Delving into the Latest Updates on Dostarlimab-gxly with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Dostarlimab, Immunoglobulin G4, anti-programmed cell death protein 1 (PDCD1) (humanized clone ABT1 gamma4-chain), disulfide with humanized clone ABT1 kappa-chain, dimer, 多斯塔利单抗

+ [9]

Target

PD-1

Mechanism

PD-1 inhibitors(Programmed cell death protein 1 inhibitors)

Therapeutic Areas

NeoplasmsUrogenital DiseasesNervous System Diseases+ [6]

Active Indication

Recurrent Endometrial CancerAdvanced Endometrial CarcinomaMismatch repair-deficient Solid Tumors+ [49]

Inactive Indication

Adenocarcinoma of EsophagusAdvanced CholangiocarcinomaBiliary Tract Neoplasms+ [10]

Originator Organization

AnaptysBio, Inc.

Active Organization

Tesaro, Inc.

GSK Plc

The University of Texas MD Anderson Cancer Center

+ [6]

Inactive Organization

Institut Gustave Roussy EURL

Drug Highest PhaseApproved

First Approval Date

EU (21 Apr 2021),

Microsatellite instability-high Endometrial CarcinomaMismatch repair-deficient Endometrial Carcinoma

RegulationPriority Review (US), Breakthrough Therapy (US), Fast Track (US), Accelerated Approval (US), Priority Review (AU)

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Gene Sequence

Sequence Code 315609369H

Source: *****

Sequence Code 315609370L

Source: *****

The second line of therapy for patients with MSI-H CRC who experience disease progression on anti-PD1 based therapies is not well defined and there is an unmet need for research for patients with anti-PD1 refractory MSI-H CRC. This study will examine the combination of niraparib and dostarlimab for a synergistic antitumor effect for patients with MSI-H CRC.

Start Date01 Jul 2024

Sponsor / Collaborator

University of Pittsburgh

[+1]

NCT06472076 / RecruitingPhase 3

A Randomized, Multicenter, Double-blind, Phase 3 Study to Investigate the Safety and Efficacy of Belrestotug in Combination With Dostarlimab Compared With Placebo in Combination With Pembrolizumab in Participants With Previously Untreated, Unresectable, Locally Advanced or Metastatic PD-L1 Selected Non-small Cell Lung Cancer (GALAXIES Lung-301)

The goal of this clinical trial is to evaluate the efficacy and safety profile of dostarlimab in combination with belrestotug when compared with pembrolizumab and placebo in participants with previously untreated, unresectable, locally advanced or metastatic PD-L1 high NSCLC. Researchers will compare belrestotug plus dostarlimab with pembrolizumab plus placebo to see if there is meaningful improvement in progression free survival (PFS) and overall survival (OS).

Start Date10 Jun 2024

Sponsor / Collaborator

GSK Plc

[+1]

100 Clinical Results associated with Dostarlimab-gxly

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100 Translational Medicine associated with Dostarlimab-gxly

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100 Patents (Medical) associated with Dostarlimab-gxly

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107

Literatures (Medical) associated with Dostarlimab-gxly

01 Mar 2024·European journal of cancer (Oxford, England : 1990)

Cross-trial comparisons for the adjuvant treatment of MSI colorectal cancer: dare to dream the future scenarios.

Article

Author: Catalano, Fabio ; Sobrero, Alberto ; Zalcberg, John R ; Pastorino, Alessandro

The remarkable outcomes achieved with neoadjuvant checkpoint inhibitors for patients diagnosed with MSI colorectal cancer hold the potential to revolutionize the treatment landscape in this context. Specifically, the combination of nivolumab plus ipilimumab in colon cancer and dostarlimab in rectal cancer has led to an unprecedented rate of complete pathological and clinical responses. Notably, these responses have been further substantiated by the absence of relapses, with a 0% relapse rate observed during the first year of follow-up. The significance of these achievements becomes even more apparent when compared to the relatively high relapse rates, ranging from 11% to 28%, observed in MSI colorectal cancer cases treated neoadjuvantly with chemo(radio)therapy. However, it is crucial to exercise caution when interpreting such exceptional responses in oncology, especially within a short follow-up period. The future implications of these findings will depend on how the data mature over time. In this manuscript, we attempt to explore the potential scenarios that may unfold in the near future.

01 Feb 2024·Current opinion in obstetrics & gynecology

Latest advances in immuno-oncology for endometrial cancer: single-agent and combination regimens

Review

Author: Richardson, Michael ; Chase, Dana M

Purpose of review:

The scope of immuno-oncology in endometrial cancer has changed rapidly in the last several years, requiring up-to-date knowledge for those who treat these patients.

Recent findings:

This article will focus on molecular profiling, recent trials, and FDA approvals of targeted immuno-oncology medications in endometrial cancer. These include immune checkpoint inhibitors alone or with combination treatment.

Summary:

The publication of the TCGA has led to significant focus on molecular subgroupings into POLEm, MMRd, NSMP, and p53m groups. For those patients with MMRd vs. MMRp tumors, there are indications for single agent immune checkpoint inhibitors with dostarlimab or pembrolizumab. For those with MMRp tumors, the addition of lenvatinib to pembrolizumab has proven clinical benefit. The recent publication of the RUBY and NRG-GY018 trials have shown clinical benefit in both subgroups with addition of immune checkpoint inhibitor to platinum-based chemotherapy. Now there is approval for use of dostarlimab in frontline chemotherapy and maintenance for advanced stage or recurrent endometrial cancer. Several upcoming trials investigating molecular subgroups from the TCGA are eagerly anticipated.

01 May 2024·Anti-cancer agents in medicinal chemistry

An Expedition on Synthetic Methodology of FDA-approved Anticancer Drugs (2018-2021)

Review

Author: Gupta, Ghanshyam Das ; Jain, Ankit ; Vishakha, S ; Verma, Sant Kumar ; Navneesh, N ; Patel, Preeti ; Kurmi, Balak Das

Abstract::

New drugs being established in the market every year produce specified structures for selective biological targeting. With medicinal insights into molecular recognition, these begot molecules open new rooms for designing potential new drug molecules. In this review, we report the compilation and analysis of a total of 56 drugs including 33 organic small molecules (Mobocertinib, Infigratinib, Sotorasib, Trilaciclib, Umbralisib, Tepotinib, Relugolix, Pralsetinib, Decitabine, Ripretinib, Selpercatinib, Capmatinib, Pemigatinib, Tucatinib, Selumetinib, Tazemetostat, Avapritinib, Zanubrutinib, Entrectinib, Pexidartinib, Darolutamide, Selinexor, Alpelisib, Erdafitinib, Gilteritinib, Larotrectinib, Glasdegib, Lorlatinib, Talazoparib, Dacomitinib, Duvelisib, Ivosidenib, Apalutamide), 6 metal complexes (Edotreotide Gallium Ga-68, fluoroestradiol F-18, Cu 64 dotatate, Gallium 68 PSMA-11, Piflufolastat F-18, 177Lu (lutetium)), 16 macromolecules as monoclonal antibody conjugates (Brentuximabvedotin, Amivantamab-vmjw, Loncastuximabtesirine, Dostarlimab, Margetuximab, Naxitamab, Belantamabmafodotin, Tafasitamab, Inebilizumab, SacituzumabGovitecan, Isatuximab, Trastuzumab, Enfortumabvedotin, Polatuzumab, Cemiplimab, Mogamulizumab) and 1 peptide enzyme (Erwiniachrysanthemi-derived asparaginase) approved by the U.S. FDA between 2018 to 2021. These drugs act as anticancer agents against various cancer types, especially non-small cell lung, lymphoma, breast, prostate, multiple myeloma, neuroendocrine tumor, cervical, bladder, cholangiocarcinoma, myeloid leukemia, gastrointestinal, neuroblastoma, thyroid, epithelioid and cutaneous squamous cell carcinoma. The review comprises the key structural features, approval times, target selectivity, mechanisms of action, therapeutic indication, formulations, and possible synthetic approaches of these approved drugs. These crucial details will benefit the scientific community for futuristic new developments in this arena.

194

News (Medical) associated with Dostarlimab-gxly

27 Jun 2024

·www.prnewswire.com

Elevation Oncology Announces Planned Combination Strategy for EO-3021 in Patients with Gastric or Gastroesophageal Junction Cancer

-- Plan to evaluate EO-3021 in combination with ramucirumab and dostarlimab; entered into clinical supply agreements with Lilly and GSK, respectively -- -- Expect to initiate dosing in combination portion of the Phase 1 trial by year-end 2024 -- -- Combination cohorts broaden market opportunity for EO-3021 to address unmet needs across second- and first-line gastric or gastroesophageal junction cancer settings -- -- On-track to provide update from ongoing Phase 1 clinical trial evaluating monotherapy EO-3021 by mid-3Q 2024, with additional data in 1H 2025 -- BOSTON, June 27, 2024 /PRNewswire/ -- Elevation Oncology, Inc. (Nasdaq: ELEV), an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs, today announced plans to expand its ongoing Phase 1 clinical trial to include two combination cohorts evaluating EO-3021 for the treatment of advanced gastric or gastroesophageal junction cancer. Following recently signed clinical supply agreements with Eli Lilly and Company (Lilly) and GSK, respectively, Elevation Oncology will evaluate EO-3021 in combination with ramucirumab, a VEGFR2 inhibitor, in second-line patients and in combination with dostarlimab, a PD-1 inhibitor, in the front-line setting. The Company expects to initiate dosing in the combination portion of the Phase 1 trial by year-end 2024. "EO-3021 has the potential to change the treatment paradigm for tumors that express Claudin 18.2, including a majority of gastric and gastroesophageal junction adenocarcinomas," said Valerie Malyvanh Jansen, M.D., Ph.D., Chief Medical Officer of Elevation Oncology. "Based on safety data from preclinical and clinical trials, we believe EO-3021 benefits from a differentiated safety profile and will be readily combinable. We also know that combination-based regimens are a mainstay of cancer care, and that the combination of two therapies with distinct mechanisms of action often enables patients to achieve deeper, more durable responses. As such, we are excited to begin evaluating EO-3021 together with ramucirumab, a VEGFR2 inhibitor, and with dostarlimab, a PD-1 inhibitor, in the second- and first-line settings, respectively. In parallel, we continue to advance our Phase 1 trial of EO-3021 monotherapy toward initial safety and efficacy data by mid-third quarter." Clinical Development Plans for EO-3021 in Combination EO-3021 is a differentiated, potential best-in-class antibody drug conjugate (ADC) targeting Claudin 18.2. EO-3021 was designed with site-specific conjugation at glutamine (Q295), with the goal of increasing the stability of the linker-payload and minimizing the potential for free monomethyl auristatin E (MMAE) compared to traditional cysteine-based conjugation. In preclinical studies and the Phase 1 clinical trial conducted by Elevation Oncology's partner, data showed a favorable tolerability profile, with limited MMAE-related toxicities. Initial development of EO-3021 in combination will explore two regimens for the treatment of gastric or gastroesophageal junction cancer: EO-3021 in combination with ramucirumab in second-line patients: Ramucirumab is a monoclonal antibody that targets VEGFR2 and is approved for use in combination with paclitaxel for the treatment of second-line gastric or gastroesophageal junction cancer with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy. With EO-3021, Elevation Oncology aims to introduce a combination agent that, when paired with ramucirumab, can potentially deliver improved safety and efficacy as compared to the approved combination of ramucirumab and paclitaxel. EO-3021 in combination with dostarlimab in front-line patients: Dostarlimab is approved alone and in combination with chemotherapy for certain types of dMMR and MSI-H endometrial cancer in the US; it also has an accelerated approval in certain dMMR solid tumors. By combining EO-3021 and an immune checkpoint inhibitor, Elevation Oncology aims to deliver synergistic benefit, potentially offering patients improved outcomes beyond those seen with existing immunotherapy regimens for gastric or gastroesophageal junction cancer in the front-line setting. Each combination cohort will include a dose escalation and expansion portion, evaluating the combination of EO-3021 and ramucirumab or EO-3021 and dostarlimab. The primary endpoints will include safety and anti-tumor activity. Elevation Oncology plans to initiate dosing in the combination portion of the Phase 1 trial by year-end 2024. In June 2024, Elevation Oncology entered into clinical supply agreements with Lilly and GSK to supply their respective compounds for these combination cohorts. Elevation Oncology will sponsor and conduct all clinical development of both combinations and will assume all costs associated with the study. All companies will retain commercial rights to their respective compounds. Elevation Oncology continues to enroll patients in the monotherapy cohort of its ongoing Phase 1 clinical trial (NCT05980416) and remains on track to share initial safety and efficacy data by mid-third quarter 2024, with additional data in the first half of 2025. About EO-3021 EO-3021 (also known as SYSA1801) is a differentiated, clinical-stage antibody drug conjugate (ADC) with best-in-class potential comprised of an immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that targets Claudin 18.2. EO-3021 is site-specifically conjugated to the monomethyl auristatin E (MMAE) payload via a cleavable linker with a drug-to-antibody ratio (DAR) of 2. Claudin 18.2 is a specific isoform of Claudin 18 that is normally expressed in gastric epithelial cells. During malignant transformation, the tight junctions may become disrupted, exposing Claudin 18.2 and allowing them to be accessible by Claudin 18.2 targeting agents. Elevation Oncology is evaluating EO-3021 in a Phase 1 study (NCT05980416) in patients with advanced, unresectable or metastatic solid tumors likely to express Claudin 18.2 including gastric, gastroesophageal junction, pancreatic or esophageal cancers. Elevation Oncology has the exclusive rights to develop and commercialize EO-3021 in all global territories outside Greater China. About Elevation Oncology, Inc. Elevation Oncology is an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs. We are leveraging our antibody-drug conjugate (ADC) expertise to advance a novel pipeline, initially targeting two clinically validated targets in oncology, Claudin 18.2 and HER3. Our lead candidate, EO-3021, is a potential best-in-class ADC designed to target Claudin 18.2 and is currently being evaluated in a Phase 1 trial (NCT05980416) in patients with advanced, unresectable or metastatic solid tumors likely to express Claudin 18.2 including gastric, gastroesophageal junction, pancreatic or esophageal cancers. Additionally, we expect to nominate a development candidate for our second program, a HER3-targeting ADC for the treatment of patients with solid tumors that overexpress HER3, in 2024. For more information, visit . Forward-Looking Statements This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, anticipated clinical development activities, expected timing of announcements of clinical results, potential benefits of Elevation Oncology's product candidates, potential market opportunities for Elevation Oncology's product candidates and the ability of Elevation Oncology's product candidates to treat their targeted indications. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These forward-looking statements may be accompanied by such words as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "goal," "intend," "may," "might," "plan," "possible," "potential," "will," "would," and other words and terms of similar meaning. Although Elevation Oncology believes that the expectations reflected in such forward-looking statements are reasonable, Elevation Oncology cannot guarantee future events, results, actions, levels of activity, performance or achievements, and the timing and results of biotechnology development and potential regulatory approval are inherently uncertain. Forward-looking statements are subject to risks and uncertainties that may cause Elevation Oncology's actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to Elevation Oncology's ability to advance its product candidates, the timing and results of preclinical studies and clinical trials, approvals and commercialization of product candidates, the receipt and timing of potential regulatory designations, Elevation Oncology's ability to fund development activities and achieve development goals, Elevation Oncology's ability to protect intellectual property, Elevation Oncology's ability to establish and maintain collaborations with third parties, and other risks and uncertainties described under the heading "Risk Factors" in documents Elevation Oncology files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and Elevation Oncology undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof. Elevation Oncology Investor and Media Contact Hannah Deresiewicz, 212-362-1200 EVP, Managing Director, Precision AQ [email protected] SOURCE Elevation Oncology

Phase 1ImmunotherapyADCDrug Approval

18 Jun 2024

·www.fiercepharma.com

Merck's Keytruda snags 40th US indication, leaps ahead of GSK with broad endometrial cancer approval

First-line endometrial cancer marks the 40th indication for Keytruda in the U.S. The world’s best-selling medicine is still adding new uses, and its latest FDA approval marks a first in the cancer immunotherapy class. Merck & Co.’s Keytruda has received the FDA’s green light for use in combination with chemotherapy, followed by the PD-1 inhibitor as a single agent, in patients with primary advanced or recurrent endometrial cancer, the company said Monday. The approval marks the 40th U.S. indication for Keytruda, which generated $25 billion in sales globally last year. The new nod also allows Keytruda to leapfrog GSK’s rival PD-1 inhibitor Jemperli, which in July 2023 got the FDA’s blessing in first-line endometrial cancer. But Keytruda’s approval still claims a first because it covers tumors regardless of their mismatch repair status, which is a genomic biomarker. Jemperli’s nod, at least for now, is limited to a small subset of patients whose cancer is mismatch repair deficient (dMMR). Keytruda won over the FDA this time with data from the phase 3 NRG-GY018 trial, or Keynote-868. In the study, the Keytruda-chemo regimen cut the risk of disease progression or death by 70% in dMMR patients and by 40% in patients with mismatch repair proficient (pMMR), compared with chemo alone. The data are slightly different from when the results of the study were first published last year. In the dMMR cohort, patients in the control arm lived a median of 6.5 months without disease progression, and the median was not reached for Keytruda. As to the pMMR group, the median progression-free survival was 8.5 months and 11.1 months for the two arms, respectively. At the interim analysis, data on whether Keytruda could extend patients’ lives remained immature with 12% deaths in the dMMR cohort and 17% in the pMMR population, according to the drug’s updated label. Although the exact overall survival data remain unclear, the FDA approval likely indicates that there’s at least no sign of any potential harm to patients’ life expectancy. While Keytruda is the first to reach a broad first-line endometrial cancer population, Jemperli’s expansion beyond the dMMR subgroup may not be far away. After a longer follow-up of part 1 of the phase 3 RUBY trial, GSK’s application to expand Jemperli’s nod to include pMMR patients has been accepted by the FDA under priority review. The target decision date is August 23 this year. In the RUBY trial, Jemperli and chemo significantly reduced the risk of death by 31% in endometrial cancer patients regardless of their tumor’s mismatch repair status. As such, Jemperli became the first PD-1/L1 inhibitor to claim a statistically significant overall survival win in first-line endometrial cancer in an overall population. In the pMMR subgroup, the Jemperli-chemo combo showed a “clinically meaningful trend” in reducing the risk of death by 21% versus chemo alone, according to data released in March. News of Keytruda’s latest approval came on the same day of an AstraZeneca announcement that its PD-L1 inhibitor Imfinzi has also secured an FDA approval in first-line dMMR endometrial cancer as part of a combination with chemo. An AZ spokesperson said the company will continue to evaluate overall survival data to potentially help Imfinzi reach even more patients. Besides, both GSK and AZ are assessing adding a PARP inhibitor to their respective immunotherapies with positive findings so far. But neither company has made any regulatory progress with their PARP-containing cocktails.

Clinical ResultPhase 3Drug ApprovalImmunotherapyPriority Review

18 Jun 2024

·firstwordpharma.com

FDA nod for Keytruda sets up three-way battle in endometrial cancer

Merck & Co.’s Keytruda (pembrolizumab) became the first anti-PD-1 therapy approved in combination with chemotherapy by the FDA for adults with primary advanced or recurrent endometrial carcinoma regardless of mismatch repair status. The company also noted that the clearance marks the third for Keytruda in endometrial cancer and the 40th indication for the product in the US.The decision came shortly after the FDA authorised AstraZeneca’s PD-L1 inhibitor Imfinzi (durvalumab) in combination with chemotherapy as a treatment for adults with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR). GSK’s PD-1-blocking antibody Jemperli (dostarlimab) is also approved in the US for the front-line treatment of advanced or recurrent dMMR endometrial cancer, while a decision is due by August 23 on whether to expand use to all adults with primary advanced or recurrent endometrial cancer.Keytruda’s new approval was based on findings from the Phase III KEYNOTE-868 study, in which Keytruda plus carboplatin and paclitaxel, followed by Keytruda alone, reduced the risk of disease progression or death by 40% in patients whose cancer was mismatch repair proficient (pMMR) and by 70% those with dMMR tumours, compared to placebo with carboplatin and paclitaxel followed by placebo alone.More to come.

Drug ApprovalClinical ResultPhase 3Accelerated Approval

100 Deals associated with Dostarlimab-gxly

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	L01XC	DB15627

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Recurrent Endometrial Cancer	EU	GlaxoSmithKline (Ireland) Ltd.	12 Jan 2024
Recurrent Endometrial Cancer	IS	GlaxoSmithKline (Ireland) Ltd.	12 Jan 2024
Recurrent Endometrial Cancer	LI	GlaxoSmithKline (Ireland) Ltd.	12 Jan 2024
Recurrent Endometrial Cancer	NO	GlaxoSmithKline (Ireland) Ltd.	12 Jan 2024
Advanced Endometrial Carcinoma	EU	GSK Plc	12 Dec 2023
Advanced Endometrial Carcinoma	IS	GSK Plc	12 Dec 2023
Advanced Endometrial Carcinoma	LI	GSK Plc	12 Dec 2023
Advanced Endometrial Carcinoma	NO	GSK Plc	12 Dec 2023
Mismatch repair-deficient Solid Tumors	US	GlaxoSmithKline LLC	17 Aug 2021
Microsatellite instability-high Endometrial Carcinoma	EU	GlaxoSmithKline (Ireland) Ltd.	21 Apr 2021
Microsatellite instability-high Endometrial Carcinoma	IS	GlaxoSmithKline (Ireland) Ltd.	21 Apr 2021
Microsatellite instability-high Endometrial Carcinoma	LI	GlaxoSmithKline (Ireland) Ltd.	21 Apr 2021
Microsatellite instability-high Endometrial Carcinoma	NO	GlaxoSmithKline (Ireland) Ltd.	21 Apr 2021
Mismatch repair-deficient Endometrial Carcinoma	EU	GlaxoSmithKline (Ireland) Ltd.	21 Apr 2021
Mismatch repair-deficient Endometrial Carcinoma	IS	GlaxoSmithKline (Ireland) Ltd.	21 Apr 2021
Mismatch repair-deficient Endometrial Carcinoma	LI	GlaxoSmithKline (Ireland) Ltd.	21 Apr 2021
Mismatch repair-deficient Endometrial Carcinoma	NO	GlaxoSmithKline (Ireland) Ltd.	21 Apr 2021

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
PD-L1 positive Non-Small Cell Lung Cancer	Phase 3	JP	GSK Plc	10 Jun 2024
PD-L1 positive Non-Small Cell Lung Cancer	Phase 3	AR	GSK Plc	10 Jun 2024
PD-L1 positive Non-Small Cell Lung Cancer	Phase 3	BE	GSK Plc	10 Jun 2024
PD-L1 positive Non-Small Cell Lung Cancer	Phase 3	BR	GSK Plc	10 Jun 2024
PD-L1 positive Non-Small Cell Lung Cancer	Phase 3	BG	GSK Plc	10 Jun 2024
PD-L1 positive Non-Small Cell Lung Cancer	Phase 3	CA	GSK Plc	10 Jun 2024
PD-L1 positive Non-Small Cell Lung Cancer	Phase 3	HR	GSK Plc	10 Jun 2024
PD-L1 positive Non-Small Cell Lung Cancer	Phase 3	CZ	GSK Plc	10 Jun 2024
PD-L1 positive Non-Small Cell Lung Cancer	Phase 3	EE	GSK Plc	10 Jun 2024
PD-L1 positive Non-Small Cell Lung Cancer	Phase 3	FI	GSK Plc	10 Jun 2024

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04165772 (ASCO2024) Manual	Phase 2	Mismatch repair-deficient Rectal Cancer Neoadjuvant	41	dostarlimab	cpgrievtol(mfwxxgdoxn) = woolvnphop tqdyxmmknp (wnjnkwfoej ) Met View more	Positive	02 Jun 2024
NCT05565378 (GALAXIES Lung-201, Company_Website) Manual	Not Applicable	Non-Small Cell Lung Cancer	-	Belrestotug + dostarlimab	gghgvxpjov(mzehycejlk) = acceptable safety profile in line with the TIGIT:PD-1 class inugibivgi (lyfntnvavi )	Positive	10 May 2024
				dostarlimab
NCT03981796 (RUBY \| ENGOT-EN6 \| GOG3031 \| NSGO, BusinessWire) Manual	Phase 3	Endometrial Carcinoma Microsatellite Stable (MSS) \| Proficient DNA Mismatch Repair (pMMR) \| MSI-High \| ... View more	-	Jemperli+carboplatin+paclitaxel	akxuwydmwf(bzxocavjzo) = xjeezfefmx tcapljbhvc (bciyatkhtg, 32.6–NR) Met View more	Positive	16 Mar 2024
				placebo+carboplatin+paclitaxel	akxuwydmwf(bzxocavjzo) = ldsxjkzagj tcapljbhvc (bciyatkhtg, 22.1–35.6) Met View more
NCT03981796 (RUBY \| ENGOT-EN6 \| GOG3031 \| NSGO, BusinessWire) Manual	Phase 3	Endometrial Carcinoma First line Proficient DNA Mismatch Repair (pMMR)	-	Dostarlimab-gxly+chemotherapy+niraparib	kncyipyszg(usxlupmemv) = slvlulnjda goncciieiq (mvyfxdyfll ) Met View more	Positive	16 Mar 2024
				Placebo+chemotherapy+placebo	kncyipyszg(usxlupmemv) = asxrcrrodh goncciieiq (mvyfxdyfll ) Met View more
GEICO 120/DORA (ESGO2024)	Phase 1	Microsatellite instability-high Endometrial Carcinoma dMMR \| MSI-H	143	Dostarlimab monotherapy	lyhigombdo(siupioewls) = gpdcnopedo dekcnrwsgd (fqfvbxnfdd )	Positive	10 Mar 2024
RUBY (NEWS) Manual	Phase 3	Advanced Endometrial Carcinoma Maintenance	-	Jemperli +Zejula	xgfqifsryt(aaannpawye) = significantly improved progression-free survival (PFS) versus placebo gojncmkfbq (qhsfitiexd )	Positive	18 Dec 2023
				placebo
GARNET (ESMO_IO2023)	Phase 1	Mismatch repair-deficient Endometrial Carcinoma Second line Tertiary Lymphoid Structure	14	Dostarlimab	ncfidittkl(bffcgcigsm) = khysjcaefb cnuhukomcl (tjdpbazfnn )	-	07 Dec 2023
				Chemotherapy	ncfidittkl(bffcgcigsm) = xfnzpenudx cnuhukomcl (tjdpbazfnn )
NCT04581824 (PERLA, ESMO_ASIA2023)	Phase 2	Metastatic Non-Squamous Non-Small Cell Lung Carcinoma First line PD-L1 status \| EGFR \| ALK ... View more	243	Dostarlimab + CT	ufljqvmsob(gbtxmryvsv) = ebkssrsywx jppmdojmha (ltsdcivjox )	Positive	02 Dec 2023
				Pembrolizumab + CT	ufljqvmsob(gbtxmryvsv) = tsakhqeujz jppmdojmha (ltsdcivjox )
NCT02715284 (GARNET, NEWS) Manual	Phase 1	Solid tumor Second line MSI-High \| Deficient DNA Mismatch Repair (dMMR)	327	dostarlimab	jpfgxfccfk(mahfttqqgg) = gpkblvoksk lbkljerqip (okguzshyuy, 38.6 - 49.6) View more	Positive	24 Nov 2023
NCT03981796 (RUBY \| ENGOT-EN6 \| GOG3031 \| NSGO , Corporate Publications) Manual	Phase 3	Endometrial Carcinoma	-	Dostarlimab+chemotherapy	lbycnkxdos(mymceviwrp) = The trial met its primary endpoint of overall survival, demonstrating a statistically significant and clinically meaningful benefit in the overall patient population. zwkkpbzirq (yujbwclmzc ) Met View more	Positive	30 Oct 2023
				Placebo+chemotherapy