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Clinical Trial News

Tenecteplase Investigated for Preventing Myocardial Infarction Post-PCI

  • A randomized controlled trial is set to evaluate intracoronary tenecteplase (TNK) for preventing periprocedural myocardial infarction (PMI) in CAD patients undergoing PCI.
  • The study will enroll 864 CAD patients with evidence of eroded plaques confirmed by IVUS, randomizing them to either TNK or saline solution post-balloon angioplasty.
  • The primary outcome is the incidence of PCI-related MI, defined by elevated high-sensitivity cardiac troponin I levels, with secondary endpoints including MACE and angiographic flow.
  • Recruitment is planned across multiple centers in China from August 2024 to August 2025, aiming to reduce PMI incidence and improve outcomes after PCI.

Novartis Highlights Extended Scemblix Data in CML and Kisqali Results in Early Breast Cancer at ASH and SABCS

• Scemblix (asciminib) demonstrates favorable safety and tolerability in newly diagnosed chronic myeloid leukemia in chronic phase (CML-CP) patients after 96 weeks, based on the Phase 3 ASC4FIRST study. • A late-breaking 4-year analysis of Kisqali (ribociclib) from the Phase III NATALEE trial shows distant disease-free survival benefits in key subgroups with HR+/HER2- early breast cancer. • Novartis is presenting data from over 65 abstracts at the American Society of Hematology (ASH) Annual Meeting and the San Antonio Breast Cancer Symposium (SABCS), showcasing advancements in hematologic diseases and cancers.

FDA Accepts GSK's Blenrep Combinations for Relapsed/Refractory Multiple Myeloma Treatment

  • The FDA has accepted GSK's Biologics License Application for Blenrep (belantamab mafodotin) combined with BorDex and PomDex.
  • The application targets multiple myeloma patients who have undergone at least one prior line of therapy, potentially redefining treatment.
  • The acceptance is based on DREAMM-7 and DREAMM-8 phase III trials, demonstrating significant improvements in progression-free survival.
  • The FDA has set a Prescription Drug User Fee Act action date of July 23, 2025, for the Blenrep combinations.

Blenrep Combination Therapy Gains Regulatory Traction for Multiple Myeloma

  • The NMPA of China has accepted for review GSK's NDA for Blenrep (belantamab mafodotin) combined with bortezomib and dexamethasone (BVd) for relapsed or refractory multiple myeloma.
  • This regulatory filing is supported by the DREAMM-7 phase III trial, demonstrating statistically significant improvements in overall survival compared to daratumumab plus bortezomib and dexamethasone (DVd).
  • The FDA has also accepted for review Blenrep combinations with bortezomib plus dexamethasone (BVd) and pomalidomide plus dexamethasone (BPd), with a decision expected by July 23, 2025.
  • These submissions mark significant steps toward redefining multiple myeloma treatment at or after first relapse, potentially offering more efficacious options with manageable side effects.

Truqap plus Abiraterone and ADT Improves rPFS in PTEN-Deficient Metastatic Hormone-Sensitive Prostate Cancer

  • The CAPItello-281 Phase III trial evaluated Truqap in combination with abiraterone and ADT for metastatic hormone-sensitive prostate cancer (mHSPC) with PTEN deficiency.
  • Results showed a statistically significant improvement in radiographic progression-free survival (rPFS) compared to abiraterone and ADT alone in this patient population.
  • The safety profile of Truqap in combination with abiraterone and ADT was consistent with the known profiles of each medicine.
  • AstraZeneca plans to present the data at an upcoming medical meeting and share it with global regulatory authorities.

Vir Biotechnology CEO to Present at Major Healthcare Conferences in Early 2024

• Vir Biotechnology's CEO Marianne De Backer will present at the 43rd Annual J.P. Morgan Healthcare Conference on January 14, 2024, highlighting the company's clinical-stage portfolio and strategic direction.
• The biopharmaceutical company is also scheduled to participate in a fireside chat at the 7th Annual Evercore ISI HealthCONx Conference on December 3, 2023, providing insights into their infectious disease and oncology programs.
• Vir Biotechnology continues to advance its clinical-stage portfolio focused on chronic hepatitis delta, chronic hepatitis B infections, and multiple solid tumor indications through T-cell engager technology.

Nasal Polyposis: Emerging Therapies and Clinical Trial Updates

• Several companies are actively developing novel therapies for nasal polyposis, showing promising advancements in treatment options. • Key players like GlaxoSmithKline, Sanofi, Regeneron, and AstraZeneca are progressing with therapies such as Fasenra, Tezepelumab and Dupixent. • Phase 3 trial data for Tezspire (tezepelumab-ekko) demonstrated a significant reduction in nasal polyp size and nasal congestion. • Biologics targeting inflammatory pathways are emerging as promising therapies for refractory cases of nasal polyposis.

Advancements in Clinical Trials for Fabry Disease, C. difficile Infections, and Mydriasis

• Clinical trials are actively progressing for Fabry Disease, with companies like Idorsia and Sanofi Genzyme developing novel therapies. • Emerging treatments like Venglustat and Pegunigalsidase alfa are expected to significantly impact the Fabry Disease market in the coming years. • Research and development efforts are also focused on Clostridium Difficile Infections, with Vedanta Biosciences leading Phase 3 trials for VE303. • Mydriasis treatments are advancing, with companies like Eyenovia exploring solutions like MYDCOMBI for pupil dilation.

Rising Lung Cancer Rates Among Young Adults Prompt Shift to Precision Oncology Approaches

  • Alarming increase in lung cancer cases among young adults and non-smokers signals a significant shift in disease demographics and risk factors.
  • Envita Medical Center implements advanced precision oncology model utilizing thousands of biomarkers to develop personalized treatment plans for improved patient outcomes.
  • Environmental exposures and infections emerge as crucial risk factors, highlighting the need for expanded early screening protocols beyond traditional smoking-related criteria.

FDA Approves Roche's PATHWAY HER2 Test as Companion Diagnostic for Biliary Tract Cancer

• The FDA has approved Roche's PATHWAY HER2 (4B5) test as a companion diagnostic for identifying biliary tract cancer (BTC) patients eligible for ZIIHERA treatment. • This approval marks the first validated HER2 test for BTC, offering a standardized method to determine eligibility for HER2-targeted therapies. • ZIIHERA is the first FDA-approved treatment for previously treated, unresectable, or metastatic HER2-positive biliary tract cancer, addressing a critical unmet need. • The PATHWAY HER2 (4B5) test expands its clinical utility, now aiding in personalized medicine for BTC patients who may benefit from targeted therapy.

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