Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1021 |
| INN | Vibostolimab |
| Status | Clinical |
| Drug code(s) | MK-7684 |
| Brand name | None |
| mAb sequence source | mAb humanized |
| 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 | None |
| Target(s) | TIGIT |
| Indications of clinical studies | Small Cell Lung Carcinoma, Non-small cell lung cancer, melanoma, Solid 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) | December 15, 2016 |
| Start of Phase 2 | December 19, 2019 |
| Start of Phase 3 | April 07, 2021 |
| 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 | Merck Sharp & Dohme Corp. |
| Licensee/Partner | None |
| Comments about company or candidate | August 08, 2024: Merck announced the discontinuation of the Phase 3 KeyVibe-008 trial (NCT05224141) based on the recommendation of an independent Data Monitoring Committee; a pre-planned analysis, data showed that the primary endpoint of overall survival (OS) met the pre-specified futility criteria. KeyVibe-003 , KeyVibe-006 and KeyVibe-007 studies are ongoing. Phase 3 studies for Non-small cell lung cancer (NCT04738487 and NCT05298423 are recruiting as of June 2, 2023; NCT05226598 is active non recruiting as of May 16, 2023); Small cell lung cancer (NCT05224141) is recruiting as of June 2, 2023; Melanoma (NCT05665595) is recruiting as of May 31, 2023. Listed as Phase 3 asset in Merck pipeline dated 3/3/2023. NCT04738487 Phase 3 study in NSCLC started in April 2021. Data from these cohort expansion studies are encouraging and support the continued development of vibostolimab, which is being evaluated alone and in combination with KEYTRUDA across multiple solid tumors, including NSCLC and melanoma. In the ongoing Phase 2 KEYNOTE-U01 umbrella study (NCT04165798), substudy KEYNOTE-01A (NCT04165070) is evaluating vibostolimab in combination with KEYTRUDA plus chemotherapy for the first-line treatment of patients with advanced NSCLC who had not received prior treatment with an anti-PD-1/PD-L1. Merck plans to initiate a Phase 3 study of vibostolimab in NSCLC in the first half of 2021. Ongoing trials in melanoma include the Phase 1/2 KEYNOTE-U02 umbrella study comprised of three substudies evaluating vibostolimab in combination with KEYTRUDA across treatment settings (substudy 02A: NCT04305041, substudy 02B: NCT04305054 and substudy 02C: NCT04303169). Nov 2018: Data presented at SITC meeting. Preliminary data showed MK-7684 as monotherapy and in combination with KEYTRUDA was generally well tolerated and had a manageable safety profile across all dose levels tested. There were no dose limiting toxicities recorded. TRAEs occurred in 56 percent of patients in the monotherapy arm and 60 percent in the combination arm of which 6 percent and 11 percent were Grade 3-4 toxicities, respectively. Phase-I clinical trials in Solid tumours in South Korea, Australia (IV) after November 2016 (NCT02964013) |
| Full address of company | Rahway, NJ 07065 USA North America United States of America https://www.merck.com/contact-us/ |
MK-7684 is a humanized, IgG1 monoclonal antibody that binds TIGIT and blocks its interaction with its ligands, CD112 and CD155. We present the dose escalation portion of the first-in-human study of MK-7684 as monotherapy or in combination with pembrolizumab in patients with advanced solid tumors. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6220479/
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |