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Clinical Trial News

STRIDE Regimen Shows Unprecedented 5-Year Survival in Unresectable Hepatocellular Carcinoma

  • The STRIDE regimen (single tremelimumab with regular interval durvalumab) demonstrated a 19.6% overall survival rate at 5 years in patients with unresectable hepatocellular carcinoma (uHCC).
  • STRIDE sustained an overall survival benefit compared to sorafenib, with a median OS of 16.43 months versus 13.77 months, respectively, and a hazard ratio of 0.76.
  • Patients treated with STRIDE experienced deeper tumor responses and enhanced overall survival, especially those achieving disease control, compared to those treated with sorafenib.
  • The safety profile of STRIDE remained consistent with previous analyses, showing no new serious treatment-related adverse events at the 5-year data cut-off.

Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma

NCT03298451Active, Not RecruitingPhase 3
AstraZeneca
Posted 10/11/2017

ESMO 2024: Immunotherapy and Novel Antibody-Drug Conjugate Show Promise in Gynecologic Cancers

  • Pembrolizumab plus chemoradiotherapy significantly improved overall survival in high-risk locally advanced cervical cancer, establishing a new standard of care.
  • In high-risk endometrial cancer, pembrolizumab added to chemotherapy after surgery showed clinically meaningful improvements in disease-free survival specifically in dMMR tumors.
  • TORL-1-23, a novel antibody-drug conjugate targeting claudin 6, demonstrated promising antitumor activity and tolerability in heavily pretreated ovarian and endometrial cancers.
  • Combination therapies and personalized medicines, including neoantigen vaccines, hold potential for future advancements in gynecologic cancer treatment.

FDA Clears Apple Watch Feature for Sleep Apnea Detection

  • The FDA has cleared Apple's new sleep apnea detection feature for Apple Watch Series 9, Series 10, and Ultra 2, accessible via a software update.
  • The feature monitors breathing disturbances using the Apple Watch's accelerometer, alerting users to consistent signs of moderate or severe sleep apnea.
  • Experts suggest the technology could increase early detection and healthcare visits, potentially reducing long-term healthcare costs associated with untreated sleep apnea.
  • While promising, healthcare professionals advise users to confirm Apple Watch data with a formal diagnosis before pursuing treatments.

FDA Approves Ebglyss (lebrikizumab-lbkz) for Moderate-to-Severe Atopic Dermatitis

  • The FDA has approved Eli Lilly's Ebglyss (lebrikizumab-lbkz) for treating moderate-to-severe atopic dermatitis in adults and children 12 years and older.
  • Ebglyss, a biologic therapy, targets the IL-13 pathway, addressing systemic inflammation linked to eczema symptoms like dry, itchy skin.
  • Clinical trials (ADvocate 1, ADvocate 2, ADhere) demonstrated significant improvements in skin clearance and itch relief compared to placebo.
  • Common adverse events included eye inflammation, injection site reactions, and shingles, with safety profiles consistent across studies.

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

  • The FDA has approved Eli Lilly's Ebglyss (lebrikizumab) for treating moderate-to-severe atopic dermatitis in adults and children 12 years and older when topical treatments are insufficient.
  • Ebglyss, a monoclonal antibody targeting IL-13, offers a less frequent, once-monthly maintenance dosing schedule compared to existing biologics like Dupixent and Adbry.
  • Clinical trials demonstrated that 38% of patients achieved clear or almost-clear skin at 16 weeks with Ebglyss, and 77% maintained these results at one year with monthly dosing.
  • Ebglyss also provided significant itch relief, with 43% of participants reporting relief at 16 weeks, and 85% maintaining relief at one year with monthly maintenance dosing.

AstraZeneca's Imfinzi Shows Positive Results in Bladder Cancer Trial

  • AstraZeneca's Imfinzi demonstrated a statistically significant improvement in overall survival for patients with locally advanced, unresectable bladder cancer who did not progress on prior platinum-based chemotherapy.
  • The Phase III NIAGARA trial results support Imfinzi as a potential new treatment option, addressing a critical unmet need in this patient population.
  • The safety profile of Imfinzi in this trial was consistent with previous studies, reinforcing its established tolerability.
  • These findings could potentially change the standard of care for patients with advanced bladder cancer, offering a new hope for improved outcomes.

FDA Approves Biotronik Lead and Catheter for Left Bundle Branch Area Pacing

  • The FDA has approved Biotronik's lead and catheter system for left bundle branch area pacing (LBBAP), offering a new option for physiological pacing.
  • LBBAP aims to improve heart failure outcomes by pacing the heart in a more natural way compared to traditional right ventricular pacing.
  • The new system provides physicians with specialized tools designed to facilitate accurate and stable lead placement in the left bundle branch area.
  • This approval expands the options available for patients needing pacing therapy, potentially reducing the risk of heart failure progression.

Medical Marijuana Use Linked to Rapid Improvements in Quality of Life, Study Finds

  • A new study reveals that medical marijuana users experience rapid and significant improvements in health-related quality of life within the first three months of use.
  • Participants reported notable gains in pain reduction, increased social functioning, and enhanced emotional well-being, indicating clinically meaningful change.
  • The research highlights the potential of medical cannabis to improve physical and emotional health, especially among younger individuals, warranting further investigation.
  • The study supports greater access to and coverage of medical cannabis treatments, providing evidence for informed decision-making by patients and healthcare providers.

Evaxion's Personalized Cancer Vaccine EVX-01 Shows Promise in Phase 2 Melanoma Trial

  • Evaxion Biotech's EVX-01, combined with pembrolizumab, demonstrated a 69% Overall Response Rate in advanced melanoma patients in a Phase 2 trial.
  • The trial showed tumor reduction in 15 out of 16 patients, highlighting the potential of EVX-01 as a melanoma treatment.
  • 79% of EVX-01's vaccine targets triggered a targeted immune response, validating Evaxion's AI-Immunology™ platform.
  • A positive correlation was observed between the AI platform's predictions and neoantigen immune response (p=0.00013), confirming its predictive capabilities.

A Single Arm Trial Evaluating the Efficacy and Safety of EVX-01 in Combination With Pembrolizumab in Adults With Unresectable or Metastatic Melanoma

NCT05309421RecruitingPhase 2
Evaxion Biotech A/S
Posted 8/30/2022

Personalized Neo-antigen Vaccine in Advanced Solid Tumors (NeoPepVac)

NCT03715985Unknown StatusPhase 1
Herlev Hospital
Posted 1/28/2019

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