TransThera reveals 2024 ESMO Asia clinical data on tinengotinib and atezolizumab in BTC

NANJING, China and GAITHERSBURG, Md., Dec. 9, 2024 /PRNewswire/ -- TransThera Sciences Nanjing, Inc. (TransThera) recently showcased a poster presentation at the 2024 European Society For Medical Oncology (ESMO) Asia Congress. This presentation focused on a clinical study involving the combination of tinengotinib and atezolizumab (Tecentriq®) for the treatment of biliary tract carcinoma (BTC).

The study, titled "Tinengotinib (TT-00420) in Combination with Atezolizumab in Chinese Patients with Biliary Tract Carcinoma (BTC): Efficacy and Safety Results from a Phase Ib/II Study," had a poster number 140P. It addressed the pressing need for effective treatments beyond the first-line therapy for BTC, as the current options lead to limited survival rates. Tinengotinib, a new multi-kinase inhibitor, might enhance the effects of immune checkpoint inhibitors (ICI) when used together.

As of September 26, 2024, 31 advanced BTC patients, who had undergone extensive prior treatments, participated in the study. Approximately 71.0% of these patients had previously received at least one form of immunotherapy. The results demonstrated promising efficacy across various subgroups of BTC patients.

For 20 patients with intrahepatic cholangiocarcinoma, the objective response rate (ORR) was 25.0%, and the disease control rate (DCR) was 80.0%. The median progression-free survival (mPFS) was 8.77 months, and the 12-month overall survival (OS) rate was 70.1%.

Among 28 patients with cholangiocarcinoma, the ORR was 25.0%, and the DCR was 75.0%. The mPFS for this group was 5.72 months, with a 64.8% 12-month OS rate.

Overall, the efficacy evaluable results for all 31 BTC patients showed an ORR of 22.6% and a DCR of 74.2%. The mPFS reached 4.11 months, and the 12-month OS rate was 61.8%. It was noted that the therapy's effectiveness was consistent, irrespective of previous ICI treatments.

Safety and tolerability were also key points of the study. During the dose escalation phase, no dose-limiting toxicity (DLT) was observed. Generally, the combination therapy was well tolerated by the heavily pre-treated BTC patients, indicating a favorable safety profile.

The encouraging results from this study suggest that the combination of tinengotinib and atezolizumab may have a synergistic effect in treating BTC and potentially other solid tumors. These findings support further research to evaluate the safety and efficacy of this combination therapy, particularly in patients who have undergone prior ICI therapy or those who have not.

Tinengotinib is an innovative multi-kinase inhibitor developed in-house by TransThera. It targets FGFRs, VEGFRs, Aurora A/B, and Janus kinases (JAK), exhibiting antitumor effects. Currently in global phase III trials in the US and China, tinengotinib has shown promise across various solid tumors. It has been granted several designations by regulatory authorities, including Orphan Drug Designation (ODD) and Fast Track Designation (FTD) by the FDA, as well as Breakthrough Therapy Designation (BTD) by China's NMPA, and ODD for biliary tract cancer by the EMA.

TransThera is a biopharmaceutical company focused on developing small molecule therapies for oncology, inflammatory, and cardiometabolic diseases. The company aims to address urgent clinical needs globally through innovative drug development.

tecnetriq® (atezolizumab) is a registered trademark of Genentech, part of the Roche Group.