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 | US: First approval for Endometrial Cancer (JEMPERLI is indicated for the treatment of adult patients with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following prior treatment with a platinum-containing regimen.). US Supplemental approvals (as of August 1, 2024 label) for: Endometrial Cancer (JEMPERLI, in combination with carboplatin and paclitaxel, followed by JEMPERLI as a single agent, is indicated for the treatment of adult patients with primary advanced or recurrent endometrial cancer (EC) or, JEMPERLI, as a single agent, is indicated for the treatment of adult patients with mismatch repair deficient (dMMR) recurrent or advanced EC, as determined by an FDA-approved test, that has progressed on or following prior treatment with a platinum-containing regimen in any setting and are not candidates for curative surgery or radiation.); Mismatch Repair Deficient Recurrent or Advanced Solid Tumors (JEMPERLI, as a single agent, is indicated for the treatment of adult patients with dMMR recurrent or advanced solid tumors, as determined by an FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options). EU: First approval for Endometrial Cancer. Supplemental approvals (as per EPAR - Product information last updated on January 21, 2025) for Endometrial Cancer (JEMPERLI is indicated in combination with carboplatin and paclitaxel for the first-line treatment of adult patients with primary advanced or recurrent endometrial cancer (EC) and who are candidates for systemic therapy. JEMPERLI is indicated as monotherapy for the treatment of adult patients with mismatch repair deficient (dMMR)/ microsatellite instability-high (MSI-H) recurrent or advanced EC that has progressed on or following prior treatment with a platinum-containing regimen.). |
| Company | GlaxoSmithKline |
| Licensee/Partner | AnaptysBio Inc |
| Comments about company or candidate | July 2023: Supplemental approval: 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). August 2021: Supplemental approval: GSK receives FDA accelerated approval for JEMPERLI (dostarlimab-gxly) for adult patients with mismatch repair-deficient (dMMR) recurrent or advanced solid tumours 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. Dostarlimab is a programmed death receptor-1 (PD-1)–blocking IgG4 humanized monoclonal antibody. Dostarlimab-gxly is produced in Chinese hamster ovary cells and has a calculated molecular weight of about 144 kDa.
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |