Tiumbio Showcases Promising Clinical Results for Novel Cancer Drug at SITC 2025

Tiumbio Unveils Groundbreaking Clinical Data at SITC 2025

On November 7, 2025, Tiumbio Co., Ltd. presented significant interim clinical results at the annual meeting of the Society for Immunotherapy of Cancer (SITC). The focus was on their innovative drug, Tosposertib (TU2218), which acts as a dual inhibitor targeting both TGF-β and VEGFR2. This promising treatment option was evaluated in combination with MSD's Keytruda (pembrolizumab) for patients grappling with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).

The Tiumbio study provides hope for numerous patients, as highlighted by the robust findings: an impressive 70.6% partial response rate and an extraordinary 82.4% disease control rate among the participants. According to the preliminary Phase II data, as of the data cutoff on July 31, 2025, 27 patients were enrolled in the trial. Among these, 17 were part of the efficacy-evaluable population, indicating that the combination therapy could reshape the treatment landscape for advanced HNSCC.

Significant Findings

Dr. Hun-Taek Kim, CEO of Tiumbio, expressed optimism regarding the data presented at SITC. He stated, “These findings mark a milestone, demonstrating that the robust antitumor activity of Tosposertib continues to be sustained with ongoing clinical data.” The collaborative potential of Tosposertib combined with Keytruda seems promising as it aims to outpace the limitations currently faced by existing therapies and their combinations.

The clinical trial observed varied responses across different previous treatment settings, revealing a 72.7% response rate in first-line therapy and 66.7% in second-line or subsequent treatments. Notably, efficacy was also consistent across different PD-L1 expression levels, demonstrating the drug's potential to address varying patient conditions effectively.

Safety and Tolerability

The drug combination was well tolerated among patients. Of the 27 enrolled participants, 17 continued treatment, illustrating good adherence and indicators of tolerability. While treatment-emergent adverse events (TEAEs) were reported in 26 patients, most were of Grade 1 or 2 severity, ensuring that the regimen is manageable for most participants. Critical safety concerns associated with narrows margin drugs like those inhibiting VEGF or TGF-β were notably absent, as there were no reports of major bleeding or cardiovascular issues.

Next Steps for Tiumbio

Tiumbio’s strategic plan includes ramping up patient enrollment in the combination therapy trials and expanding clinical sites globally. These efforts are geared towards hastening the required studies for regulatory approval and facilitating earlier access to treatment for patients suffering from recurrent or metastatic head and neck cancer. Tiumbio is determined to pursue further combination trials and broaden its therapeutic indications by collaborating with global partners.

Tosposertib is not just a step forward for Tiumbio but potentially a transformative option that could drastically improve outcomes for patients with limited therapeutic options. The future looks bright as clinical trials are further explored, potentially reshaping how oncologists approach treatment protocols for challenging and resistant cancer types. For additional information on Tiumbio and their ongoing research, visit Tiumbio’s website and connect via LinkedIn.

About Tiumbio Co., Ltd.

Tiumbio is an innovative biopharmaceutical company dedicated to developing therapies that alleviate the burden of severe diseases. Their mission resonates in the pursuit of scientific advancements that tailor better quality of life for affected patients. Tiumbio stands at the forefront of biopharmaceutical innovation, aiming to expand hope and therapeutic efficacy for those in need.