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GV20 Therapeutics Reports First Clinical Data for AI-Designed Checkpoint Inhibitor GV20-0251 in Advanced Solid Tumors

Monoclonal AntibodyOncologyAI
  • GV20 Therapeutics presented Phase 1 data for GV20-0251, marking the first clinical results for an AI-designed antibody targeting an AI-predicted immune checkpoint IGSF8.
  • The study enrolled 38 heavily pre-treated patients and demonstrated favorable safety with no dose-limiting toxicities across all dose levels from 0.5 to 20 mg/kg.
  • Two confirmed partial responses were observed in 12 evaluable metastatic cutaneous melanoma patients, with 14 of 29 patients showing stable disease including tumor shrinkage.
  • The drug showed dose-proportional pharmacokinetics with a 25.6-day half-life and full target occupancy on circulating T cells at doses ≥3 mg/kg.

A Study of GV20-0251 Monotherapy and GV20-0251 in Combination With Pembrolizumab in Participants With Solid Tumor Malignancies

NCT05669430RecruitingPhase 1
GV20 Therapeutics
Posted 3/23/2023

McKesson Acquires $2.49 Billion Controlling Stake in Florida Cancer Specialists to Expand Community Oncology Platform

Oncology
  • McKesson Corporation agreed to purchase a 70% controlling stake in Florida Cancer Specialists' Core Ventures for approximately $2.49 billion in cash to strengthen its oncology platform.
  • The acquisition brings Florida Cancer Specialists, with over 250 physicians and 280 advanced practice providers across nearly 100 Florida locations, into McKesson's US Oncology Network.
  • The transaction aims to advance community-based cancer care by combining operational expertise to increase access to high-quality, affordable oncology services and treatments.
  • Florida Cancer Specialists will maintain independent ownership while gaining access to McKesson's differentiated oncology care products, services, and clinical trial capabilities through Sarah Cannon Research Institute.

Daiichi Sankyo and Merck Expand Collaboration to Develop Novel DLL3-Targeting T-Cell Engager for Small Cell Lung Cancer

Oncology
• Daiichi Sankyo and Merck have expanded their existing partnership to include MK-6070, an investigational DLL3-targeting T-cell engager, with Merck receiving $170 million upfront in the agreement.
• MK-6070 targets delta-like ligand 3 (DLL3), which is highly expressed in small cell lung cancer and neuroendocrine tumors, and has received FDA Orphan Drug Designation for SCLC treatment.
• The companies plan to evaluate MK-6070 in combination with ifinatamab deruxtecan (I-DXd) in patients with small cell lung cancer, addressing an aggressive cancer with significant unmet treatment needs.

A Study in Participants With Advanced Cancers Associated With Expression of DLL3 (MK-6070-001/HPN328-4001)

NCT04471727RecruitingPhase 1
Harpoon Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Posted 12/14/2020

Novel Nanoparticle Immunotherapy Shows Promise in Delaying Prostate Cancer Treatment Resistance

Oncology
• University of Sheffield researchers have developed a new nanoparticle-based immunotherapy that significantly delays resistance to androgen deprivation therapy (ADT) in prostate cancer patients.
• The innovative approach targets macrophages around blood vessels in prostate tumors, causing them to release interferon-beta which activates T cells to attack cancer cells.
• This breakthrough could potentially extend the effectiveness of hormone therapy for thousands of men, addressing a critical gap as traditional immunotherapies have historically shown limited success in prostate cancer.

Global Breast Cancer Therapeutics Market Expected to Reach $78.61 Billion by 2033

OncologyTargeted TherapyMonoclonal AntibodyAIPrecision MedicineDrug Approval
• The global breast cancer therapeutics market, valued at $32.93 billion in 2023, is projected to reach $78.61 billion by 2033, growing at a CAGR of 9.09% over the next decade.
• North America dominates the market with a 38.61% revenue share, driven by high breast cancer prevalence and presence of key pharmaceutical companies including Pfizer, Roche, and Novartis.
• Targeted therapies hold the largest market segment at 64.85%, with hormone receptor-positive treatments accounting for 66.97% of the market as precision medicine approaches gain traction.

NIH's Novel Five-Drug Combination Shows Promise for Relapsed Aggressive B-Cell Lymphoma

Targeted TherapyOncologyMonoclonal Antibody
  • NIH researchers have developed ViPOR, a non-chemotherapy five-drug regimen that achieved complete remission in 38% of patients with relapsed or refractory diffuse large B-cell lymphoma.
  • The treatment was particularly effective in two specific subtypes: non-GCB DLBCL (62% complete response) and double-hit GCB DLBCL (53% complete response), offering new hope for patients with limited options.
  • At the two-year mark, 36% of all treated patients were still alive and 34% remained disease-free, with some maintaining remission beyond four years despite previously facing poor prognoses.

Roche's Columvi Demonstrates 41% Reduction in Death Risk in Phase III DLBCL Trial

OncologyDrug Approval
  • Roche's Phase III STARGLO study showed Columvi plus chemotherapy reduced death risk by 41% versus rituximab plus chemotherapy in relapsed/refractory diffuse large B-cell lymphoma patients.
  • The combination achieved a median overall survival of 25.5 months compared to 12.9 months for the control arm, with complete response rates of 58.5% versus 25.3%.
  • Results position Columvi as the first CD20xCD3 bispecific antibody to demonstrate survival benefit in DLBCL in a randomized Phase III trial.
  • The data will be submitted to global health authorities including FDA and EMA to support conversion from accelerated to full approval.

A Phase III Study Evaluating Glofitamab in Combination With Gemcitabine + Oxaliplatin vs Rituximab in Combination With Gemcitabine + Oxaliplatin in Participants With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

NCT04408638Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 2/23/2021

An Open-Label Study Comparing Glofitamab and Polatuzumab Vedotin + Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone Versus Pola-R-CHP in Previously Untreated Patients With Large B-Cell Lymphoma

NCT06047080RecruitingPhase 3
Hoffmann-La Roche
Posted 9/18/2023

Liso-Cel CAR-T Therapy Shows Promising Results Across Multiple Lymphoma Subtypes

CAR-TOncology
  • Lisocabtagene maraleucel (liso-cel) demonstrates clinically meaningful activity across various lymphoma subgroups, including mantle cell lymphoma, diffuse large B-cell lymphoma, and follicular lymphoma.
  • In relapsed/refractory mantle cell lymphoma patients, liso-cel achieved a median overall survival of 13.5 months and progression-free survival of 7.4 months despite heavy pretreatment.
  • Follicular lymphoma patients show particularly stellar response rates with durable complete remissions lasting nearly 3 years of follow-up.
  • Experts advocate for exploring liso-cel use in earlier treatment lines, particularly for high-risk patient subgroups who may benefit from better-preserved T-cell health.

Study Evaluating the Safety and Pharmacokinetics of JCAR017 in B-cell Non-Hodgkin Lymphoma (TRANSCEND-NHL-001)

NCT02631044CompletedPhase 1
Juno Therapeutics, a Subsidiary of Celgene
Posted 1/6/2016

A Study to Compare the Efficacy and Safety of JCAR017 to Standard of Care in Adult Subjects With High-risk, Transplant-eligible Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphomas

NCT03575351CompletedPhase 3
Celgene
Posted 10/23/2018

CARsgen's Satri-cel Shows Promise in Phase 1 Trial for Gastrointestinal Cancers

CAR-TOncology
  • Final results from the Phase 1 trial of satricabtagene autoleucel (satri-cel) demonstrate promising efficacy and manageable safety in patients with Claudin18.2-positive advanced gastrointestinal cancers, particularly gastric and gastroesophageal junction cancers.
  • The groundbreaking CAR T-cell therapy targeting Claudin18.2 represents a significant advancement in solid tumor treatment, with results simultaneously published in Nature Medicine and presented at the 2024 ASCO Annual Meeting.
  • Satri-cel has received multiple regulatory designations including RMAT designation from the FDA and PRIME eligibility from the EMA, positioning it as a potential first-in-class therapy globally for Claudin18.2-positive solid tumors.

Study to Evaluate the Efficacy, Safety and Pharmacokinetics of CT041 Autologous CAR T-cell Injection

NCT04581473Active, Not RecruitingPhase 1
CARsgen Therapeutics Co., Ltd.
Posted 10/23/2020

Claudin18.2 CAR-T (CT041) in Patients with Gastric, Pancreatic Cancer, or Other Specified Digestive Cancers

NCT04404595Active, Not RecruitingPhase 1
CARsgen Therapeutics Co., Ltd.
Posted 10/23/2020

Chimeric Antigen Receptor T Cells Targeting claudin18.2 in Solid Tumors.

NCT03874897CompletedPhase 1
Peking University
Posted 3/26/2019

A Study to Evaluate the Efficacy and Safety of CT041 After Adjuvant Chemotherapy for Pancreatic Cancer

NCT05911217RecruitingPhase 1
CARsgen Therapeutics Co., Ltd.
Posted 7/11/2023

Bispecific Antibodies Show Promise in Multiple Myeloma Treatment Across Different Patient Populations

OncologyCAR-TMonoclonal Antibody
  • Talquetamab demonstrated a 71.4% objective response rate and 28.6% complete response rate in heavily pretreated relapsed/refractory multiple myeloma patients, including those with poor functional status and prior CAR-T therapy.
  • The teclistamab combination with daratumumab and lenalidomide achieved a 92.3% overall response rate and 80.8% complete response rate in newly diagnosed multiple myeloma patients ineligible for transplant.
  • Both bispecific antibody treatments showed manageable safety profiles with cytokine release syndrome as the primary toxicity, though infection risk requires careful monitoring and prophylaxis.
  • These findings expand treatment options for multiple myeloma patients across the disease spectrum, from newly diagnosed to heavily pretreated cases.

Dose Escalation Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma

NCT03399799Active, Not RecruitingPhase 1
Janssen Research & Development, LLC
Posted 12/16/2017

A Study of Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab and Lenalidomide (Tal-DR) in Participants With Newly Diagnosed Multiple Myeloma

NCT05552222RecruitingPhase 3
Janssen Research & Development, LLC
Posted 10/25/2022
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