Request Demo

Last update 08 May 2025

Dostarlimab-gxly

Last update 08 May 2025

Overview

R&D Status

Clinical Result

Translational Medicine

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

+ [10]

Target

PD-1

Action

inhibitors

Mechanism

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

Therapeutic Areas

NeoplasmsUrogenital DiseasesNervous System Diseases+ [8]

Active Indication

Advanced Endometrial CarcinomaRecurrent Endometrial CancerMismatch repair-deficient Solid Tumors+ [81]

Inactive Indication

Advanced biliary tract cancerBile Duct NeoplasmsClear Cell Sarcoma+ [5]

Originator Organization

AnaptysBio, Inc.

Active Organization

Tesaro, Inc.

GSK PlcGlaxoSmithKline (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), Priority Review (United States)

Structure/Sequence

Sequence Code 315609369H

Source: *****

Sequence Code 315609370L

Source: *****

Clinical Trials associated with Dostarlimab-gxly

NCT06879717

/ RecruitingPhase 1/2

A Phase I/IIa Study of Roginolisib in Combination With Dostarlimab With or Without Docetaxel in Patients With Advanced Non-squamous NSCLC Who Have Progressed on Standard of Care Immune Checkpoint Therapy and Platinum Doublet Chemotherapy or Standard Immunotherapy Without Chemotherapy (PULMO-1)

The goal of this clinical trial is to learn how roginolisib works in combination with dostarlimab with or without docetaxel in adult patients with advanced non small-cell lung cancer. The main questions it aims to answer are:
To compare across the treatment arms the proportion of patients with a reduction in Treg cells To evaluate the safety and tolerability of roginolisib plus dostarlimab, with or without docetaxel

Start Date01 May 2025

Sponsor / Collaborator

iOnctura SA

NCT06897527

/ Not yet recruitingPhase 4

Phase 4, Open Label, Non-comparative, Interventional, Multicenter Study to Evaluate the Safety of Dostarlimab in Adult Patients in India With Mismatch Repair Deficient (dMMR)/Microsatellite Instability-high (MSI-H) Recurrent or Advanced Endometrial Cancer (EC) That Has Progressed on or Following Prior Treatment With a Platinum-containing Regimen

The goal of this study is to evaluate the safety profile of dostarlimab in Indian adults with recurrent or advanced endometrial cancer.

Start Date17 Apr 2025

Sponsor / Collaborator

GSK Plc

NCT06405230

/ Not yet recruitingPhase 1/2

A Pilot/Exploratory Translational Study to Evaluate Response to Dostarlimab and Pembrolizumab in Patient-derived Organoids and by Zirconium-89 Labelled Programmed Death Ligand 1 Positron Emission Tomography in Participants With Recurrent Non-small Cell Lung Cancer

The goal of this clinical trial is to investigate the utility of two biomarker tools: Patient-derived organoid (PDOs) and PDL1 PET imaging for predicting how participants with recurrent NSCLC respond to standard of care treatment in the advanced/metastatic stages.

Start Date31 Mar 2025

Sponsor / Collaborator

GSK Plc

100 Clinical Results associated with Dostarlimab-gxly

100 Translational Medicine associated with Dostarlimab-gxly

100 Patents (Medical) associated with Dostarlimab-gxly

159

Literatures (Medical) associated with Dostarlimab-gxly

01 Apr 2025·INTERNATIONAL JOURNAL OF GYNECOLOGICAL CANCER

Phase 2b, open-label, single-arm, multicenter pilot study of the efficacy, safety, and tolerability of dostarlimab in women with early-stage mismatch repair-deficient endometrioid endometrial adenocarcinoma

Article

Author: Mak, Blossom ; Kuchel, Anna ; Brand, Alison ; McNally, Orla ; Gebski, Val ; Mileshkin, Linda ; Jobling, Thomas ; Goh, Jeffrey ; Obermair, Andreas ; Baxter, Eva

BACKGROUND:

The standard treatment for endometrial cancer is hysterectomy with or without bilateral salpingo-oophorectomy; however, this may not be an optimal choice for women who have not completed childbearing or who are at a high risk of surgical complications. Conservative treatment with levonorgestrel intrauterine devices appear to be effective in patients with early-stage endometrial cancer; however, patients with mismatch repair-deficient (dMMR) tumors have a low likelihood of responding to levonorgestrel intrauterine devices.

PRIMARY OBJECTIVE:

To assess the efficacy of dostarlimab, an active immune checkpoint inhibitor that targets the programmed cell death protein-1 receptor, in patients with early-stage dMMR endometrioid endometrial adenocarcinoma.

STUDY HYPOTHESIS:

Administration of 4 3-weekly cycles of 500 mg dostarlimab followed by a 3-week rest period and 3 6-weekly cycles of 1000 mg dostarlimab will be safe and efficacious in early-stage dMMR endometrial cancer patients.

TRIAL DESIGN:

Non-randomized, open-label, pilot, multicenter phase2b study designed to evaluate the efficacy and safety of dostarlimab in 10 women aged ≥18 years with a clinically confirmed diagnosis of early-stage and dMMR endometrioid endometrial adenocarcinoma.

MAJOR INCLUSION/EXCLUSION CRITERIA:

Eligible patients must have histologically proven stage I, International Federation of Gynecology and Obstetrics grade 1 or 2 dMMR endometrioid endometrial adenocarcinoma and desire for fertility preservation. Exclusions include, but are not limited to, patients with other high-risk endometrial cancer cell types, a poor medical risk due to uncontrolled medical conditions, or those who experienced grade 3 or higher immune-related adverse events from prior immunotherapy.

PRIMARY ENDPOINT(S):

The primary endpoint is the number of participants achieving investigator-assessed pathological complete response within 6 months of treatment.

SAMPLE SIZE:

Ten (10) women ≥18 years of age will be enrolled.

ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS:

Accruals are expected to be completed by 2027, with the presentation of results by 2029.

TRIAL REGISTRATION:

NCT06278857.

01 Apr 2025·INTERNATIONAL JOURNAL OF GYNECOLOGICAL CANCER

Patient-reported outcomes in the subpopulation of patients with mismatch repair-deficient/microsatellite instability-high primary advanced or recurrent endometrial cancer treated with dostarlimab plus chemotherapy compared with chemotherapy alone in the ENGOT-EN6-NSGO/GOG3031/RUBY trial

Article

Author: Thijs, Anna M ; Vincent, Veena ; Miller, Eirwen M ; Myers, Tashanna ; Pothuri, Bhavana ; Mirza, Mansoor Raza ; Landrum, Lisa M ; Pennington, Kathryn P ; Sharma, Sudarshan ; Ataseven, Beyhan ; Powell, Matthew A ; Zub, Oleksandr ; Monk, Bradley J ; Meyers, Oren ; Black, Destin ; Fleming, Evelyn ; Stuckey, Ashley ; Garside, Jamie ; Denschlag, Dominik ; Hietanen, Sakari ; Herzog, Thomas J ; Novak, Zoltan ; Gilbert, Lucy ; Holloway, Robert ; Cloven, Noelle ; Podzielinski, Iwona ; Valabrega, Giorgio ; Secord, Angeles Alvarez ; Chase, Dana ; Gogoi, Radhika

Objective:

In the ENGOT-EN6-NSGO/GOG3031/RUBY trial, dostarlimab+carboplatin–paclitaxel demonstrated significant improvement in progression free survival and a positive trend in overall survival compared with placebo+carboplatin–paclitaxel, with manageable toxicity, in patients with primary advanced or recurrent endometrial cancer. Here we report on patient-reported outcomes in the mismatch repair-deficient/microsatellite instability-high population, a secondary endpoint in the trial.

Methods:

Patients were randomized 1:1 to dostarlimab+carboplatin–paclitaxel or placebo+carboplatin–paclitaxel every 3 weeks for 6 cycles followed by dostarlimab or placebo monotherapy every 6 weeks for ≤3 years or until disease progression. Patient-reported outcomes, assessed with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 and Endometrial Cancer Module, were prespecified secondary endpoints. A mixed model for repeated measures analysis, a prespecified exploratory analysis, was conducted to generate least-squares means to compare between-treatment differences while adjusting for correlations across multiple time points within a patient and controlling for the baseline value. Results are provided with 2-sided, nominal p values.

Results:

Of 494 patients enrolled, 118 were mismatch repair-deficient/microsatellite instability-high. In this population, mean change from baseline to end of treatment showed visual improvements in global quality of life (QoL), emotional and social function, pain, and back/pelvis pain for dostarlimab+carboplatin–paclitaxel. Meaningful differences (least-squares mean [standard error]) favoring the dostarlimab arm were reported for change from baseline to end of treatment for QoL (14.7 [5.45]; p=0.01), role function (12.7 [5.92]); p=0.03), emotional function (14.3 [4.92]; p<0.01), social function (13.5 [5.43]; p=0.01), and fatigue (−13.3 [5.84]; p=0.03).

Conclusions:

Patients with mismatch repair-deficient/microsatellite instability-high primary advanced or recurrent endometrial cancer receiving dostarlimab+carboplatin–paclitaxel demonstrated improvements in several QoL domains over patients receiving placebo+carboplatin–paclitaxel. The observed improvements in progression free survival and overall survival while improving or maintaining QoL further supports dostarlimab+carboplatin–paclitaxel as a standard of care in this setting.

Trial registration:

ClinicalTrials.govNCT03981796

01 Mar 2025·BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

Population pharmacokinetics and exposure–response relationships of dostarlimab in primary advanced or recurrent endometrial cancer in part 1 of RUBY

Article

Author: Oaknin, Ana ; Segev, Yakir ; Zub, Oleksandr ; Koliadi, Anthoula ; Pothuri, Bhavana ; Berton, Dominique ; Zajic, Stefan ; Alskär, Oskar ; Jørgensen, Trine Lembrecht ; Gennigens, Christine ; Backes, Floor J. ; Melhem, Murad ; Krivak, Tom ; André, Thierry ; Bouberhan, Sara ; Shahin, Mark S. ; Pishchyk, Mikalai ; Buscema, Joseph ; Kuchimanchi, Mita ; Hanze, Eva ; Jain, Angela

Aims:

Dostarlimab‐gxly is a humanized monoclonal antibody of the IgG4 isotype that binds to the programmed cell death protein‐1 (PD‐1) receptor and blocks its ligands. RUBY (NCT03981796) is a two‐part multicentre study in patients with recurrent or primary advanced endometrial cancer. The overall aims were to characterise the population pharmacokinetics (PopPK) from Part 1 of this study, identify relevant covariates of interest, and assess exposure–efficacy/safety (ER) relationships.

Methods:

A PopPK model developed using GARNET (NCT02715284) study data for dostarlimab monotherapy was externally validated with RUBY Part 1 study data. Subsequently, the model was updated with data across the two studies. Exposure–safety analyses for adverse events related to dostarlimab alone or in combination with standard of care (SOC) were modelled using logistic regression. Exposure–efficacy analysis included Cox proportional hazards analysis of the primary efficacy endpoint of progression‐free survival (PFS).

Results:

For the model update, 7957 pharmacokinetics observations from 868 patients pooled from both RUBY and GARNET studies were available. The model was consistent with the previous model. Dostarlimab clearance was estimated to be 7.79% lower when dostarlimab was given as SOC combination therapy. However, no significant covariates were clinically relevant. Hepatic or renal impairment did not affect pharmacokinetics. Among the safety endpoints, only rash showed a small yet statistically significant effect (P < .05) in all subjects; however, this was not not deemed clinically relevant. There were no other clinically significant exposure–safety or exposure–PFS relationships.

Conclusions:

The addition of chemotherapy to dostarlimab had limited effect on dostarlimab PopPK, with no clinically significant covariates or clinically relevant exposure–safety or exposure–PFS relationships.

288

News (Medical) associated with Dostarlimab-gxly

23 hours ago

·www.prnewswire.com

iOnctura commences randomized Phase I/II study in non-small cell lung cancer

First patient dosed in study investigating roginolisib + dostarlimab +/- docetaxel in patients with NSCLC who have progressed on prior immunotherapy/chemo Study will evaluate safety of the combination and explore whether targeting PI3Kδ with immunotherapy may rebalance the immune system to prevent or reverse resistance to current standard immunotherapy/chemo in NSCLC GENEVA and AMSTERDAM, May 8, 2025 /PRNewswire/ -- iOnctura, a clinical-stage biopharmaceutical company combating neglected and hard-to-treat cancers, today announces it has dosed the first patient in the randomized Phase I/II study investigating lead asset roginolisib in combination with dostarlimab with or without docetaxel, in patients with advanced non-small cell lung cancer (NSCLC). NSCLC is the most common type of lung cancer. Lung cancer is the leading cause of cancer death globally, accounting for approximately 1 in 5 of all cancer deaths[1]. Anti-programmed death-ligand 1 (PD-L1) or anti-programmed cell death protein 1 (PD1) immunotherapy is a standard therapy for NSCLC patients with no actionable mutations in the first or second lines of therapy, with or without chemotherapy. However, treatment is often of limited duration as the cancer cells develop resistance to the treatment. Rebalancing the immune system via PI3Kδ inhibition is thought to re-invigorate anti-tumour immune cells and thus is a promising mechanism to overcome resistance to current immunotherapies[2]. Michele Maio, MD, PhD, Professor of Medical Oncology at the University of Siena and Director of the Center for Immuno-Oncology at the University Hospital of Siena (Italy), Primary Coordinating Investigator of the Phase I/II study said: 'There is a significant lack of treatment options for NSCLC patients who have progressed on immunotherapy and chemotherapy. We will be investigating whether the combination of roginolisib with dostarlimab and +/- chemotherapy can be given safely and may provide a novel treatment option in patients who no longer respond to their current treatment.' Emerging clinical and translational biomarker data supports the hypothesis that combining roginolisib with an anti-PD-L1/PD1 agent, with or without docetaxel, may prevent or reverse drug resistance in NSCLC and may show synergistic anti-tumor immune activity without significant addition of toxicity. Firstly, the combination of anti-PD1 and roginolisib had an anti-tumor effect in vitro [3]. Secondly, ex vivo evaluation of NSCLC samples from patients responding and failing to immunotherapy showed that roginolisib rebalanced the composition of immune cells by inhibiting regulatory T-cells and enhancing CD8+ T cell killing cells3. Finally, roginolisib augmented the cytotoxicity of chemotherapy and immunotherapy3. Dostarlimab is a PD-1-blocking antibody approved in the US in combination with chemotherapy for certain patients with endometrial cancer, as well as a single agent for certain patients with dMMR tumours that have progressed on or following prior treatment. It has also demonstrated clinical activity in combination with chemotherapy in NSCLC[4]. Under a supply agreement with iOnctura, GSK will supply dostarlimab for use in the trial. iOnctura will retain worldwide rights to roginolisib. The Phase I/II open-label, randomized, parallel-arm PULMO-01 study (NCT06879717) will assess roginolisib in combination with dostarlimab, with or without docetaxel. The study will enrol approximately 45 patients who have progressed on standard-of-care immune checkpoint therapy. It will investigate the safety of the combination and the proportion of patients with a reduction in peripheral blood regulatory T cells in each arm. Roginolisib is an allosteric modulator of PI3Kδ, widely recognized as a 'master switch' of cancer. Inhibition of PI3Kδ unleashes a multi-pronged anti-tumor and immune response to combat the tumor[5]. Roginolisib has demonstrated an unprecedented clinical profile in solid and liquid cancers[6], and is currently being investigated in a randomized Phase II clinical trial in uveal melanoma. A separate Phase I/II study in myelofibrosis is being initiated. About iOnctura iOnctura is a clinical-stage precision oncology company combating neglected and hard-to-treat cancers with a pipeline of first-in-class small molecules. The bold new treatments extend lives and improve healthspans, changing the outlook for patients and their families. Lead asset, roginolisib, is an allosteric modulator of PI3Kδ with a unique chemical structure and binding mode. Allosteric modulation is a new archetype for precise inhibition of PI3Kδ, promising clinical activity without the detrimental tolerability seen with previous generations of inhibitors. Roginolisib is being investigated in multiple randomized Phase II studies in solid and hematological malignancies. iOnctura BV is headquartered in Amsterdam, The Netherlands with its wholly owned Swiss subsidiary, iOnctura SA, located in Geneva, Switzerland. iOnctura is backed by specialist institutional investors including Syncona, M Ventures, Inkef Capital, EIC Fund, VI Partners, Schroders Capital and XGEN Venture. About roginolisib Roginolisib is an allosteric modulator of PI3Kδ with a unique chemical structure and binding mode. Allosteric modulation is a new archetype for precise inhibition of PI3Kδ, promising clinical activity without the detrimental tolerability seen with previous generations of inhibitors. The PI3K signaling pathway is one of the most commonly dysregulated pathways across multiple cancer types. The potential of roginolisib has been validated by positive clinical signals in Phase I in solid tumor and hematological malignancies, including a doubling of overall survival compared to historical controls in rare eye cancer, uveal melanoma. The company has carefully designed its clinical program to allow full development in uveal melanoma, while in parallel validating the program in larger market indications. The Phase II OCULE-01 study in uveal melanoma started in March 2025 and the Phase I/II PULMO-01 study in NSCLC started in May 2025. Further studies in other malignancies, including myelofibrosis, are being initiated. [1] World Health Organisation, June 2023 [2] Exposito et al., Cancer Res (2023) 83 (15): 2513–2526 [3] Riganti et al., Poster Presentation, EACR 2023 [4] Lim et al., Nature Communications (2023) 14:7301 [5] AACR Volume 3, Issue 4, April 2023, Poster presentation, SITC 2022 [6] Poster presentation, ESMO-IO 2023 SOURCE iOnctura WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2ImmunotherapyClinical ResultPhase 1AACR

03 May 2025

·endpts.com

Earnings season continues; FDA delays PDUFA date; AACR recap; and more

Welcome back to Endpoints Weekly, our roundup of the top headlines in biopharma. Earnings season continued this week, with more comments from pharma executives on the potential impact of tariffs, new details around Pfizer and Moderna’s cost-efficiency efforts, and more. Read below for a recap of the top news out of this week’s earnings calls. We’ve also got a summary of data out of the American Association for Cancer Research’s annual meeting, where Lei Lei Wu reported from Chicago. And Endpoints News’ Andrew Dunn welcomed Arc Institute co-founder Patrick Hsu to our special Slack channel to discuss all things AI. Stay tuned next week as more companies, including BioNTech, Novo Nordisk, Takeda and more, report their earnings. — Nicole DeFeudis 💲 More pharma companies reported their Q1 earnings this week, including AstraZeneca, Novartis, Pfizer, GSK, Eli Lilly, Moderna and Amgen. Tariffs were a central theme during earnings calls, as drugmakers provided some detail on the potential impact to their business. “Our goal, as I mentioned, is to have 100% of our products produced in the US for the US,” Novartis CEO Vas Narasimhan said during a first-quarter earnings call with the media Tuesday. AstraZeneca CEO Pascal Soriot said the company “can actually move the manufacturing of products that are made in Europe, move it to the US for supply to the US. And we can also potentially do the other way around.” Here’s what else our reporters tracked: The privately-held biotech Stealth BioTherapeutics said its rare disease drug was delayed this week. A person familiar with the situation said the company hadn’t been asked to run more trials or provide more data, that the FDA hadn’t identified any safety concerns, and that the agency hadn’t raised manufacturing issues, Endpoints’ Max Gelman reported. The apparent delay comes amid upheaval at health agencies, though several companies have said in earnings calls and interviews in recent weeks that they aren’t seeing an impact on their interactions with the FDA so far. The agency made decisions on time for two other drugs this week: Johnson & Johnson’s rare disease drug Imaavy and Satsuma Pharmaceuticals’ migraine drug Atzumi. The agency also hit PDUFA dates for other big-name medicines in recent weeks, like Dupixent, Amvuttra, Uplizna and Eylea. Stealth’s drug had an original decision deadline in January, but the company said the FDA requested more time to review supplemental material. Max examines lingering questions around the situation here . AACR recap: Data from GSK, Merck and more 🔬Scientists descended on Chicago this week for the American Association for Cancer Research’s annual meeting. Some in attendance, including cancer scientists, former NIH leaders and patient advocates, spoke about how cuts to science funding could impact cancer research. “It is a time to be clear-eyed about what is happening and to decide what role each of us is willing to play,” Yale oncologist Patricia LoRusso said during a panel. Read more here . Elsewhere, GSK presented data showing that its PD-1 inhibitor Jemperli induced a 100% complete response rate in 49 patients with a specific type of rectal cancer after six months. Even though the results were excellent, Endpoints’ Elizabeth Cairns reported that they are unlikely to have major commercial implications. Jemperli is already approved in this cancer type, known as mismatch repair deficient (MMRd) solid tumors, though only after the patient has progressed on prior treatment and has no further options. The new data could move the product into the neoadjuvant setting for dMMR cancers, but it’s still a tiny patient population. Only around 3% of solid tumors carry the dMMR biomarker. Merck also impressed with Keytruda data in head and neck cancer, showing that adding Keytruda before and after surgery cut the risk of disease recurrence or death by 27%. Patients in the study remained disease-free for more than four years at the median. 🌎 The US’ drug infrastructure has historically been robust, making it an attractive country in which to run clinical trials. But some companies say uncertainty is driving them to look elsewhere for their studies. Jared Whitlock examined this phenomenon in a story this week . Of note, companies find FDA Commissioner Marty Makary’s comments on rare disease approval pathways and animal testing largely promising. “Since we are in the ultra-rare disease space, Makary’s words on creating paths for rare [diseases] creates hope, and we are looking forward to learning more about his plans,” Mahzi Therapeutics CEO Yael Weiss said. While overseas trials have limitations, agencies in Europe, Canada, Australia and the UK have worked in recent years to harmonize guidelines with the FDA. 🎤 Endpoints’ Andrew Dunn welcomed Patrick Hsu to the newsroom’s Slack channel earlier this month to share his thoughts from the frontlines of the AI bio space. Hsu co-founded the Arc Institute in 2021, a Palo Alto, CA-based nonprofit research organization that has spearheaded some leading AI biology research. “I think AI will become a universal copilot that we use for everything,” he said during the interview. Read more here . DON’T MISS:

Drug Approval

30 Apr 2025

·endpts.com

GSK's supply chain 'reset' after Haleon spinoff to ease tariff impact, CEO says

GSK said its decoupling with Haleon is a key reason why it views itself as “well-positioned” in the face of potential pharma-specific tariffs. When the drugmaker went through its “ demerger ” with the consumer health business in 2022, there were “very intentional, deliberate choices to reset” its supply chain for “regional resilience” as well as “double sourcing” to allow for flexibility, CEO Emma Walmsley said. It has “mitigation options” that it could execute across its manufacturing networks once pharma levies are in place, the UK company said in a statement. “We’re watching it very carefully … we are well-prepared,” Walmsley said during GSK’s first-quarter earnings call with the media. Some drug developers and CDMOs have similarly expressed how their earlier moves — which were made even before the talk of tariffs emerged — would help them navigate sector-specific levies regardless of what these might look like. President Donald Trump’s tariffs have been a central theme during this earnings season as drugmakers disclose their exposures and strategies to varying degrees. Last week, Roche CEO Thomas Schinecker said the pharma tariffs could have a negative impact on dealmaking. But Walmsley somewhat disagreed, saying “there are some opportunities” for deals and that half of GSK’s pipeline comes from this business development approach. “We’re constantly looking at things … and we also continue to look at the opportunities out of China on BD. We’ve done several good deals ,” she said. GSK’s disappointing vaccine sales stood out in Q1. Sales for this franchise dropped 6% in the quarter due to “known headwinds,” GSK said. Shingrix struggled in the US due to “harder-to-reach unvaccinated customers” and increased channel inventory consumption. As for Arexvy, sales disappointed because of the FDA’s Advisory Committee on Immunization Practices’ constricted recommendation only for people aged 60 to 74. But Jefferies analysts said GSK’s vaccine sales of £2.1 billion were actually better than consensus expectations of £2.05 billion. Shingrix beat forecasts with £867 million in worldwide sales, although Arexvy sales are still notably low at £78 million. Walmsley added that both vaccines still have room for growth internationally. Despite these market challenges, Walmsley told the media GSK does not intend to change its R&D plans for vaccines. Overall, GSK had a positive total sales profile, pulling in £7.5 billion in Q1, up 4% at constant exchange rates. Its shares were up by as much as 4% on the London Stock Exchange on Wednesday morning. The company’s specialty medicines portfolio had a particularly solid performance at £2.9 billion — a 17% jump — beating Jefferies’ consensus estimates of £2.84 billion. “We’ve been able to strengthen the portfolio with a shift to more specialty medicines, and that creates oxygen through the gross margin,” Walmsley said. Notably, Jemperli pulled in £174 million in Q1 compared with a lower benchmark of £145 million. GSK said Jemperli’s US sales momentum is supported by the drug’s approval in all patients with primary advanced or recurrent endometrial cancer. GSK also touted its market progress with Ojjaara at £112 million, as the myelofibrosis therapy makes headway in the US and other territories. But analysts noted the drug’s sales just missed forecasts at £117 million. Nonetheless, GSK’s overall showing on Wednesday follows the optimistic tune played in February, when it set a higher bar for its 2031 sales outlook to at least $40 billion. This is a £2 billion jump from a prior target. Looking at its clinical pipeline, GSK discontinued a Phase 2 trial of an anti-IL18 antibody, codenamed GSK1070806, for atopic dermatitis due to pipeline prioritization. Endpoints News previously reported that GSK’s ViiV Healthcare stopped work on its HIV antiviral named VH3739937.

Drug ApprovalVaccinePhase 2Clinical Result

100 Deals associated with Dostarlimab-gxly

External Link

KEGG	Wiki	ATC	Drug Bank
-	Dostarlimab-gxly	L01XC	DB15627

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Advanced Endometrial Carcinoma	European Union	GlaxoSmithKline (Ireland) Ltd.	12 Jan 2024
Advanced Endometrial Carcinoma	Iceland	GlaxoSmithKline (Ireland) Ltd.	12 Jan 2024
Advanced Endometrial Carcinoma	Liechtenstein	GlaxoSmithKline (Ireland) Ltd.	12 Jan 2024
Advanced Endometrial Carcinoma	Norway	GlaxoSmithKline (Ireland) Ltd.	12 Jan 2024
Recurrent Endometrial Cancer	European Union	GlaxoSmithKline (Ireland) Ltd.	12 Jan 2024
Recurrent Endometrial Cancer	Iceland	GlaxoSmithKline (Ireland) Ltd.	12 Jan 2024
Recurrent Endometrial Cancer	Liechtenstein	GlaxoSmithKline (Ireland) Ltd.	12 Jan 2024
Recurrent Endometrial Cancer	Norway	GlaxoSmithKline (Ireland) Ltd.	12 Jan 2024
Mismatch repair-deficient Solid Tumors	United States	GlaxoSmithKline LLC	17 Aug 2021
Microsatellite instability-high Endometrial Carcinoma	European Union	GlaxoSmithKline (Ireland) Ltd.	21 Apr 2021
Microsatellite instability-high Endometrial Carcinoma	Iceland	GlaxoSmithKline (Ireland) Ltd.	21 Apr 2021
Microsatellite instability-high Endometrial Carcinoma	Liechtenstein	GlaxoSmithKline (Ireland) Ltd.	21 Apr 2021
Microsatellite instability-high Endometrial Carcinoma	Norway	GlaxoSmithKline (Ireland) Ltd.	21 Apr 2021
Mismatch repair-deficient Endometrial Carcinoma	European Union	GlaxoSmithKline (Ireland) Ltd.	21 Apr 2021
Mismatch repair-deficient Endometrial Carcinoma	Iceland	GlaxoSmithKline (Ireland) Ltd.	21 Apr 2021
Mismatch repair-deficient Endometrial Carcinoma	Liechtenstein	GlaxoSmithKline (Ireland) Ltd.	21 Apr 2021
Mismatch repair-deficient Endometrial Carcinoma	Norway	GlaxoSmithKline (Ireland) Ltd.	21 Apr 2021

Developing

10 top R&D records.

to view more data

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	GlaxoSmithKline Research & Development Ltd.	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	Croatia	GSK Plc	10 Jun 2024
PD-L1 positive Non-Small Cell Lung Cancer	Phase 3	Czechia	GSK Plc	10 Jun 2024

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04581824 (PERLA, ESMO_ELCC2025)	Phase 2	Metastatic Non-Squamous Non-Small Cell Lung Carcinoma First line PD-L1 status	-	Dostarlimab plus chemotherapy	evbguyhbii(dltczohfyd) = bfcnqljbko rvnrwgciwc (sfwpibthdc, 14.5 - 27.3) View more	Positive	26 Mar 2025
				Pembrolizumab plus chemotherapy	evbguyhbii(dltczohfyd) = qszdthgczd rvnrwgciwc (sfwpibthdc, 11.6 - 19.3) View more
NCT06655818 (CTgov)	Phase 1/2	Multiple Myeloma	4	Mafodotin+Dostarlimab+Belantamab	zqjuaqpnlb = oisapudwqe mfykpcxrwp (lrdmrlgzwv, nzmamjpblv - gwicxckojv) View more	-	03 Mar 2025
NCT03602859 (FIRST-ENGOT-OV44, PipelineReview) Manual	Phase 3	Ovarian Cancer First line	-	SOC + Placebo	picsdwuqkg(uelixfwxjc) = The trial met its primary endpoint of PFS demonstrating a statistically significant difference with the addition of dostarlimab to both standard of care carboplatin-paclitaxel chemotherapy and niraparib maintenance, with or without bevacizumab. wdshuarbsm (nmycgvoggr ) Met View more	Positive	20 Dec 2024
				SOC + niraparib
NCT05723562 (AZUR-1, Company_Website) Manual	Phase 2	Mismatch repair-deficient Rectal Cancer First line MSI-High \| Deficient DNA Mismatch Repair (dMMR)	42	dostarlimab	ffrmcbunjn(zrhpzdmomg) = vedajauwmm vybipimaco (ndwnhopcvl )	Positive	16 Dec 2024
Korean expanded access program (ESMO_ASIA2024)	Not Applicable	Recurrent Endometrial Cancer dMMR \| MSI-H	29	Dostarlimab 500mg	czjgcxkwwr(jneobqnuag) = Serious AEs occurred in 4 (13.8%) pts; none were directly related to treatment sicyjsopeq (sukvhbuagg ) View more	Positive	07 Dec 2024
NCT04581824 (PERLA, SITC2024) Manual	Phase 2	Non-squamous non-small cell lung cancer	243	Dostarlimab + CT	tdptkqgomf(ackafgyhlh) = ppkykehwxs feegyveihg (jnjxwfmvss, 14.5 - 27.3)	Positive	05 Nov 2024
				Pembrolizumab + CT	tdptkqgomf(ackafgyhlh) = nwzarxjqyu feegyveihg (jnjxwfmvss, 11.6 - 19.3)
NCT05565378 (GALAXIES Lung-201, ESMO2024) Manual	Phase 2	PD-L1 positive Non-Small Cell Lung Cancer First line PD-L1 High Expression (TPS >= 50%)	124	Dostarlimab 500 mg	ifqicocrys(qgwkpnhnpw) = cpdvnxcntb rvjolchnjo (eaoenqbloc, 21.1 - 56.3) View more	Positive	14 Sep 2024
				Dostarlimab 500 mg + Belrestotug 100 mg	ifqicocrys(qgwkpnhnpw) = ssvubnsuaw rvjolchnjo (eaoenqbloc, 43.9 - 80.1) View more
NCT05565378 (GALAXIES Lung-201, GlobeNewswire) Manual	Phase 2	PD-L1 positive Non-Small Cell Lung Cancer First line PD-L1 High Expression	124	Dostarlimab	agvolsmidj(ymspeqzyel) = bowlbvxowx fnxmmzhrvz (myxparmelx, 21.1–56.3) View more	Positive	14 Sep 2024
				Dostarlimab + belrestotug 100 mg	agvolsmidj(ymspeqzyel) = lvcllumjcd fnxmmzhrvz (myxparmelx, 43.9–80.1) View more
NCT05065021 (Re-VOLVE, ESMO2024) Manual	Phase 2	Ovarian Cancer	20	Niraparibniraparibbevacizumabpaclitaxeldostarlimab	xvvopoczmi(iyewrmgteu) = kkulkxmflb tpwwawrqds (oitsfezope ) View more	Positive	14 Sep 2024
NCT04581824 (PERLA, WCLC2024) Manual	Phase 2	metastatic non-small cell lung cancer	-	Dostarlimab + Chemotherapy	egumkruinp(zzcgdnktdz) = tymieiqwzs zixahkfwip (lsggemgjfw, 45.8 - 27.1)	Positive	09 Sep 2024
				Pembrolizumab + Chemotherapy	egumkruinp(zzcgdnktdz) = rrqybwzmwr zixahkfwip (lsggemgjfw, 36.8 - 17.6)

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

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.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis