Roche Submits New Clinical Trial Applications in China for TIGIT Inhibitor Tiragolumab and VEGF/Ang2 Bispecific Antibody Faricimab

Reposted from: Medical Insights

According to the public information released by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration, Roche has submitted four new clinical trial applications in China for its investigational new drugs, tiragolumab injection and faricimab injection, which were accepted on June 13. Tiragolumab is a key investigational TIGIT inhibitor under development by Roche, while faricimab is a bispecific antibody that simultaneously targets VEGF and Ang2. Currently, both drugs have entered Phase III clinical trials globally.

Tiragolumab Injection: TIGIT Inhibitor

Tiragolumab is a TIGIT immune checkpoint inhibitor under key development by Roche. TIGIT, fully named T-cell immunoglobulin and ITIM domain protein, is an immune checkpoint protein expressed in various immune cells, including CD8-positive T cells, CD4-positive T cells, and natural killer (NK) cells. TIGIT serves as a specific negative regulator of the CD226 co-stimulatory receptor, and its expression is critically associated with T cell exhaustion.

Studies have found that TIGIT is highly expressed in tumor-infiltrating T cells across various cancer types. Moreover, both PD-1 and TIGIT are expressed in memory T cells with stem-like characteristics, whereas other checkpoint proteins such as LAG-3 and TIM-3 are not expressed in these cells. Therefore, Roche believes that dual targeting of PD-L1 and TIGIT holds promise not only for reversing conventional T-cell exhaustion but also for increasing the number of memory T cells with stem-like characteristics, thereby generating more effector T cells and achieving enhanced tumor-killing efficacy. Currently, Roche is investigating the efficacy of combining tiragolumab with the PD-L1 inhibitor Tecentriq (atezolizumab) in indications such as cervical cancer, non-small cell lung cancer, and small cell lung cancer.

At the recently concluded ASCO, Roche announced Phase 2 clinical data on the combination therapy of tiragolumab and Tecentriq for non-small cell lung cancer (NSCLC). CITYSCAPE is a global, randomized, double-blind Phase 2 clinical study designed to evaluate the efficacy of tiragolumab in combination with Tecentriq as first-line treatment for patients with PD-L1-positive metastatic or locally advanced unresectable NSCLC.

Preliminary analysis results from the trial showed that the combination therapy of tiragolumab and Tecentriq met both primary co-endpoints: the objective response rate (ORR) in patients receiving the combination therapy was significantly improved to 31.3%, compared with 16.2% in the control group (placebo + Tecentriq); the progression-free survival (PFS) in the combination therapy group was 5.4 months, higher than 3.6 months in the control group; the combination therapy also reduced the risk of disease progression or death by 43%.

Furthermore, exploratory analysis in patients with high PD-L1 expression showed that the combination therapy increased the objective response rate (ORR) to 55.2%, significantly higher than the 17.2% observed in the control group, and also reduced the risk of disease progression or death by 67%.

Faricimab Injection: A Bispecific Antibody Targeting VEGF and Ang2

Faricimab is a bispecific antibody developed by Roche that simultaneously targets VEGF and Ang2. This candidate drug can inhibit VEGF activity while also improving vascular stability and reducing retinal inflammation by inhibiting Ang2 activity. Currently, Roche is developing faricimab for the treatment of indications such as wet age-related macular degeneration (AMD) and diabetic macular edema (DME), and it has entered Phase 3 clinical trials. According to earlier data released by Roche, in Phase 2 clinical trials involving patients with diabetic macular edema, faricimab significantly improved patients’ vision compared to the active control.

According to information from the Chinese Drug Clinical Trial Registration and Information Publicity Platform, Roche is conducting a randomized, double-blind, international multicenter (including China) Phase 3 clinical study. The study aims to evaluate the efficacy, safety, durability, and pharmacokinetic profile of faricimab 6 mg administered at intervals of up to 16 weeks, compared with aflibercept monotherapy administered every 8 weeks, in patients with choroidal neovascularization (CNV) secondary to age-related macular degeneration (also known as neovascular AMD [nAMD]).

Congratulations to Roche on the submission of new clinical trial applications in China for its TIGIT inhibitor tiragolumab injection and its VEGF/Ang2 bispecific antibody faricimab injection. We hope these studies proceed smoothly and benefit patients at an early date.

Original Title: Roche’s TIGIT Inhibitor and VEGF/Ang2 Bispecific Antibody Submit Clinical Trial Applications in China, Globally Entered Phase 3 Clinical Trials!

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