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Dual-Targeted CAR-T Therapy KITE-363 Shows 87% Response Rate in Relapsed B-Cell Lymphoma

CAR-TOncology
  • KITE-363, a dual CD19/CD20-targeted CAR-T therapy, achieved an 87% objective response rate with 78% complete responses in CAR-T naive patients with relapsed/refractory large B-cell lymphoma.
  • The therapy demonstrated superior CAR-T cell expansion compared to existing treatments, with peak levels 3-5 fold higher than axicabtagene ciloleucel.
  • Safety profile showed manageable toxicity with no grade 3 or 4 cytokine release syndrome or neurotoxicity in primary refractory patients at the recommended dose.
  • Primary refractory patients achieved 80% response rates with 67% complete responses, addressing a critical unmet need in this difficult-to-treat population.

Study of KITE-363 or KITE-753 in Participants With Relapsed and/or Refractory B-cell Lymphoma

NCT04989803RecruitingPhase 1
Kite, A Gilead Company
Posted 10/27/2021

Epcoritamab Demonstrates Durable 3-Year Remissions in Relapsed/Refractory Large B-Cell Lymphoma

Drug ApprovalOncology
  • Epcoritamab-bysp achieved durable complete responses in patients with relapsed/refractory large B-cell lymphoma, with 96% of complete responders at 2 years maintaining remission at 3 years.
  • The median duration of complete response was 36.1 months, with the longest ongoing complete response exceeding 43 months in the EPCORE NHL-1 study.
  • Among patients who discontinued treatment for reasons other than disease progression, complete response was maintained for a median of 14 months after stopping therapy.
  • The bispecific T-cell engager demonstrated manageable safety profile with COVID-19, cytokine release syndrome, and diarrhea as the most common treatment-emergent adverse events.

A Study Comparing the Efficacy and Safety of Polatuzumab Vedotin With Rituximab-Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab-Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Diffuse Large B-Cell Lymphoma

NCT03274492Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 11/16/2017

Study to Compare the Effectiveness and Safety of Golcadomide Plus R-CHOP vs Placebo Plus R-CHOP in Participants With Previously Untreated High-risk Large B-cell Lymphoma

NCT06356129RecruitingPhase 3
Celgene
Posted 6/19/2024

A Safety and Preliminary Efficacy Study of CC-99282, Alone and in Combination With Anti-lymphoma Agents in Participants With Relapsed or Refractory Non-Hodgkin Lymphomas (R/R NHL)

NCT03930953Active, Not RecruitingPhase 1
Celgene
Posted 5/20/2019

A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous Anti-Neoplastic Agents in Adult Participants With Non-Hodgkin Lymphoma

NCT05283720RecruitingNot Applicable
Genmab
Posted 6/14/2022

Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL)

NCT04663347Active, Not RecruitingPhase 1
Genmab
Posted 11/3/2020

Open Label Study to Evaluate the Safety and Efficacy of Lenalidomide With MOR00208 in Patients With R-R DLBCL

NCT02399085CompletedPhase 2
MorphoSys AG
Posted 3/29/2016

The Pathogenesis and Prognostic Factors of Lymphoma

NCT06203652Recruiting
Shanghai Zhongshan Hospital
Posted 6/5/2023

First-in-Human (FIH) Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma

NCT03625037Active, Not RecruitingPhase 1
Genmab
Posted 6/26/2018

HER3-DXd Demonstrates Promising Intracranial Activity in Phase II TUXEDO-3 Trial for Brain Metastases

Oncology
  • The phase II TUXEDO-3 trial showed patritumab deruxtecan (HER3-DXd) achieved intracranial response rates of 23.8% in metastatic breast cancer and 30% in advanced non-small cell lung cancer patients with active brain metastases.
  • HER3-DXd demonstrated activity across all breast cancer subtypes and showed potential to overcome resistance in patients previously treated with antibody-drug conjugates.
  • The study represents the first evaluation of intracranial and extracranial efficacy for this novel anti-cancer drug in patients with brain metastases and leptomeningeal disease from solid tumors.
  • Results from the leptomeningeal cohort showed 65% of patients remained alive after 3 months, with findings published simultaneously in Nature Medicine due to the high unmet medical need.

HER3-DXd in Breast Cancer and NSCLC Brain Metastases and Solid Tumor Leptomeningeal Disease

NCT05865990RecruitingPhase 2
MedSIR
Posted 11/24/2023

Meitheal Pharmaceuticals Launches Generic Abraxane in US Market to Address Cancer Treatment Access

Oncology
  • Meitheal Pharmaceuticals has launched paclitaxel protein-bound particles for injectable suspension, a generic version of Abraxane, through an exclusive licensing agreement with parent company Hong Kong King-Friend Industry.
  • The 100mg/vial formulation is indicated for treating metastatic breast cancer, metastatic adenocarcinoma of the pancreas, and locally advanced or metastatic non-small cell lung cancer.
  • This launch expands Meitheal's generic injectable portfolio to 68 products and represents the company's 12th product launch in 2024, with 20 additional products planned for the year.
  • The generic paclitaxel aims to address treatment accessibility challenges for cancer patients facing expensive or unavailable complex therapies.

Mabwell's Novel Long-Acting G-CSF Drug MAILISHENG Receives NMPA Approval for Chemotherapy-Induced Neutropenia

Drug ApprovalOncology
  • Mabwell received NMPA approval for Albipagrastim alfa (MAILISHENG), marking China's first novel G-CSF drug developed with albumin long-acting fusion technology.
  • Phase III trial data in 496 breast cancer patients demonstrated superior efficacy with 42% relative risk reduction in febrile neutropenia compared to control.
  • The drug addresses a significant unmet need, as 65.5% of patients receiving certain chemotherapy regimens experience grade 3 or 4 neutropenia.
  • MAILISHENG represents Mabwell's first commercialized innovative drug, utilizing human serum albumin fusion to extend half-life and reduce dosing frequency.

BioLineRx Reports Promising Pancreatic Cancer Trial Results with 64% Response Rate for Motixafortide Combination

Oncology
  • BioLineRx's CheMo4METPANC Phase 2 pilot study demonstrated a 64% overall response rate and 91% disease control rate in first-line pancreatic cancer patients treated with motixafortide combination therapy.
  • Four of eleven patients remained progression-free after more than one year, with two patients achieving complete responses and undergoing definitive surgical treatment.
  • The combination therapy increased CD8+ T-cell tumor infiltration across all patients, suggesting enhanced immune system activation against pancreatic tumors.
  • The trial has been expanded from 30 to 108 patients based on encouraging results, representing the first large randomized study of motixafortide with PD-1 inhibitor in pancreatic cancer.

Chemo4METPANC Combination Chemokine Inhibitor, Immunotherapy, and Chemotherapy in Pancreatic Adenocarcinoma

NCT04543071RecruitingPhase 2
Gulam Manji
Posted 11/9/2020

CSPC Pharmaceutical Announces Potential $5 Billion Drug Licensing Deals Following Q1 Revenue Decline

Oncology
  • CSPC Pharmaceutical Group revealed it is in talks with three parties for licensing deals worth up to $5 billion in potential fees, including a targeted cancer therapy and other novel drug candidates.
  • The announcement came after disappointing Q1 2024 results showing a 21.91% revenue drop to 7.02 billion yuan and 8.36% decline in net profit to 1.48 billion yuan.
  • The company has already completed two major licensing deals this year, including a $150 million upfront payment from BeiGene and a $15 million deal with Radiance Biopharma.
  • Chinese biotech licensing deals with multinational partners are surging, with lawyers reporting at least seven deals in 2023 and five already identified in 2024.

Samsung Bioepis Secures Korean Approval for Denosumab Biosimilar XBRYK, Completing Global Regulatory Trifecta

Drug ApprovalOncology
  • Samsung Bioepis received Korean regulatory approval for XBRYK, a biosimilar to Amgen's bone cancer drug XGEVA, used to prevent fractures in patients with bone metastases and treat rare bone tumors.
  • The approval follows earlier Korean approval of OVODENS, a biosimilar to Amgen's PROLIA for osteoporosis treatment, giving Samsung access to a combined global market worth $6.599 billion annually.
  • Samsung has now secured regulatory approval for both denosumab biosimilars across all three major markets including the United States and Europe.
  • The Korean prescription market for denosumab-based products is valued at approximately 187 billion won, with Samsung's biosimilars expected to provide more cost-effective treatment options for bone disease patients.

China Approves Zanidatamab as First Dual HER2-Targeted Bispecific Antibody for Biliary Tract Cancer

Drug ApprovalOncology
  • China's National Medical Products Administration granted conditional approval to zanidatamab for previously treated, unresectable or metastatic HER2-positive biliary tract cancer, marking the first dual HER2-targeted bispecific antibody approved for this indication in China.
  • The approval triggers a $20 million milestone payment to Zymeworks from partner BeOne Medicines, with potential for up to $144 million in additional development and commercial milestones plus tiered royalties up to 19.5%.
  • Zanidatamab represents a significant advancement for HER2-positive biliary tract cancer patients, a population with historically high unmet medical need and poor prognoses, affecting approximately 11%-25.2% of biliary tract cancer patients.
  • The conditional approval follows previous regulatory successes, including FDA approval in November 2024 and a positive opinion from the European Medicines Agency in April 2025.

Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer

NCT06282575RecruitingPhase 3
Jazz Pharmaceuticals
Posted 7/19/2024

A Study of ZW25 (Zanidatamab) in Subjects With Advanced or Metastatic HER2-Amplified Biliary Tract Cancers

NCT04466891CompletedPhase 2
Jazz Pharmaceuticals
Posted 10/1/2020

Outcomes4Me Raises $21M to Expand AI-Driven Cancer Care Platform Globally

AIOncology
  • Outcomes4Me secured $21 million in funding led by Salica Investments to accelerate its AI-driven cancer care platform that serves over 280,000 patients.
  • The Boston-based company's platform integrates clinical guidelines, genomics, trial matching, and symptom tracking to help cancer patients navigate their care journey.
  • Seven of the top 10 global cancer pharmaceutical companies are already customers, demonstrating strong market adoption since commercial launch in 2022.
  • The funding will support international expansion, enhanced AI capabilities, and scaling partnerships with health systems and life sciences companies worldwide.

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