Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 156 |
| INN | Dostarlimab |
| Status | Approved |
| Drug code(s) | TSR-042, GSK4057190A |
| Brand name | Jemperli |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG4 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | PD-1 |
| Indications of clinical studies | Breast cancer, Ovarian cancer, Rectal Adenocarcinoma, solid tumors, endometrial cancer |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Approved EU, US, Australia |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | December 15, 2015 |
| Start of Phase 2 | |
| Start of Phase 3 | October 15, 2018 |
| Date BLA/NDA submitted to FDA | December 19, 2019 |
| Year of first approval (global) | 2021 |
| Date of first US approval | April 22, 2021 |
| INN, US product name | Dostarlimab, dostarlimab-gxly |
| US or EU approved indications | Recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum-containing chemotherapy and whose cancers are deficient in their ability to repair DNA inside the cell, as determined by an FDA-approved test. July 2023: US Food and Drug Administration (FDA) has approved Jemperli (dostarlimab) in combination with carboplatin and paclitaxel, followed by Jemperli as a single agent for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR), as determined by an FDA-approved test, or microsatellite instability-high (MSI-H). |
| Company | GlaxoSmithKline |
| Licensee/Partner | AnaptysBio Inc |
| Comments about company or candidate | Authorized in EU on April 21, 2021 BLA 761174 submitted Dec 19, 2019 was approved April 22, 2021; BLA 761223 submitted Dec 18, 2020 was approved Aug 17, 2021. Jan 2020: GSK announced at JP Morgan Healthcare conference that they anticipate approval in 2nd line endometrial cancer in 2020. TESARO acquired by GSK in 2019. NCT04165772 Phase 2 in Rectal Adenocarcinoma not yet recruiting when posted on Nov 18, 2019. NCT03981796 Phase 3 in edometrial cancer started recruiting Jul 18, 2019. NCT03955978 Phase 1 in endometrial cancer not yet recruiting as of May 20, 2019. NCT03602859 Phase 3 study and NCT03574779 Phase 2 study in ovarian cancer started in Oct 2018. Second Phase 1 study started in Oct 2017. The GARNET study is intended to support a Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA) in 2019, and support a request for accelerated approval The primary endpoints of this trial are overall response rate (ORR) and duration of response, and secondary endpoints include disease control rate, progression free survival (PFS), and overall survival (OS). The addition of cohorts for patients with other tumor types, including those with MSI-H tumors, is also planned. This is the first clinical development program within a broader plan that includes potential label expansion trials of TSR-042 in multiple cancers in combination with ZEJULA, TSR-022, TESARO’s anti-TIM-3 antibody, and TSR-033, TESARO’s anti-LAG-3 antibody. NCT02715284 Phase 1 started in March 2016 IND submitted in Dec 2015 [https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/761174Orig1s000MultidisciplineR.pdf] |
| Full address of company | 980 Great West Road Brentford Middlesex, TW8 9GS, United Kingdom Europe United Kingdom https://www.gsk.com/en-gb/contact-us/ |
Immune checkpoint target. S228P hinge mutation.
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |