Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1038 |
| INN | Tiragolumab |
| Status | Clinical |
| Drug code(s) | MTIG7192A, RO7092284, RG6058 |
| Brand name | None |
| mAb sequence source | mAb human |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | Trangenic animal (OmniRat) |
| Target(s) | TIGIT |
| Indications of clinical studies | Melanoma, Head and Neck cancer, Triple-Negative Breast Cancer, Esophageal Cancer, Liver cancer, Cervical Cancer, Small cell lung cancer, multiple myeloma/NHL (single Phase 1 study), non-small cell lung cancer, locally advanced or metastatic tumors |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Phase 3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | May 15, 2016 |
| Start of Phase 2 | June 30, 2018 |
| Start of Phase 3 | February 04, 2020 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | None |
| Date of first US approval | |
| INN, US product name | None |
| US or EU approved indications | None |
| Company | Genentech |
| Licensee/Partner | None |
| Comments about company or candidate | Roche update lists tiragolumab as a 2025 expected regulatory submission. July 4, 2024: Roche has reported that its Phase II/III SKYSCRAPER-06 (NCT04619797) clinical trial of tiragolumab along with Tecentriq (atezolizumab) and chemotherapy as first-line treatment for non-squamous non-small cell lung cancer (NSCLC) failed to meet primary endpoints. Phase 2/3 study for Non-small cell lung cancer (NCT04619797), phase 3 studies for Non-small cell lung cancer (NCT04294810 recruiting as of May 25, 2023, NCT04513925 is active not recruiting as of May 22, 2023); Esophageal cancer (NCT04543617 is recruiting as of May 25, 2023, NCT04540211 is active not recruiting as of April 12, 2023). May 2023: ASCO abstract - The addition of tira to atezo + bev resulted in higher ORR and longer PFS compared with atezo + bev, and no new safety signals were identified. These data suggest that tira + atezo + bev may be a promising novel first-line treatment option for patients with uHCC, and support further study in this setting. Clinical trial information: NCT04524871 (https://meetings.asco.org/abstracts-presentations/219773) May 2022: Phase III SKYSCRAPER-01 study, evaluating the investigational anti-TIGIT immunotherapy tiragolumab plus Tecentriq® (atezolizumab) versus Tecentriq alone as an initial (first-line) treatment for people with PD-L1-high locally advanced or metastatic non-small cell lung cancer (NSCLC) did not meet its co-primary endpoint of progression-free survival. March 2022: Genentech announced that the Phase III SKYSCRAPER-02 study, evaluating the investigational anti-TIGIT immunotherapy tiragolumab plus Tecentriq® (atezolizumab) and chemotherapy (carboplatin and etoposide) as an initial (first-line) treatment for people with extensive-stage small cell lung cancer (ES-SCLC), did not meet its co-primary endpoint of progression-free survival. Jan 2020: Genentech, a member of the Roche Group, announced that tiragolumab, a novel cancer immunotherapy designed to bind to TIGIT, has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA), in combination with Tecentriq (atezolizumab) for the first-line treatment of people with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression with no EGFR or ALK genomic tumor aberrations. NCT04300647 Phase 2 in cervical cancer not yet recruiting when first posted on March 9, 2020. NCT04294810 Phase 3 in NSCLC recruiting on March 4, 2020. NCT04256421 Phase 3 in small cell lung cancer started in Feb 2020. NCT04045028 Phase 1 study of Tiragolumab as a Single Agent and In Combination With Daratumumab In Patients With Relapsed Or Refractory Multiple Myeloma, and As a Single Agent and In Combination With Rituximab In Patients With Relapsed Or Refractory B-Cell Non-Hodgkin Lymphoma not yet recruiting as of Aug 5 2019. NCT03563716 Phase 2 study in NSCLC started in June 2018. NCT02794571 Phase 1 study started in May 2016 |
| Full address of company | South San Francisco, California, United States North America United States of America https://www.gene.com/contact-us/visit-us |
Immune checkpoint inhibitor. Anti-TIGIT (MTIG7192A, RG6058) is a fully human monoclonal antibody designed to bind to TIGIT and prevent its interaction with poliovirus receptor (PVR).
| Anticipated events | Marketing application submission in NSCLC expected in 2025 (?); Phase 3 data in H2 2024 |
| Factor(s) contributing to discontinuation | None |