Gene Tektronox anti-TIGIT antibody Tiragolumab has been identified by the FDA as a breakthrough therapy

On January 5, Genentech, a member of the Roche Group, announced that its new cancer immunotherapy, Tiragolumab, which is targeted in combination with TIGIT, has been recognized by the FDA as a breakthrough therapy (BTD) and intended to be used to treat tumor PD-L1 highly expressed tumor PD-L1 without EGFR or ALK genomic tumor distortion in patients with metastasis non-small cell lung cancer (NSCL).
Tiragolumab is the first anti-TIGIT molecule to be awarded BTD by the FDA, based on Phase 2 clinical trial data called CITYSCAPE.
CITYSCAPE test showed that simultaneous targeting of immunosuppressive subjects TIGIT and PD-L1 may enhance anti-tumor activity by potentially amplifying the immune response.
The full results of THE CITYSCAPE, published at the 2020 annual meeting of the American Society of Clinical Oncology (ASCO), showed an improvement in the overall remission rate (ORR of 37% vs. 21% of the risk of disease deterioration or death (no progression survival PFS) compared to the adilijuzumant monodring treatment over an average of 10.9 months of follow-up.
exploratory analysis conducted in a high-level PD-L1 (tumor ratio score TPS≥50%) population showed that ORR was clinically significant compared to adiliju single-drug therapy (66% vs 24%). The medium PFS (HR=0.30, 95% CI: 0.15-0.61) was not reached compared to the 4.11 months of the single-drug treatment of atiliju.
BTD's findings are intended to accelerate the development and review of drugs for the treatment of serious or life-threatening diseases, and preliminary evidence suggests that it may show substantial improvements relative to existing therapies.
this marks the 37th BTD of the Genente drug combination.
TIGIT (T cellreceptor with Ig and ITIM domains), known as T-cell immunoglobulins and ITIM domain proteins, is an immuno checkpoint inhibitor expressed primarily on the surface of T-cells and NK cells.
PD-L1 is also a protein that functions in immune system suppression.
the use of tiragolumab and atili-pearl monoantigen to block both path pathps may increase anti-tumor activity by enhancing the body's immune response to cancer cells.
targeting multiple immune path pathrapies in this way has the potential to build on previous advances in cancer immunotherapy, expand into the early stages of the disease, and offer new treatment options in areas where high levels of unsequal needs are available.
Tiragolumab is an all-human monoclonal antibody that targets TIGIT, a protein-like body that binds to immune cells.
Tiragolumab works as an immune amplifier, potentially enhancing the body's immune response.
by binding to TIGIT, tiragolumab blocks its interaction with a protein called a poliovirus receptor (PVR, or CD155), which inhibits the body's immune response.
blocking TIGIT and PD-L1 may work together to re-activate T cells and enhance the anti-tumor activity of natural killer (NK) cells.
Genente is investigating the potential of tiragolumab in an extensive development project based on the observed benefits of atili-pearl monoantigen, while expanding into the early stages of the disease and new areas of unseeded needs.
this includes randomized trials in metastatic NSCLC (SKYSCRAPER-01 and SKYSCRAPER-06) and small cell lung cancer (SKYSCRAPER-02), as well as the exploration of tiragolumab in the early stages of the disease, including Phase 3 NSCLC (SKYSCRAPER-03) and localized advanced esophageal cancer (SKYSCRAPER-07).
at the same time, Tiragolumab is also being studied in metastatic esophageal squamous cell carcinoma (SKYSCRAPER-08) and cervical cancer (SKYSCRAPER-04) and is being tested early in other tumor types.
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: Genentech's Novel Anti-TIGIT Tiragolumab Granted FDA Research Therapy Designation in With Tecentriq for PD-L1-High Small Lung Cell Cancer. Retrieved 2021-01-05, from