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Clinical Trial News

BMS-986012 Plus Nivolumab Shows Promise in Extensive-Stage Small Cell Lung Cancer

  • Interim analysis of a phase 2 trial reveals that adding BMS-986012 to nivolumab and chemotherapy shows a modest PFS benefit in ES-SCLC.
  • The combination therapy also demonstrated promising overall survival (OS) signals, particularly in patients with brain metastases at baseline.
  • The safety profile of the BMS-986012 regimen was manageable, with pruritus being the most notable difference compared to nivolumab plus chemotherapy.
  • Planning is underway for a phase 3 study to confirm these findings and further evaluate the efficacy of BMS-986012 in ES-SCLC.

A Study of BMS-986012 in Combination With Carboplatin, Etoposide, and Nivolumab as First-line Therapy in Extensive-stage Small Cell Lung Cancer

NCT04702880Active, Not RecruitingPhase 2
Bristol-Myers Squibb
Posted 3/17/2021

Nutrition Remains Critical in MASH Management Despite New Drug Approval, Experts Emphasize

  • Despite the recent FDA approval of resmetirom for MASH treatment, nutrition and weight loss continue to play a fundamental role in disease management and patient outcomes.
  • Dietary interventions must be personalized to account for cultural differences and individual patient needs, with reduced sugar and carbohydrate intake being vital for liver health.
  • A multidisciplinary approach involving endocrinologists and nutritionists is crucial for optimal patient care, particularly in cases of advanced liver disease.

FDA Approves Eli Lilly's Ebglyss (Lebrikizumab) for Moderate-to-Severe Atopic Dermatitis

  • The FDA has approved Eli Lilly's Ebglyss (lebrikizumab-lbkz) for treating moderate-to-severe atopic dermatitis in patients 12 years and older.
  • Ebglyss, a targeted IL-13 inhibitor, offers a new first-line biologic option for patients whose eczema is not well-controlled with topical treatments.
  • Clinical trials demonstrated that Ebglyss significantly improved skin clearance and itch relief, with many patients maintaining results after one year.
  • Ebglyss is expected to be available in the U.S. in the coming weeks, with Lilly offering patient support programs to ensure access.

Long-term Safety and Efficacy Study of Lebrikizumab (LY3650150) in Participants With Moderate-to-Severe Atopic Dermatitis (ADjoin)

NCT04392154CompletedPhase 3
Eli Lilly and Company
Posted 6/15/2020

A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer

NCT03701334Active, Not RecruitingPhase 3
Novartis Pharmaceuticals
Posted 12/7/2018

Evaluation of the Efficacy and Safety of Lebrikizumab (LY3650150) in Moderate to Severe Atopic Dermatitis (ADvocate1)

NCT04146363CompletedPhase 3
Eli Lilly and Company
Posted 9/24/2019

Efficacy and Safety of Benralizumab in EGPA Compared to Mepolizumab.

NCT04157348Active, Not RecruitingPhase 3
AstraZeneca
Posted 10/29/2019

Safety and Efficacy of Lebrikizumab (LY3650150) in Combination With Topical Corticosteroid in Moderate-to-Severe Atopic Dermatitis.

NCT04250337CompletedPhase 3
Eli Lilly and Company
Posted 2/3/2020

Evaluation of the Efficacy and Safety of Lebrikizumab (LY3650150) in Moderate to Severe Atopic Dermatitis

NCT04178967CompletedPhase 3
Eli Lilly and Company
Posted 10/29/2019

Bicara, Zenas, and MBX Bio Launch IPOs, Raising $703M for Clinical Trials

  • Bicara Therapeutics raised $315 million to fund a pivotal trial of ficerafusp alfa for head and neck squamous cell carcinoma (HNSCC).
  • Zenas Biopharma secured $225 million to advance obexelimab, a bifunctional antibody, through Phase 3 trials for IgG4-related disease and Phase 2 trials for multiple sclerosis, lupus, and wAIHA.
  • MBX Biosciences garnered $163 million to support clinical trials of MBX 2109 for chronic hypoparathyroidism and MBX 1416 for post-bariatric hypoglycemia.

Japan Approves CSL and Arcturus Therapeutics' Updated sa-mRNA COVID-19 Vaccine Targeting JN.1 Variant

  • Japan's MHLW has approved CSL and Arcturus Therapeutics' updated self-amplifying mRNA (sa-mRNA) COVID-19 vaccine, KOSTAIVE®, for adults 18 and older.
  • The updated vaccine targets the JN.1 lineage of Omicron subvariants, aligning with WHO recommendations for the 2024/2025 immunization program.
  • Meiji Seika Pharma, CSL's exclusive partner in Japan, will distribute the vaccine in time for the October COVID-19 vaccination campaign.
  • Clinical data supports the vaccine's safety and superior immunogenicity against Omicron BA 4/5 compared to conventional mRNA boosters, with immunity lasting up to one year.

Belzutifan Shows Durable PFS and ORR in Advanced Clear Cell RCC

  • Belzutifan maintained improved progression-free survival (PFS) and objective response rate (ORR) compared to everolimus in previously treated advanced clear cell RCC.
  • The median PFS was 5.6 months with belzutifan vs 5.6 months with everolimus; however, belzutifan did not outperform everolimus in overall survival (OS).
  • Belzutifan led to a higher ORR than everolimus (22.7% vs 3.5%), with durable responses lasting over two years in some patients.
  • The safety profile of belzutifan was comparable to everolimus, with most treatment-related adverse events having a quick onset.

A Study of Belzutifan (MK-6482) Versus Everolimus in Participants With Advanced Renal Cell Carcinoma (MK-6482-005)

NCT04195750Active, Not RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 2/27/2020

Novel Strategies Emerge to Optimize Treatment in EGFR-Mutant NSCLC

  • Research at ESMO Congress 2024 highlights the importance of understanding resistance mechanisms in EGFR-mutant NSCLC to improve treatment outcomes.
  • Amivantamab plus chemotherapy demonstrates a deepening survival benefit post-osimertinib progression, marking it as a potentially effective second-line regimen.
  • Zipalertinib shows promising anti-tumor activity in EGFR exon 20 insertion-mutated NSCLC patients who progressed on amivantamab, with manageable toxicity.
  • Molecular resistance testing at disease progression is crucial for personalized treatment choices, including chemotherapy, antibody-drug conjugates, and other combinations.

Digital Medicine Support Models Tested for Alcohol Use Disorder

A 12-month randomized controlled trial evaluated the effectiveness of various digital medicine support models in reducing heavy drinking days and improving quality of life among individuals with mild-to-moderate Alcohol Use Disorder (AUD). The study found significant reductions in heavy drinking days across all groups, with the clinically integrated group showing the most substantial decrease. However, no significant differences in effectiveness were observed among the self-monitored, peer-supported, and clinically integrated groups. The study highlights the potential of digital health interventions in addressing AUD, emphasizing the importance of patient preferences and the need for further research to optimize these interventions.

Mobile Health for Alcohol Use Disorders in Clinical Practice

NCT04011644CompletedNot Applicable
University of Wisconsin, Madison
Posted 3/23/2020

ARANOTE Trial: Darolutamide Plus ADT Significantly Improves Outcomes in mHSPC

  • The Phase III ARANOTE trial investigated darolutamide plus androgen deprivation therapy (ADT) in metastatic hormone-sensitive prostate cancer (mHSPC).
  • Darolutamide combined with ADT demonstrated a statistically significant improvement in outcomes compared to ADT alone in mHSPC patients.
  • Bayer presented comprehensive analysis from the ARANOTE trial at the European Society for Medical Oncology (ESMO) Congress 2024.
  • The ARANOTE trial's design and objectives were presented, highlighting the assessment of darolutamide and ADT versus ADT alone.

ESMO 2024: Novel Therapies and Individualized Treatments Highlighted for Lung Cancer

  • MARIPOSA-2 data is expected to confirm the benefits of novel targeted therapy combinations in lung cancer, showing consistent improvement across efficacy endpoints.
  • Ongoing advancements in targeted therapies, immunotherapy combinations, and antibody-drug conjugates are anticipated to be showcased at ESMO 2024.
  • Future directions in lung cancer treatment aim towards individualized therapies, focusing on both efficacy and improved quality-of-life for patients.

A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer

NCT04487080Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 9/30/2020

A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non- Small Cell Lung Cancer After Osimertinib Failure

NCT04988295Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 11/17/2021

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