Clinical Trial News
NGS-MRD Monitoring Predicts Relapse Risk in AML Patients Post-Transplant
• NGS-MRD assay demonstrates prognostic value in AML patients undergoing allo-HSCT, both before and one month after transplantation, irrespective of mutation type.
• Persistent mutations detected by NGS-MRD pre- and post-HSCT are significantly associated with increased post-transplant relapse and worse overall survival.
• The optimal timing for NGS-MRD assessment varies with conditioning intensity: pre-HSCT for myeloablative conditioning (MAC) and post-HSCT for reduced-intensity conditioning (RIC).
• Serial NGS-MRD monitoring post-transplantation offers a feasible approach to refine risk stratification and guide MRD-driven therapeutic decisions in AML.
First-in-Human Study of PF-06647020 (Cofetuzumab) in Patients with Advanced Solid Tumors
A phase I study evaluated the safety, tolerability, and pharmacokinetics of PF-06647020 in patients with advanced solid tumors. The study involved dose escalation and expansion to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D). PF-06647020 was administered intravenously every 3 weeks or every 2 weeks, with the RP2D established at 2.8 mg/kg every 3 weeks. The study also assessed the drug's antitumor activity and immunogenicity, with a focus on patients with advanced ovarian cancer, NSCLC, and TNBC.
Highlighted Clinical Trials:
Pfizer
Posted 10/17/2014
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.
HyBryte™: A Promising Skin Directed Therapy for Cutaneous T-Cell Lymphoma
HyBryte™, a novel skin-directed therapy utilizing visible light activation, has shown promising results in treating early-stage Cutaneous T-Cell Lymphoma (CTCL) with minimal side effects, as evidenced by Phase 3 clinical trial outcomes.
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
• 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.