely to tackle both FGFR and other compensatory pathways known to contribute to resistance. The findings of this Phase 2 study indicate durable responses and meaningful clinical benefits, making a Phase 3 registration study a logical next step."
The Chief Medical Officer of TransThera, Dr. Jean Fan, echoed Dr. Javle's sentiments, expressing pride in the recognition that came from the publication in such a prestigious journal. She noted that the study provided vital insights into treatment strategies for patients facing CCA that has resisted chemotherapy and FGFR inhibitors. Dr. Fan reaffirmed TransThera’s commitment to advancing global enrollment in clinical trials and offering new treatment options for patients suffering from metastatic cholangiocarcinoma.
Tinengotinib, an internally developed, multi-kinase inhibitor, fights against tumors by targeting key pathways, including FGFRs and VEGFRs, along with other proteins involved in cell division. Ongoing trials in both the US and China are shedding light on tinengotinib’s potential efficacy across various solid tumors. The drug has received Orphan Drug and Fast Track Designations from the FDA for CCA treatment and has also been recognized with Breakthrough Therapy Designation in China. Additionally, the European Medicines Agency has granted Orphan Drug Designation for biliary tract cancer, showcasing tinengotinib’s prominence in oncological research and treatment.
TransThera is a biopharmaceutical firm concentrating on innovative therapies targeting oncology, inflammation, and metabolic disorders. Through meticulous research in translational medicine, the company aims to bring forth novel drug candidates aimed at addressing critical clinical needs worldwide. With the promising discoveries surrounding tinengotinib, TransThera strives to remain at the forefront of developments in cancer treatment, emphasizing their commitment to global health advancements. For further information on their initiatives, interested parties can visit www.transthera.com.
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