Roche's Tiragolumab receives breakthrough drug funding...

Roche recently announced that the U.S. Food and Drug Administration (FDA) has awarded TIGIT target new cancer immunotherapy Tiragolumab Breakthrough Drug Qualification (BTD), a combination of anti-PD-L1 therapy Tecentriq (Tai Santqi, Common name: atezolizumab, atiliju single anti), first-line treatment of tumors showing PD-L1 high expression, no EGFR or ALC genome tumor distortion metastasis non-small cell lung cancer (NSCLC) patients.
noted that Tiragolumab is the first anti-TIGIT molecule to be awarded BTD by the FDA, and also marks the 37th BTD obtained by Roche Pharmaceuticals.
this BTD is based on random data from phase II CITYSCAPE study, which provides the first evidence that simultaneous targeting of immunosuppressive subjects TIGIT and PD-L1 may enhance anti-tumor activity by potentially amplifying the immune response.
Tiragolumab is a new type of cancer immunotherapy targeted at TIGIT, an immuno checkpoint protein expressed on immune cells identified by Roche's own scientists as an immune amplifier that works by potentially enhancing the body's immune response.
TGIT and PD-L1 both play an important role in immunosuppression, and blocking both pathways may enhance anti-tumor activity by enhancing the body's immune response to cancer cells.
target multiple immune pathways in this way, with the potential to build on previous advances in cancer immunotherapy to the early stages of the disease and to offer new treatment options in areas where high levels of unsealed needs are available. "We have been studying TIGIT as a new cancer immunotherapy target for nearly a decade, and we are pleased that the FDA has recognized Tiragolumab's potential to significantly improve the prognostication of certain types of lung cancer patients," said Dr. Levi Garraway,
Roche's chief medical officer and head of global product development.
look forward to advancing our tiragolumab development program, which includes combination therapy without chemotherapy and early trials of multiple types of cancers that are difficult to meet.
"CITYSCAPE is the first randomized study in TIGIT, a global, randomized, double-blind study conducted in 135 patients with PD-L1-positive, local late-stage non-excisive or metastasis NSCLC, evaluating the efficacy and safety of Tiragolumab and Tecentriq monotherapy for initial (first-line) therapy.
the study's common primary endpoints are total mitigation rate (ORR) and progress-free lifetime (PFS), with secondary endpoints including safety and total lifetime (OS).
results showed that tiragolumab and Tecentriq combined first-line treatment PD-L1 positive metastasis NSCLC has encouraging efficacy and safety.
the full results of the study were presented at the American Society of Clinical Oncology (ASCO) 2020 Virtual Science Conference.
data were: (1) a medium follow-up of 10.9 months, and in the group of intentional therapy (ITT) patients, the combined treatment of tiragolumab and Tecentriq reached 2 major endpoints at the same time compared to Tecentriq monotherapy : Significant increase in total remission rate (ORR) (37% vs. 21%), significantly reduced risk of disease deterioration or death by 42% (medium PFS: 5.6 months vs 3.9 months; HR=0.58).
(2) an exploratory analysis of patients with high expression of PD-L1 (TPS≥50%) showed that the combined treatment of tiragolumab and Tecentriq significantly improved ORR (66%) compared to Tecentriq single-drug therapy vs 24%), significantly reducing the risk of disease deterioration or death by 70% (medium PFS: not up to vs 4.11 months; HR s 0.30, 95% CI: 0.15-0.61).
(3) In this study, tiragolumab and Tecentriq combined therapy had good tolerance, and in terms of the occurrence of all-cause adverse events (AE) of all level 3 or above, the combined therapy was similar to Tecentriq monotherapy (48% vs 44%).
Tiragolumab is a monoclonal antibody that targets TIGIT, a protein-like protein that binds to expression on immune cells.
by binding TIGIT, tiragolumab blocks TIGIT's interaction with a protein called a poliovirus subject (PVR, or CD155).
combination of TIGIT and PPR inhibits the body's immune response.
Tecentriq belongs to the anti-PD-(L)1 therapy, a monoclonal antibody that targets a protein called PD-L1 expressed in combination with tumor cells and tumor-immersed immune cells, blocking its interaction with PD-1 and B7.1 receptors.
by inhibiting PD-L1, Tecentriq can activate T-cells, which have the potential to serve as a basis for cancer immunotherapy, targeted drugs, and various cancer chemotherapy programs.
blocking TIGIT and PD-L1 may co-activate T cells to enhance the anti-tumor activity of NK cells.
is the scientific basis for a joint drug use study between Tiragolumab and Tecentriq.
Currently, Roche is evaluating the potential of tiragolumab in an extensive development project based on the clinical benefits observed in the combined treatment of tiragolumab and Tecentriq, while expanding to the early stages of the disease and new areas with significantly unsolveed medical needs.
the project includes randomized trials of therapeutic metastatic NSCLC (SKYSCRAPER-01 and SKYSCRAPER-06 studies) and small cell lung cancer (SKYSCRAPER-02 studies), as well as exploration of the early stages of tiragolumab, including Phase III NSCLC (SKYSCRAPER-07 Study) and Local Late Esophageal Cancer (SKYSCRAPER-07 Study).
addition, tiragolumab is being studied in metastatic esophageal squamous cell carcinoma (SKYSCRAPER-08 study) and cervical cancer (SKYSCRAPER-04 study), and several early trials have investigated Tiragolumab's treatment of other types of tumors.
(Bio Valley Bioon.com) Original source: Roche's novel anti-TIGIT tiragolumab granted FDA Program Therapy Designation in the composition with Tecentriq for PD-L1-high non-small cell lung cancer This article is from BioGun, for more information please download Bio Valley APP (