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Clinical Trial News

Novartis' Scemblix Shows Promising 96-Week Data in First-Line CML Treatment

• Scemblix (asciminib) demonstrates favorable safety and tolerability compared to investigator-selected TKIs in newly diagnosed CML-CP patients. • The ASC4FIRST Phase III study's 96-week results support Scemblix as a potential first-line treatment option for chronic myeloid leukemia. • Novartis is presenting over 65 abstracts at ASH and SABCS, highlighting their commitment to cancer and blood disorder research.

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

• The FDA has approved Roche's PATHWAY HER2 (4B5) test to identify biliary tract cancer (BTC) patients eligible for ZIIHERA, a HER2-targeted therapy. • This marks the first FDA-approved companion diagnostic for HER2 status assessment in BTC, addressing a critical gap in personalized medicine for this cancer. • Biliary tract cancer has a poor prognosis due to late diagnosis and limited treatment options, making this approval a significant step forward. • The PATHWAY HER2 test expands its clinical utility, previously used for breast cancer, to now guide HER2-targeted therapy in BTC patients.

FDA Approves BridgeBio's Attruby, Setting Up Competition with Pfizer's Vyndamax in ATTR-CM Market

• The FDA has approved BridgeBio Pharma's Attruby (acoramidis) for transthyretin amyloidosis cardiomyopathy (ATTR-CM), a heart condition leading to heart failure and death. • Attruby demonstrated a 42% reduction in composite all-cause mortality and recurrent cardiovascular-related hospitalizations compared to placebo in the ATTRibute-CM trial. • BridgeBio is launching Attruby at a list price of $18,759 for a 28-day supply, positioning it to compete with Pfizer's Vyndamax, which dominates the ATTR-CM market. • Several other companies, including Alnylam and AstraZeneca/Ionis, are also developing therapies for ATTR, potentially disrupting the current treatment landscape.

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.

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