MedPath

Clinical Trial News

Melanocortin Antagonists Emerge as Promising Treatment for Cancer Cachexia

  • Cancer cachexia, a devastating wasting syndrome affecting up to 40% of cancer patients, is gaining recognition as a critical therapeutic target beyond traditional tumor-focused treatments.
  • Novel melanocortin-4 receptor antagonist TCMCB07 demonstrates promising results in animal studies, successfully crossing the blood-brain barrier and preserving body mass without significant adverse effects.
  • Research indicates targeting the central melanocortin system could revolutionize cancer treatment approaches, with potential applications extending to other chronic conditions like kidney disease and COPD.

Iterum Therapeutics' Sulopenem Application Review Progresses, FDA Action Date on Track

• Iterum Therapeutics completed a late-cycle meeting with the FDA regarding its sulopenem etzadroxil/probenecid application for uncomplicated urinary tract infections. • The FDA has indicated that an Advisory Committee meeting is not currently necessary, maintaining the target action date of July 25. • During the meeting, the FDA communicated ongoing review issues, to which Iterum Therapeutics has provided responses, moving the process forward. • Sulopenem is being reviewed for treating uncomplicated urinary tract infections caused by quinolone non-susceptible pathogens, addressing a critical need.

Bispecific Antibodies Emerge as Promising Therapeutic Strategy in Cancer Treatment

• Johnson & Johnson's Rybrevant approval marks the growing potential of bispecific antibodies in cancer therapy, targeting two proteins simultaneously to enhance efficacy. • Bispecific antibodies are being developed for various hematological malignancies like lymphoma, multiple myeloma, and leukemia, with some also targeting solid tumors like lung and prostate cancer. • Clinical trials are actively evaluating bispecific antibodies that bind to CD3 on T cells and tumor-specific antigens, such as CD20 in lymphoma and BCMA in multiple myeloma. • Several companies, including Roche, AbbVie, Genmab, Pfizer, and Regeneron, are advancing bispecific antibody candidates through Phase 2 and Phase 3 trials, indicating a competitive landscape.

Lorlatinib Shows Promising Efficacy in ALK-Rearranged NSCLC with 21.8 Month Median PFS

Real World EvidenceOncologyTargeted Therapy
  • A real-world study of lorlatinib in ALK-rearranged non-small cell lung cancer demonstrated a median progression-free survival of 21.8 months, significantly higher than in previous trials.
  • The objective response rate was 43% with disease control achieved in 94% of patients, while 81% of patients with brain metastases showed objective response for intracranial lesions.
  • Patients experiencing adverse events, particularly hypercholesterolemia and edema, had significantly better outcomes than those without side effects, suggesting a potential correlation between drug exposure and efficacy.

First-Time Drug Launches: McKinsey Data Shows 67% of Products Miss Sales Targets Despite Growing Market Share

• Recent McKinsey analysis reveals first-time drug launchers have tripled their market share over the past decade, yet 67% of products fail to meet launch expectations and sales forecasts.
• Pre-commercial companies should initiate launch planning approximately 24 months before launch during Phase 2, with early KOL engagement being crucial for success, particularly in specialty and rare disease therapies.
• Digital engagement has seen dramatic growth, with Veeva Pulse reporting a five-fold increase in Approved Emails and six-fold rise in online meetings, requiring robust content management strategies.

Alume Biosciences' ALM-488 Receives FDA Fast Track Designation for Surgical Nerve Visualization

  • Alume Biosciences' ALM-488, a fluorescent peptide-dye conjugate, has been granted Fast Track designation by the FDA to improve intraoperative nerve visualization.
  • The Fast Track designation will allow for more frequent interactions with the FDA, expediting the development and review process of ALM-488.
  • ALM-488 is currently in a Phase 1/2 clinical trial, with anticipated completion in Q2 2021, evaluating its efficacy in patients undergoing head and neck surgery.
  • ALM-488 binds to the extracellular matrix of nerves, illuminating motor, sensory, autonomic, and degenerated nerves during various surgical procedures.

Healthware Group Unveils Strategic Digital Health Roadmap for Healthcare Industry Evolution

  • COVID-19 has catalyzed widespread adoption of digital health technologies, prompting Healthware Group to release a comprehensive whitepaper guiding pharmaceutical, medical device, and insurance tech companies through digital transformation.
  • The roadmap emphasizes scaling proven digital solutions with scientific rigor, focusing on key areas including digital sales, virtual clinical trials, and telehealth advancement.
  • Industry stakeholders must rebuild their digital capabilities from the ground up to adapt to the rapidly evolving healthcare landscape, according to Healthware Group CEO Roberto Ascione.

AtriCure's EPi-Sense System Receives FDA Approval for Long-Standing Persistent Afib Treatment

• AtriCure's EPi-Sense system has gained FDA approval for treating long-standing persistent atrial fibrillation (Afib), offering a new option for a challenging patient population. • The Converge clinical trial demonstrated the superiority of Hybrid AF therapy using the EPi-Sense system compared to endocardial catheter ablation alone. • Hybrid AF therapy showed a 29% absolute improvement in efficacy at 12 months and a 35% absolute improvement at 18 months compared to catheter ablation. • The EPi-Sense system improves electrophysiology lab efficiency by reducing endocardial ablation times by over 40 minutes, enhancing patient throughput.

FDA Approves VENTANA MMR RxDx Panel as Companion Diagnostic for Dostarlimab in Endometrial Cancer

  • The FDA has approved Roche's VENTANA MMR RxDx panel, the first immunohistochemistry predictive test to identify endometrial cancer patients eligible for dostarlimab (Jemperli) monotherapy.
  • Dostarlimab received accelerated approval for recurrent or advanced dMMR endometrial cancer based on the GARNET trial, where 42.3% of patients showed objective response with 93% of responders maintaining response for at least 6 months.
  • The companion diagnostic works by detecting mismatch repair deficiency (dMMR) in endometrial cancer, providing clinicians with a crucial tool to identify patients most likely to benefit from this PD-1 inhibitor therapy.

Study of TSR-042, an Anti-programmed Cell Death-1 Receptor (PD-1) Monoclonal Antibody, in Participants With Advanced Solid Tumors

NCT02715284RecruitingPhase 1
Tesaro, Inc.
Posted 3/7/2016

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.