MedPath

Tagged News

Bispecific T-Cell Engagers Show Promise as Later-Line Therapies for Relapsed/Refractory DLBCL

CAR-TDrug ApprovalOncology
  • Two bispecific T-cell engagers, epcoritamab-bysp and glofitamab-gxbm, received FDA accelerated approval in 2023 for relapsed/refractory diffuse large B-cell lymphoma, offering new treatment options for heavily pretreated patients.
  • Both agents demonstrate remarkable activity with overall response rates above 50-60% and complete response rates around 40% in patients with CAR T-cell therapy failure, addressing a significant unmet medical need.
  • Epcoritamab offers convenient subcutaneous administration in outpatient settings with manageable cytokine release syndrome rates below 3%, while glofitamab provides fixed-duration therapy with durable responses lasting over one year after treatment completion.
  • These bispecific antibodies may challenge the paradigm that CAR T-cell therapy is the only curative option for relapsed/refractory patients, with emerging data suggesting potential for long-term disease control.

A Dose Escalation Study of Glofitamab (RO7082859) as a Single Agent and in Combination With Obinutuzumab, Administered After a Fixed, Single Pre-treatment Dose of Obinutuzumab in Participants With Relapsed/Refractory B-cell Non-hodgkin's Lymphoma

NCT03075696RecruitingPhase 1
Hoffmann-La Roche
Posted 2/21/2017

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

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

Samuraciclib Shows Promise in Advanced Breast Cancer Patients After CDK4/6 Inhibitor Failure

OncologyTargeted TherapyPrecision Medicine
  • Phase I clinical trials demonstrate samuraciclib, a selective CDK7 inhibitor, has an acceptable safety profile with manageable gastrointestinal side effects and shows clinical activity in various advanced solid tumors.
  • In HR+/HER2- breast cancer patients who progressed on CDK4/6 inhibitors, the combination of samuraciclib with fulvestrant achieved a clinical benefit rate of 36% and median progression-free survival of 3.7 months.
  • Exploratory analysis revealed patients without TP53 mutations had significantly longer progression-free survival (7.4 months vs 1.8 months), suggesting TP53 status may serve as a potential biomarker for treatment response.

Modular Study to Evaluate CT7001 Alone in Cancer Patients With Advanced Malignancies

NCT03363893CompletedPhase 1
Carrick Therapeutics Limited
Posted 11/14/2017

Avutometinib-Defactinib Combination Shows 45% Response Rate in Low-Grade Serous Ovarian Cancer

Targeted TherapyOncology
  • A phase II trial of avutometinib combined with defactinib demonstrated a 45% response rate in patients with advanced low-grade serous ovarian cancer, nearly twice as effective as current best treatments.
  • Patients with KRAS mutations showed particularly strong responses at 60%, while those without mutations still achieved a 29% response rate, both significantly higher than standard therapy response rates of 0-14%.
  • The dual RAF/MEK inhibitor combination proved over four times more effective than avutometinib alone, with previous phase I data showing an average progression-free survival of 23 months.
  • Low-grade serous ovarian cancer affects approximately 700 women annually in the UK and represents about 10% of all ovarian cancer cases, typically affecting younger women with poor response to conventional treatments.

A Study of MEK162 vs. Physician's Choice Chemotherapy in Patients With Low-grade Serous Ovarian, Fallopian Tube or Peritoneal Cancer

NCT01849874TerminatedPhase 3
Pfizer
Posted 6/27/2013

Trametinib in Treating Patients With Recurrent or Progressive Low-Grade Ovarian Cancer or Peritoneal Cavity Cancer

NCT02101788Active, Not RecruitingPhase 2
National Cancer Institute (NCI)
Posted 2/27/2014

Phase I Trial of Defactinib and VS-6766.

NCT03875820Active, Not RecruitingPhase 1
Institute of Cancer Research, United Kingdom
Posted 12/12/2017

A Study of Avutometinib (VS-6766) V. Avutometinib (VS-6766) + Defactinib in Recurrent Low-Grade Serous Ovarian Cancer with and Without a KRAS Mutation

NCT04625270Active, Not RecruitingPhase 2
Verastem, Inc.
Posted 12/21/2020

Revumenib Shows Promise in Phase 1 Trial for KMT2A-Rearranged and NPM1-Mutated Acute Leukemia

OncologyTargeted Therapy
  • Revumenib, a first-in-class menin inhibitor, demonstrated a 30% complete remission rate in heavily pretreated patients with KMT2A-rearranged or NPM1-mutated acute leukemia, with 78% achieving undetectable measurable residual disease.
  • The oral therapy works by disrupting the menin-KMT2A interaction, downregulating key leukemogenic genes and promoting differentiation of leukemic cells, addressing a critical unmet need for these poor-prognosis genetic subtypes.
  • While QT interval prolongation was the most common treatment-related adverse event (53%), the phase 1 trial established recommended phase 2 dosing with manageable safety profile, supporting further development of this targeted therapy.

BriaCell Advances Pivotal Study for Bria-IMT in Metastatic Breast Cancer Following Positive FDA Feedback

Oncology
  • BriaCell Therapeutics has received positive FDA feedback for its pivotal study of Bria-IMT in combination with a checkpoint inhibitor for advanced metastatic breast cancer, potentially accelerating commercialization.
  • The FDA has agreed on the eligible patient population—breast cancer patients who have failed available approved therapies—and the primary endpoint of survival improvement compared to physician's choice of treatment.
  • BriaCell is also preparing to launch its Bria-OTS personalized treatment program, which matches patients' HLA type with pre-manufactured cells, with dosing expected to begin in the first half of 2023.

Genmab and AbbVie Submit Regulatory Applications for Epcoritamab Bispecific Antibody in Relapsed/Refractory B-Cell Lymphomas

Oncology
  • Genmab submitted a Biologics License Application to the FDA for subcutaneous epcoritamab to treat relapsed/refractory large B-cell lymphoma after two or more lines of systemic therapy.
  • AbbVie's Marketing Authorization Application for epcoritamab in relapsed/refractory diffuse large B-cell lymphoma has been validated by the European Medicines Agency.
  • The regulatory submissions are supported by results from the pivotal EPCORE NHL-1 Phase 2 trial evaluating epcoritamab's safety and efficacy in patients with CD20+ mature B-cell non-Hodgkin lymphoma.
  • Epcoritamab is an investigational bispecific antibody designed to simultaneously bind CD3 on T-cells and CD20 on B-cells, inducing T-cell mediated killing of malignant B-cells.

Photocure and Karl Storz Launch Advanced Blue Light Cystoscopy System in US Market

Oncology
  • Photocure ASA announces the commercial availability of Karl Storz's New Blue Light equipment powered by Saphira technology in the United States for bladder cancer detection.
  • The advanced system shows strong market demand with orders outpacing previous systems, signaling potential for blue light cystoscopy to become standard of care for bladder cancer visualization.
  • Bladder cancer affects 1.72 million patients globally with high recurrence rates up to 78% over five years, making improved detection technology critically important for patient outcomes.

Tagrisso Plus Savolitinib Shows Promising 49% Response Rate in EGFR-Mutated Lung Cancer with MET Resistance

Targeted TherapyOncologyPrecision Medicine
• Preliminary results from the SAVANNAH Phase II trial demonstrated that Tagrisso (osimertinib) plus savolitinib achieved a 49% objective response rate in EGFR-mutated NSCLC patients with high levels of MET overexpression who progressed on Tagrisso.
• MET was identified as the most common resistance biomarker in EGFR-mutated lung cancer, with 62% of patients screened showing MET overexpression and/or amplification after progression on Tagrisso.
• The combination therapy showed the highest response rate (52%) in patients with high MET levels who had not received prior chemotherapy, potentially offering a less toxic alternative to the current standard of chemotherapy after targeted therapy failure.

Lead Pharma and Oxeltis Secure €800K Grant to Develop First-in-Class DLBCL Therapy

OncologyDrug Discovery
  • Lead Pharma and Oxeltis received an €800K EUREKA Eurostars grant to fund their three-year EPIGENEXT project developing a first-in-class small molecule therapy for diffuse large B-cell lymphoma.
  • DLBCL affects approximately 115,000 people worldwide annually, with 30-50% of patients experiencing relapse after standard R-CHOP treatment and poor long-term survival rates.
  • The collaboration aims to address the significant unmet medical need in DLBCL treatment, where current chemotherapy approaches cause debilitating side effects and fail to cure nearly half of patients.

Cullinan Oncology and Taiho Pharmaceutical Forge $275M Strategic Collaboration for EGFR Inhibitor CLN-081/TAS6417

Targeted TherapyOncologyPrecision Medicine
  • Taiho Pharmaceutical will acquire Cullinan Pearl for $275 million upfront plus up to $130 million in regulatory milestones, gaining exclusive global rights to CLN-081/TAS6417 outside the U.S.
  • CLN-081/TAS6417 is an oral, irreversible EGFR inhibitor targeting exon 20 insertion mutations in non-small cell lung cancer, which affect approximately 2-3% of NSCLC patients globally.
  • The companies will jointly develop and co-commercialize the drug in the U.S. with equal profit sharing, while Taiho will commercialize in territories outside the U.S. and China.
© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy