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Clinical Trial News

JSKN003 Demonstrates Promising Efficacy in HER2-Positive Cancers and Platinum-Resistant Ovarian Cancer

  • JSKN003, an anti-HER2 bispecific antibody-drug conjugate, shows a 56.8% objective response rate in heavily pretreated platinum-resistant ovarian cancer patients.
  • In HER2-positive solid tumors, JSKN003 achieves a 75% objective response rate and an 89.3% disease control rate, indicating strong antitumor activity.
  • The bispecific ADC exhibits a favorable safety profile with manageable adverse events, supporting further clinical evaluation in various cancer types.
  • These findings, presented at ESMO Congress 2024, highlight JSKN003's potential as a novel treatment option for advanced, heavily pretreated cancers.

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

NCT05494918RecruitingPhase 1
Alphamab (Australia) Co Pty Ltd.
Posted 9/2/2022

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

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

FDA Approves Ocrevus Zunovo as First Subcutaneous Option for Multiple Sclerosis

  • The FDA has approved Ocrevus Zunovo, a subcutaneous formulation of ocrelizumab, for relapsing and primary progressive multiple sclerosis.
  • Ocrevus Zunovo offers a twice-yearly, 10-minute injection, providing an alternative to intravenous infusions.
  • The approval is supported by Phase III OCARINA II trial data, demonstrating comparable efficacy and safety to intravenous Ocrevus.
  • This new formulation aims to improve treatment access and flexibility for patients and healthcare providers.

A Phase III, Non-Inferiority, Randomized, Open-Label, Parallel Group, Multicenter Study To Investigate The Pharmacokinetics, Pharmacodynamics, Safety And Radiological And Clinical Effects Of Subcutaneous Ocrelizumab Versus Intravenous Ocrelizumab In Patients With Multiple Sclerosis

NCT05232825Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 5/3/2022

RYBREVANT® Plus Chemotherapy Shows Positive Overall Survival Trend in EGFR-Mutated Lung Cancer

  • Updated results from the Phase 3 MARIPOSA-2 study reveal that RYBREVANT® (amivantamab) combined with chemotherapy demonstrates consistent benefits in post-progression outcomes for patients with EGFR-mutated NSCLC.
  • The combination therapy shows a favorable trend toward improved overall survival compared to chemotherapy alone, suggesting a potential shift in the treatment landscape for this patient population.
  • Amivantamab plus chemotherapy significantly improves treatment discontinuation rates, with nearly five times as many patients remaining on therapy at 18 months compared to chemotherapy alone.
  • Patients treated with the amivantamab combination experienced a 27 percent reduction in the risk of symptomatic progression, highlighting the potential for more durable treatment options.

A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non- Small Cell Lung Cancer After Osimertinib Failure

NCT04988295Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 11/17/2021

Luvelta Plus Bevacizumab Shows Promise in Late-Stage Ovarian Cancer

  • Sutro Biopharma's luvelta, combined with bevacizumab, achieved a 56% objective response rate at the recommended phase 2 dose (4.3 mg/kg) in late-stage ovarian cancer patients.
  • The combination therapy demonstrated a 35% overall response rate, irrespective of Folate Receptor-α (FRα) expression, offering a potential non-biomarker-driven treatment approach.
  • An expansion phase with an additional 23 patients is ongoing, with initial data expected in the first half of 2025, to further evaluate the efficacy and safety of the combination.
  • No new safety signals were observed, reinforcing the tolerability of luvelta in combination with bevacizumab, with neutropenia being the most common adverse event.

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.

Systolic Blood Pressure Intervention Trial

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

Action to Control Cardiovascular Risk in Diabetes (ACCORD)

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

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.

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