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ARANOTE Trial: Nubeqa Plus ADT Significantly Improves Outcomes in mHSPC

  • The Phase III ARANOTE trial demonstrated that darolutamide (Nubeqa) plus androgen deprivation therapy (ADT) significantly improved radiological progression-free survival (rPFS) in mHSPC patients.
  • Nubeqa reduced the risk of radiographic progression or death by 58% compared to placebo plus ADT, showing a clinically meaningful benefit.
  • The safety profile of Nubeqa plus ADT was comparable to that of placebo plus ADT, with similar rates of adverse events.
  • These findings support Nubeqa as a potential new treatment option for metastatic hormone-sensitive prostate cancer, addressing a critical unmet need.

NUBEQA® (darolutamide) Plus ADT Significantly Improves Outcomes in Metastatic Hormone-Sensitive Prostate Cancer

  • The Phase III ARANOTE trial demonstrated that NUBEQA plus androgen deprivation therapy (ADT) significantly improved radiological progression-free survival (rPFS) in mHSPC patients.
  • NUBEQA plus ADT reduced the risk of radiological progression or death by 46% compared to placebo plus ADT (HR 0.54; 95% CI 0.41-0.71; P<0.0001).
  • The safety profile of NUBEQA in the ARANOTE trial was consistent with previous studies, with similar rates of serious adverse events between treatment arms.

Darolutamide in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer

NCT02799602CompletedPhase 3
Bayer
Posted 11/30/2016

TREMFYA® (guselkumab) Approved by FDA for Ulcerative Colitis Treatment

  • The FDA has approved TREMFYA® (guselkumab) for treating adults with moderately to severely active ulcerative colitis (UC).
  • TREMFYA® is the first fully-human, dual-acting monoclonal antibody targeting both IL-23 and the CD64 receptor for UC treatment.
  • Clinical trials showed significant improvement in UC symptoms and endoscopic appearance of the intestinal lining with TREMFYA®.
  • This approval expands TREMFYA®'s indications, building on its use for plaque psoriasis and psoriatic arthritis.

Kisqali Deepens Benefit in Early Breast Cancer, Reducing Recurrence Risk by 28.5%

  • Updated analysis of the Phase III NATALEE trial shows Kisqali plus endocrine therapy reduces the risk of breast cancer recurrence by 28.5% compared to endocrine therapy alone.
  • The invasive disease-free survival benefit of Kisqali was consistent across all pre-specified patient subgroups, including those with node-negative disease.
  • Secondary endpoints, including distant disease-free survival, also showed consistent results, with a trend for improved overall survival.
  • Safety profile of Kisqali remains consistent with previous reports, with generally low-grade symptomatic adverse events.

A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer

NCT03701334Active, Not RecruitingPhase 3
Novartis Pharmaceuticals
Posted 12/7/2018

GV20 Therapeutics Reports First Clinical Data for AI-Designed Checkpoint Inhibitor GV20-0251 in Advanced Solid Tumors

Monoclonal AntibodyOncologyAI
  • GV20 Therapeutics presented Phase 1 data for GV20-0251, marking the first clinical results for an AI-designed antibody targeting an AI-predicted immune checkpoint IGSF8.
  • The study enrolled 38 heavily pre-treated patients and demonstrated favorable safety with no dose-limiting toxicities across all dose levels from 0.5 to 20 mg/kg.
  • Two confirmed partial responses were observed in 12 evaluable metastatic cutaneous melanoma patients, with 14 of 29 patients showing stable disease including tumor shrinkage.
  • The drug showed dose-proportional pharmacokinetics with a 25.6-day half-life and full target occupancy on circulating T cells at doses ≥3 mg/kg.

A Study of GV20-0251 Monotherapy and GV20-0251 in Combination With Pembrolizumab in Participants With Solid Tumor Malignancies

NCT05669430RecruitingPhase 1
GV20 Therapeutics
Posted 3/23/2023

Polatuzumab Offers New Hope for Diffuse Large B-Cell Lymphoma Treatment in India

  • Polatuzumab, a first-in-class anti-CD79b antibody-drug conjugate, has been approved in India for first-line treatment of Diffuse Large B-Cell Lymphoma (DLBCL).
  • Clinical trial data indicates a 27% reduction in the risk of disease progression, relapse, or death compared to the standard R-CHOP chemotherapy regimen.
  • Experts emphasize the importance of early and effective treatment with Polatuzumab to prevent relapse, particularly within the first two years post-treatment.
  • The availability of Polatuzumab represents a significant advancement, offering improved outcomes for DLBCL patients in India.

PD-1 Blockades Show Feasibility and Tolerability in Elderly Patients with Metastatic Esophageal Squamous Cell Carcinoma

  • A retrospective study evaluates the effectiveness and safety of PD-1 blockade monotherapy in elderly patients (≥65 years) with metastatic esophageal squamous cell carcinoma (ESCC).
  • Results showed a 23.1% objective response rate (ORR) and a 56.4% disease control rate (DCR) with PD-1 blockade, suggesting potential benefits in this population.
  • The median overall survival (OS) was 10.9 months, with ECOG performance status and number of metastatic lesions identified as independent prognostic factors.
  • While generally tolerable, the study highlights the need for vigilance regarding immune-related adverse events, particularly pneumonitis and liver function abnormalities, in elderly patients.

FDA Finalizes Guidance on Optimizing Dosage for Oncology Therapies

  • The FDA has finalized guidance emphasizing early dose optimization in oncology drug development to minimize toxicity and improve patient outcomes.
  • The guidance encourages sponsors to engage with the FDA early, utilizing modeling to identify appropriate dosages for evaluation in clinical trials.
  • Dose optimization studies should leverage data from similar therapies and consider endpoints like overall response rate and progression-free survival.
  • The FDA may place clinical holds on protocols with inadequately supported dosages, underscoring the importance of thorough dose exploration.

FDA Approves Roche's Ocrevus (Zunovo) for Multiple Sclerosis

  • The U.S. Food and Drug Administration (FDA) has approved Roche's Ocrevus (Zunovo) for the treatment of multiple sclerosis, offering a new therapeutic option.
  • Ocrevus, developed by Roche, represents a significant advancement in the treatment landscape for patients with relapsing and progressive forms of MS.
  • Roche's Ocrevus is part of a broad portfolio of pharmaceutical products targeting various disease areas, including immunology and neuroscience.
  • The approval underscores Roche's commitment to developing innovative medicines and diagnostic tools across a range of therapeutic areas.

FDA Approves Lilly's EBGLYSS (lebrikizumab-lbkz) for Atopic Dermatitis Treatment in Patients 12 and Older

  • The FDA has approved Eli Lilly's EBGLYSS (lebrikizumab-lbkz) for treating moderate-to-severe atopic dermatitis in patients aged 12 and older, offering a new targeted treatment option.
  • EBGLYSS, an IL-13 inhibitor, is administered via injection with an initial dose followed by bi-weekly maintenance, potentially shifting to monthly injections based on clinical response.
  • Clinical trials (ADvocate 1, ADvocate 2, and ADhere) supported the approval, demonstrating EBGLYSS's effectiveness in achieving clear or almost clear skin in treated patients.
  • Lilly is preparing to launch EBGLYSS in the US with patient support programs, expanding its availability after approvals in the EU and Japan, with Almirall handling European commercialization.

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