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Instil Bio Appoints Veteran Oncologist Jamie Freedman as Chief Medical Officer to Advance PD-L1xVEGF Bispecific

Oncology
  • Instil Bio has appointed Jamie Freedman, M.D., Ph.D., as Chief Medical Officer to lead development of AXN-2510, a novel PD-L1xVEGF bispecific antibody for solid tumors.
  • Dr. Freedman brings over 20 years of biopharmaceutical leadership experience and has contributed to 15 drug approvals across multiple therapeutic areas.
  • The appointment strengthens Instil Bio's clinical leadership as the company advances AXN-2510, which Dr. Freedman believes has potential to redefine standard of care for solid tumors.

Lilly's Next-Generation ADC Shows 55% Response Rate in Platinum-Resistant Ovarian Cancer

Oncology
  • Eli Lilly's investigational folate receptor alpha-targeting ADC LY4170156 demonstrated a 55% overall response rate at the recommended Phase 2 dose in heavily pre-treated platinum-resistant ovarian cancer patients.
  • The therapy showed anti-tumor activity across all folate receptor alpha expression levels, including in patients previously treated with mirvetuximab soravtansine, addressing a significant unmet medical need.
  • The Phase 1 study enrolled 95 patients who received a median of five prior systemic regimens, with encouraging safety profile and no treatment-emergent neuropathy or ocular toxicity observed.
  • Lilly plans to rapidly advance the compound into registrational Phase 3 clinical trials based on these promising initial results presented at the 2025 ASCO Annual Meeting.

A Study of LY4170156 in Participants With Selected Advanced Solid Tumors

NCT06400472RecruitingPhase 1
Eli Lilly and Company
Posted 5/20/2024

Viz.ai Partners with Novartis to Develop AI-Powered Cancer Care Solutions for Prostate and Breast Cancer

AIOncologyPrecision Medicine
  • Viz.ai and Novartis announced a multi-year strategic collaboration to develop AI-powered workflows within the Viz Oncology Suite, focusing on prostate and breast cancer patient identification and care coordination.
  • The partnership will create two new solutions: Viz Prostate Cancer to streamline patient identification for guideline-based treatments, and Viz Breast Cancer to automate patient review and facilitate multidisciplinary care coordination.
  • The collaboration addresses critical gaps in cancer care, as only one in four prostate cancer patients receive guideline-recommended therapy, while breast cancer remains the most widely diagnosed cancer in the United States with complex care journeys.
  • This strategic alliance marks Viz.ai's expansion into oncology, building on their AI-powered disease detection platform that currently serves over 1,700 hospitals and health systems across the U.S. and Europe.

BeOne Medicines Reports Promising Early Data for Two Novel Breast Cancer Therapies at ASCO 2025

Oncology
  • BeOne Medicines presented first clinical data for two investigational breast cancer therapies at ASCO 2025, marking a pivotal milestone for the company's emerging oncology pipeline.
  • The B7-H4-targeting ADC BG-C9074 demonstrated a 16.1% confirmed overall response rate and 73.2% disease control rate in heavily pretreated patients with advanced solid tumors.
  • The CDK2 inhibitor BG-68501 showed manageable safety profiles in HR+/HER2- breast cancer patients with prior CDK4/6 inhibitor exposure, supporting continued development.
  • Both therapies exhibited favorable tolerability with no treatment-related deaths, positioning them as potential next-line options for addressing critical gaps in breast cancer treatment.

A Study to Examine the Safety of Different Doses of BG-68501 Given to Participants With Advanced-Stage Tumors

NCT06257264RecruitingPhase 1
BeiGene
Posted 3/11/2024

Phase 1a/1b First-in-Human Study of BG-C9074 Alone and in Combination With Tislelizumab in Participants With Advanced Solid Tumors

NCT06233942RecruitingPhase 1
BeiGene
Posted 4/12/2024

Bristol Myers Squibb Partners with BioNTech in $11.1 Billion Deal for Dual-Target Cancer Immunotherapy

Oncology
  • Bristol Myers Squibb will pay BioNTech $1.5 billion upfront plus $2 billion in anniversary payments through 2028 for a 50% partnership in BNT327, a bispecific antibody targeting both PD-L1 and VEGF proteins.
  • BNT327 represents a new class of cancer immunotherapies that simultaneously targets two of the most important cancer drug targets, following the success of ivonescimab which outperformed Keytruda in Phase 3 lung cancer trials.
  • The experimental drug is currently in Phase 3 trials for both small cell and non-small cell lung cancer, with a third late-stage trial in triple-negative breast cancer planned to start by year-end.
  • This partnership positions Bristol Myers to compete in the emerging bispecific antibody race alongside Pfizer, Merck, Akeso, and Summit Therapeutics in what could become a foundational immuno-oncology treatment approach.

HARMONi-3

2024-513087-26-00RecruitingPhase 3
Summit Therapeutics Inc.
Posted 10/26/2023

Safety and Effectiveness of BNT327, an Investigational Therapy in Combination With Chemotherapy for Patients With Untreated Small-cell Lung Cancer

NCT06712355Active, Not RecruitingPhase 3
BioNTech SE
Posted 2/3/2025

MHRA Approves Serplulimab as First Anti-PD-1 Therapy for Small Cell Lung Cancer in UK

Monoclonal AntibodyDrug ApprovalOncology
  • The UK's Medicines and Healthcare products Regulatory Agency approved serplulimab (Hetronifly) as the first anti-PD-1 monoclonal antibody for treating extensive-stage small cell lung cancer.
  • Clinical trial data showed patients receiving serplulimab with chemotherapy lived an average of 15.4 months compared to 10.9 months with chemotherapy alone.
  • The approval provides a new treatment option for an aggressive cancer type that accounts for 10-15% of lung cancer cases and typically has poor prognosis.
  • Serplulimab is administered intravenously every three weeks in combination with carboplatin and etoposide chemotherapy for first-line treatment.

A Randomized, Double-blind, Placebo Controlled Phase III Study to Investigate Efficacy and Safety of HLX10 + Chemotherapy (Carboplatin- Etoposide) in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC)

NCT04063163Unknown StatusPhase 3
Shanghai Henlius Biotech
Posted 9/12/2019

Mixed Results for Adjuvant Immunotherapy in High-Risk Cutaneous Squamous Cell Carcinoma

Oncology
  • The phase 3 KEYNOTE-630 trial found that adjuvant pembrolizumab did not significantly improve progression-free survival in patients with high-risk cutaneous squamous cell carcinoma following surgery and radiation.
  • Despite missing its primary endpoint, pembrolizumab demonstrated a 50% reduction in cancer recurrence rates, with locoregional recurrence occurring in 13.8% versus 25.3% of placebo patients.
  • The competing phase 3 C-POST trial showed cemiplimab reduced the risk of recurrence or death by 68% compared to placebo, with FDA approval expected for this indication.
  • Treatment paradigms are shifting toward neoadjuvant immunotherapy approaches, with upcoming trials exploring response-adapted surgery and radiation strategies.

A Study to Compare the Administration of Encorafenib + Binimetinib + Nivolumab Versus Ipilimumab + Nivolumab in BRAF-V600 Mutant Melanoma With Brain Metastases

NCT04511013RecruitingPhase 2
SWOG Cancer Research Network
Posted 1/6/2021

Pembrolizumab (MK-3475) Versus Placebo Following Surgery and Radiation in Participants With Locally Advanced Cutaneous Squamous Cell Carcinoma (MK-3475-630/KEYNOTE-630)

NCT03833167Active, Not RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 4/1/2019

Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients With High Risk Cutaneous Squamous Cell Carcinoma

NCT03969004Active, Not RecruitingPhase 3
Regeneron Pharmaceuticals
Posted 6/4/2019

Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma

NCT02760498CompletedPhase 2
Regeneron Pharmaceuticals
Posted 4/7/2016

Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAFV600 Melanoma

NCT02224781Active, Not RecruitingPhase 3
National Cancer Institute (NCI)
Posted 9/8/2015

Study of REGN2810 (Anti-PD-1) in Patients With Advanced Malignancies

NCT02383212CompletedPhase 1
Regeneron Pharmaceuticals
Posted 2/2/2015

Gilead's Dual-Target CAR-T Therapy Achieves 62% Response Rate in Recurrent Glioblastoma

CAR-TOncology
  • Gilead Sciences' dual-target CAR-T therapy shrank tumors in 62% of patients with recurrent glioblastoma, a rare achievement for this fatal brain cancer.
  • The experimental treatment targets both EGFR and interleukin-13 receptor alpha 2, injected directly into spinal fluid to overcome glioblastoma's multiple tumor cell populations.
  • While responses were encouraging, benefits proved largely temporary with many patients relapsing within two to three months after treatment.
  • Kite is developing a triple-target version to improve persistence and plans to test the therapy in newly diagnosed patients next year.

World-First Clinical Trial Demonstrates Exercise Significantly Improves Colon Cancer Survival

Oncology
  • A groundbreaking 17-year international clinical trial involving 889 colon cancer patients shows that structured exercise programs reduce cancer recurrence risk by 28% and death risk by 37%.
  • The CO.21 Challenge study, published in the New England Journal of Medicine, is the first clinical trial designed specifically to test whether exercise can improve cancer survival outcomes.
  • Researchers emphasize that exercise should now be considered a standard treatment for colon cancer rather than just a quality-of-life intervention, requiring integration into healthcare systems.
  • The study involved patients with Stage 3 or high-risk Stage 2 colon cancer who completed surgery and chemotherapy, with participants following a 3-year structured exercise program of 2.5 hours weekly moderate-intensity activity.

Health Education Materials With/Out a Physical Activity Program for Patients Who Have Undergone Treatment for High-Risk Stage II or Stage III Colon Cancer

NCT00819208Active, Not RecruitingNot Applicable
Canadian Cancer Trials Group
Posted 6/2/2009

Johnson & Johnson's Pasritamig Shows Promising Anti-Tumor Activity in First-in-Human Prostate Cancer Trial

Oncology
  • Johnson & Johnson announced first-in-human Phase 1 results for pasritamig, a novel bispecific T-cell engager targeting KLK2, showing promising anti-tumor activity in metastatic castration-resistant prostate cancer patients.
  • The study demonstrated a favorable safety profile with 40% of patients experiencing no treatment-related adverse events and no treatment discontinuations due to toxicity.
  • Among 33 patients in the efficacy group, 42.4% achieved ≥50% PSA reduction with a median radiographic progression-free survival of 7.9 months.
  • The drug's convenient once-every-six-weeks outpatient dosing schedule represents a potential advantage for community-based cancer care delivery.

A Study of JNJ-78278343, a T-Cell-Redirecting Agent Targeting Human Kallikrein 2 (KLK2), for Advanced Prostate Cancer

NCT04898634Active, Not RecruitingPhase 1
Janssen Research & Development, LLC
Posted 7/13/2021

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