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Clinical Trial News

FDA Finalizes Guidance on Optimizing Dosage for Oncology Therapies

  • The FDA has finalized guidance emphasizing early dose optimization in oncology drug development to minimize toxicity and improve patient outcomes.
  • The guidance encourages sponsors to engage with the FDA early, utilizing modeling to identify appropriate dosages for evaluation in clinical trials.
  • Dose optimization studies should leverage data from similar therapies and consider endpoints like overall response rate and progression-free survival.
  • The FDA may place clinical holds on protocols with inadequately supported dosages, underscoring the importance of thorough dose exploration.

FDA Approves Roche's Ocrevus (Zunovo) for Multiple Sclerosis

  • The U.S. Food and Drug Administration (FDA) has approved Roche's Ocrevus (Zunovo) for the treatment of multiple sclerosis, offering a new therapeutic option.
  • Ocrevus, developed by Roche, represents a significant advancement in the treatment landscape for patients with relapsing and progressive forms of MS.
  • Roche's Ocrevus is part of a broad portfolio of pharmaceutical products targeting various disease areas, including immunology and neuroscience.
  • The approval underscores Roche's commitment to developing innovative medicines and diagnostic tools across a range of therapeutic areas.

FDA Approves Lilly's EBGLYSS (lebrikizumab-lbkz) for Atopic Dermatitis Treatment in Patients 12 and Older

  • The FDA has approved Eli Lilly's EBGLYSS (lebrikizumab-lbkz) for treating moderate-to-severe atopic dermatitis in patients aged 12 and older, offering a new targeted treatment option.
  • EBGLYSS, an IL-13 inhibitor, is administered via injection with an initial dose followed by bi-weekly maintenance, potentially shifting to monthly injections based on clinical response.
  • Clinical trials (ADvocate 1, ADvocate 2, and ADhere) supported the approval, demonstrating EBGLYSS's effectiveness in achieving clear or almost clear skin in treated patients.
  • Lilly is preparing to launch EBGLYSS in the US with patient support programs, expanding its availability after approvals in the EU and Japan, with Almirall handling European commercialization.

TROP2-Directed ADCs Show Promise in Recurrent Gynecological Cancers

• Datopotamab deruxtecan (Dato-DXd) demonstrated promising outcomes in recurrent endometrial and ovarian cancers after platinum-based chemotherapy, with manageable safety profiles. • In endometrial cancer, Dato-DXd showed an ORR of 27.5% and a DCR of 85%, while in ovarian cancer, the ORR was 42.9% and the DCR was 91.4%. • Sacituzumab govitecan (Sac-TMT), another TROP2-directed ADC, showed comparable efficacy, with TROP2 expression potentially influencing treatment outcomes, particularly in ovarian cancer. • Both Dato-DXd and Sac-TMT offer hope for patients with recurrent gynecological cancers, with Dato-DXd projected to reach $6.1 billion in global annual sales by 2030.

JSKN003 Shows Promise in HER2-Positive Solid Tumors and Platinum-Resistant Ovarian Cancer

• JSKN003 demonstrated a 56.8% objective response rate in heavily pretreated patients with platinum-resistant ovarian cancer, irrespective of HER2 expression. • In HER2-positive solid tumors, JSKN003 achieved a 75% objective response rate and an 89.3% disease control rate, showcasing encouraging antitumor activity. • The bispecific antibody-drug conjugate exhibited a favorable safety profile in both studies, with manageable adverse events and no treatment-related deaths reported. • These findings support further clinical investigation of JSKN003 as a potential treatment option for advanced HER2-expressing cancers and platinum-resistant ovarian cancer.

Safety and Tolerability of JSKN003 in Chinese Subjects With Advanced Solid Tumors

NCT05744427RecruitingPhase 1
Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Posted 3/15/2023

First-In-Human Study in Subjects With Advanced or Metastatic Solid Malignant Tumors

NCT05494918CompletedPhase 1
Alphamab (Australia) Co Pty Ltd.
Posted 9/2/2022

GSK and iTeos' Belrestotug Shows Promise in NSCLC Treatment

• Belrestotug, a TIGIT inhibitor from GSK and iTeos, combined with dostarlimab, demonstrated a doubled overall response rate in PD-L1-high NSCLC patients compared to dostarlimab alone. • Interim Phase II GALAXIES Lung-201 trial data revealed a significant decrease in circulating tumor DNA (ctDNA) with the belrestotug/dostarlimab combination, suggesting a deeper response. • Belrestotug 400mg has been selected for the Phase III GALAXIES Lung-301 trial, comparing the belrestotug/Jemperli combination against Keytruda monotherapy in NSCLC. • The belrestotug combination showed increased treatment-related adverse events, indicating a need for careful monitoring and management of immune-related toxicities.

New Survey Reveals 12% of Americans Suffer from Chronic Insomnia as Sleep Health Concerns Rise

  • Recent nationwide survey by the American Academy of Sleep Medicine finds 12% of Americans are diagnosed with chronic insomnia, with highest prevalence among adults aged 25-44 years.
  • Sleep deficiency and untreated sleep disorders are linked to increased risks of cardiovascular disease, hypertension, diabetes, and other chronic conditions according to the National Heart, Lung, and Blood Institute.
  • Research shows that poor sleep patterns significantly impact cognitive function, mental health, and daily productivity, with emerging evidence connecting sleep disruption to increased risks of Alzheimer's disease and type 2 diabetes.

India ICMR Partners with Industry to Advance Phase I Clinical Trials

  • The Indian Council of Medical Research (ICMR) has formalized partnerships with industry and academic institutions to facilitate first-in-human phase one clinical trials for four novel pharmaceutical agents.
  • The collaborations will support diverse research projects, including a CAR-T cell therapy study for chronic lymphocytic leukemia and trials for a small molecule targeting multiple myeloma.
  • Four institutions across India will form a network to conduct these early-phase clinical trials, supported by infrastructure and manpower to ensure efficient trial execution.
  • According to Dr. Rajiv Bahl, establishing a phase one clinical trial infrastructure is crucial for fostering the development of indigenous molecules and innovative treatments.

WHO Approves Bavarian Nordic's Mpox Vaccine, Enhancing Global Access

  • Bavarian Nordic's mpox vaccine has received prequalification from the World Health Organization, ensuring broader global access.
  • The WHO's prequalification validates the vaccine's safety and efficacy, facilitating its procurement and distribution in resource-limited settings.
  • This approval marks a significant step in global efforts to control and prevent mpox outbreaks, especially in vulnerable populations.

Exact Sciences' Blood Test Shows Promise in Colon Cancer Detection

  • Exact Sciences' blood-based test detected 88.3% of colon cancers in a study of over 3,000 samples, demonstrating promising sensitivity.
  • The test also showed a specificity of 90.1%, correctly identifying individuals without cancer, and detected 31.2% of advanced precancers.
  • These initial results, presented at the European Society for Medical Oncology conference, suggest the test could be a competitive alternative to existing options.
  • A larger, more definitive study is underway, with results expected in the first half of next year, followed by an application for FDA approval.

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