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Clinical Trial News

FDA Approves Eli Lilly's Eczema Drug

  • The U.S. Food and Drug Administration (FDA) has approved Eli Lilly's drug for the treatment of eczema, offering a new therapeutic option for patients.
  • This approval marks a significant advancement in dermatological treatments, potentially improving the quality of life for individuals suffering from eczema.
  • The drug's efficacy and safety were demonstrated through rigorous clinical trials, meeting the FDA's standards for approval and market release.

RP1/Nivolumab Combination Shows Durable Responses in Advanced Melanoma

  • The combination of RP1 and nivolumab demonstrated a 33.6% overall response rate in patients with advanced melanoma who had progressed on anti-PD-1 therapy.
  • Median duration of response was 21.6 months, with a complete response rate of 15.0%, indicating clinically meaningful and durable antitumor activity.
  • The combination therapy exhibited a favorable safety profile, with most treatment-related adverse events being grade 1 or 2, and a grade 3 or higher TRAE rate of 12.8%.
  • A confirmatory phase 3 trial, IGNYTE-3, is actively recruiting to further evaluate the RP1 plus nivolumab combination in advanced melanoma patients.

VO and Nivolumab vs Physician's Choice in Advanced Melanoma That Progressed on Anti-PD-1 & Anti-CTLA-4 Drugs (IGNYTE-3)

NCT06264180RecruitingPhase 3
Replimune Inc.
Posted 7/11/2024

Study of RP1 Monotherapy and RP1 in Combination With Nivolumab

NCT03767348RecruitingPhase 2
Replimune Inc.
Posted 9/20/2017

Intensive Blood Pressure Lowering Linked to Improved Stroke-Free Survival in High-Risk Patients

  • A pooled analysis of SPRINT and ACCORD-BP trials reveals that intensive blood pressure control (target <120 mmHg) is associated with improved stroke-free survival.
  • The study defined stroke-free survival as the time to either death or stroke, whichever occurred first, providing a clinically relevant composite endpoint.
  • Analysis of over 14,000 participants showed that intensive BP lowering may offer a significant benefit in reducing the combined risk of stroke and mortality.
  • The findings suggest that individual stroke risk assessment could help tailor blood pressure targets to maximize benefits and minimize potential adverse events.

Action to Control Cardiovascular Risk in Diabetes (ACCORD)

NCT00000620CompletedPhase 3
National Heart, Lung, and Blood Institute (NHLBI)
Posted 9/1/1999

Systolic Blood Pressure Intervention Trial

NCT01206062CompletedNot Applicable
National Heart, Lung, and Blood Institute (NHLBI)
Posted 10/1/2010

Novavax's Updated COVID-19 Vaccine Now Available at Major U.S. Pharmacies

• Novavax's 2024-2025 formula COVID-19 vaccine (NVX-CoV2705) is now stocked at major pharmacies across the U.S. for individuals aged 12 and older. • The updated vaccine targets the JN.1 variant and has demonstrated cross-reactivity against JN.1 lineage viruses, offering a protein-based alternative. • Novavax has more than doubled the number of locations stocking its vaccine compared to last year, with a more convenient pre-filled syringe presentation. • The vaccine has received Emergency Use Authorization from the FDA and is available at locations including CVS, Walgreens, Rite Aid and Costco.

mRNA-4359 Immunotherapy Shows Promise in Early Trial for Advanced Solid Cancers

  • Early phase I data indicates that mRNA-4359 immunotherapy is well-tolerated and elicits an immune response in patients with advanced solid tumors.
  • The investigational mRNA cancer immunotherapy targets common tumor markers, training the immune system to recognize and fight cancer cells.
  • In a small cohort, eight out of sixteen evaluable patients showed stable disease, with no tumor growth or new tumors observed.
  • The trial is ongoing, recruiting patients with melanoma and lung cancer to further assess the safety and efficacy of mRNA-4359 in combination with pembrolizumab.

Kura Oncology Advances Precision Medicine Pipeline with Ziftomenib and KO-2806

  • Kura Oncology is focusing on precision medicines for cancer, targeting genetic mutations to improve treatment efficacy and safety.
  • Ziftomenib, a drug targeting acute myeloid leukemia (AML) with NPM1 and KMT2A mutations, has received Breakthrough Therapy Designation from the FDA.
  • KO-2806, a next-generation farnesyl transferase inhibitor, is in Phase 1 trials for renal and lung cancers, showing promise in early studies.
  • Kura Oncology's financial position is strong, with cash reserves projected to support operations through 2027, ensuring continued pipeline development.

FDA Approves Roche's Tecentriq Hybreza, a Subcutaneous Anti-PD-(L)1 Cancer Immunotherapy

  • The FDA has approved Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) as the first subcutaneous PD-(L)1 inhibitor for cancer immunotherapy.
  • Tecentriq Hybreza offers a faster administration time of approximately seven minutes compared to the 30-60 minutes required for intravenous Tecentriq.
  • This subcutaneous formulation maintains the established safety and efficacy profile of intravenous Tecentriq across its approved indications.
  • Tecentriq Hybreza is now approved for all IV indications of Tecentriq in the U.S., covering certain lung, liver, skin, and soft tissue cancers.

FDA Nears Decisions on Vanda, Zevra, Heron, Merck, BMS, Sanofi/Regeneron

• Vanda Pharmaceuticals awaits FDA decision on tradipitant for gastroparesis, a condition affecting millions in the U.S., with a verdict expected by September 18. • Zevra Therapeutics anticipates potential approval of arimoclomol for Niemann-Pick disease type C (NPC) by September 21, following positive advisory committee support. • The FDA is set to decide on Heron Therapeutics' extended-release needle for Zynrelef by September 23, designed to simplify drug preparation and administration. • Merck seeks approval for Keytruda in pleural mesothelioma, with a decision due September 25, based on Phase II/III KEYNOTE-483 trial data showing improved survival. • Bristol Myers Squibb awaits FDA decision on KarXT for schizophrenia by September 26, potentially offering a novel mechanism of action targeting muscarinic receptors. • Sanofi and Regeneron anticipate a decision on Dupixent for COPD by September 27, supported by Phase III BOREAS and NOTUS trials demonstrating reduced exacerbations.

mRNA Vaccine Pipeline Heats Up: Late-Stage Candidates Target Flu, COVID, CMV, and Cancer

  • Pfizer and BioNTech are advancing an mRNA influenza vaccine, PF-07252220, demonstrating superiority over existing flu vaccines in Phase III trials.
  • Moderna's mRNA-1083, a combination COVID-19/influenza vaccine, showed strong immune responses in Phase III, potentially extending the sales of COVID-19 vaccines.
  • GSK acquired rights to CureVac's mRNA vaccines against COVID-19 (GSK4388067) and influenza (GSK4382276), both currently in Phase II trials.
  • Moderna's mRNA-4157, a therapeutic cancer vaccine, is being explored in Phase III in combination with Merck’s Keytruda, targeting head and neck cancer and melanoma.

FDA Nears Decisions on Key Therapies for Gastroparesis, Niemann-Pick Disease, Schizophrenia, COPD, Mesothelioma, and Post-Surgical Pain

• The FDA is expected to decide on Vanda Pharmaceuticals' tradipitant for gastroparesis by September 18, potentially offering a novel NK-1R antagonist treatment option. • Zevra Therapeutics awaits a verdict by September 21 on arimoclomol for Niemann-Pick disease type C, an ultrarare neurodegenerative disorder with no approved therapies. • A decision is anticipated by September 26 on Bristol Myers Squibb's KarXT for schizophrenia, representing a new pharmacological approach targeting muscarinic receptors.

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