A Phase II, Multicenter, Randomized, Double-Blind Study of Tobemstomig/RO7247669 Combined With Nab-Paclitaxel Compared With Pembrolizumab Combined With Nab-Paclitaxel in Participants With Previously Untreated, PD-L1-Positive, Locally-Advanced Unresectable or Metastatic Triple-Negative Breast Cancer

Start Date30 Apr 2024

Sponsor / Collaborator

Hoffmann-La Roche, Inc.

NCT05908786

/ Active, not recruitingPhase 1/2

A Phase Ib/II, Open-Label, Multicenter, Randomized Platform Study Evaluating The Efficacy and Safety of Neoadjuvant Immunotherapy Combinations in Patients With Surgically Resectable Hepatocellular Carcinoma (MORPHEUS-NEO HCC)

This is a Phase Ib/II, open-label, multicenter, randomized platform study to evaluate neoadjuvant immunotherapy combinations in participants with resectable HCC. The study is designed with the flexibility to open new treatment arms as new agents become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, or modify the participant population.

Start Date05 Dec 2023

Sponsor / Collaborator-

JPRN-jRCT2031230196

/ RecruitingPhase 1IIT

Phase 1 study of Tobemstomig in patients with advanced solid tumors

Start Date29 Aug 2023

Sponsor / Collaborator-

100 Clinical Results associated with Tombestomig

100 Translational Medicine associated with Tombestomig

100 Patents (Medical) associated with Tombestomig

Literatures (Medical) associated with Tombestomig

Case reports in ophthalmology

Bilateral Paracentral Corneal Melting and Left-Eye Perforation under Tobemstomig Novel Treatment

Author: González de Los Mártires, Pablo ; Olazaran Gamboa, Leire ; Garmendia, Iñigo Salmerón ; Guerrero Pérez, Gonzalo ; Gangoitia Gorrotxategi, Nerea ; Berástegui Arbeloa, Lara ; Jiménez Alonso, Ana

Introduction: We present a rare occurrence of bilateral corneal melting and a left-eye corneal perforation in an oncologic patient undergoing a new biological therapy. Case Presentation: A 63-year-old male with a two-day history of a painful left red eye and bilateral visual impairment was enrolled in a multicenter phase-II study comparing tobemstomig/RO7247669, a PD1-LAG3 bispecific antibody, with nivolumab. Clinical examination revealed a bilateral central corneal thinning, and corneal OCT imaging indicated a significant stromal thinning of 124 μm in the right eye and a central corneal perforation of 286 μm in the left eye. Subsequently, the patient underwent surgical intervention involving an autologous partial scleral patch with a Gundersen conjunctival flap in the left eye, alongside a comprehensive topical and systemic treatment regimen. Due to this immune-related adverse event, the patient was excluded from the clinical trial subsequently later revealing he had been on the bispecific treatment. Conclusion: While immune checkpoint inhibitors hold promise in oncology, they can lead to ocular surface issues, including dry-eye keratitis and, in severe cases, anterior segment thinning culminating in corneal perforation. Timely withdrawal of immunotherapy, coupled with multi-level treatment involving anti-inflammatory and corneal healing approaches, is crucial. In cases of corneal perforation, surgical intervention such as cyanoacrylate application or tectonic surgery becomes imperative.

News (Medical) associated with Tombestomig

23 Oct 2024

·endpts.com

Roche says it is undeterred by upcoming biosimilar threat to Vabysmo

Roche’s competition in the eye disease space is intensifying with Regeneron’s high-dose Eylea and a looming biosimilar challenge, but the Swiss pharma said its blockbuster eye drug Vabysmo is holding strong. “We’re extremely pleased with the momentum that we see with Vabysmo in the US market and we would expect to see that to continue, especially given that we’ve just introduced the pre-filled syringe,” Roche’s pharma chief Teresa Graham said in a media call Wednesday. The company has already seen 80% conversion to the pre-filled syringe from the original vial packaging, she added. But the entrance of Eylea biosimilars could challenge Vabysmo’s momentum. On Tuesday, Amgen said it is moving forward with the launch of its Eylea biosimilar called Pavblu following an appeals court decision against Regeneron. A Roche spokesperson told Endpoints News in an email that the company is “prepared for market entry [of biosimilars] under any timing.” While Eylea blocks VEGF and PlGF, Roche’s drug acts on VEGF and Ang-2, which is a protein that helps regulate vascular remodeling and inflammation. Vabysmo’s “unique mechanism of action, the high level of drying that we’re seeing and the durability positions it extremely well against all of the products that are currently in the market,” Graham said. The pre-filled Vabysmo syringe won FDA approval in July for wet age-related macular degeneration, diabetic macular edema and macular edema following retinal vein occlusion, offering a ready-to-use alternative to the Vabysmo vials. The drug’s third-quarter sales reached CHF 1 billion ($1.6 billion), up 59% from the same time last year. Last year, the FDA greenlit Regeneron’s high-dose version of Eylea for wet AMD, DME and diabetic retinopathy. That same year, the Eylea franchise reached $5.9 billion in sales, which was significantly ahead of Vabysmo’s CHF 2.4 billion ($2.8 billion). Roche’s drug was later to market than Eylea. Nonetheless, Vabysmo shot to blockbuster status during its first full launch year after an approval in 2022. As for Roche’s pipeline, the company dropped several early- to mid-stage programs, including its PD-1xLAG3 antibody tobemstomig, which was in Phase 2 development for solid tumors. Other cuts included Phase 1 multiple myeloma asset forimtamig and some candidates for hepatitis B. The Swiss drugmaker said it is still interested in anti-tau approaches in Alzheimer’s disease, despite ending its partnership with UCB for a tau-targeting antibody. Graham described the termination as a “portfolio prioritization-driven decision.” The company’s Genentech unit is working with Sangamo to develop an epigenetic repressor to prevent the production of tau protein.

Drug ApprovalPhase 2Phase 1

11 Oct 2022

·www.prnewswire.com

Esophageal Cancer Clinical Trial Pipeline Insights Featuring 80+ Companies | DelveInsight

The prevalence of esophageal cancer has been rising since the past few years, which prompts the growing demand for the treatment options. The market is driven by the increasing prevalence of cancer and the increase in research & development. The Companies developing the potential therapies in the last stage of development include Celgene,Jiangsu HengRui Medicine Co., Seagen, and several others. LAS VEGAS, Oct. 11, 2022 /PRNewswire/ -- DelveInsight's ' Esophageal Cancer Pipeline Insight – 2022 ' report provides comprehensive global coverage of available, marketed, and pipeline esophageal cancer therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the esophageal cancer pipeline domain. Key Takeaways from the Esophageal Cancer Pipeline Report DelveInsight's esophageal cancer pipeline report depicts a robust space with 80+ active players working to develop 90+ pipeline therapies for esophageal cancer treatment. Leading esophageal cancer companies such as Shanghai Henlius Biotech, CStone Pharmaceuticals, Jiangsu HengRui Medicine Co., Ltd., AstraZeneca, Symphogen, Hoffmann-La Roche, Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Sinocelltech Ltd., Eli Lilly and Company, Ipsen, Jacobio Pharmaceuticals Co., Ltd., Shire, GlaxoSmithKline, Keythera Pharmaceuticals (Australia) Pty Ltd, Sunshine Lake Pharma Co., Ltd., Novartis Pharmaceuticals, Sanofi, Seagen Inc., Rapa Therapeutics LLC, Incyte Corporation, Atreca, Inc., Exelixis, Bayer, BeiGene, Lyell Immunopharma, Sichuan Baili Pharmaceutical, AP Biosciences.,Leap Therapeutics, Inc., Adlai Nortye Biopharma Co., Ltd., Athenex, Inc., Pfizer, Genentech, Hangzhou Neoantigen Therapeutics, Janssen Pharmaceutical, Curis, Inc.,Merck KGaA, Apexigen, Inc,Shenzhen Hornetcorn Bio-technology Company, LTD, MacroGenics, Bristol-Myers Squibb, Integral Molecular, CARTEXELL, EMD Serono, and others are evaluating new drugs for esophageal cancer treatment. Key esophageal cancer pipeline therapies in various stages of development include Serplulimab, CS1001, Camrelizumab, Durvalumab, Sym021, Spartalizumab, Sym022, Sym023, Regorafenib, S095033, INCB099318, RO7121661, XB002, LGK974, Abemaciclib, ladiratuzumab vedotin, ATRC-101, SGN-PDL1V, RO7247669, THOR-707, Letetresgene Autoleucel, TNO155, Anlotinib Hydrochloride, Larotinib, SCT-I10A, KF-0210, SCT200, Ramucirumab, Cabozantinib, JAB-3068, Onivyde, JAB-3312, SGN-B6A, RAPA-201,Ociperlimab, SI B001,Apatinib, AP 203, QEQ278, JAB-3312, DKN-01, AN0025, HR 070803,Oraxol, Sunitinib malate, Tiragolumab, iNeo Vac P01, Amivantamab, CA-4948, M1231, APX005M, DC-CIK, Margetuximab, Temozolomide, and others. In September 2022, Daiichi Sankyo and Sarah Cannon Research Institute (SCRI) announced that extended follow-up data from a phase I/II trial of DS-7300, continued to show promising durable tumor response in patients with several types of heavily pretreated cancers including lung, prostate or esophageal cancer.A response rate of 32% (95% CI: 24-41) was observed with 38 responses (33 confirmed; 28%; 95% CI: 20-37) in 118 patients with various solid tumors including small cell lung cancer (SCLC), squamous non-small cell lung cancer (NSCLC), metastatic castration-resistant prostate cancer (CRPC), esophageal squamous cell carcinoma (ESCC), head and neck squamous cell carcinoma (HNSCC) or endometrial cancer receiving doses of DS-7300 ranging from 4.8 mg/kg to 16.0 mg/kg. In September 2022, Integral Molecular, has licensed a panel of monoclonal antibodies (MAbs) to CARTEXELL, enabling CARTEXELL to develop CAR-T cell therapies using Integral Molecular's Claudin 18.2 (CLDN18.2) MAbs. Under the terms of the agreement, Integral Molecular will provide an exclusive worldwide license to CARTEXELL to use the panel of high-affinity, high-specificity, and fully humanized CLND18.2 MAbs for the development of CAR-T cell therapies against solid tumors including gastric, lung, pancreatic and esophageal cancers. CARTEXELL will be solely responsible for all research, development, and commercial activities. In August 2022, BeiGene announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted a supplemental biologics license application (sBLA) for tislelizumab in combination with chemotherapy as first-line treatment in patients with unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC). In May 2022, Shanghai Junshi Biosciences Co., Ltd, announced that the China National Medical Products Administration (NMPA) has approved the supplemental new drug application (sNDA) for toripalimab in combination with paclitaxel and cisplatin in the first-line treatment of patients with unresectable locally advanced/recurrent or distant metastatic esophageal squamous cell carcinoma (ESCC). The sNDA was accepted by the NMPA in July 2021. This is the fifth indication approved for toripalimab in China and will benefit Chinese patients with advanced ESCC. In May 2022, Bristol Myers Squibb, announced that the U.S. Food and Drug Administration (FDA) has approved both Opdivo (nivolumab) (injection for intravenous use) in combination with fluoropyrimidine- and platinum-containing chemotherapy and Opdivo plus Yervoy (ipilimumab) as a first-line treatment for adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) regardless of PD-L1 status. The approvals are based on the Phase III CheckMate -648 trial, which evaluated Opdivo in combination with chemotherapy (n=321) and Opdivo plus Yervoy (n=325) each compared to chemotherapy alone (n=324), and was the largest Phase III trial of immunotherapy in first-line ESCC. In January 2022, Lyell Immunopharma, Inc., announced that the U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug (IND) application to initiate a Phase I clinical trial for LYL132, an investigational T-cell receptor (TCR) therapy for patients with solid tumors expressing New York esophageal squamous cell carcinoma 1 (NY-ESO-1) that the company is developing in collaboration with GSK. Request a sample and discover the recent advances in esophageal cancer treatment @ Esophageal Cancer Pipeline Report The esophageal cancer pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage esophageal cancer drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the esophageal cancer pipeline landscape. Esophageal Cancer Overview Esophageal cancer grows in the esophagus, the tube that connects the throat to the stomach. Tumors develop in the mucosa, the inner lining of the esophagus. Esophageal cancer is classified into two types, each with its own set of risk factors: Adenocarcinoma -Adenocarcinomas are cancers that begin in gland cells at the bottom of the esophagus. This is the most common type of esophageal cancer. It usually happens near the stomach. The exact esophageal cancer causes are not known. Most esophageal cancer symptoms do not appear until cancer has progressed to an advanced stage, when it may be challenging to treat. Other, more common conditions can cause esophageal cancer symptoms. The most common esophageal cancer symptom is difficulty swallowing, particularly a sensation of food stuck in the chest. There are several tests used for esophageal cancer diagnosis. The most common include endoscopy with biopsy and endoscopic ultrasonography. Find out more about esophageal cancer drugs in development @ New Treatment for Esophageal Cancer A snapshot of the Esophageal Cancer Pipeline Drugs mentioned in the report: Learn more about the emerging esophageal cancer pipeline therapies @ Esophageal Cancer Clinical Trials Esophageal Cancer Therapeutics Assessment The esophageal cancer pipeline report proffers an integral view of esophageal cancer emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Esophageal Cancer Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Intra-articular, Intraocular, Intrathecal, Intravenous, Ophthalmic, Oral, Parenteral, Subcutaneous, Topical, Transdermal Therapeutics Assessment By Molecule Type: Oligonucleotide, Peptide, Small molecule Therapeutics Assessment By Mechanism of Action: Prostaglandin E EP4 receptor antagonists, ERBB 2 receptor antagonists, Phosphorylation inhibitors, Antibody-dependent cell cytotoxicity, Apoptosis stimulants, CD40 antigen stimulants, Immunostimulants, Programmed cell death-1 receptor antagonists, T lymphocyte stimulants, Programmed cell death-1 ligand-1 inhibitors, Epidermal growth factor receptor antagonists. Key Esophageal Cancer Companies: Shanghai Henlius Biotech, CStone Pharmaceuticals, Jiangsu HengRui Medicine Co., Ltd., AstraZeneca, Symphogen, Hoffmann-La Roche, Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Sinocelltech Ltd., Eli Lilly and Company, Ipsen, Jacobio Pharmaceuticals Co., Ltd., Shire, GlaxoSmithKline, Keythera Pharmaceuticals (Australia) Pty Ltd, Sunshine Lake Pharma Co., Ltd., Novartis Pharmaceuticals, Sanofi, Seagen Inc., Rapa Therapeutics LLC, Incyte Corporation, Atreca, Inc., Exelixis, Bayer, BeiGene, Lyell Immunopharma, Sichuan Baili Pharmaceutical, AP Biosciences.,Leap Therapeutics, Inc., Adlai Nortye Biopharma Co., Ltd., Athenex, Inc., Pfizer, Genentech, Hangzhou Neoantigen Therapeutics, Janssen Pharmaceutical, Curis, Inc.,Merck KGaA, Apexigen, Inc,Shenzhen Hornetcorn Bio-technology Company, LTD, MacroGenics, Bristol-Myers Squibb, Integral Molecular, CARTEXELL and others Key Esophageal Cancer Pipeline Therapies: Serplulimab, CS1001, Camrelizumab, Durvalumab, Sym021, Spartalizumab, Sym022, Sym023, Regorafenib, S095033, INCB099318, RO7121661, XB002, LGK974, Abemaciclib, ladiratuzumab vedotin, ATRC-101, SGN-PDL1V, RO7247669, THOR-707, Letetresgene Autoleucel, TNO155, Anlotinib Hydrochloride, Larotinib, SCT-I10A, KF-0210, SCT200, Ramucirumab, Cabozantinib, JAB-3068, Onivyde, JAB-3312, SGN-B6A, RAPA-201,Ociperlimab, SI B001,Apatinib, AP 203, QEQ278, JAB-3312, DKN-01, AN0025, HR 070803,Oraxol, Sunitinib malate, Tiragolumab, iNeo Vac P01, Amivantamab, CA-4948, M1231, APX005M, DC-CIK, Margetuximab, Temozolomide and others. Dive deep into rich insights for esophageal cancer drugs, visit @ Chemo Drugs for Esophageal Cancer Treatment Table of Contents For further information on the esophageal cancer pipeline therapeutics, reach out @ New Drug for Esophageal Cancer Treatment Related Reports Esophageal Cancer Market Esophageal Cancer Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key esophageal cancer companies including Merck KGaA, Shenzhen Hornetcorn Biotechnology, Apexigen, Inc., Highlight Therapeutics, among others. Esophageal Cancer Epidemiology Forecast Esophageal Cancer Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted esophageal cancer epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Esophageal Squamous Cell Carcinoma Pipeline Esophageal Squamous Cell Carcinoma Pipeline Insight – 2022 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key esophageal squamous cell carcinoma companies, including BeiGene, AstraZeneca, Ipsen, Shire, Sanofi, Seagen, among others. Esophageal Squamous Carcinoma Market Esophageal Squamous Carcinoma Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key esophageal squamous carcinoma companies, including BeiGene, AstraZeneca, Ipsen, Shire, Sanofi, Seagen, among others. Esophageal Squamous Cell Carcinoma Epidemiology Esophageal Squamous Cell Carcinoma Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted esophageal squamous cell carcinoma epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Other Trending Reports Goitre Market | Thymus Cancer Market | US Healthcare Outlook Report | Venous Stenosis Market | Negative Pressure Wound Therapy Systems Market | Global Kinase Inhibitor in Autoimmune Diseases Market | Metrorrhagia Market | Dysfunctional Uterine Bleeding Market | Hypereosinophilic Syndrome Market | Age-related Vision Dysfunction Market | Dental Lasers Market | CRISPR Therapies Pipeline Insight | Cell And Gene Therapy For Multiple Myeloma Market | Drug Hypersensitivity Market | Dysthymia Market | Persistent Depressive Disorder Market | Cancer Vaccines Market | Weight Loss/Weight Management (Obesity) Market | Food Allergy Market | Obsessive-Compulsive Disorder Market | Tumor Ablation Market | Physiotherapy Equipment Market | Chimeric Antigen Receptor (CAR) T-Cell Therapy Market | Anti-hypertension Market | Radiofrequency Ablation Devices Market | Global Messenger RNA (mRNA)-based Vaccines and Therapeutics Market | Gastro Intestinal Bleeding Market | Trastuzumab Biosimilars Insight | Varicose Veins Market | Germ Cell Tumor Market | Intracardiac Echocardiography Devices Market | India Healthcare Report | Crows Feet Market | Seborrhoeic Dermatitis Market | Injectable Drug Delivery Devices Market | Structural Heart Devices Market | Substance (Drug) Abuse Market | Insulin Glargine Biosimilar Insight About DelveInsight DelveInsight is a leading Business Consultant, and Market Research firm focused exclusively on life sciences. Connect with us at LinkedIn Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

Gene TherapyAntibodyBiosimilarOligonucleotideCell Therapy

100 Deals associated with Tombestomig

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Indication	Highest Phase	Country/Location	Organization	Date
PD-L1 positive Triple Negative Breast Cancer	Phase 2	United States	Roche Holding AG	18 Jul 2023
PD-L1 positive Triple Negative Breast Cancer	Phase 2	Argentina	Roche Holding AG	18 Jul 2023
PD-L1 positive Triple Negative Breast Cancer	Phase 2	Australia	Roche Holding AG	18 Jul 2023
PD-L1 positive Triple Negative Breast Cancer	Phase 2	Brazil	Roche Holding AG	18 Jul 2023
PD-L1 positive Triple Negative Breast Cancer	Phase 2	Czechia	Roche Holding AG	18 Jul 2023
PD-L1 positive Triple Negative Breast Cancer	Phase 2	Côte d'Ivoire	Roche Holding AG	18 Jul 2023
PD-L1 positive Triple Negative Breast Cancer	Phase 2	Germany	Roche Holding AG	18 Jul 2023
PD-L1 positive Triple Negative Breast Cancer	Phase 2	Hungary	Roche Holding AG	18 Jul 2023
PD-L1 positive Triple Negative Breast Cancer	Phase 2	Israel	Roche Holding AG	18 Jul 2023
PD-L1 positive Triple Negative Breast Cancer	Phase 2	Italy	Roche Holding AG	18 Jul 2023

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05775289 (BO44178, ESMO_ELCC2025) Manual	Phase 2	Non-Small Cell Lung Cancer First line	181	Tobemstomig + Platinum-based Chemotherapy	fdulbmnjfs(mgdecjyihm) = qmggsmirem dkougionak (gxvajawgxl ) View more	Negative	27 Mar 2025
NCT05775289 (BO44178, ESMO_ELCC2025) Manual	Phase 2	Non-Small Cell Lung Cancer First line	181	Pembrolizumab + Chemotherapy	fdulbmnjfs(mgdecjyihm) = usezpuoihr dkougionak (gxvajawgxl ) View more	Negative	27 Mar 2025
NCT04140500 (NP41300, ESMO2022) Manual	Phase 1	Metastatic Solid Tumor	35	RO7247669	qwcvjhomrv(gzaalslzxt) = mjchhsmdrw uazbxgbhib (mmtnefwxmy ) View more	Positive	10 Sep 2022

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