An Open-label, Multicenter, Roll-over Study for Patients Who Have Completed a Prior Novartis-sponsored Sabatolimab (MBG453) Study and Are Judged by the Investigator to Benefit From Continued Treatment With Sabatolimab.

This study is intended to collect safety data from participants who completed the parent protocols but are still benefiting from study treatment. The study population consists of participants who tolerate study treatment of the parent studies. Collecting safety information from long-term exposure might offer the unique opportunity to detect rare Adverse Events.

Start Date13 Feb 2023

Sponsor / Collaborator

Novartis Pharmaceuticals Corp.

NL-OMON51829 / RecruitingNot Applicable

An open-label, multi-center rollover protocol for continued characterization of safety and tolerability for subjects who have participated in a Novartis-sponsored spartalizumab study as single agent or in combination with other study treatments - CPDR001X2X01B

Start Date30 Aug 2022

Sponsor / Collaborator

Novartis AG

NCT05210413 / RecruitingPhase 1/2IIT

Spartalizumab and Low-dose PAzopanib in Refractory or Relapsed Solid TumOrs of Pediatric and Adults

Immunotherapies have revolutionized medical oncology following the remarkable and, in some cases, unprecedented outcomes observed in certain groups of patients with cancer. However results in adults and mainly in pediatric cancer are still disappointing.
Modulators of angiogenesis, such as VEGF, have a broad range of diverse effects on the immune system and the tumor micro-environment that are mainly immunosuppressive. In patients with early-stage disease, anti-VEGF therapy can lead to antitumor effects by modulating immune mechanisms - provided that therapy is maintained for an adequate length and tumors are sufficiently immunogenic. Nevertheless, blocking angiogenic molecules using a strategy based on a single therapeutic approach is likely insufficient to generate a complete or robust immune response against cancer, especially in patients with advanced-stage disease.
Based on the results of previous studies which evaluated the safety profile of spartalizumab, of pazopanib and the combination of antiangiogenic agents with checkpoint inhibitors, a study combining spartalizumab and low-dose pazopanib in refractory or relapsed solid tumors of pediatric and adults is proposed. This study will include 2 separate cohorts:
the pediatric cohort will consist of a phase I study (dose-finding and expansion phases) combining pazopanib at a fixed dose of 225 mg/m2 and spartalizumab with four potential candidate doses (2, 3, 4 and 6 mg/kg).
the adult cohort will consist of a phase II study combining pazopanib at a fixed dose of 400 mg and spartalizumab at the RP2D of 400 mg every 4 weeks.

Start Date17 May 2022

Sponsor / Collaborator

Centre Hospitalier Universitaire de Bordeaux

[+3]

100 Clinical Results associated with Spartalizumab

100 Translational Medicine associated with Spartalizumab

100 Patents (Medical) associated with Spartalizumab

Literatures (Medical) associated with Spartalizumab

31 Dec 2024·Oncoimmunology

A phase 2, multicenter, open-label study of anti-LAG-3 ieramilimab in combination with anti-PD-1 spartalizumab in patients with advanced solid malignancies

Article

Author: Lin, Chia-Chi ; Kyi, Chrisann ; Chiu, Joanne ; Askoxylakis, Vasileios ; Carvajal, Richard D ; Spratlin, Jennifer ; Chowdhury, Niladri Roy ; Garralda, Elena ; Gusenleitner, Daniel ; Maur, Michela ; Esaki, Taito ; Siu, Lillian L ; Sarantopoulos, John ; Rolland, Fréderic ; Cassier, Philippe A ; Zhang, Tian ; Soo, Ross A ; Schöffski, Patrick ; Ma, Brigette ; Martin, Miguel ; Deschler-Baier, Barbara ; Weickhardt, Andrew ; De Braud, Filippo ; Hui, Rina ; Akerley, Wallace ; Rispoli, Lawrence ; Hong, David S ; Samant, Tanay S ; Tan, Daniel Sw ; Kwak, Eunice L

Ieramilimab, a humanized anti-LAG-3 monoclonal antibody, was well tolerated in combination with the anti-PD-1 antibody spartalizumab in a phase 1 study. This phase 2 study aimed to further investigate the efficacy and safety of combination treatment in patients with selected advanced (locally advanced or metastatic) solid malignancies. Eligible patients with non-small cell lung cancer (NSCLC), melanoma, renal cell carcinoma (RCC), mesothelioma, and triple-negative breast cancer (TNBC) were grouped depending on prior anti-PD-1/L1 therapy (anti-PD-1/L1 naive or anti-PD-1/L1 pretreated). Patients received ieramilimab (400 mg) followed by spartalizumab (300 mg) every 3 weeks. The primary endpoint was objective response rate (ORR), along with safety, pharmacokinetics, and biomarker assessments. Of 235 patients, 142 were naive to anti-PD-1/L1 and 93 were pretreated with anti-PD-1/L1 antibodies. Durable responses (>24 months) were seen across all indications for patients naive to anti-PD-1/L1 and in melanoma and RCC patients pretreated with anti-PD1/L1. The most frequent study drug-related AEs were pruritus (15.5%), fatigue (10.6%), and rash (10.6%) in patients naive to anti-PD-1/L1 and fatigue (18.3%), rash (14.0%), and nausea (10.8%) in anti-PD-1/L1 pretreated patients. Biomarker assessment indicated higher expression of T-cell-inflamed gene signature at baseline among responding patients. Response to treatment was durable (>24 months) in some patients across all enrolled indications, and safety findings were in accordance with previous and current studies exploring LAG-3/PD-1 blockade.

01 Jan 2024·European journal of cancer (Oxford, England : 1990)

First-in-human study of naporafenib (LXH254) with or without spartalizumab in adult patients with advanced solid tumors harboring MAPK signaling pathway alterations

Article

Author: Dummer, Reinhard ; Janku, Filip ; Iyer, Gopakumar ; McCarthy, Fiona ; Maur, Michela ; Kim, Tae Min ; Chen, Chi ; Kiladjian, Jean-Jacques ; Cooke, Vesselina ; Basu, Sumit ; Marmé, Frederik ; Moschetta, Michele ; de Jonge, Maja ; Baffert, Fabienne ; Ascierto, Paolo Antonio ; Buigues, Amparo ; van der Wekken, Anthonie J ; Elez, Elena ; Kim, Jaeyeon ; Spreafico, Anna ; Yamamoto, Noboru ; Giorgetti, Elisa

BACKGROUND:

We investigated naporafenib (LXH254), a pan-RAF kinase inhibitor, with or without spartalizumab, in patients with advanced solid tumors harboring MAPK pathway alterations.

METHODS:

This first-in-human phase 1 study had two dose-escalation arms: single-agent naporafenib (starting at 100 mg once-daily [QD]) and naporafenib (starting at the recommended dose/regimen)/spartalizumab (400 mg every 4 weeks). The naporafenib/spartalizumab dose-expansion part enrolled patients with KRAS-mutated non-small cell lung cancer (NSCLC) and NRAS-mutated melanoma. The primary objectives were to establish the maximum tolerated doses (MTD)/recommended doses for expansion (RDE) and evaluate tolerability and safety.

RESULTS:

A total of 142 patients were included in the naporafenib dose-escalation (n = 87), naporafenib/spartalizumab dose-escalation (n = 12) and naporafenib/spartalizumab dose-expansion (n = 43) arms. The MTD/RDE of naporafenib was 600 mg twice-daily (BID). In naporafenib escalation, five patients experienced 7 dose-limiting toxicities: decreased platelet count (1200 mg QD); neuralgia, maculopapular rash, pruritus (600 mg BID); increased blood bilirubin, hyponatremia, peripheral sensory neuropathy (800 mg BID). No DLTs occurred in the naporafenib/spartalizumab arm: the RDE was established at 400 mg BID. The most common treatment-related adverse events were rash and dermatitis acneiform (each 24.1%; naporafenib), nausea and pruritus (each 33.3%; naporafenib/spartalizumab; escalation) and rash (39.5%; naporafenib/spartalizumab; expansion). Naporafenib reduced DUSP6 expression in tumors. Two partial responses (PRs) occurred in naporafenib escalation, and 1 complete response and 3 PRs in the naporafenib/spartalizumab NRAS-mutated melanoma and KRAS-mutated NSCLC arms, respectively.

CONCLUSIONS:

Naporafenib, with or without spartalizumab, showed an acceptable safety profile, pharmacodynamic activity and limited antitumor activity. Additional naporafenib combination therapies are currently under investigation.

18 Jan 2024·Endocrine-related cancer

Immunotherapy for endocrine tumours: a clinician’s perspective

Review

Author: Angelousi, Anna ; Chatzellis, Eleftherios ; Koumarianou, Anna ; Kaltsas, Gregory ; Tzoulis, Ploutarchos ; Tsoli, Marina

Immunotherapy has revolutionised the treatment of oncological patients, but its application in various endocrine tumours is rather limited and is mainly used when conventional therapies have failed. Immune checkpoint inhibitors (ICIs) have been employed in progressive adrenocortical carcinoma, primarily utilizing the anti-PD-L1 agent pembrolizumab, obtaining overall response rates ranging between 14% and 23%. In contrast, the response rate in phaeochromocytoma/paraganglioma was substantially less at 9%, considering the small number of patients treated. Similarly, the response rate in advanced differentiated thyroid carcinomas treated with pembrolizumab was also low at 9%, although the combination of ICIs with tyrosine kinase inhibitors showed higher efficacy. Low response rates to ICIs have also been observed in progressive medullary thyroid cancer, except in tumours with a high mutation burden (TMB). Pembrolizumab or spartalizumab can be utilized in patients with high TMB anaplastic thyroid cancer, obtaining better response rates, particularly in patients with high PD-L1 expression. Immunotherapy has also been used in a few cases of parathyroid carcinoma, showing limited antitumour effect. Pituitary carcinomas may exhibit a more favourable response to ICIs compared to aggressive pituitary tumours, particularly corticotroph tumours. Patients with advanced neuroendocrine tumours achieve an overall response rate of 15%, which varies according to the primary tumour site of origin, degree of differentiation, and therapeutic regimen utilised. Future research is needed to evaluate the potential role of immunohistochemical biomarkers, such as programmed death 1/programmed death ligand 1 and TMB, as predictors for the response to immunotherapy. Furthermore, randomised prospective studies could provide more robust data on the efficacy and side effects of ICIs.

News (Medical) associated with Spartalizumab

25 Apr 2023

·www.fiercebiotech.com

Novartis prunes assets, axing 10% of pipeline programs to narrow R&D focus

The number of projects in Novartis’ pipeline fell from 150 to 134. Novartis has undertaken an old-fashioned decimation of its pipeline. The Swiss drugmaker has decided to dump or out-license 10% of its R&D projects to narrow its sights on five core therapeutic areas and focus investment on its most promising programs within those spaces. In recent quarters, Novartis has decided to make five therapeutic areas—cardiovascular, hematology, solid tumors, immunology and neuroscience—and a small clutch of technology platforms the focus of its R&D activities. More recently, disclosures about partnered programs that Novartis is dumping gave hints that an overhaul was underway. Now, Novartis has shared a full look at its slimmed-down pipeline. “We reduced our pipeline size by about 10%. And that's primarily as we prune assets that are outside of those five core therapeutic areas, or in the sixth area we call TAX which incubate certain therapeutic areas we're interested in,” Novartis CEO Vas Narasimhan, M.D., said on an early morning call with the media. “So we've taken the principal decision that if it doesn't fit within that framework, we are either going to stop the programs or divest them.” Expanding on the decision in a later call with analysts, Narasimhan explained that part of the pipeline “cleanup” had been the result of benchmarking Novartis’ R&D against its fellow Big Pharmas. “We had more projects than our peers, which led us to have less investment per project versus the peer set,” the CEO explained. “We think that's important because in having strong investment in the early stage pre-clinically or in early clinical can also help us go faster, go broader into more lines of therapy, more indications.” As a result of the changes, the number of projects in Novartis’ pipeline has fallen from 150 to 134. Solid tumors, an ongoing area of focus, took the biggest hit, with the number of active projects falling from 42 to 32 between the two updates. Addressing the significant reduction in early-stage cancer assets, Narasimhan told analysts that Novartis had removed candidates with targets that “are no longer priority tumors for the company.” Below, we provide an overview of the programs that Novartis dropped from its pipeline in its quarterly pipeline update. But before getting to that, there is one candidate clinging on that is nonetheless worth discussing. In the fourth quarter, Novartis listed six studies involving spartalizumab, an anti-PD-1 checkpoint inhibitor that failed a phase 3 melanoma trial in 2020. Today, only one study remains. Phase 2 ADPT06: A cognitive impairment candidate that Novartis tested in a phase 2 platform clinical trial of various anti-inflammatory agents. The mechanism of action is unknown. Novartis tested canakinumab, sold in other indications as Ilaris, in the same trial of patients with mild cognitive impairment due to Alzheimer's disease. HSY244: An atrial fibrillation candidate that Novartis took into phase 2 in 2020. Novartis “prematurely ended” the study, per the European database, but ClinicalTrials.gov still lists it as recruiting patients. Ensovibep: The COVID-19 antiviral that Novartis bought at the start of last year for 150 million Swiss francs ($168 million). Within months, Novartis’ plan to bring the molecule to market unraveled as the FDA requested phase 3 data. Novartis licensed the asset from Molecular Partners. LKA651: A MorphoSys-partnered EPO inhibitor that Novartis studied in diabetic macular edema. Novartis completed a phase 2 clinical trial of the drug candidate last summer. Phase 1 FIA586: The final domino to fall in Novartis’ exit from nonalcoholic steatohepatitis (NASH). The Swiss drugmaker wrapped up an early-phase trial of the candidate in mild and moderate hepatic impairment last summer. MHS552: An autoimmune disease candidate that Novartis was studying in a phase 1 lupus trial when it decided to pull the plug. The company filed to test the molecule in type 1 diabetes but withdrew the study before enrolling any patients. ADPT03: A BCL11A program targeting sickle cell disease. Intellia disclosed that Novartis had stopped work on an ex vivo, CRISPR-edited cell therapy designed to reduce the activity of BCL11A earlier this year. JEZ567: A anti-CD123 CAR-T cell therapy that Novartis was developing in acute myeloid leukemia. MAK683: An inhibitor of embryonic ectoderm development protein that Novartis has studied in people with diffuse large B-cell lymphoma since 2016. WVT078: A BCMAxCD3 bispecific antibody that Novartis studied in multiple myeloma. The presence of many other BCMA candidates at other companies makes WVT078 a poor fit for Novartis’ focus on “high value medicines with transformative potential for patients.”

Phase 2Cell TherapyPhase 1ImmunotherapyClinical Result

16 Nov 2022

·www.fiercebiotech.com

Novartis halts phase 1 cancer trial of CD73 antagonist over efficacy, but combo studies continue

A failed study of Novartis' CD73 antagonist enrolled 127 participants with advanced malignancies who received NZV930 either as a monotherapy or in combination. Novartis has halted a phase 1 trial of its CD73 antagonist due to a low likelihood of efficacy, although the Big Pharma will continue to explore the therapy’s potential as part of a combo regimen. The trial of NZV930 was “terminated early because data review showed low likelihood of efficacy in the patients recruited in that clinical setting,” a Novartis spokesperson confirmed to Fierce Biotech. The decision was not safety-related, they added. The study, which began in July 2018, enrolled 127 participants with advanced malignancies who received NZV930 either as a monotherapy or in combination with Novartis’ checkpoint inhibitor spartalizumab or its adenosine A2a receptor antagonist NIR178, according to ClinicalTrials.gov. Novartis will continue to evaluate whether NZV930 is effective when used in combination with other investigational agents, the spokesperson told Fierce. They pointed to an ongoing phase 1 trial of KAZ954 in advanced solid tumors that includes a cohort receiving the investigational therapy in combination with NZV930. The aim of CD73 antagonists is to block the CD73 enzyme from producing adenosine, which can suppress the body’s immune response to cancer. Novartis is not alone in exploring this mechanism: I-Mab’s uliledlimab showed promise alongside Junshi Bioscience’s PD-1 inhibitor toripalimab in initial phase 2 data, while AstraZeneca’s CD73 antagonist oleclumab is in phase 2 trials for pancreatic cancer and phase 3 trials for lung cancer, including in combination with Imfinzi.

Phase 2Phase 1Clinical Trial FailurePhase 3Clinical Trial Termination

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 Spartalizumab

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KEGG	Wiki	ATC	Drug Bank
D11605	-	-	DB14892

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Melanoma	Phase 3	US	Novartis Pharmaceuticals Corp.	17 Feb 2017
Melanoma	Phase 3	JP	Novartis Pharmaceuticals Corp.	17 Feb 2017
Melanoma	Phase 3	AR	Novartis Pharmaceuticals Corp.	17 Feb 2017
Melanoma	Phase 3	AU	Novartis Pharmaceuticals Corp.	17 Feb 2017
Melanoma	Phase 3	AT	Novartis Pharmaceuticals Corp.	17 Feb 2017
Melanoma	Phase 3	BE	Novartis Pharmaceuticals Corp.	17 Feb 2017
Melanoma	Phase 3	BR	Novartis Pharmaceuticals Corp.	17 Feb 2017
Melanoma	Phase 3	BG	Novartis Pharmaceuticals Corp.	17 Feb 2017
Melanoma	Phase 3	CA	Novartis Pharmaceuticals Corp.	17 Feb 2017
Melanoma	Phase 3	CL	Novartis Pharmaceuticals Corp.	17 Feb 2017

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04736485 (GASPAR, ESMO2023) Manual	Phase 2	Stomach Cancer First line	67	spartalizumab + fluorouracil+leucovorin+oxaliplatin+ docetaxel	ypogdosrcq(puzeejppoh) = wdlvymfxjy jvxktpmcnk (ttgoiwfyzt ) View more	Positive	23 Oct 2023
				spartalizumab + fluorouracil+leucovorin+oxaliplatin+ docetaxel (operative)	cxozfugqju(avimavpvas) = mbesefdpsc fveudelilr (ghpfsmzpyy ) View more
NCT04581343 (PanCAN-SR1, AACR2022) Manual	Phase 1	Secondary malignant neoplasm of pancreas	10	Gemcitabine+Nab-paclitaxel+Canakinumab+Spartalizumab	taichjolkm(ltxiycvkro) = The most common Grade 3/4 AEs were neutropenia (60%) and anemia (50%), with no fatal AEs. yewblqreea (dhpjyfvpdj )	Positive	15 Nov 2022
NCT04323436 (ESMO2022) Manual	Phase 2	Non-Small Cell Lung Cancer First line MET exon 14 skipping mutation	31	Capmatinib 400 mg+Spartalizumab 400 mg	jxjhwznbbq(syuaogjoch) = gnghwwxrae xjggspcyuz (rojvlahcxq, 21.8 - 57.8) View more	Negative	10 Sep 2022
NCT04581343 (PanCAN-SR1, ASCO2022) Manual	Phase 1	Secondary malignant neoplasm of pancreas	10	gemcitabine+nab-paclitaxel+canakinumab+spartalizumab	diryhkohua(wwhqhuocba) = gemcitabine (1000 mg/m2 IV) and nab-paclitaxel (125 mg/m2 IV) on day 1,8,15; canakinumab (250 mg via subcutaneous injection) and spartalizumab (400 mg IV) on day 1; of each 28 day cycle qzjghyfddk (djicssnwsi )	Positive	02 Jun 2022
NCT02967692 (COMBI-i, ASCO2022) Manual	Phase 3	BRAF V600 mutation-positive Melanoma First line BRAF V600 Mutation	532	Dabrafenib Mesylate+Trametinib dimethyl sulfoxide+Spartalizumab	qbpujyfmpb(nivimxjmfm) = ioujvizyfq btzaynhlxy (lfwnsuytpx ) View more	Negative	02 Jun 2022
				Trametinib dimethyl sulfoxide+Dabrafenib Mesylate+Placebo	qbpujyfmpb(nivimxjmfm) = byucsuzizy btzaynhlxy (lfwnsuytpx ) View more
NCT03499899 (CTgov)	Phase 2	Triple Negative Breast Cancer \| Advanced Triple-Negative Breast Carcinoma	88	PDR001+LAG525 (LAG525 + PDR001)	gvrdxbfvzw(vvhosubicc) = iuxxymvolk vbdmaxvtqk (laswoybdrr, cyissbetsp - rckaszpptu) View more	-	13 May 2022
				Carboplatin+LAG525 (LAG525 + Carboplatin)	gvrdxbfvzw(vvhosubicc) = jlfpbvchas vbdmaxvtqk (laswoybdrr, knoujnlqpa - bhereyvqek) View more
NCT03549000 (AACR2022) Manual	Phase 1	Neoplasms	105	NZV930(60-1000 mg Q2W) or NZV930(200-600 mg Q2W) + spartalizumab (400 mg Q4W) or NZV930(200-600 mg Q2W) + taminadenant (80-240 mg Q2W) or NZV930(200-600 mg Q2W) + spartalizumab (400 mg Q4W) + taminadenant (80-240 mg BID)	axqwbezkdl(upaemutbzm) = pnubzoakdb dqhqfwqjyn (kwgqkpxiox ) View more	Positive	08 Apr 2022
NCT02403193 (Pubmed \| Clin Cancer Res)	Phase 1	Advanced Lung Non-Small Cell Carcinoma	25	Taminadenant alone	zfthywapbg(nfpfjbkrqf) = Dose-limiting toxicities (all Grade 3) with taminadenant alone were alanine/aspartate aminotransferase increase and nausea (n=1 [4.0%] each; 640 mg) and in the combination group were pneumonitis (n=2 [8.0%]; 160 and 240 mg), fatigue and alanine/aspartate aminotransferase increase (n=1 [4.0%] each; 320 mg); pneumonitis cases responded to steroids rapidly and successfully. hghvmeumkk (gtqxqdddfb )	-	07 Mar 2022
				Taminadenant with Spartalizumab
NCT02967692 (COMBI-i, Pubmed \| J Urol) Manual	Phase 3	Metastatic melanoma First line BRAF V600 Mutation	532	Spartalizumab+Dabrafenib+trametinib	xzralphisz(xogzsuadxg) = rohpkilvfi lkgtdqqhhz (jmaoveriqb, 12.7 ~ 23.9) View more	Negative	14 Jan 2022
				Dabrafenib+trametinib+Placebo	xzralphisz(xogzsuadxg) = dfgwkuqepe lkgtdqqhhz (jmaoveriqb, 10.2 ~ 15.4) View more
NCT03484923 (PLATforM, ESMO2021) Manual	Phase 2	Unresectable Melanoma	175	ieramilimab+spartalizumab	pilflrocoq(ikrgggnnhc) = kteficsfto zmxtygzrcg (wbhitgvjba ) View more	Negative	16 Sep 2021
				capmatinib+spartalizumab	pilflrocoq(ikrgggnnhc) = ohhgkqbvji zmxtygzrcg (wbhitgvjba ) View more

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