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Clinical Trial News

FDA to Review Belantamab Mafodotin and Linvoseltamab Combinations for Multiple Myeloma

  • The FDA has accepted a BLA for belantamab mafodotin combinations with bortezomib plus dexamethasone and pomalidomide plus dexamethasone for multiple myeloma treatment.
  • Regeneron's linvoseltamab BLA resubmission has been accepted by the FDA, with a decision expected by July 10, 2025, for relapsed/refractory multiple myeloma.
  • Clinical trials DREAMM-7 and DREAMM-8 support the belantamab mafodotin BLA, while LINKER-MM1 supports the linvoseltamab BLA, showcasing improved progression-free survival.
  • Both belantamab mafodotin and linvoseltamab are under review by other regulatory authorities, potentially expanding treatment options for multiple myeloma patients.

A Trial to Learn How Well Linvoseltamab Works Compared to the Combination of Elotuzumab, Pomalidomide and Dexamethasone for Adult Participants With Relapsed/Refractory Multiple Myeloma

NCT05730036RecruitingPhase 3
Regeneron Pharmaceuticals
Posted 9/18/2023

Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma

NCT04246047Active, Not RecruitingPhase 3
GlaxoSmithKline
Posted 5/7/2020

A Study to Assess the Anti-Tumor Activity and Safety of Odronextamab in Adult Patients With B-cell Non-Hodgkin Lymphoma Who Have Been Previously Treated With Other Cancer Therapies

NCT03888105RecruitingPhase 2
Regeneron Pharmaceuticals
Posted 11/13/2019

A Study to Examine the Effects of Novel Therapy Linvoseltamab in Combination With Other Cancer Treatments for Adult Patients With Multiple Myeloma That is Resistant to Current Standard of Care Treatments

NCT05137054RecruitingPhase 1
Regeneron Pharmaceuticals
Posted 8/17/2022

Phase 1/2 Study of REGN5458 in Adult Patients With Relapsed or Refractory Multiple Myeloma

NCT03761108RecruitingPhase 1
Regeneron Pharmaceuticals
Posted 1/23/2019

Study to Investigate the Safety and Tolerability of Odronextamab in Patients With CD20+ B-Cell Malignancies

NCT02290951Active, Not RecruitingPhase 1
Regeneron Pharmaceuticals
Posted 1/9/2015

A Trial to Learn if Odronextamab is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Different Types of Chemotherapy for Participants With Follicular Lymphoma

NCT06091254RecruitingPhase 3
Regeneron Pharmaceuticals
Posted 12/12/2023

Belantamab Mafodotin Plus Pomalidomide and Dexamethasone (Pd) Versus Bortezomib Plus Pd in Relapsed/Refractory Multiple Myeloma

NCT04484623Active, Not RecruitingPhase 3
GlaxoSmithKline
Posted 10/1/2020

Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)

NCT04501666CompletedPhase 3
Galderma R&D
Posted 9/11/2020

A Trial to Learn if Odronextamab Combined With Chemotherapy is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Chemotherapy for Adult Participants With Follicular Lymphoma

NCT06097364RecruitingPhase 3
Regeneron Pharmaceuticals
Posted 11/14/2023

Injectable Oxygen Microbubbles Show Promise in Treating Hypoxemia and Preventing Organ Damage

  • Researchers have developed injectable oxygen microbubbles for rapid oxygen delivery during critical moments of cardiac or respiratory arrest, addressing the limitations of traditional methods.
  • In preclinical testing, pH-sensitive microbubbles delivered precise amounts of oxygen, significantly improving survival and preventing catastrophic organ damage in hypoxemic conditions.
  • The microbubbles are engineered with a solid-like polymer shell that dissolves into tiny soluble molecules when triggered by blood pH, ensuring rapid dissolution and preventing blood-flow obstruction.
  • This innovative approach represents a potential platform technology for delivering various gases in focused amounts, opening possibilities for treating other medical conditions beyond hypoxemia.

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.

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