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

+ [11]

Target

PD-1

Action

inhibitors

Mechanism

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

Therapeutic Areas

NeoplasmsUrogenital DiseasesNervous System Diseases+ [9]

Active Indication

Advanced Endometrial CarcinomaRecurrent Endometrial CancerMismatch repair-deficient Solid Tumors+ [80]

Inactive Indication

Advanced Bile Duct CarcinomaClear Cell SarcomaGestational Trophoblastic Disease+ [6]

Originator Organization

AnaptysBio, Inc.

Active Organization

GSK Plc

Tesaro, Inc.GlaxoSmithKline (Ireland) Ltd.

+ [7]

Inactive Organization-

License Organization

AnaptysBio, Inc.Sagard Healthcare Royalty Partners LP

GSK Plc

+ [1]

Drug Highest PhaseApproved

First Approval Date

European Union (21 Apr 2021),

Microsatellite instability-high Endometrial CarcinomaMismatch repair-deficient Endometrial Carcinoma

RegulationBreakthrough Therapy (United States), Fast Track (United States), Accelerated Approval (United States), Priority Review (Australia), Commissioner's National Priority Voucher (United States), Priority Review (United States)

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Structure/Sequence

Sequence Code 315609369H

Source: *****

Sequence Code 315609370L

Source: *****

The goal of this clinical trial is to see how well dostarlimab works when administered with the chemotherapy drugs carboplatin and paclitaxelin in treating EC in Chinese participants. The study aims to understand the treatments effectiveness, safety, how the drugs behave in the body, and whether it causes any immune reactions.

Start Date27 Nov 2025

Sponsor / Collaborator

GSK Plc

CTIS2024-519798-20-00

/ Not yet recruitingPhase 2IIT

Phase II randomized trial of XELOX plus DoSTARlimab versus XELOX alone as Consolidation Treatment after Standard Chemoradiation in pMMR/MSS or MSI-Low Locally Advanced Rectal Cancer (LARC) Patients – IMMUNOSTAR Trial - GOIRC-02-2024

Start Date01 Oct 2025

Sponsor / Collaborator-

NCT07013851

/ Not yet recruitingPhase 2IIT

Phase II Clinical Trial to Assess the Efficacy of Dostarlimab as Neoadjuvant Therapy in Patients With MMRd/MSI-H Stage II-III Endometrial Cancer

The study for which participation is requested is a phase II clinical trial to assess the efficacy of dostarlimab as neoadjuvant therapy in patients with MMRd/MSI-H stage II-III endometrial cancer. The study is conducted in Spain with an estimated number of 25 patients for phase II. The main objective of this phase-II study is to evaluate the clinical complete response (cCR) after neoadjuvant therapy with dostarlimab.

Start Date01 Oct 2025

Sponsor / Collaborator

GSK Plc

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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190

Literatures (Medical) associated with Dostarlimab-gxly

31 Dec 2025·Future Science OA

Immune checkpoint inhibitors or targeted therapy by mismatch repair status in endometrial cancer: a meta-analysis

Review

Author: Zeng, Ting ; Zhao, Jing ; Shu, Chuqiang ; Chen, Yan ; Tang, Yi ; Huang, Kui ; Zhang, Pu

OBJECTIVE:

This study evaluated the benefits of immune checkpoint inhibitors (ICIs) and/or targeted therapies in mismatch repair-deficient (dMMR) and mismatch repair-proficient (pMMR) patients with advanced or recurrent endometrial cancer (EC) via network meta-analysis.

METHODS:

English databases were searched from inception through January 2025. Randomized controlled trials (RCTs) assessing the efficacy and safety of related therapies for patients with EC stratified by MMR status were included. The main evaluation indicators included progression-free survival (PFS), overall survival (OS), the objective response rate (ORR), and severe adverse events (SAEs).

RESULTS:

Ten studies were included in the analysis. The results indicated that in the dMMR population, ICIs provide superior survival benefits. Among these, Dostarlimab combined with carboplatin and paclitaxel (CP) had the highest PFS and OS rates. For the pMMR population, Selinexor + CP offers significant benefits over CP alone, although OS outcome data are limited. In pMMR patients with prior chemotherapy, the lenvatinib + pembrolizumab strategy may provide additional PFS benefits relative to chemotherapy treatment.

CONCLUSIONS:

ICIs offered advantages for the dMMR population, whereas selinexor could provide survival benefits for the pMMR population. For pMMR patients who have received prior chemotherapy, the lenvatinib plus pembrolizumab strategy shows promise.

01 Nov 2025·INTERNATIONAL JOURNAL OF GYNECOLOGICAL CANCER

Checkpoint inhibitor rechallenge in advanced endometrial cancer: revisiting the immune landscape beyond first-line therapy

Review

Author: Flint, Michelle ; Slomovitz, Brian M ; Coleman, Robert L ; Eskander, Ramez N ; Monk, Bradley J ; Podder, Vivek

The integration of immune checkpoint inhibitors into frontline therapy for advanced or recurrent endometrial cancer has transformed treatment paradigms, particularly for patients with mismatch repair-deficient (dMMR) tumors. However, this advancement has introduced a pressing clinical challenge: how to manage patients who experience disease progression following exposure to a prior immune checkpoint inhibitor. Despite the absence of prospective guidance, immune checkpoint inhibitor rechallenge is already occurring in clinical practice. Notably, 35% of patients in the dostarlimab arm of the RUBY trial received subsequent immunotherapy off-protocol, highlighting the gap between evolving clinical behavior and available evidence. Emerging retrospective data suggest that retreatment with immune checkpoint inhibitors may be clinically and biologically plausible, particularly in biomarker-enriched populations. In a study, 54.5% of patients with dMMR endometrial cancer responded to second-line immune checkpoint inhibitor rechallenge, including complete responses. Additional reports indicate that combining immune checkpoint inhibitors with anti-vascular endothelial growth factors or multi-kinase inhibitors, such as lenvatinib or cabozantinib, may enhance immune reactivation even in microsatellite-stable or carcinosarcoma histologies. Nonetheless, toxicity remains a concern, with grade 3 to 4 immune-related adverse events and high rates of dose modification reported. Mechanistic insights point to immune escape pathways, including vascular endothelial growth factor-driven immunosuppression, MLH1 methylation, and high subclonal neoantigen burden, as contributors to immune checkpoint inhibitor resistance. These findings support the use of rational combinations and novel targets. Prospective trials such as NRG-GY025 are now evaluating dual checkpoint blockade in immune checkpoint inhibitor-pretreated dMMR endometrial cancer. In contrast, synthetic lethality strategies, such as the Werner helicase inhibitor HRO761 in high microsatellite instability tumors, represent promising non-immune-based rechallenge approaches. As immune checkpoint inhibitor exposure becomes commonplace in earlier treatment settings, there is an urgent need for biologically informed, individualized strategies to guide post-immune checkpoint inhibitor management. Future progress will depend on refining rechallenge criteria, optimizing combination regimens, and developing predictive biomarkers to identify patients most likely to benefit from retreatment.

03 Oct 2025·MEDICINE

Global safety profile of PD-1/PD-L1 inhibitors in hepatic autoimmune disorders: A global disproportionality analysis

Article

Author: Kong, Jaehyun ; Hwang, Jiyoung ; Yon, Dong Keon ; Cho, Jaehyeong ; Park, Jaeyu ; Oh, Jeongseon ; Kim, Tae Hyeong ; Kim, Tae Hyeon

The increasing use of programmed cell death protein-1 (PD-1) and programmed death-ligand 1 (PD-L1) inhibitors in cancer therapy has raised concerns regarding immune-related adverse events. However, global pharmacovigilance studies on autoimmune diseases remain scarce. This study aimed to evaluate the signal detection between PD-1/PD-L1 inhibitors and hepatic autoimmune disorders. A global pharmacovigilance study was conducted using data from individual case safety reports. The analysis centered on PD-1/PD-L1 inhibitors, classified by Anatomical Therapeutic Chemical codes (e.g., atezolizumab, avelumab, budigalimab, cemiplimab, dostarlimab, durvalumab, nivolumab, pembrolizumab, sintilimab, spartalizumab, and tislelizumab). Hepatic autoimmune disorders were defined based on MedDRA Version 26.0 (Maintenance and Support Services Organization, McLean). Disproportionality analyses were performed using reporting odds ratios with 95% confidence intervals and information components (ICs), with IC0.25, to evaluate potential signal detection. A total of 1401 reports of hepatic autoimmune disorders associated with PD-1/PD-L1 inhibitors were identified. Nivolumab (59.89%) and pembrolizumab (27.62%) accounted for the highest reports. Notably, nivolumab (reporting odds ratio, 117.52 [95% confidence interval, 109.52–126.10]; IC, 6.67 [IC0.25, 6.60]) and pembrolizumab (55.69 [50.31–61.64]; 5.65 [5.55]) showed the notable reporting signals, followed by cemiplimab, atezolizumab, durvalumab, avelumab, sintilimab, and tislelizumab. Subgroup analysis showed a stronger signal for hepatic autoimmune disorders in males than in females treated with PD-1/PD-L1 inhibitors. Additionally, the mean time to onset was 22.90 days (standard deviation: 81.66), although some reports presented with substantially delayed onset. Most PD-1/PD-L1 inhibitors showed pharmacovigilance signals for hepatic autoimmune disorders, particularly nivolumab and pembrolizumab. Although our findings do not permit causal inference, these findings underscore the necessity for sustained hepatic monitoring, risk stratification, and appropriate therapeutic management.

343

News (Medical) associated with Dostarlimab-gxly

23 Dec 2025

·www.globenewswire.com

LIXTE and its Collaborators Expand Clear Cell Ovarian Cancer Trial

--Plans to double the Number of Patients in Study-- --Company Expects Initial Findings to be presented in 2026-- BOCA RATON, Fla., Dec. 23, 2025 (GLOBE NEWSWIRE) -- LIXTE Biotechnology Holdings, Inc. (“LIXTE” or the “Company”) (Nasdaq: LIXT), a biotech company focused on advancing cancer treatments, today announced it is expanding its collaboration with The University of Texas MD Anderson Cancer Center and pharmaceutical manufacturer GSK on an ongoing clinical trial with LIXTE’s proprietary compound, LB-100, to treat ovarian clear cell cancer. The trial, which combines LB-100 with GSK’s Dostarlimab to enhance the effectiveness of immunotherapy, was initiated in January 2024. It is directed by lead clinical investigator Amir Jazaeri, MD, Professor of Gynecologic Oncology, at MD Anderson. A second trial site was added earlier this year at the Robert H. Lurie Comprehensive Cancer Center (Lurie Cancer Center) of Northwestern University, led by Emily M. Hinchcliff, MD, MPH. MD Anderson and Northwestern Medical Center plan to double the number of enrollments in the trial to 42 patients, after successfully attaining its initial target of 21 patients earlier this year. The Company also announced that it expects data to be presented from the trial on the initial 21 patients in the first half of 2026. “We are gratified to be expanding the patient population of this important clinical trial,” said Bas van der Baan, LIXTE’s Chief Scientific Officer, who leads the Company’s LB-100 program. “There is a tremendous unmet need in the treatment of ovarian clear cell cancer. Based on extensive published preclinical data, we believe LB-100 has the potential to significantly enhance chemotherapies and immunotherapies and improve patient outcomes.” Geordan Pursglove, LIXTE’s Chief Executive Officer, added: “Expansion of this important trial is in keeping with LIXTE’s mission of treating cancer with exceptional, innovative therapies and cutting-edge technologies. With each step forward, we are hopeful of attaining our goal.” About LIXTE Biotechnology Holdings, Inc. LIXTE Biotechnology Holdings, Inc. is a clinical-stage pharmaceutical company focused on new targets for cancer drug development and developing and commercializing cancer therapies. LIXTE has demonstrated that its first-in-class lead clinical PP2A inhibitor, LB-100, is well-tolerated in cancer patients at doses associated with anti-cancer activity. Based on extensive published preclinical data (see www.lixte.com), LB-100 has the potential to significantly enhance chemotherapies and immunotherapies and improve outcomes for patients with cancer. LIXTE’s lead compound, LB-100, is part of a pioneering effort in an entirely new field of cancer biology – activation lethality – that is advancing a new treatment paradigm. LIXTE's new approach is covered by a comprehensive patent portfolio. Proof-of-concept clinical trials are currently in progress for Ovarian Clear Cell Carcinoma and Metastatic Colon Cancer. Additional information about LIXTE can be found at www.lixte.com. Forward-Looking Statement Disclaimer This announcement contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, and Section 21E of the Securities Exchange Act of 1934. For example, statements regarding the Company's financial position, business strategy and other plans and objectives for future operations, and assumptions and predictions about future activities, including the continuing development of proprietary compounds, the planning, funding, coordination and potential results of clinical trials, the patent and legal costs to protect and maintain the Company's intellectual property worldwide, and the Company’s ability to maintain compliance with Nasdaq’s continued listing requirements, are all forward-looking statements. These statements, also including, but not limited to, expectation of presenting initial findings in the first half of 2026, are generally accompanied by words such as "intend," anticipate," "believe," "estimate," "potential(ly)," "continue," "forecast," "predict," "plan," "may," "will," "could," "would," "should," "expect" or the negative of such terms or other comparable terminology. The Company believes that the assumptions and expectations reflected in such forward-looking statements are reasonable, based on information available to it on the date hereof, but the Company cannot provide assurances that these assumptions and expectations will prove to have been correct or that the Company will take any action that the Company may presently be planning. However, these forward-looking statements are inherently subject to known and unknown risks and uncertainties. Actual results or experience may differ materially from those expected or anticipated in the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, regulatory policies, available cash resources, research results, competition from other similar businesses, and market and general economic factors. Readers are urged to read the risk factors set forth in the Company’s filings with the United States Securities and Exchange Commission at https://www.sec.gov. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. For more information about LIXTE, contact: info@lixte.comGeneral Phone: (631) 830-7092; Investor Phone: (888) 289-5533orPondelWilkinson Inc. Investor Relations pwinvestor@pondel.comRoger Pondel: (310) 279-5965; Laurie Berman: (310) 279-5962

ImmunotherapyClinical Study

05 Dec 2025

·pharma.economictimes.indiatimes.com

GSK India Plots Big ‘Reinvention’

Mumbai: Global biopharma major GlaxoSmithKline Pharmaceuticals , best known in India for its blockbuster legacy brands Augmentin and Calpol , is charting a bold comeback in the country. The London-headquartered company, which has completed over a century in India's pharma market, is plotting its most ambitious transformation in decades as it targets doubling its India revenue to ₹8,000 crore within 4-5 years, India MD Bhushan Akshikar told ET in an exclusive interview. This will be driven by a strategic pivot from its ₹4,000-crore base of legacy portfolio of general medicines-including medications in anti-infective, pain management, respiratory and vaccines-into specialty drugs in high-growth areas of oncology and liver diseases as well as nascent areas such as adult vaccination . "Reinvention and impact are the two words that define our journey in India. Taking cue from our past but remaining completely focused on the future is how I see the next decade for us," said Akshikar. "Our base business will continue to grow while on top of that we are launching in areas where we can make a sizeable impact," he added. The bet will be on innovation-led growth, accelerated clinical trials in India, and concurrent launches of global assets to double size by the end of the decade. It is building new categories like adult vaccination , scaling up its newly launched oncology portfolio and preparing early access pathways for pipeline assets including a novel potential cure for chronic Hepatitis B . Iconic brands like Augmentin , which leads India's crowded amoxicillin-clavulanate market with 22% share, and Calpol , which dominates the paracetamol segment, will continue to provide scale. At the same time, the company aims for its Freshness Index, the share of new assets in total revenue, to reach at least 10%. One of its biggest pivots to innovation is most visible in adult vaccination. Two and a half years ago, GSK launched Shingrix, first adult vaccine for herpes in India. "From a zero base, we have built consumer awareness, empowered patients, and created a vaccination ecosystem," he said. With an aging population, with 11% of Indians over 60 years old, adult vaccination is set to become a growth engine for GSK . GSK also looks to rebuild its portfolio in oncology-a multi-billion dollar and rapidly expanding segment of the India pharmaceutical market-as a core growth driver in line with its global strategy of becoming a focused biopharmaceutical player. A couple of months ago GSK re-entered India's oncology market with the launch of Jemperli (dostarlimab) and Zejula (niraparib)-precision therapies indicated in treatment of certain gynaecological cancers. GSK had exited the oncology segment globally about a decade ago after selling most of its cancer portfolio to Novartis . "We have almost 12 global trials where we have Phase III A and IIIB happening in India including our two new assets that we recently launched-Jemperli and Zejula. One of the assets of dostarlimab-a monoclonal antibody and immunotherapy-is also undergoing trials in India in head and neck, colorectal, non-small cell lung cancers. Each one of these will open up different segments for us to create impact," said Akshikar. Liver disease is a strategic priority as well. GSK completed global trials for bepiroversin-an investigational antisense oligonucleotide therapy being-a potential first functional cure for chronic hepatitis B , in which India participated. Another future focus area for GSK in India will be its global capability centre. "We are seeing R&D based work including early work in protocol development, clinical operations, while on commercial side we are getting innovative assets early on. Together that gives us confidence that GSK will continue to keep India at centre of its strategy," said Akshikar. By Rica Bhattacharyya & Vikas Dandekar ,

VaccinePhase 3ImmunotherapyOligonucleotide

21 Nov 2025

·www.fiercepharma.com

GSK's Tesaro, AnaptysBio lock horns in court over Jemperli agreement

Tesaro has filed a lawsuit against AnaptysBio in Delaware over claims that the antibody-focused biotech is in “material breach” of an ongoing licensing deal for PD-1 drug Jemperli (dostarlimab). Some four years into Jemperli’s commercial life span, a rift has emerged between GSK subsidiary Tesaro and the potential cancer blockbuster’s original developer, AnaptysBio.Tesaro has filed a lawsuit against Anaptys in Delaware over claims that the antibody-focused biotech is in “material breach” of an ongoing licensing deal for PD-1 drug Jemperli (dostarlimab), GSK said in a Thursday press release.Anaptys followed up Friday morning by announcing its own complaint in Delaware Chancery Court, making the case that it is in fact Tesaro that has “materially breached the parties' collaboration and exclusive license agreement.” The biotech went on to allege that GSK “has tortiously interfered with” the deal.The brouhaha stems back to a licensing deal from 2014, under which Tesaro paid Anaptys $17 million upfront—with the promise of tens of millions more in potential milestone payments—for exclusive rights to antibody programs going after the targets PD-1, TIM-3 and LAG-3. More recently, GSK acquired Tesaro for roughly $5.1 billion in 2018.Subsequently, Jemperli in 2021 won its first FDA nod to be used in patients with previously treated advanced or recurrent mismatch repair-deficient (dMMR) endometrial cancer. The medication has since gone on to significantly expand its dMMR reach and pick up a green light in certain other solid tumors, as well. Despite Tesaro announcing its legal case first, the move came in response to Anaptys' argument that the GSK subsidiary was failing to live up to the license agreement, GSK explained in its release.“GSK and Tesaro are firmly of the view that these allegations are entirely without merit,” the press release states.For its part, Anaptys contends not only that Tesaro breached the terms of the Jemperli licensing agreement but that GSK “induced” its subsidiary to do so. The biotech specifically took issue with the fact that Tesaro is engaging in clinical trials that include rival PD-1 antagonists to Jemperli, like Merck & Co.’s megablockbuster Keytruda.Further, Anaptys argued that Tesaro “failed to use commercially reasonable efforts” to secure an “‘optimum commercial return’” for Jemperli. Instead, the GSK unit purportedly took part in “a course of conduct with GSK to favor GSK’s antibody-drug conjugate (ADC) product candidates, including by pairing those ADCs with PD-1 antagonists that directly compete with Jemperli,” according to Anaptys.This isn’t the first time the partners have butted heads. Anaptys noted that it filed a similar complaint against GSK in 2020 alleging breaches of the same agreement. In that instance, the biotech’s concerns related to an experimental combination of the GSK ovarian cancer med Zejula with Merck’s Keytruda, arguing that the decision to wed those rival drugs was done “without the consent of Anaptys.”“This complaint resulted in a settlement that included a cash payment, a royalty on Zejula and a substantial increase in royalties on sales of Jemperli due to Anaptys,” the biotech pointed out.Anaptys stressed that it attempted to “engage in good faith discussions” to resolve its concerns with Tesaro but had no choice other than to retaliate in court after Tesaro filed its lawsuit “without notice” on Thursday.“Anaptys contends that Tesaro’s claims are entirely without merit and intends to pursue all appropriate legal remedies against Tesaro, including dismissal of such claims at the earliest opportunity and the potential for additional litigation,” the biotech said in its release.While the court case is proceeding, GSK and Tesaro are still required to honor milestone and royalty payment obligations on Jemperli, Anaptys noted. GSK has previously estimated that Jemperli sales could reach $1.4 billion to $2.8 billion at peak. In 2025’s third quarter, the drug brought home (PDF) sales of 230 million pounds sterling (around $301 million), growing nearly 80% at constant currencies over the sum it generated during the period in 2024. Meanwhile, Anaptys in late September unveiled a plan to split into two separate, publicly traded companies—one focused on the biopharma's clinical-stage pipeline and the other concerned exclusively with managing its royalty-based agreements, including that for Jemperli. The split is expected to be finalized by the end of 2026, Anaptys said earlier this year.

License out/inAcquisitionADCPatent Infringement

100 Deals associated with Dostarlimab-gxly

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External Link

KEGG	Wiki	ATC	Drug Bank
-	Dostarlimab-gxly	L01XC	DB15627

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Advanced Endometrial Carcinoma	European Union	GlaxoSmithKline Trading Services Ltd.	12 Jan 2024
Advanced Endometrial Carcinoma	Iceland	GlaxoSmithKline Trading Services Ltd.	12 Jan 2024
Advanced Endometrial Carcinoma	Liechtenstein	GlaxoSmithKline Trading Services Ltd.	12 Jan 2024
Advanced Endometrial Carcinoma	Norway	GlaxoSmithKline Trading Services Ltd.	12 Jan 2024
Recurrent Endometrial Cancer	European Union	GlaxoSmithKline Trading Services Ltd.	12 Jan 2024
Recurrent Endometrial Cancer	Iceland	GlaxoSmithKline Trading Services Ltd.	12 Jan 2024
Recurrent Endometrial Cancer	Liechtenstein	GlaxoSmithKline Trading Services Ltd.	12 Jan 2024
Recurrent Endometrial Cancer	Norway	GlaxoSmithKline Trading Services Ltd.	12 Jan 2024
Mismatch repair-deficient Solid Tumors	United States	GlaxoSmithKline LLC	17 Aug 2021
Microsatellite instability-high Endometrial Carcinoma	European Union	GlaxoSmithKline Trading Services Ltd.	21 Apr 2021
Microsatellite instability-high Endometrial Carcinoma	Iceland	GlaxoSmithKline Trading Services Ltd.	21 Apr 2021
Microsatellite instability-high Endometrial Carcinoma	Liechtenstein	GlaxoSmithKline Trading Services Ltd.	21 Apr 2021
Microsatellite instability-high Endometrial Carcinoma	Norway	GlaxoSmithKline Trading Services Ltd.	21 Apr 2021
Mismatch repair-deficient Endometrial Carcinoma	European Union	GlaxoSmithKline Trading Services Ltd.	21 Apr 2021
Mismatch repair-deficient Endometrial Carcinoma	Iceland	GlaxoSmithKline Trading Services Ltd.	21 Apr 2021
Mismatch repair-deficient Endometrial Carcinoma	Liechtenstein	GlaxoSmithKline Trading Services Ltd.	21 Apr 2021
Mismatch repair-deficient Endometrial Carcinoma	Norway	GlaxoSmithKline Trading Services 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	United States	GSK Plc	10 Jun 2024
PD-L1 positive Non-Small Cell Lung Cancer	Phase 3	China	GSK Plc	10 Jun 2024
PD-L1 positive Non-Small Cell Lung Cancer	Phase 3	Japan	GSK Plc	10 Jun 2024
PD-L1 positive Non-Small Cell Lung Cancer	Phase 3	Argentina	GSK Plc	10 Jun 2024
PD-L1 positive Non-Small Cell Lung Cancer	Phase 3	Belgium	GSK Plc	10 Jun 2024
PD-L1 positive Non-Small Cell Lung Cancer	Phase 3	Brazil	GSK Plc	10 Jun 2024
PD-L1 positive Non-Small Cell Lung Cancer	Phase 3	Bulgaria	GSK Plc	10 Jun 2024
PD-L1 positive Non-Small Cell Lung Cancer	Phase 3	Canada	GSK Plc	10 Jun 2024
PD-L1 positive Non-Small Cell Lung Cancer	Phase 3	Finland	GSK Plc	10 Jun 2024
PD-L1 positive Non-Small Cell Lung Cancer	Phase 3	France	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


ESMO_ASIA2025	Not Applicable	Microsatellite instability-high cancer microsatellite instability-high (MSI-H)	83	Immune Checkpoint Inhibitor	ainwapkqxb(gbvtkykmsw) = vqvtmoujaw jrillkjcev (gdxhbsdhxm ) View more	Positive	05 Dec 2025
NCT03602859 (FIRST/ENGOT-OV44, ESMO2025)	Phase 3	Ovarian Cancer First line \| Maintenance	1,016	PBCT + placebo ± bev with nira + placebo ± bev MT	whiskaurxe(vultfpbhjp) = jyearbkzzj xqjinjywny (bxrwyulmlk ) View more	Positive	17 Oct 2025
				PBCT + dost ± bev with dost + nira ± bev MT	whiskaurxe(vultfpbhjp) = bbyxhsxidv xqjinjywny (bxrwyulmlk ) View more
NCT03981796 (RUBY, ESMO2025)	Phase 3	Recurrent Endometrial Cancer First line MMRp/MSS	376	Dostarlimab + carboplatin-paclitaxel (D+CP)	pcwhppjxjk(smbazkgfid) = wcrweoagtj pvyejkuytp (ixpnbunmrl, 59.2 - 72.8) View more	Positive	17 Oct 2025
				Placebo + carboplatin-paclitaxel (P+CP)	pcwhppjxjk(smbazkgfid) = kwjyxtgcdm pvyejkuytp (ixpnbunmrl, 45.6 - 60.2) View more
NCT03981796 (RUBY, ESMO2025)	Phase 3	Recurrent Endometrial Cancer dMMR \| MSS	1,118	Dostarlimab + carboplatin-paclitaxel (D+CP)	toecurdpif(rwkrjukkzn) = ywjvarisjd yggdmyawvz (zrirlqmbfj )	Positive	17 Oct 2025
				Placebo + carboplatin-paclitaxel (P+CP)	toecurdpif(rwkrjukkzn) = qvkywhapbk yggdmyawvz (zrirlqmbfj )
NCT04581824 (PERLA, ESMO2025)	Phase 2	Metastatic Non-Squamous Non-Small Cell Lung Carcinoma First line ctDNA \| bTMB	189	Dostarlimab + chemotherapy	qulgjqrjrs(qvvcplatif) = brsdixmjrx kggfheqtws (jbhgyiqqdp ) View more	Positive	17 Oct 2025
				Pembrolizumab + chemotherapy	qulgjqrjrs(qvvcplatif) = soxcxguwub kggfheqtws (jbhgyiqqdp ) View more
NCT04581824 (PERLA, Pubmed \| JTO Clin Res Rep)	Phase 2	Metastatic Non-Squamous Non-Small Cell Lung Carcinoma First line	153	Dostarlimab + Chemotherapy	tkzjoimnye(wagpjerqvt) = ivbqzwdlly yhrqzufbmj (oyelkeibld, 14.5 - 27.3) View more	Positive	01 Oct 2025
				Pembrolizumab + Chemotherapy	tkzjoimnye(wagpjerqvt) = agoaumhklh yhrqzufbmj (oyelkeibld, 11.6 - 19.3) View more
NCT04493060 (CTgov)	Phase 2	Pancreatic Carcinoma, Familial \| Metastatic Pancreatic Ductal Adenocarcinoma	22	niraparib+dostarlimab	efewleykng = okwchqrwwu wnfchhhfny (yopakntvpq, pciqyualtf - ejwznmbrni) View more	-	07 Aug 2025
NCT03574779 (OPAL Phase II Trial \| OPAL, CTgov)	Phase 2	Ovarian Cancer	77	Niraparib+Bevacizumab+Dostarlimab (Cohort A (Dostarlimab + Bevacizumab + Niraparib))	jnzyoiphcp = culnzwlukw jxuhwzvehv (hqdivdjmla, tqcqkjyndq - aefaoznocw) View more	-	15 Jul 2025
				taxane+Niraparib (Cohort C (Niraparib OR Platinum-taxane))	jnzyoiphcp = fyrgxmraxy jxuhwzvehv (hqdivdjmla, cpmhvenwqp - yyxxaahpbw) View more
NCT03981796 (ENGOT-EN6-NSGO/GOG-3031/RUBY, ASCO2025)	Phase 3	Recurrent Endometrial Cancer dMMR/MSI-H \| MMRp/MSS	494	Dostarlimab plus Carboplatin-Paclitaxel (DOST+CP)	bsagrpqxym(ncupcghxtl) = wyrjyagwtk vvttiihlbq (arqxopqarr ) View more	Positive	30 May 2025
				Placebo plus Carboplatin-Paclitaxel (PBO+CP)	bsagrpqxym(ncupcghxtl) = hspafflgtb vvttiihlbq (arqxopqarr ) View more
NCT05065021 (Re-VOLVE, ASCO2025)	Phase 2	Ovarian Cancer BRCA \| CCNE1 \| CHEK2	43	Niraparib 200-300mg/Bevacizumab 7.5mg/kg	fphngagbbo(soffizkgnp) = No G3-G4 immune related AE rirpyqsmje (kdtyqpwhsc )	Positive	30 May 2025
				Niraparib/Bevacizumab/Dostarlimab 500mg

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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