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Clinical Trial News

Daiichi Sankyo and Merck Withdraw Patritumab Deruxtecan BLA After Phase 3 Trial Fails to Meet Overall Survival Endpoint

  • Daiichi Sankyo and Merck voluntarily withdrew their Biologics License Application for patritumab deruxtecan in EGFR-mutated NSCLC after the confirmatory HERTHENA-Lung02 Phase 3 trial failed to demonstrate statistically significant overall survival benefit.
  • The HER3-directed antibody drug conjugate showed previously reported statistically significant progression-free survival in the Phase 3 trial, but this was insufficient for regulatory approval without the overall survival benefit.
  • Despite the setback, companies plan to conduct further biomarker analyses to identify patients who may benefit from the treatment and continue development across 15 cancer types.
  • The decision highlights ongoing challenges in treating EGFR-mutated non-small cell lung cancer in second-line and later settings, where significant unmet medical needs persist.

HERTHENA-Lung01: Patritumab Deruxtecan in Subjects With Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer

NCT04619004Active, Not RecruitingPhase 2
Daiichi Sankyo
Posted 2/2/2021

HERTHENA-Lung02: A Study of Patritumab Deruxtecan Versus Platinum-based Chemotherapy in Metastatic or Locally Advanced EGFRm NSCLC After Failure of EGFR TKI Therapy

NCT05338970Active, Not RecruitingPhase 3
Daiichi Sankyo
Posted 7/8/2022

A Study Comparing BL-B01D1 With Topotecan in Patients With Recurrent Small Cell Lung Cancer

NCT06500026RecruitingPhase 3
Sichuan Baili Pharmaceutical Co., Ltd.
Posted 8/7/2024

Genor Biopharma Secures NMPA Approval for Lerociclib CDK4/6 Inhibitor in Advanced Breast Cancer

Drug ApprovalTargeted TherapyOncology
  • Genor Biopharma Holdings Ltd. received China National Medical Products Administration (NMPA) approval for Lerociclib (GB491), a novel CDK4/6 inhibitor for advanced breast cancer treatment.
  • The oral bioavailable drug targets hormone receptor-positive, human epidermal growth factor receptor 2-negative locally advanced or metastatic breast cancer in adult patients.
  • Lerociclib will be used in combination with aromatase inhibitors as initial therapy or with fulvestrant following endocrine therapy progression.
  • The approval represents a significant milestone resulting from successful collaboration between Genor Biopharma and G1 Therapeutics Inc.

China's Mazdutide Achieves Breakthrough as World's First GCG/GLP-1 Dual Receptor Agonist for Weight Loss

  • Chinese researchers published Phase III clinical trial results for Mazdutide in the New England Journal of Medicine, marking the world's first GCG/GLP-1 dual receptor agonist for weight management.
  • The drug demonstrated significant weight-loss effects along with additional metabolic benefits including reductions in waist circumference, blood pressure, blood lipids and uric acid levels.
  • Mazdutide addresses obesity through dual mechanisms of appetite suppression and metabolic acceleration by targeting both GCG and GLP-1 receptors, offering advantages over single-target therapies.
  • The breakthrough positions China's drug development capabilities at world-class standards and supports the national Healthy China 2030 initiative amid rising obesity rates.

A Phase 3 Study to Evaluate the Efficacy of XW003 in Adults With Overweight or Obesity

NCT05813795CompletedPhase 3
Hangzhou Sciwind Biosciences Co., Ltd.
Posted 4/5/2023

Court Rulings Shape Patent Safe Harbor Provision's Impact on Pharmaceutical Development

  • Recent legal analyses examine the scope of the patent safe harbor provision under 35 U.S.C. § 271(e)(1) and its critical role in protecting pharmaceutical development activities from patent infringement claims.
  • Courts are actively interpreting what constitutes "reasonably related" activities under the statute, balancing patent rights with public interest in advancing medical research and ensuring timely therapy access.
  • Legal disputes highlight ongoing complexities in determining the boundaries of this exemption, particularly regarding activities performed during drug development and FDA regulatory approval processes.

Disc Medicine Presents Comprehensive Hematology Portfolio Data at EHA 2025 Congress

Monoclonal Antibody
  • Disc Medicine will present data from multiple hematology programs at the European Hematology Association 2025 Congress, including long-term extension trial results for bitopertin in erythropoietic protoporphyria.
  • The company will showcase additional durability data from Phase 1b studies of DISC-0974 in myelofibrosis anemia patients and new data from DISC-3405 studies in healthy volunteers.
  • Management plans to host a corporate update conference call on June 16 to review the presented data as the company progresses toward major milestones in the second half of 2025.

Oncology Clinical Trials Embrace AI and Digital Solutions to Enhance Patient-Centric Approaches

AI
  • Industry experts at the 15th Annual Clinical Trial in Oncology West Coast conference highlighted AI's transformative potential in matching the right patient populations with appropriate therapies to improve trial success rates.
  • Telehealth integration and wearable devices are being implemented to reduce patient burden and improve trial adherence, with virtual consent conferences and remote monitoring showing promise in oncology studies.
  • Pharmaceutical companies are prioritizing advancement of therapeutic agents with compelling early clinical signals while implementing "white glove" support approaches to enhance site and patient engagement.
  • Digital solutions face implementation challenges, with only 16% of breast cancer study participants using wearables, emphasizing the need for better adherence strategies and addressing privacy concerns.

Noxopharm Receives Ethics Approval for First-in-Human Trial of SOF-SKN in Cutaneous Lupus

  • Noxopharm has secured Human Research Ethics Committee approval for the HERACLES clinical trial, marking the first-in-human study of SOF-SKN for chronic inflammatory diseases.
  • The Phase 1 trial will evaluate SOF-SKN's safety profile at four different concentrations specifically for cutaneous lupus erythematosus treatment.
  • The study will be conducted in Melbourne by Doherty Clinical Trials, leveraging Australia's expertise in inflammatory disease research and early-phase clinical trials.
  • This milestone represents the first clinical trial from Noxopharm's Sofra technology platform, following successful preclinical testing and regulatory preparation.

Innovent Initiates Phase 3 Trial of Picankibart for Psoriasis Patients with Inadequate IL-17 Response

Monoclonal Antibody
  • Innovent Biologics has dosed the first participant in a Phase 3 study evaluating picankibart, an anti-IL-23p19 antibody, for psoriasis patients who had inadequate response to prior IL-17 inhibitor treatment.
  • The randomized, double-blind trial will enroll approximately 310 participants to compare picankibart against continued IL-17 monoclonal antibody therapy, with the primary endpoint being skin clearance at week 16.
  • Previous Phase 2 data showed that 64.6% of patients with inadequate biologic response achieved skin lesion clearance after switching to picankibart, with response rates remaining stable through week 44.
  • The study addresses a critical unmet need, as real-world data indicates 28.5% of psoriasis patients discontinue IL-17 therapy due to primary failure and 24.3% experience secondary failure.

A Study of IBI112 in Chinese Patients With Psoriasis Who Were Previously Treated With Biologics

NCT05970978CompletedPhase 2
Innovent Biologics (Suzhou) Co. Ltd.
Posted 8/28/2023

A Study of Switching to Picankibart in Chinese Patients With Plaque Psoriasis With an Inadequate Response to Interleukin-17 Monoclonal Antibody Therapy

NCT06945107RecruitingPhase 3
Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.
Posted 5/27/2025

Implantable Biobattery Achieves 99.6% Tumor Reduction in Breakthrough Drug-Free Cancer Treatment

  • A novel implantable biobattery developed by researchers at University of Wollongong and Jilin University reduced tumor size from over 1,000 mm³ to just 4 mm³ in 14 days, achieving a 99.6% reduction.
  • The device works by releasing zinc and manganese ions that create a hostile microenvironment for cancer cells while stimulating the body's immune system to target and destroy tumors.
  • This breakthrough represents a potential paradigm shift toward drug-free cancer immunotherapy, offering targeted treatment with reduced side effects compared to conventional chemotherapy and radiation.
  • The research team is now advancing toward preclinical and clinical trials to translate this laboratory success into real-world patient treatments.

Japan Launches World's First Clinical Trials for Artificial Blood in 2025

  • Japan will begin the world's first clinical trials for artificial blood by March 2025, led by Nara Medical University, marking a potential breakthrough in emergency medicine.
  • The artificial blood uses hemoglobin vesicles from expired donations encased in protective shells, eliminating blood type compatibility requirements and offering a two-year shelf life.
  • The technology addresses Japan's critical blood shortage crisis driven by an aging population and declining birth rates, with potential global applications.
  • If successful, the artificial blood could enter clinical use by 2030, providing a universal blood substitute for emergency situations and remote areas.

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