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

Tesaro, Inc.

GSK PlcGlaxoSmithKline Trading Services 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

RegulationPriority Review (United States), Breakthrough Therapy (United States), Fast Track (United States), Accelerated Approval (United States), Priority Review (Australia), Commissioner's National Priority Voucher (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 Date30 Nov 2025

Sponsor / Collaborator

GSK Plc

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

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-

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: Hwang, Jiyoung ; Kong, Jaehyun ; 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.

339

News (Medical) associated with Dostarlimab-gxly

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

21 Nov 2025

·www.globenewswire.com

Anaptys Announces $100 Million Stock Repurchase Plan

SAN DIEGO, Nov. 21, 2025 (GLOBE NEWSWIRE) -- AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, today announced that its Board of Directors has authorized an amended Stock Repurchase Plan under which the Company may repurchase up to $100.0 million of the Company’s outstanding common stock, par value $0.001 per share. This amendment is in addition to the $6.4 million that remained as of Nov. 20, 2025 under the current $75.0 million Stock Repurchase Plan of which Anaptys has repurchased a total of 3,443,188 shares of common stock (11.2% shares outstanding before the start of this repurchase plan).Excluding any additional potential purchases under this Stock Repurchase Plan, Anaptys anticipates ending 2025 with approximately $300 million in cash, cash equivalents and investments, including an anticipated accrual of a one-time $75 million commercial sales milestone in Q4 2025 due from GSK once Jemperli achieves $1 billion in worldwide net sales. The shares may be repurchased from time to time in open market transactions, or other means in accordance with Rule 10b5-1 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), and Rule 10b-18 of the Exchange Act. The timing, number of shares repurchased, and prices paid for the stock under this program will depend on general business and market conditions as well as corporate and regulatory limitations, prevailing stock prices, and other considerations. The Stock Repurchase Plan will expire on March 31, 2026, may be suspended or discontinued at any time, and does not obligate the company to acquire any amount of common stock. About Anaptys Anaptys is a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics for autoimmune and inflammatory diseases. The company’s pipeline includes rosnilimab, a pathogenic T cell depleter, which has completed a Phase 2b trial for rheumatoid arthritis; ANB033, a CD122 antagonist, in a Phase 1b trial for celiac disease with plans to expand development into an additional indication; and ANB101, a BDCA2 modulator, in a Phase 1a trial. Anaptys has also discovered and out-licensed in financial collaborations multiple therapeutic antibodies, including a PD-1 antagonist (Jemperli (dostarlimab-gxly)) to GSK and an IL-36R antagonist (imsidolimab) to Vanda Pharmaceuticals. To learn more, visit www.AnaptysBio.com or follow us on LinkedIn. Anaptys recently announced the intent to separate its biopharma operations from its substantial royalty assets by year-end 2026, enabling investors to align their investment philosophies and portfolio allocation with the strategic opportunities and financial objectives of each company. Learn more here. Forward-Looking StatementsThis 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: the company’s ability to execute the Stock Repurchase Plan, in whole or in part; year-end cash estimates; the potential to receive any additional milestones and royalties from the GSK collaboration, and the timing therefor; and expectations regarding the structure, infrastructure, timing and taxation of the proposed separation into two companies. Statements including words such as “plan,” “continue,” “expect,” or “ongoing” and statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they do not fully materialize or prove incorrect, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Forward-looking statements are subject to risks and uncertainties that may cause the company’s actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to the company’s ability to advance its product candidates, obtain regulatory approval of and ultimately commercialize its product candidates, the timing and results of preclinical and clinical trials, the company’s ability to fund development activities and achieve development goals, the company’s ability to protect intellectual property and other risks and uncertainties described under the heading “Risk Factors” in documents the company 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 the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof. Contact:Nick MontemaranoExecutive Director, Investor Relations858.732.0178investors@anaptysbio.com

Phase 1Phase 2Immunotherapy

21 Nov 2025

·www.globenewswire.com

Anaptys Initiates Litigation Against Tesaro, a GSK Subsidiary

SAN DIEGO, Nov. 21, 2025 (GLOBE NEWSWIRE) -- AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, announced it has filed a Verified Complaint in Delaware Chancery Court, requesting a court declaration that TESARO, Inc. (“Tesaro”) has materially breached the parties’ Collaboration and Exclusive License Agreement (“Collaboration Agreement”) and that GSK (Tesaro’s corporate parent) has tortiously interfered with the Collaboration Agreement. Anaptys has requested that the court declare that Anaptys is entitled to all rights and remedies under the Collaboration Agreement. The Complaint contends that Tesaro breached, and GSK induced Tesaro to breach, multiple material Collaboration Agreement terms. Under these terms, Tesaro agreed that it would not conduct or participate in research, development, manufacturing or commercialization of any PD-1 antagonist other than those licensed by Anaptys to Tesaro. The Collaboration Agreement also provides that Tesaro will “use Commercially Reasonable Efforts to . . . obtain the optimum commercial return for [Jemperli] in all major markets throughout the world.” Despite these obligations, the Complaint contends that Tesaro (i) violated its exclusivity obligations by participating in past, ongoing, and upcoming governed clinical trials with PD-1 antagonists that compete with Jemperli, including Keytruda, and (ii) failed to use Commercially Reasonable Efforts to obtain the “optimum commercial return” for Jemperli by, among other things, participating 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. In 2020, Anaptys similarly filed a complaint against GSK regarding breaches of its obligations under the Collaboration Agreement. Those breaches at the time related to GSK’s planned clinical trial of Zejula, another of GSK’s oncology programs, in combination with Keytruda, without the consent of Anaptys. This planned trial violated Tesaro’s exclusivity obligations. 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. While Anaptys had approached Tesaro to engage in good faith discussions to potentially resolve these claims, on Nov. 20, 2025, Tesaro, without notice, initiated a lawsuit against Anaptys. Tesaro’s complaint includes requests for injunctive relief, claiming that Anaptys has breached the Collaboration Agreement. Tesaro’s claim for breach is predicated on an allegation that Anaptys has improperly alleged that Tesaro had breached the Collaboration Agreement. Tesaro seeks to improperly restrain Anaptys from exercising its legal rights under the Collaboration Agreement in violation of Delaware’s anti-SLAPP statute and other legal protections. 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 parties have agreed to request an expedited schedule with the Delaware Chancery Court, with trial anticipated in July 2026. Milestone and royalty payment obligations to Anaptys pursuant to the Collaboration Agreement continue to be due during the proceedings. About the Collaboration and Exclusive License Agreement In March 2014, Anaptys entered into the Collaboration Agreement with Tesaro, an oncology-focused biopharmaceutical company now a part of GSK. Currently, under the Collaboration Agreement, Tesaro is developing Jemperli (dostarlimab) as a monotherapy, and in combination with additional therapies, for various solid tumor indications. Anaptys is eligible to receive royalties upon sales of Jemperli, equal to 8% of net sales below $1.0 billion, 12% of net sales between $1.0 billion and $1.5 billion, 20% of net sales between $1.5 billion and $2.5 billion and 25% of net sales above $2.5 billion. In Q4 2025, Anaptys anticipates accruing a one-time $75 million commercial sales milestone from Tesaro once Jemperli achieves $1 billion in worldwide net sales. The royalty term under this collaboration extends at least through expiration of composition of matter coverage on the molecule which expires in 2035 in the U.S. and in 2036 in the EU.Currently, Jemperli receivables from Tesaro are payable to Sagard as a result of prior capped non-recourse monetizations and will terminate once Sagard has received an aggregate of either $600 million by March 31, 2031, or $675 million any time thereafter. Anaptys estimates Sagard will have accrued $250 million in royalties and sales milestones through year end 20251 and anticipates the full paydown of $600 million between Q2 2027 and Q2 2028. About Anaptys Anaptys is a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics for autoimmune and inflammatory diseases. The company’s pipeline includes rosnilimab, a pathogenic T cell depleter, which has completed a Phase 2b trial for rheumatoid arthritis; ANB033, a CD122 antagonist, in a Phase 1b trial for celiac disease with plans to expand development into an additional indication; and ANB101, a BDCA2 modulator, in a Phase 1a trial. Anaptys has also discovered and out-licensed in financial collaborations multiple therapeutic antibodies, including a PD-1 antagonist (Jemperli (dostarlimab-gxly)) to GSK and an IL-36R antagonist (imsidolimab) to Vanda Pharmaceuticals. To learn more, visit www.AnaptysBio.com or follow us on LinkedIn. Anaptys recently announced the intent to separate its biopharma operations from its substantial royalty assets by year-end 2026, enabling investors to align their investment philosophies and portfolio allocation with the strategic opportunities and financial objectives of each company. Learn more here. Forward-Looking StatementsThis 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: the potential termination of the Collaboration Agreement, the timing and potential outcome of proceedings in Delaware Chancery Court, the return of Jemperli to the company, and the nature of the remedies we may obtain in such proceedings. Statements including words such as “plan,” “continue,” “expect,” or “ongoing” and statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they do not fully materialize or prove incorrect, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Forward-looking statements are subject to risks and uncertainties that may cause the company’s actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to the company’s ability to advance its product candidates, obtain regulatory approval of and ultimately commercialize its product candidates, the timing and results of preclinical and clinical trials, the company’s ability to fund development activities and achieve development goals, the company’s ability to protect intellectual property and other risks and uncertainties described under the heading “Risk Factors” in documents the company 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 the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof. Contact:Nick MontemaranoExecutive Director, Investor Relations858.732.0178investors@anaptysbio.com 1. Anticipate ~$250 million of Sagard accruals by YE 2025 including $143 million paid through June 30, 2025, approximately $75 million accrued in the third quarter of 2025 and assumes a ~15% quarter-over-quarter growth rate for Jemperli in Q4 2025

License out/inPhase 2Phase 1ADC

100 Deals associated with Dostarlimab-gxly

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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


NCT03602859 (FIRST/ENGOT-OV44, ESMO2025)	Phase 3	Ovarian Cancer First line \| Maintenance	1,016	PBCT + placebo ± bev with nira + placebo ± bev MT	orbznucsos(cftpenjzam) = aircfmhjey gbvovnldun (btuipbkztv ) View more	Positive	17 Oct 2025
				PBCT + dost ± bev with dost + nira ± bev MT	orbznucsos(cftpenjzam) = ibgcpsnzpu gbvovnldun (btuipbkztv ) View more
NCT03981796 (RUBY, ESMO2025)	Phase 3	Recurrent Endometrial Cancer First line MMRp/MSS	376	Dostarlimab + carboplatin-paclitaxel (D+CP)	cvmlhhxmez(fpgxqeboaj) = bcvrodwsmk erioedvtcs (dygnwxekwq, 59.2 - 72.8) View more	Positive	17 Oct 2025
				Placebo + carboplatin-paclitaxel (P+CP)	cvmlhhxmez(fpgxqeboaj) = clckrscwrd erioedvtcs (dygnwxekwq, 45.6 - 60.2) View more
NCT03981796 (RUBY, ESMO2025)	Phase 3	Recurrent Endometrial Cancer dMMR \| MSS	1,118	Dostarlimab + carboplatin-paclitaxel (D+CP)	siuyatcjyx(tslvqrvlpt) = xnhwuaejuj xbggqwiffr (zjttunsymp )	Positive	17 Oct 2025
				Placebo + carboplatin-paclitaxel (P+CP)	siuyatcjyx(tslvqrvlpt) = bfeqihzcko xbggqwiffr (zjttunsymp )
NCT04581824 (PERLA, ESMO2025)	Phase 2	Metastatic Non-Squamous Non-Small Cell Lung Carcinoma First line ctDNA \| bTMB	189	Dostarlimab + chemotherapy	wvcseudysi(yypqfketlo) = uevlevtiha hvlfnlzkib (wboddjysdz ) View more	Positive	17 Oct 2025
				Pembrolizumab + chemotherapy	wvcseudysi(yypqfketlo) = ozsprgotez hvlfnlzkib (wboddjysdz ) View more
NCT04581824 (PERLA, Pubmed \| JTO Clin Res Rep)	Phase 2	Metastatic Non-Squamous Non-Small Cell Lung Carcinoma First line	153	Dostarlimab + Chemotherapy	pqbnildoww(iffkkccfpd) = cdljovrpfr crwasyuuqc (yvgfhoglwf, 14.5 - 27.3) View more	Positive	01 Oct 2025
				Pembrolizumab + Chemotherapy	pqbnildoww(iffkkccfpd) = mvcqfhbmmf crwasyuuqc (yvgfhoglwf, 11.6 - 19.3) View more
NCT04493060 (CTgov)	Phase 2	Pancreatic Carcinoma, Familial \| Metastatic Pancreatic Ductal Adenocarcinoma	22	niraparib+dostarlimab	orhoupmwwz = kazxufsszm pcdzmbnyjw (rfkfbshnas, urgjywpsbq - dauxiavplx) 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))	byhvhqvqzx = asrgsebnwf aglbknwvgz (oliniplmmb, eddyvropff - nihpjiedce) View more	-	15 Jul 2025
				taxane+Niraparib (Cohort C (Niraparib OR Platinum-taxane))	byhvhqvqzx = zzdfxesjtv aglbknwvgz (oliniplmmb, iwatxsytmv - pylcwoyiob) View more
NCT05065021 (Re-VOLVE, ASCO2025)	Phase 2	Ovarian Cancer BRCA \| CCNE1 \| CHEK2	43	Niraparib 200-300mg/Bevacizumab 7.5mg/kg	nhcjzgrtmf(ozxvoagtsu) = No G3-G4 immune related AE alfgbnmrcu (zaoqacrlpa )	Positive	30 May 2025
				Niraparib/Bevacizumab/Dostarlimab 500mg
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)	nyslstcrqi(gblkiphkfr) = bdwnjjdpvo jlunsxiuhe (xbhbrcbkhj ) View more	Positive	30 May 2025
				Placebo plus Carboplatin-Paclitaxel (PBO+CP)	nyslstcrqi(gblkiphkfr) = lvywdnxexh jlunsxiuhe (xbhbrcbkhj ) View more
NCT06062420 (GALAXIES H&N-202, GlobeNewswire) Manual	Phase 2	PD-L1-positive head and neck squamous cell carcinoma First line PD-L1 Positive	-	Dostarlimab + Belrestotug	hktsmtrbil(wranimdfuk) = showed a trend below the meaningful threshold ykpziiwnng (fqboyrilya )	Negative	13 May 2025
				Dostarlimab

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