预约演示

更新于：2025-01-13

Dostarlimab-gxly

多塔利单抗

更新于：2025-01-13

概要

基本信息

药物类型

单克隆抗体

别名

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]

靶点

PD-1

作用机制

PD-1抑制剂(细胞程序性死亡-1抑制剂)

治疗领域

肿瘤泌尿生殖系统疾病神经系统疾病+ [6]

在研适应症

晚期子宫内膜癌复发性子宫内膜癌MMRD实体瘤+ [63]

非在研适应症

晚期胆道癌胆管癌透明细胞肉瘤+ [5]

原研机构

AnaptysBio, Inc.

在研机构

Tesaro, Inc.

GSK PlcGlaxoSmithKline (Ireland) Ltd.

+ [7]

非在研机构-

最高研发阶段批准上市

首次获批日期

欧盟 (2021-04-21),

MSI-H 子宫内膜癌错配修复缺陷子宫内膜癌

最高研发阶段(中国)临床3期

特殊审评优先审评 (美国)、突破性疗法 (美国)、快速通道 (美国)、加速批准 (美国)、优先审评 (澳大利亚)

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结构/序列

Sequence Code 315609369H

来源: *****

Sequence Code 315609370L

来源: *****

关联

项与多塔利单抗相关的临床试验

NCT06762405

/ Not yet recruiting临床3期IIT

PRODIGE 90 - (FFCD 2204) - PREDIR-NEOREC Neoadjuvant Dostarlimab with Short Course Radiotherapy in a Watch-and-wait Strategy for Microsatellite Unstable or Mismatch Repair-deficient Locally Advanced Rectal Cancer Patients: a Randomized Phase II Trial Phase II Randomized Study Non-comparative - Multicenter

Total neoadjuvant treatment (TNT) including radiotherapy and induction or consolidation systemic chemotherapy has become the standard treatment for patients with stage II and III rectal adenocarcinoma. Along with the improvement of DFS, this preoperative treatment has paved the way to a paradigm-shifting nonoperative management. Indeed, rectal preservation has become a new goal for patients without detectable residual cancer after TNT with the option to reserve surgery for those with cancer regrowth (25-40%). Five to 10% of non-metastatic rectal cancer patients are molecularly characterized as microsatellite unstable (MSI) or mismatch repair-deficient (dMMR), and present a decreased response to systemic chemotherapy. As this tumor phenotype is associated with high immunogenicity, immunotherapy with anti-PD1 molecules has recently emerged as the new standard first line treatment in the metastatic setting, with long duration of cancer control for at least 40% of patients. In patients with localized rectal tumors, it has been suggested that immunotherapy alone may induce complete clinical response and may allow these patients to be considered for nonoperative therapeutic approaches.
Finally, given the efficacy of immunotherapy in MSI rectal patients, we did not want to differ for 5 weeks this treatment with the risk of disease progression by given long-course RT. In the present trial, radiotherapy is evaluated as a " potentiating " treatment for immunotherapy rather than as a " local treatment " in a TNT strategy.

开始日期2025-05-01

申办/合作机构

Centre Hospitalier Universitaire de Dijon

NCT06757244

/ Not yet recruiting临床2期IIT

DOVIPA, a Phase II Study Evaluating Efficacy and Safety of DOstarlimab and Oral VItamin D3 with Folinic Acid, 5FU, Irinotecan Plus Oxalipaltin (mFOLFIRINOX) in Non Pretreated Metastatic PAncreatic Cancer

The goal of this clinical trial is to estimate the antitumor response of mFOLFIRINOX + Dostarlimab + oral HD vitamin D3 in patients with non-pretreated histologically confirmed metastatic Stage IV adenocarcinoma of the pancreas. The patients must have an Eastern Cooperative Oncology Group (ECOG)-Performance Status (PS) 0 or 1 and adequate organ functions.
The main objective of the study will be assessed by estimating Objective response rate (ORR) according to Response Evaluation Criteria version 1.1 (RECIST 1.1) in patients with pancreatic adenocarcinoma and measurable disease.
The Secondary objectives are :
* To assess the safety and tolerability of mFOLFIRINOX + Dostarlimab + HD Vitamin D according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 by evaluating the Median Progression Free Survival (mPFS) in months, the Median Overall Survival (mOS) in months, the Median Duration of Response (mDOR) in months and Clinical benefit rate according to RECIST 1.1 (CBR)
* To further evaluate the antitumor efficacy of mFOLFIRINOX + Dostarlimab + oral HD Vitamin D by evaluating the type, frequency, and severity of treatment-emergent adverse events (TEAEs); adverse events of special interest (AESIs); safety laboratory findings There are also exploratory objectives to better understand the pancreatic adenocarcinoma.
Participants will be cared for in the digestive oncology department. A selection review will be carried out to check compliance with the study eligibility criteria. Patients included in the study will be treated with 4 cycles of induction therapy. Each cycle lasts 6weeks and includes chemotherapy such as mFolfirinox D1,D15 and D29, combined with dostarlimab 500 mg every 3 weeks and daily oral vitamin D3.
At the end of the induction treatment period, maintenance treatment will be instituted with LV5FU chemotherapy combined with dostarlimab 1000 mg every 6 weeks and daily oral vitamine D3. Treatment will be maintained until progression or unacceptable toxicity.
Throughout this period, patients will be monitored for their safety. Imaging examinations will also be carried out to monitor the progression of tumour disease.

开始日期2025-01-15

申办/合作机构

Hopital Foch

[+1]

NCT06521567

/ Recruiting临床1/2期

Phase 1/2 Dose Determination and Dose Expansion Study of Cobolimab in Combination With Dostarlimab in Pediatric and Young Adult Participants With Newly Diagnosed and Relapsed/Refractory Tumors (POPSTAR)

The goal of this interventional study is to determine the strength of cobolimab and dostarlimab that is most tolerated in children and young adults who have advanced solid tumors. This study also aims: (a) to check if it is safe to use cobolimab and dostarlimab combination in children and young adults, (b) to see how to manage the side effects that may occur, and (c) the effect of this treatment in participants

开始日期2024-12-31

申办/合作机构

GSK Plc

100 项与多塔利单抗相关的临床结果

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100 项与多塔利单抗相关的转化医学

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100 项与多塔利单抗相关的专利（医药）

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155

项与多塔利单抗相关的文献（医药）

2025-02-01·CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY

Cardiotoxicity associated with immune checkpoint inhibitors: Systematic review and meta-analysis

Review

作者: Provenzani, Alessio ; Carollo, Anna ; Cutaia, Sofia ; Novara, Maria Eugenia ; Piazza, Lavinia ; Rizzo, Sergio ; Di Martino, Enrica

BACKGROUND AND AIMS:

The aim of this systematic review was to assess the risk of cardiac toxicity in patients undergoing approved PD-1 (nivolumab, pembrolizumab, cemiplimab, dostarlimab), PD-L1 (atezolizumab, avelumab, durvalumab), and CTLA-4 (ipilimumab) inhibitors.

RESULTS:

Among a total of 2272 articles, 11 phase II and III clinical trials included: 5463 patients and 175 cardiac adverse events. The most common cardiac disorder was atrial fibrillation (12 %), while cardiac arrest and cardiac failure (6 %) led to death in three cases. Overall, ICI treatment increased the risk of cardiotoxicity compared with control groups (RR=1.62, 95 %-CI= 1.18-2.24, p-value=0.0033; OR=1.71, 95 %-CI= 1.20-2.42, p-value=0.0027).

CONCLUSIONS:

This study proved that the recognition of frequency and severity of all grade cardiotoxicity associated with ICIs is still underestimated. Thus, a systematic cardiological screening becomes necessary, in order to intercept the potential cardiological complications beforehand and optimize the outcomes of the respective treatment with PD-1, PD-L1 and CTLA-4 inhibitors.

2025-01-01·Med

If it is a solid tumor target, then it may be a hematologic cancer target: Bridging the great divide

Review

作者: Adashek, Jacob J ; Munoz, Javier L ; Kurzrock, Razelle

Tumor-agnostic US Food and Drug Administration approvals are transforming oncology. They include larotrectinib/entrectinib/repotrectinib (NTRK fusions), selpercatinib (RET fusions), dabrafenib/trametinib (BRAF^V600E mutations), pembrolizumab/dostarlimab (microsatellite instability), pembrolizumab (high tumor mutational burden), and trastuzumab deruxtecan (HER2 3+ expression) (all solid cancers). Pemigatinib is approved for FGFR1-rearranged myeloid/lymphoid neoplasms. The genomically driven tissue-agnostic approach has a strong biological rationale (cancer is a disease of the genome), yields remarkably high response rates, and provides drug access to patients with an unmet need (rare/ultra-rare malignancies). Despite the solid tumor focus, both solid and hematologic cancers can harbor identical driver molecular abnormalities and respond to cognate therapies. For example, BRAF^V600E and IDH1/2 mutations; ALK, FGFR, and NTRK fusions; PD-L1 amplification; and CD70 antigens are druggable in both solid and blood malignancies by gene-/immune-targeted therapies/chimeric antigen receptor T cells. Future biomarker-based tissue-agnostic basket studies/approvals should bridge the great divide and include both solid and hematologic cancers.

2025-01-01·GYNECOLOGIC ONCOLOGY

Efficacy and safety of dostarlimab in combination with chemotherapy in patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer in a phase 3, randomized, placebo-controlled trial (ENGOT-EN6-NSGO/GOG-3031/RUBY)

Article

作者: Chase, Dana M. ; Gold, Michael A. ; Herrstedt, Jørn ; Chase, Dana M ; Fleming, Evelyn ; Bolling, Magnus Frödin ; Billingsley, Caroline ; Thijs, Anna M. ; Powell, Matthew A. ; Shahin, Mark S ; He, Zangdong ; Kommoss, Stefan ; Willmott, Lyndsay ; Powell, Matthew A ; Ring, Kari ; Ghamande, Sharad A. ; O'Malley, David M ; Gill, Sarah E ; Boere, Ingrid ; Black, Destin ; Nevadunsky, Nicole ; Thijs, Anna M ; Shahin, Mark S. ; Stevens, Shadi ; Gold, Michael A ; Cibula, David ; Balas, Morad Marco ; Mirza, Mansoor Raza ; Sharma, Sudarshan ; McCourt, Carolyn ; Nowicki, Paul ; Gilbert, Lucy ; O'Malley, David M. ; Ghamande, Sharad A ; Savarese, Antonella ; Buscema, Joseph ; Callahan, Michael ; Gill, Sarah E.

OBJECTIVES:

Part 1 of the RUBY trial (NCT03981796) demonstrated improved survival in patients with primary advanced or recurrent endometrial cancer (EC) treated with dostarlimab plus carboplatin-paclitaxel versus placebo plus carboplatin-paclitaxel. Here, we examine additional efficacy and safety data from patients with mismatch repair deficient/microsatellite instability-high (dMMR/MSI-H) EC in the RUBY trial.

METHODS:

Patients were randomized 1:1 to dostarlimab 500 mg or placebo plus carboplatin-paclitaxel every 3 weeks for 6 cycles followed by dostarlimab or placebo every 6 weeks for up to 3 years. In the dMMR/MSI-H population of RUBY Part 1, analysis of progression-free survival by investigator assessment compared with blinded independent central review, sensitivity analyses of the source-verified population compared with the randomized population, and analysis of safety in this population were completed.

RESULTS:

In total, 118 patients with dMMR/MSI-H were enrolled in the RUBY trial (53, dostarlimab arm; 65, placebo arm). At the first interim analysis, a 72% reduction in the risk of progression or death (P < 0.0001) was seen with dostarlimab plus carboplatin-paclitaxel by investigator assessment per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), which was consistent with blinded independent central review per RECIST v1.1. Likewise, sensitivity analyses of the source-verified dMMR/MSI-H population compared with the randomized dMMR/MSI-H population were consistent for progression-free survival and overall survival. Safety results seen in the dMMR/MSI-H population were similar to those previously reported for the overall population.

CONCLUSIONS:

All primary and secondary efficacy assessments demonstrate the consistent benefit of dostarlimab plus carboplatin-paclitaxel. The improvements seen in survival and the manageable safety profile support the favorable benefit-risk profile for dostarlimab plus carboplatin-paclitaxel in patients with dMMR/MSI-H primary advanced or recurrent EC.

377

项与多塔利单抗相关的新闻（医药）

2025-01-13

·PRNewswire

Elevation Oncology Provides Updates on Differentiated ADC Programs and Upcoming Milestones

-- Initiated dosing in Phase 1 clinical trial cohort evaluating Claudin 18.2 ADC EO-3021 in combination with ramucirumab or dostarlimab in patients with advanced gastric/gastroesophageal junction (GEJ) cancer -- -- Expect to report initial data from combination cohort in 4Q 2025 or 1Q 2026 -- -- On-track to report additional monotherapy data from dose escalation and expansion cohorts of ongoing Phase 1 clinical trial in 1H 2025 -- -- Plan to present preclinical data for HER3 ADC EO-1022 in 1H 2025 and file an Investigational New Drug (IND) application in 2026 -- BOSTON, Jan. 13, 2025 /PRNewswire/ -- Elevation Oncology, Inc. (Nasdaq: ELEV), an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs, today announced program updates and upcoming milestones. "We are rapidly advancing EO-3021 to address significant unmet needs in treating earlier lines of advanced gastric/GEJ cancer, where we believe we have a unique ability to improve on the standard of care," said Joseph Ferra, President and Chief Executive Officer of Elevation Oncology. "As we enter 2025, we are honing our focus, leveraging the competitive anti-tumor activity and differentiated safety profile of EO-3021 to explore combination approaches in the first- and second-line settings. With our Phase 1 clinical trial ongoing and now enrolling both monotherapy and combination cohorts, we are in a leading position to explore the compelling potential of EO-3021, our differentiated Claudin 18.2 ADC, to improve outcomes for people living with advanced gastric/GEJ cancer." Mr. Ferra continued, "We look forward to sharing additional data from our Phase 1 dose escalation and expansion study of EO-3021 in the first half of 2025. With this readout, we aim to build on the promising initial data reported in August 2024, reinforcing EO-3021's robust anti-tumor activity and potential better combinability, while garnering additional insights to inform our go-forward clinical development efforts. We are enthusiastic about the potential of EO-3021 in addressing meaningful market opportunities and look forward to a transformative 2025." Program Updates and Upcoming Milestones EO-3021: Elevation Oncology is developing EO-3021, a differentiated, potentially best-in-class antibody drug conjugate (ADC) for the treatment of patients with advanced, unresectable or metastatic solid tumors likely to express Claudin 18.2, including gastric/GEJ cancer. In August 2024, Elevation Oncology reported promising initial monotherapy data from the dose escalation portion of its ongoing Phase 1 clinical trial of EO-3021, demonstrating competitive efficacy, with a 42.8% confirmed overall response rate (ORR) in a biomarker-enriched population, and a differentiated safety profile, including minimal hematological toxicity and hepatotoxicity, and no peripheral neuropathy/hypoesthesia. Based on these data, Elevation Oncology is focusing the clinical development of EO-3021 on the first- and second-line treatment of advanced gastric/GEJ cancer, where EO-3021's key attributes can potentially provide differentiated benefits and address unmet needs in both patient outcomes and safety. Monotherapy : The dose expansion portion of Elevation Oncology's Phase 1 clinical trial of monotherapy EO-3021 is ongoing. As of January 2025, Elevation Oncology has implemented prospective Claudin 18.2 expression testing as part of the patient screening process, focusing enrollment on patients with ≥25% of tumor cells at IHC 1+/2+/3+. Elevation Oncology expects to report additional safety and efficacy data from the dose escalation and expansion portions of the study in the first half of 2025. Combination: Patient dosing is ongoing in the combination portion of Elevation Oncology's Phase 1 clinical trial of EO-3021. The combination cohorts are evaluating EO-3021 in combination with dostarlimab, a PD-1 inhibitor, in the first line setting and with ramucirumab, a VEGFR2 inhibitor, in the second line setting. By combining EO-3021 and dostarlimab, an immune checkpoint inhibitor, Elevation Oncology aims to deliver synergistic benefit, potentially offering patients improved outcomes beyond those seen with the existing combination of immunotherapy and chemotherapy. The combination of an immunotherapy and chemotherapy agent is the standard of care for the treatment of gastric/GEJ cancer in the front-line setting. With the EO-3021 and ramucirumab combination, Elevation Oncology aims to deliver improved tolerability and synergistic anti-tumor activity compared to the approved combination of ramucirumab and paclitaxel. The combination of ramucirumab and paclitaxel is the standard of care for the treatment of second-line gastric/GEJ cancer. Elevation Oncology expects to report initial data from the combination cohorts in the fourth quarter of 2025 or the first quarter of 2026. EO-1022: Elevation Oncology is developing EO-1022, a differentiated HER3 ADC for the treatment of patients with HER3-expressing solid tumors, including breast cancer, EGFR-mutant non-small cell lung cancer, and pancreatic cancer. EO-1022 combines seribantumab, a fully human anti-HER3 monoclonal antibody, and a monomethyl auristatin E (MMAE) payload with site-specific conjugation to glycan. It is designed to leverage seribantumab's desirable internalization capability and the latest site-specific ADC technology to deliver a safe, effective option for patients living with solid tumors that express HER3. Elevation Oncology expects to present preclinical data for EO-1022 in the first half of 2025 and to file an IND application in 2026. Financial Guidance Elevation Oncology expects that its cash, cash equivalents and marketable securities as of September 30, 2024, will be sufficient to fund its current operations into 2026. About Elevation Oncology, Inc. Elevation Oncology is an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs. We are leveraging our ADC expertise to advance a novel pipeline, initially targeting two clinically validated targets in oncology, Claudin 18.2 and HER3. Our lead candidate, EO-3021, is a potential best-in-class, Claudin 18.2 ADC and is currently being evaluated in a Phase 1 trial (NCT05980416) as a monotherapy, and in combinations with dostarlimab or ramucirumab, in patients with advanced, unresectable or metastatic gastric/gastroesophageal adenocarcinoma that express Claudin 18.2. We are also advancing EO-1022, a HER3 ADC for the treatment of patients living with solid tumors that express HER3, through preclinical development. For more information, visit . Forward-Looking Statements This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, anticipated clinical and preclinical development activities, expected timing of announcements of clinical and preclinical results, potential benefits of product candidates, potential market opportunities for product candidates, the ability of product candidates to treat their targeted indications and Elevation Oncology's expectations about its cash runway. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These forward-looking statements may be accompanied by such words as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "goal," "intend," "may," "might," "plan," "possible," "potential," "will," "would," and other words and terms of similar meaning. Although Elevation Oncology believes that the expectations reflected in such forward-looking statements are reasonable, Elevation Oncology cannot guarantee future events, results, actions, levels of activity, performance or achievements, and the timing and results of biotechnology development and potential regulatory approval are inherently uncertain. Forward-looking statements are subject to risks and uncertainties that may cause Elevation Oncology's actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to Elevation Oncology's ability to advance its product candidates, the timing and results of preclinical studies and clinical trials, approvals and commercialization of product candidates, the receipt and timing of potential regulatory designations, Elevation Oncology's ability to fund development activities and achieve development goals, Elevation Oncology's ability to protect intellectual property, Elevation Oncology's ability to establish and maintain collaborations with third parties, and other risks and uncertainties described under the heading "Risk Factors" in documents Elevation Oncology files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and Elevation Oncology undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof. Elevation Oncology Investor and Media Contact Gracie Tong Senior Director, Investor Relations and Corporate Communications [email protected] SOURCE Elevation Oncology WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床1期免疫疗法抗体药物偶联物临床结果

2025-01-13

·PipelineReview

GSK Enters Agreement to Acquire IDRx, Inc.

PLYMOUTH, MA, USA I January 13, 2025 I GSK plc (LSE/NYSE: GSK) and IDRx, Inc. (IDRx) today announced that they have entered into an agreement under which GSK will acquire IDRx, a Boston-based, clinical-stage biopharmaceutical company dedicated to developing precision therapeutics for the treatment of GIST. Under the agreement, GSK will pay $1 billion upfront, with potential for an additional $150 million success-based regulatory approval milestone payment. The acquisition includes lead molecule, IDRX-42, a highly selective KIT TKI being developed as a first- and second-line therapy for the treatment of GIST. GIST typically presents in the GI tract with 80% of cases driven by mutations in the KIT gene that lead to the growth, proliferation, and survival of tumour cells (primary or activating mutations). 1 90% of patients treated in the first-line develop new KIT mutations (secondary or resistance mutations) that typically lead to relapse with limited therapeutic options. 2 Currently, there are no approved TKIs that inhibit the full spectrum of clinically relevant primary and secondary mutations in KIT. IDRX-42 has demonstrated activity against all key primary and secondary KIT mutations, designed to improve outcomes for patients with GIST. This breadth of mutational coverage, in addition to high selectivity which could improve tolerability, provides potential for a best-in-class profile. Luke Miels, Chief Commercial Officer, GSK, said: “IDRX-42 complements our growing portfolio in gastrointestinal cancers. This acquisition is consistent with our approach of acquiring assets that address validated targets and where there is clear unmet medical need, despite existing approved products.” Tony Wood, Chief Scientific Officer, GSK, said: “We are excited by the early data from IDRX-42 and its unique ability to target all clinically relevant KIT mutations present in GIST, a major gap in the current standard of care. We look forward to accelerating its development in 2025 to redefine treatment.” Updated clinical data from StrateGIST 1, an ongoing phase I/Ib trial of IDRX-42 in patients with advanced GIST, were presented in an oral presentation at the Connective Tissue Oncology Society (CTOS) 2024 Annual Meeting. These data show promising anti-tumour activity of IDRX-42 in patients with advanced GIST with a manageable safety profile. Across patients with second-line or greater GIST, and amongst all KIT mutation subsets, the objective response rate (ORR) by modified RECIST v1.1 in the total efficacy evaluable population was 29% (n=87), including one complete response (CR) and 24 partial responses (PRs). Amongst patients who have had one prior line of therapy, the ORR was 53% (n=15) including one CR and 7 PRs. 3 Across all patients, two of the PRs were awaiting confirmation at the time of the data cut, both of which were subsequently confirmed. The emerging durability data from StrateGIST 1 was also favourable. IDRX-42 was generally well-tolerated and treatment-related adverse events (TRAEs) were mainly low grade at the recommended phase Ib dose. 4 Tim Clackson, CEO, IDRx, said: “We are looking forward to working with GSK to advance IDRX-42 for patients with GIST given there have been no major advances to the standard of care for almost 20 years. Combining our experience to date with GSK’s expertise in GI cancers, global clinical development capability, and strong commercial presence in oncology will help to accelerate the development of this novel medicine for patients.” GSK has a growing portfolio in development targeting the significant medical need in GI cancers, including ongoing trials with dostarlimab and GSK5764227 (GSK’227), a B7-H3-targeted antibody-drug conjugate. This agreement reflects GSK’s portfolio approach of identifying potentially best-in-class molecules with targeted mechanisms of action. The transaction supports GSK’s ambitions for growth through 2031 and beyond. IDRx was founded in 2021 with a mission to address the limitations of today’s precision cancer medicines with highly potent and selective targeted therapies to stop key tumor escape mechanisms and prolong patients’ response to therapy. IDRx investors include Andreessen Horowitz (a16z), Casdin Capital, Nextech Invest, Forge Life Science Partners, RA Capital Management, Commodore Capital, Blackstone Multi-Asset Investing and Rock Springs Capital. IDRx co-founders include George Demetri, M.D., FACP, FASCO, FAACR, Nicholas Lydon, Ph.D., Alexis Borisy, Robert Forrester and Ben Auspitz. Financial considerations Under the terms of the agreement, GSK will acquire one hundred percent (100%) of the outstanding equity interests (including all options and other incentive equity) in IDRx for up to $1.15 billion of total cash consideration, comprising an upfront payment of $1 billion with potential for an additional $150 million success-based regulatory approval milestone payment. GSK will also be responsible for success-based milestone payments as well as tiered royalties for IDRX-42 owed to Merck KGaA, Darmstadt, Germany. This transaction is subject to customary conditions, including applicable regulatory agency clearances under the Hart-Scott-Rodino Act in the US. For IDRx, Centerview Partners LLC is acting as exclusive financial advisor and Goodwin Procter LLP as legal counsel. For GSK, Leerink Partners LLC is acting as the exclusive financial advisor. About GIST Gastrointestinal stromal tumours (GIST) are the most common subtype of soft tissue sarcoma, with about 80,000 to 120,000 patients diagnosed with GIST per year worldwide. 5 GIST typically presents in the GI tract with 80% of cases driven by mutations in the KIT gene that lead to the growth, proliferation, and survival of tumour cells (primary or activating mutations in exons 9 and 11). 6 Additionally, about 90% of patients treated in the first-line develop new KIT mutations (secondary or resistance mutations in exons 13 and 17) that typically lead to relapse with limited therapeutic options. 7 There are no approved TKIs that inhibit the full spectrum of clinically relevant primary and secondary mutations in KIT. About IDRX-42 IDRX-42 is a highly selective, investigational small molecule tyrosine kinase inhibitor (TKI) designed to target all key KIT mutations in GIST. The U.S. Food and Drug Administration (FDA) has granted IDRX-42 Fast Track designation for the treatment of patients with GIST after disease progression on or intolerance to imatinib, and Orphan Drug designations for the treatment of GIST. About IDRx IDRx is a clinical-stage biopharmaceutical company dedicated to transforming cancer care with intelligently designed precision therapies. IDRx aims to address the limitations of today’s precision cancer medicines with highly potent and selective targeted therapies to stop key tumour escape mechanisms and prolong response to therapy. About GSK GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com. References 1 Bauer S, George S, von Mehren M, Heinrich MC. Early and Next-Generation KIT/PDGFRA Kinase Inhibitors and the Future of Treatment for Advanced Gastrointestinal Stromal Tumor. Front Oncol. 2021 Jul 12;11:672500. 2 Zhou S, Abdihamid O, Tan F, Zhou H, Liu H, Li Z, Xiao S, Li B. KIT mutations and expression: current knowledge and new insights for overcoming IM resistance in GIST. Cell Commun Signal. 2024 Feb 27;22(1):153. 3 George et al CTOS 2024 4 George et al CTOS 2024 5 Søreide K, Sandvik OM, Søreide JA, Giljaca V, Jureckova A, Bulusu VR. Global epidemiology of gastrointestinal stromal tumours (GIST): A systematic review of population-based cohort studies. Cancer Epidemiol. 2016 Feb;40:39-46. 6 Bauer S, George S, von Mehren M, Heinrich MC. Early and Next-Generation KIT/PDGFRA Kinase Inhibitors and the Future of Treatment for Advanced Gastrointestinal Stromal Tumor. Front Oncol. 2021 Jul 12;11:672500. 7 Zhou S, Abdihamid O, Tan F, Zhou H, Liu H, Li Z, Xiao S, Li B. KIT mutations and expression: current knowledge and new insights for overcoming IM resistance in GIST. Cell Commun Signal. 2024 Feb 27;22(1):153. SOURCE: GlaxoSmithKline

引进/卖出快速通道

2025-01-13

·Pharmaceutical Technology

JP Morgan 2025: GSK acquires IDRx in $1.15bn deal

The deal includes an upfront payment of $1bn and an additional $150m tied to regulatory milestones. Credit: Bloomberg via Getty Images. GSK has announced a definitive agreement to acquire IDRx, a US-based biotechnology company specialising in treatments for gastrointestinal cancers, for up to $1.15bn in cash, marking the first deal of the 2025 JP Morgan Healthcare Conference. The deal – which includes an upfront payment of $1bn and an additional $150m tied to regulatory milestones – underscores GSK’s strategy to bolster its oncology portfolio. Under the acquisition, GSK will take full ownership of IDRx, including all outstanding equity interests and incentive equity. The transaction also transfers responsibility to GSK for milestone payments and tiered royalties associated with IDRx’s lead drug candidate, IDRX-42, originally licensed from MSD in 2022. IDRX-42 is a selective tyrosine kinase inhibitor (TKI) designed to treat gastrointestinal stromal tumours (GIST) by targeting all major KIT mutations, which are critical drivers of the disease. Unlike existing TKIs, IDRX-42 has the potential to inhibit the complete spectrum of clinically relevant primary and secondary KIT mutations, a gap in the current standard of care. In August 2024, Boston-headquartered IDRx secured $120m in a Series B funding round to fund the clinical development of IDRX-42. The candidate has received orphan drug designation from the US Food and Drug Administration (FDA) for the treatment of GIST and is currently being evaluated in the Phase I/IIb StrateGIST 1 trial (NCT05489237). Preliminary trial results suggest promise – among patients with metastatic or surgically unresectable GIST, the overall response rate was 29% across all KIT mutation subsets, including one complete response and 24 partial responses. For patients who received one prior line of therapy, the overall response rate was 53%. TKIs have demonstrated significant commercial potential in oncology. For example, AstraZeneca’s Tagrisso (osimertinib), approved for non-small cell lung cancer (NSCLC), generated $5.8bn in sales in 2023 while Novartis’ Gleevec, another leading TKI, earned $561m in 2023, as per both companies’ financials. IDRX-42 adds to GSK’s existing gastrointestinal cancer programmes, which include ongoing clinical trials with checkpoint inhibitor Jemperli (dostarlimab) and the B7-H3-targeted antibody-drug conjugate GSK5764227. The acquisition also builds on GSK’s recent oncology-focused investments such as the 2022 purchase of Sierra Oncology for $1.9bn. In the announcement accompanying the acquisition, GSK’s chief commercial officer Luke Miels said: “IDRX-42 complements our growing portfolio in gastrointestinal cancers. This acquisition is consistent with our approach of acquiring assets that address validated targets and where there is clear unmet medical need, despite existing approved products.” GSK is due to present at the JP Morgan Healthcare Conference 2025 on 14 January. The conference is taking place in San Francisco, US, between 13 and 16 January.

上市批准并购孤儿药临床结果临床1期

100 项与多塔利单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	多塔利单抗	L01XC	DB15627

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
晚期子宫内膜癌	欧盟	GlaxoSmithKline (Ireland) Ltd.	2024-01-12
晚期子宫内膜癌	冰岛	GlaxoSmithKline (Ireland) Ltd.	2024-01-12
晚期子宫内膜癌	列支敦士登	GlaxoSmithKline (Ireland) Ltd.	2024-01-12
晚期子宫内膜癌	挪威	GlaxoSmithKline (Ireland) Ltd.	2024-01-12
复发性子宫内膜癌	欧盟	GlaxoSmithKline (Ireland) Ltd.	2024-01-12
复发性子宫内膜癌	冰岛	GlaxoSmithKline (Ireland) Ltd.	2024-01-12
复发性子宫内膜癌	列支敦士登	GlaxoSmithKline (Ireland) Ltd.	2024-01-12
复发性子宫内膜癌	挪威	GlaxoSmithKline (Ireland) Ltd.	2024-01-12
MMRD实体瘤	美国	GlaxoSmithKline LLC	2021-08-17
MSI-H 子宫内膜癌	欧盟	GlaxoSmithKline (Ireland) Ltd.	2021-04-21
MSI-H 子宫内膜癌	冰岛	GlaxoSmithKline (Ireland) Ltd.	2021-04-21
MSI-H 子宫内膜癌	列支敦士登	GlaxoSmithKline (Ireland) Ltd.	2021-04-21
MSI-H 子宫内膜癌	挪威	GlaxoSmithKline (Ireland) Ltd.	2021-04-21
错配修复缺陷子宫内膜癌	欧盟	GlaxoSmithKline (Ireland) Ltd.	2021-04-21
错配修复缺陷子宫内膜癌	冰岛	GlaxoSmithKline (Ireland) Ltd.	2021-04-21
错配修复缺陷子宫内膜癌	列支敦士登	GlaxoSmithKline (Ireland) Ltd.	2021-04-21
错配修复缺陷子宫内膜癌	挪威	GlaxoSmithKline (Ireland) Ltd.	2021-04-21

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
PD-L1阳性非小细胞肺癌	临床3期	日本	GSK Plc	2024-06-10
PD-L1阳性非小细胞肺癌	临床3期	阿根廷	GSK Plc	2024-06-10
PD-L1阳性非小细胞肺癌	临床3期	比利时	GSK Plc	2024-06-10
PD-L1阳性非小细胞肺癌	临床3期	巴西	GSK Plc	2024-06-10
PD-L1阳性非小细胞肺癌	临床3期	保加利亚	GSK Plc	2024-06-10
PD-L1阳性非小细胞肺癌	临床3期	加拿大	GSK Plc	2024-06-10
PD-L1阳性非小细胞肺癌	临床3期	克罗地亚	GSK Plc	2024-06-10
PD-L1阳性非小细胞肺癌	临床3期	捷克	GSK Plc	2024-06-10
PD-L1阳性非小细胞肺癌	临床3期	爱沙尼亚	GSK Plc	2024-06-10
PD-L1阳性非小细胞肺癌	临床3期	芬兰	GSK Plc	2024-06-10

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分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03602859 (FIRST-ENGOT-OV44, PipelineReview) 人工标引	临床3期	卵巢癌一线	-	SOC + Placebo	簾廠選鏇選網餘衊窪衊(齋築壓襯鏇鬱蓋鑰遞選) = 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. 鹹觸獵窪製鑰遞獵膚積 (築獵網網襯糧積觸鏇廠 ) 达到更多	积极	2024-12-20
				SOC + niraparib
NCT05723562 (AZUR-1, Company_Website) 人工标引	临床2期	错配修复缺陷直肠癌一线 MSI-High \| Deficient DNA Mismatch Repair (dMMR)	42	dostarlimab	顧憲鑰顧糧顧獵獵糧築(窪製鏇築鹽選觸製襯鹹) = 觸鏇淵醖遞積鏇構壓鹹壓積鬱廠夢鑰襯顧鏇構 (夢積積齋蓋構蓋願築獵 )	积极	2024-12-16
Korean expanded access program (ESMO_ASIA2024)	N/A	复发性子宫内膜癌 dMMR \| MSI-H	29	Dostarlimab 500mg	餘淵夢顧選鏇簾窪遞積(製繭鑰憲簾顧糧鬱顧願) = Serious AEs occurred in 4 (13.8%) pts; none were directly related to treatment 夢醖餘醖窪範蓋醖夢願 (簾衊觸鏇壓餘廠襯築膚 ) 更多	积极	2024-12-07
NCT04581824 (PERLA, SITC2024) 人工标引	临床2期	非鳞状非小细胞肺癌	243	Dostarlimab + CT	獵獵鹹窪顧鬱簾築餘鹽(範齋製艱鹽窪齋醖鏇鹹) = 蓋選餘鑰繭淵鬱選蓋壓製鹹蓋齋壓鬱鏇壓夢築 (鹹積襯築餘繭淵餘選淵, 14.5 ~ 27.3)	积极	2024-11-05
				Pembrolizumab + CT	獵獵鹹窪顧鬱簾築餘鹽(範齋製艱鹽窪齋醖鏇鹹) = 鬱醖簾簾顧顧憲淵觸鬱製鹹蓋齋壓鬱鏇壓夢築 (鹹積襯築餘繭淵餘選淵, 11.6 ~ 19.3)
NCT04581824 (PERLA, SITC2024)	临床2期	非鳞状非小细胞肺癌 programmed death-ligand (PD-L)-1 status	243	Dostarlimab + CT	壓艱膚鏇窪淵鏇積顧獵(獵鏇襯夢獵簾顧衊構鑰) = 艱繭顧選願襯觸願製遞廠鏇遞餘顧顧選齋積壓 (範構鹹糧夢鹽積襯窪遞, 14.5 ~ 27.3)	积极	2024-11-05
				Pembrolizumab + CT	壓艱膚鏇窪淵鏇積顧獵(獵鏇襯夢獵簾顧衊構鑰) = 餘壓選築鬱選範衊簾膚廠鏇遞餘顧顧選齋積壓 (範構鹹糧夢鹽積襯窪遞, 11.6 ~ 19.3)
NCT05565378 (GALAXIES Lung-201, GlobeNewswire) 人工标引	临床2期	PD-L1阳性非小细胞肺癌一线 PD-L1 High Expression	124	Dostarlimab	糧鑰憲鏇繭構繭夢顧壓(廠艱壓窪製衊遞網顧糧) = 積醖廠壓蓋構鏇淵選餘積構築鑰壓築齋範淵範 (膚餘窪膚積遞壓糧壓膚, 21.1–56.3) 更多	积极	2024-09-14
				Dostarlimab + belrestotug 100 mg	糧鑰憲鏇繭構繭夢顧壓(廠艱壓窪製衊遞網顧糧) = 衊繭築積糧夢製壓範積積構築鑰壓築齋範淵範 (膚餘窪膚積遞壓糧壓膚, 43.9–80.1) 更多
NCT05065021 (Re-VOLVE, ESMO2024) 人工标引	临床2期	卵巢癌	20	Niraparibniraparibbevacizumabpaclitaxeldostarlimab	鏇壓醖鏇壓範繭淵衊顧(鹹蓋積鑰鹹糧蓋淵餘鹹) = 範壓獵餘願網鹹構糧構窪艱願獵製繭顧齋鹽鏇 (壓繭範獵膚蓋廠夢淵淵 ) 更多	积极	2024-09-14
NCT04581824 (PERLA, WCLC2024) 人工标引	临床2期	转移性非小细胞肺癌	-	Dostarlimab + Chemotherapy	餘壓淵積餘獵構願鬱襯(繭蓋鑰願鬱淵廠製製糧) = 壓餘顧齋鹹繭觸範鏇築鹽遞簾遞鬱憲憲餘鬱顧 (鏇繭鏇廠遞積窪願蓋顧, 45.8 ~ 27.1)	积极	2024-09-09
				Pembrolizumab + Chemotherapy	餘壓淵積餘獵構願鬱襯(繭蓋鑰願鬱淵廠製製糧) = 蓋積壓願齋衊構鹹淵襯鹽遞簾遞鬱憲憲餘鬱顧 (鏇繭鏇廠遞積窪願蓋顧, 36.8 ~ 17.6)
NCT03981796 (RUBY, ESMO_GCC2024) 人工标引	临床3期	晚期子宫内膜癌 \| 复发性子宫内膜癌一线	494	Dostarlimab+carboplatin-paclitaxel	壓襯憲願廠鹹顧壓網夢(鬱艱簾齋遞鹹築窪鑰壓) = 獵襯廠壓窪鏇廠鬱繭淵醖遞範觸醖糧顧餘鑰製 (襯觸簾膚簾廠糧餘壓餘, 32.6 ~ NR) 更多	积极	2024-06-21
				Placebo+carboplatin-paclitaxel	壓襯憲願廠鹹顧壓網夢(鬱艱簾齋遞鹹築窪鑰壓) = 廠壓憲獵範積遞醖顧鹽醖遞範觸醖糧顧餘鑰製 (襯觸簾膚簾廠糧餘壓餘, 22.1 ~ 35.6) 更多
BusinessWire 人工标引	临床2期	错配修复缺陷直肠癌一线 Deficient DNA Mismatch Repair (dMMR)	42	Dostarlimab-gxly	範膚襯蓋製糧繭衊淵艱(製襯襯夢觸簾製築壓壓) = 廠築鹽壓鬱齋襯淵範衊範夢醖顧窪鑰衊遞衊獵 (壓顧糧獵醖淵窪鏇糧範 ) 更多	积极	2024-06-03