Genentech Announces FDA Breakthrough Therapy Designation for Tiragolumab in Combination with Atezolizumab for First-Line Treatment of PD-L1-High Metastatic NSCLC

EO Healthcare learned on January 5 that a subsidiary of the Roche GroupGenentech(Genentech) announced that its novel cancer immunotherapy tiragolumab, which targets TIGIT, was granted Breakthrough Therapy Designation (BTD) by the PDA, in combination with AstraZeneca'sPD-L1Tecentriq® (atezolizumab) in combination for first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors exhibit high PD-L1 expression and lack EGFR or ALK genomic tumor aberrations.

TiragolumabIt is the first anti-TIGIT molecule to receive Breakthrough Therapy Designation (BTD) approved by the FDA, based on randomized data from its Phase II CITYSCAPE trial. The CITYSCAPE data demonstrated that simultaneously targeting the immunosuppressive receptors TIGIT and PD-L1 can enhance antitumor activity by amplifying the immune response.

According to data from the CITYSCAPE trial presented at the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting, during a median follow-up of 10.9 months, combination therapy demonstrated an improved overall response rate (ORR: 37% vs. 21% with atezolizumab monotherapy) and a 42% reduction in the risk of disease progression or death (progression-free survival [PFS]). An exploratory analysis conducted in patients with high PD-L1 expression (Tumor Proportion Score [TPS] ≥50%) showed a clinically meaningful improvement in ORR compared with atezolizumab monotherapy (66% vs. 24%). The median PFS was not reached in the combination therapy group, compared with 4.11 months for atezolizumab monotherapy (HR=0.30; 95% CI: 0.15–0.61).

Dr. Levi Garraway, Chief Medical Officer and Head of Global Product Development at Genentech, stated, “We look forward to advancing the tiragolumab development program, which includes chemotherapy-free combinations and trials in earlier stages of disease across multiple cancer types with high unmet need.”

Genentech, Inc. is investigating the potential of tiragolumab within a broad development program that builds on the benefits observed with Tecentriq, while expanding into earlier stages of disease and new areas of unmet need. This includes randomized trials in metastatic non-small cell lung cancer (NSCLC) and small cell lung cancer, as well as Phase III studies of tiragolumab in early-stage NSCLC and locally advanced esophageal cancer. Research on tiragolumab is also underway in metastatic squamous cell carcinoma of the esophagus and cervical cancer, with early-phase trials conducted in other tumor types.

Tiragolumab is a fully humanized monoclonal antibody that targets and binds to the TIGIT protein receptor on immune cells. Tiragolumab functions as an immune amplifier by potentially enhancing the body’s immune response. By binding to TIGIT, tiragolumab blocks its interaction with a protein known as poliovirus receptor (PVR, or CD155), which can suppress the body’s immune response. Blocking TIGIT and PD-L1 may synergistically reactivate T cells and enhance the antitumor activity of natural killer (NK) cells.

This article is sourced from IYIOU, an original piece by author Mi Congcong. For reprinting or collaboration, please click hereReprint Notice, Unauthorized reposting will be subject to legal action.