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Pfizer's BRAFTOVI Combination Therapy Halves Death Risk in BRAF-Mutant Metastatic Colorectal Cancer

Targeted TherapyPrecision MedicineOncology
  • Pfizer announced that its BRAFTOVI® combination regimen demonstrated a 50% reduction in death risk for patients with BRAF V600E-mutant metastatic colorectal cancer.
  • The targeted therapy represents a major advance in treating this specific genetic subtype of colorectal cancer.
  • This breakthrough could significantly improve survival outcomes for patients harboring the BRAF V600E mutation in metastatic disease.

BRAID Trial Shows Additional Imaging Could Triple Breast Cancer Detection in Women with Dense Breasts

Oncology
  • The BRAID trial found that contrast-enhanced mammography and abbreviated MRI could detect up to 3,500 additional breast cancers annually in women with dense breasts.
  • Women with dense breast tissue, comprising 10% of those aged 50-70, face up to four times higher breast cancer risk but current screening guidelines don't account for breast density.
  • Additional imaging detected 85 cancers among over 9,000 women with dense breasts who had previously received negative mammogram results.
  • Researchers estimate these enhanced screening protocols could save approximately 700 lives per year by enabling earlier diagnosis and treatment.

HKUMed's Combined Locoregional-Immunotherapy Achieves 46% Complete Response Rate in Advanced Liver Cancer

Oncology
  • Researchers at the University of Hong Kong demonstrated that combined locoregional therapy and immunotherapy (LRT-IO) achieved complete response in 46% of patients with locally advanced unresectable liver cancer.
  • Patients achieving complete response showed significantly improved three-year survival rates of 76% compared to 28% in non-responders, with outcomes comparable to curative surgery.
  • The study represents the largest and first long-term follow-up investigation of LRT-IO treatment, providing evidence for a "watch-and-wait" strategy in advanced liver cancer management.
  • The treatment approach has gained recognition with inclusion of the similar "START-FIT" protocol in China's National Guidelines for Liver Cancer Management in 2024.

ENHERTU Receives First-Ever Time-Limited Reimbursement for Gastric Cancer in Canada

Oncology
• Canada's Drug Agency has issued a Time-Limited Reimbursement recommendation for ENHERTU (trastuzumab deruxtecan), marking the first such approval for HER2-positive gastric cancer patients.
• The innovative reimbursement pathway is expected to make ENHERTU available to eligible patients nearly two years faster than traditional approval processes while confirmatory Phase III trials continue.
• This milestone follows Health Canada's conditional approval of ENHERTU in January 2025 for adult patients with unresectable, locally advanced or metastatic HER2-positive gastric cancer who have received prior trastuzumab-based therapy.

Tevogen Bio Expands TVGN 489 Pipeline to Include Patients 65 and Older, Targeting $1 Billion Launch Year Revenue

Oncology
  • Tevogen Bio announced plans to expand TVGN 489's target population to include patients aged 65 and older, building on previous specialty care pipeline projections of nearly $1 billion in launch year revenue.
  • The expansion comes as the U.S. reports cases of the new COVID variant NB.1.8.1, with the company prioritizing clinical manufacturing capacity to address unmet medical needs.
  • TVGN 489's comprehensive pipeline targets SARS-CoV-2 infections across multiple patient populations including cancer patients, autoimmune disease patients, and Long COVID sufferers.
  • The company's ExacTcell platform supports the expanded pipeline, with updated revenue forecasts and risk-adjusted net present value calculations to follow.

Caris Life Sciences Files for $300 Million IPO to Advance AI-Powered Precision Oncology Platform

Precision MedicineAIOncology
  • Caris Life Sciences has filed for an initial public offering aiming to raise up to $300 million, with plans to list on Nasdaq under the ticker symbol "CAI".
  • The company has developed an AI-powered precision medicine platform for oncology, built on a massive dataset of over 6.5 million tests from 849,000 cases, generating measurements of more than 38 billion molecular markers.
  • Caris' commercial portfolio includes MI Profile, a tissue-based molecular profiling solution, and Caris Assure, a blood-based profiling solution launched in Q1 2024 for therapy selection.

Ziftomenib Shows Promise in Pivotal KOMET-001 Trial for Relapsed/Refractory NPM1-Mutant AML

Oncology
  • Roswell Park's Dr. Eunice Wang will present pivotal results from the KOMET-001 trial showing clinical activity of menin inhibitor ziftomenib in patients with relapsed/refractory NPM1-mutant acute myeloid leukemia at ASCO 2025.
  • A systematic review led by Dr. Muhammad Awidi reveals important findings on immune checkpoint inhibitor safety and efficacy in solid organ transplant recipients, addressing critical concerns about transplant rejection risk.
  • The ASCO 2025 Annual Meeting will feature multiple Roswell Park presentations on cancer disparities, including research on racial differences in outcomes for HER2-positive metastatic breast cancer patients treated with antibody-drug conjugates.

First in Human Study of Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia

NCT04067336RecruitingPhase 1
Kura Oncology, Inc.
Posted 9/12/2019

GV20 Therapeutics to Present AI-Designed Immune Checkpoint Inhibitor Data for Advanced Melanoma at ASCO 2025

Monoclonal AntibodyOncology
  • GV20 Therapeutics will present updated Phase 1 data on GV20-0251, the first AI-designed antibody targeting the novel immune checkpoint IGSF8, at ASCO 2025.
  • The presentation will showcase clinical and translational findings from patients with advanced solid tumors resistant to anti-PD(L)1 therapies, with a focus on melanoma patients showing primary resistance.
  • GV20-0251 represents a significant advancement in AI-driven drug discovery, having progressed from target identification to IND filing in just three years with promising early efficacy data.

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

Pharmaceutical Industry Sees Wave of Board Appointments as Companies Strengthen Leadership

Oncology
  • Pharmaceutical and biotech companies across Europe and North America have made significant board appointments, bringing industry veterans and scientific experts to strengthen their leadership teams.
  • Notable appointments include former CDC Director Dr. Julie Louise Gerberding joining ARTIDIS and former Roche neuroscience head Dr. Paulo Fontoura taking on dual advisory roles.
  • Companies ranging from clinical-stage biotechs to established pharmaceutical firms are adding expertise in areas including oncology, neuroscience, infectious diseases, and antimicrobial resistance.

Real-World Study Reveals Lower Immune-Related Adverse Events in Latin American Liver Cancer Patients Treated with Atezolizumab-Bevacizumab

Monoclonal AntibodyOncologyReal World Evidence
  • A multinational study of 99 Latin American patients with unresectable hepatocellular carcinoma found only 18% experienced immune-related adverse events (irAEs) with atezolizumab-bevacizumab therapy, significantly lower than clinical trial rates.
  • Most irAEs were mild to moderate, primarily affecting the liver and thyroid, with half resolving within 30 days and only eight patients requiring steroid treatment.
  • Patients with elevated baseline alpha-fetoprotein levels (≥400 ng/mL) showed significantly higher risk for developing irAEs, potentially serving as a predictive biomarker.
  • The occurrence of immune-related side effects did not impact overall survival, with both groups achieving identical median survival of 18.5 months.

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