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Clinical Trial News

Decitabine Plus CHAG Regimen Shows Promise in Relapsed/Refractory AML

  • A study shows that combining decitabine with the CHAG priming regimen yields a high complete remission rate (74.2%) in relapsed/refractory AML patients.
  • The overall response rate was 82.2%, with manageable side effects and no treatment-related deaths, suggesting a potential new treatment strategy.
  • The median relapse-free survival was 4.3 months, and the median overall survival was 7.75 months, warranting further investigation with larger studies.
  • Decitabine combined with CHAG may offer deeper remissions, with a significant number of patients achieving MRD-negative status after treatment.

AstraZeneca's Prostate Cancer Drug Demonstrates Promising Phase III Results

  • AstraZeneca's prostate cancer drug has shown promising Phase III results, indicating a potential advancement in treatment.
  • The drug's efficacy could significantly impact the management of prostate cancer, offering new hope for patients.
  • Further details on the specific outcomes and benefits are anticipated to be released, pending comprehensive data analysis.
  • The positive results may lead to changes in treatment protocols and improved patient outcomes in the future.

FDA Approves Roche's Companion Diagnostic for HER2-Targeted Therapy in Biliary Tract Cancer

• The FDA has approved Roche's Pathway anti-HER2/neu antibody test as a companion diagnostic for biliary tract cancer (BTC). • This is the first FDA-approved diagnostic to identify HER2-positive BTC patients eligible for Jazz Pharmaceuticals' Ziihera (zanidatamab-hrii). • The test utilizes immunohistochemistry (IHC) on Roche's Ventana BenchMark system, standardizing HER2 assessment and reducing variability. • Biliary tract cancer has a poor prognosis, and this approval marks a step forward in personalized medicine for BTC patients.

Hanmi Pharmaceutical Advances BH3120 Immunotherapy Trials Targeting Solid Tumors

  • Hanmi Pharmaceutical presented clinical trial progress for BH3120, a novel dual-targeting immunotherapy, at the SITC conference.
  • Phase 1 trials are underway in the US and South Korea, evaluating BH3120 as a monotherapy for advanced or metastatic solid tumors.
  • A separate Phase 1 trial is assessing BH3120 in combination with MSD's KEYTRUDA® (pembrolizumab) for advanced solid tumors.
  • BH3120 leverages Hanmi's Pentambody platform to target PD-L1 on cancer cells and 4-1BB on immune cells, enhancing tumor cell recognition and killing.

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.

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