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Clinical Trial News

HUTCHMED Highlights Clinical Data on Fruquintinib, Surufatinib, and Savolitinib at Upcoming Conferences

  • HUTCHMED will present Phase II trial results of osimertinib plus savolitinib as first-line treatment for EGFRm, MET-aberrant advanced NSCLC, showing a significantly higher objective response rate compared to osimertinib alone.
  • Subgroup analyses from the FRESCO-2 trial will be presented, demonstrating the efficacy and safety of fruquintinib in refractory metastatic colorectal cancer patients with and without liver metastasis, and by age.
  • Data on surufatinib, both as a monotherapy and in combination with other treatments, will be presented for advanced hepatocellular carcinoma, neuroendocrine tumors, and soft tissue sarcoma.

Antennova to Present Phase I/Ib Data on ATN-037 at ESMO Congress 2024

  • Antennova will present data from the STAMINA-01 trial of ATN-037, a CD73 inhibitor, at the ESMO Congress 2024 on September 16.
  • The study evaluates ATN-037 as a monotherapy and in combination with pembrolizumab in patients with advanced solid tumors.
  • Early data shows a 43.8% disease control rate with ATN-037 monotherapy and a 20% overall response rate with the combination therapy.
  • The Phase II dose optimization and expansion of ATN-037 is ongoing in Australia and planned for China in late October 2024.

Natera's Signatera Shows 10-Fold Overall Survival Advantage in Colorectal Cancer

  • Natera will present new data on Signatera, its MRD test, at the ESMO Congress, including findings from the CIRCULATE-Japan GALAXY trial.
  • Signatera-positive patients in the GALAXY trial had a significantly shorter overall survival compared to Signatera-negative patients, with a hazard ratio of approximately 10.
  • Updated analysis from the GALAXY arm of CIRCULATE-Japan includes the first prospective read-out of overall survival based on MRD in over 2,100 patients.
  • Additional presentations at ESMO will highlight new Signatera data in breast cancer and squamous cell carcinoma of the head and neck.

Eisai's Foscenvivint Shows Promise in Pancreatic Cancer Development Pipeline

  • Eisai is advancing the development of Foscenvivint for pancreatic cancer treatment, expanding their oncology portfolio beyond established drugs like Lenvima and Halaven.
  • The pharmaceutical company's global presence, with research facilities across Japan, US, and UK, positions them strongly to conduct comprehensive clinical development of Foscenvivint.
  • Eisai's track record in successful drug development, including LEQEMBI for Alzheimer's and Lenvima for endometrial carcinoma, suggests promising potential for Foscenvivint's approval pathway.

Alfasigma Advances Filgotinib Maleate Development for IgG4-Related Disease Treatment

• Alfasigma is developing filgotinib maleate as a potential therapeutic option for Immunoglobulin G4-Related Disease (IgG4-RD), expanding treatment possibilities for this rare inflammatory condition.
• The drug candidate demonstrates broad therapeutic potential, being investigated across multiple autoimmune conditions including Sjögren's syndrome, psoriatic arthritis, and Crohn's disease.
• Alfasigma, headquartered in Bologna, Italy, leverages its global presence across 15 countries to advance filgotinib maleate's development program.

IMUNON's IMNN-001 Shows Promise in Advanced Ovarian Cancer Treatment

  • IMUNON will host an Ovarian Cancer R&D Day on September 18, 2024, featuring updates on IMNN-001, an investigational therapy for ovarian cancer.
  • Phase 2 OVATION 2 study data showed IMNN-001 treatment was associated with an 11.1-month increase in median overall survival in advanced ovarian cancer patients.
  • The R&D Day will include presentations from experts discussing the clinical significance of OVATION 2 results and the potential role of IMNN-001 in treatment.
  • IMUNON executives will outline the next steps for IMNN-001's development program, including plans for a Phase 3 registration study.

HR20013 Shows Non-Inferiority in Preventing Chemotherapy-Induced Nausea and Vomiting

  • A recent study, HR20013, has demonstrated non-inferiority compared to standard antiemetic therapy in preventing chemotherapy-induced nausea and vomiting (CINV).
  • The PROFIT study assessed the efficacy and safety of HR20013, providing evidence for its potential as an alternative treatment option for CINV.
  • The findings suggest that HR20013 could offer a comparable level of protection against CINV, potentially expanding the available options for patients undergoing chemotherapy.
  • Further research may explore HR20013's specific advantages or suitability for certain patient subgroups experiencing CINV.

Lecanemab Shows Promise in Slowing Cognitive Decline in Early Alzheimer's Disease

  • Lecanemab, trialed at HMRI, effectively removes amyloid from the brain, potentially preventing Alzheimer's and slowing cognitive decline.
  • The drug slowed mental decline by 25% in individuals with mild dementia, marking it as a potentially effective treatment.
  • The clinical trial involved screening participants aged 65-80 for amyloid accumulation, followed by bi-weekly infusions of Lecanemab or a placebo.
  • Lecanemab is under consideration for approval by the Therapeutic Goods Administration (TGA) in Australia, with potential approval expected by the end of 2024.

ASC22 and Chidamide Combination Shows Promise in Reducing HIV Reservoir Size

  • A Phase II clinical trial evaluated the combination of ASC22, an anti-PD-L1 antibody, and chidamide, a histone deacetylase inhibitor, in HIV-infected adults on ART.
  • The study demonstrated a reduction in total and integrated HIV DNA in PBMCs, suggesting a decrease in the HIV reservoir size after 12 weeks of treatment.
  • The combination therapy also led to improvements in HIV-specific CD8+ T cell function, indicating enhanced immune control of HIV.
  • The treatment was generally well-tolerated, with adverse events monitored throughout the study period.

Functional Cure Study of Anti-PD-L1 Antibody ASC22 in Combination With Chidamide in HIV-infected Patients With Antiviral Suppression

NCT05129189RecruitingPhase 2
Shanghai Public Health Clinical Center
Posted 6/29/2022

MacroGenics' Vobramitamab Duocarmazine Shows Promise in Metastatic Castration-Resistant Prostate Cancer

  • MacroGenics announced Phase 2 data for vobramitamab duocarmazine (vobra duo) in metastatic castration-resistant prostate cancer (mCRPC) at ESMO 2024.
  • The TAMARACK trial evaluated vobra duo, an antibody-drug conjugate targeting B7-H3, in mCRPC patients.
  • Updated safety and efficacy data, including the primary endpoint of 6-month radiographic progression-free survival (rPFS), were presented.
  • MacroGenics will host a conference call on September 16, 2024, to discuss the TAMARACK poster data and provide a corporate update.

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