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01-07-2021 | NSCLC | AdisInsight Report

Dostarlimab: First Approval

Author: Anthony Markham

Published in: Drugs | Issue 10/2021

Abstract

Dostarlimab (Jemperli™; GlaxoSmithKline) is a humanized monoclonal antibody programmed death-1 (PD-1) receptor antagonist being developed for the treatment of various cancers. Based on preliminary results from the GARNET trial dostarlimab has recently been approved in the EU and USA for the treatment of adult patients with mismatch repair deficient recurrent or advanced endometrial cancer. This article summarizes the milestones in the development of dostarlimab leading to these first approvals.

Food & Drug Administration. FDA grants accelerated approval to dostarlimab-gxly for dMMR endometrial cancer [media release]. 22 Apr 2021. https://www.fda.gov/drugs.

GlaxoSmithKline. Jemperli (Dostarlimab): US prescribing information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761174s000lbl.pdf. Accessed 27 May 2021.

GlaxoSmithKline. European Commission approves GSK’s JEMPERLI (dostarlimab), the first anti-PD-1 therapy approved for recurrent or advanced endometrial cancer [media release]. 23 Apr 2021. https://www.gsk.com.

GlaxoSmithKline. Jemperli (Dostarlimab) summary of product characteristics (SmPC). 2021. https://www.ema.europa.eu/en/medicines/human/summaries-opinion/jemperli. Accessed 7 May

GlaxoSmithKline, Tesaro. GSK completes acquisition of TESARO, an oncology focused biopharmaceutical company [media release]. 22 Jan 2019. https://www.gsk.com.

Tesaro, AnaptysBio. TESARO and AnaptysBio announce collaboration and exclusive worldwide license agreement for multiple immuno-oncology programs [media release]. 13 Mar 2014. https://ir.anaptysbio.com.

Tesaro, AnaptysBio. TESARO and AnaptysBio expand immuno-oncology collaboration to include novel bispecific antibody candidate [media release]. 2 Dec 2014. https://ir.anaptysbio.com.

Laken H, Kehry M, McNeeley P, et al. Identification and characterization of TSR-042, a novel anti-human PD-1 therapeutic antibody. Eur J Cancer. 2016;69(Suppl 1):S102.CrossRef

Oaknin A, Tinker AV, Gilbert L, et al. Clinical activity and safety of the anti-programmed death 1 monoclonal antibody dostarlimab for patients with recurrent or advanced mismatch repair-deficient endometrial cancer: a nonrandomized phase 1 clinical trial. JAMA Oncol. 2020;6(11):1766–72.CrossRef

10.

Oaknin A, Gilbert L, Tinker AV, et al. Safety and antitumor activity of dostarlimab in patients with advanced or recurrent DNA mismatch repair deficient (dMMR) or proficient (MMRp) endometrial cancer: results from GARNET [abstract no. LBA36]. In: 2020 ESMO Virtual Congress. 2020.

11.

Cancernetwork. Dostarlimab shows promising antitumor activity in mismatch repair deficient, proficient endometrial cancer. 2020. https://www.cancernetwork.com/view/dostarlimab-shows-promising-antitumor-activity-in-mismatch-repair-deficient-proficient. Accessed 7 May 2021.

12.

Andre T, Berton D, Curigliano G, et al. Safety and efficacy of anti-PD-1 antibody dostarlimab in patients (pts) with mismatch repair-deficient (dMMR) solid cancers: results from GARNET study [abstract no. 9]. J Clin Oncol 2021;39(Suppl 3)CrossRef

13.

Subramanian J, Moreno V, Bosch-Barrera J, et al. Safety and efficacy of dostarlimab in patients (pts) with recurrent/advanced non-small cell lung cancer (NSCLC). Ann Oncol. 2020;31(Suppl 4):S886–7.CrossRef

14.

Davar D, Boasberg P, Eroglu Z, et al. A phase 1 study of TSR-022 (Anti-TIM-3) in combination with TSR-042 (Anti-PD-1) [abstract no. O21]. In: Society for Immunotherapy of Cancer. 2018.

15.

Gabrail NY, Bessudo A, Hmilton EP, et al. IOLite: Multipart, phase 1b, dose-finding study of the PD-1 inhibitor dostarlimab in combination with the PARP inhibitor niraparib +/- bevacizumab (bev), or with platinum-based chemotherapy +/- bev for advanced cancer [abstract no. 2560 plus poster]. J Clin Oncol 2019;37(Suppl 15).CrossRef

16.

Randall LM, O’Malley DM, Monk BJ, et al. MOONSTONE/GOG-3032: a phase II, open-label, single-arm study to evaluate the efficacy and safety of niraparib + dostarlimab in patients with platinum-resistant ovarian cancer. Ann Oncol. 2020;31(Suppl 4):S646–7.CrossRef

17.

Hardy-Bessard AC, Moore KN, Mirza MR, et al. ENGOT-OV44/FIRST study: a randomized, double-blind, adaptive, phase III study of standard of care (SOC) platinum-based therapy +/- dostarlimab followed by niraparib +/- dostarlimab maintenance as firstline (1L) treatment of stage 3 or 4 ovarian cancer (OC) [abstract no. TPS6101]. J Clin Oncol 2020;38:(Suppl 15).CrossRef

18.

Tesaro. TESARO announces expansion to second stage of JASPER trial of ZEJULA^® in combination with TSR-042 in non-small cell lung cancer [media release]. 04 Sep 2018. https://www.globenewswire.com

19.

Ramalingam SS, Thara E, Rao S, et al. JASPER: Efficacy and safety of first-line (1L) niraparib plus a programmed death receptor 1 inhibitor (PD-1i) in patients with advanced non-small cell lung cancer (NSCLC). Ann Oncol. 2020;31(Suppl 4):S819–20.CrossRef

20.

Nooka AK, Weisel K, van de Donk NW, et al. Belantamab mafodotin in combination with novel agents in relapsed/refractory multiple myeloma: DREAMM-5 study design. Future Oncol. 2021. https://doi.org/10.2217/fon-2020-1269.CrossRefPubMed

21.

Mirza MR, Coleman RL, Hanker LC, et al. ENGOT-EN6/NSGO-RUBY: a phase III, randomized, doubleblind, multicenter study of dostarlimab + carboplatinpaclitaxel versus placebo + carboplatin-paclitaxel in recurrent or primary advanced endometrial cancer (EC) [abstract no. TPS6107]. J Clin Oncol 2020;38(Suppl 15).

22.

Oaknin A, Iglesias M, Alarcon JD, et al. Randomized, open-label, phase II trial of dostarlimab (TSR-042), as maintenance therapy for patients with high-risk locally advanced cervical cancer after chemo-radiation: ATOMICC study [abstract no. 880TiP]. Ann Oncol. 2020;31:s645.CrossRef

23.

Athenex Inc. Quantum Leap Healthcare Collaborative and Athenex announce the selection of oral paclitaxel plus encequidar in combination with dostarlimab, an anti-PD-1, in the I-SPY 2 TRIAL targeting stage 2/3 HER2+ and HER2- breast cancers [media Release]. 08 Sep 2020. https://www.globenewswire.com.

Title: Dostarlimab: First Approval
Author: Anthony Markham
Publication date: 01-07-2021
Publisher: Springer International Publishing
Keywords: NSCLC
NSCLC
Endometrial Cancer
Endometrial Cancer
Published in: Drugs / Issue 10/2021
Print ISSN: 0012-6667
Electronic ISSN: 1179-1950
DOI: https://doi.org/10.1007/s40265-021-01539-5

2024 ASCO Annual Meeting

Springer Medicine

Dostarlimab: First Approval

Abstract

2024 ASCO Annual Meeting

Springer Medicine

Abstract

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