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Clinical Trial News

Daiichi Sankyo's DS-9606 Shows Promise in Phase I Solid Tumor Trial

  • Daiichi Sankyo's DS-9606, an antibody-drug conjugate (ADC) targeting Claudin-6 (CLDN6), demonstrates encouraging initial clinical activity in advanced solid tumors.
  • The Phase I trial assessed DS-9606's safety and tolerability across various doses, with no dose-limiting toxicities reported and manageable adverse events.
  • Preliminary efficacy results revealed confirmed objective responses in heavily pretreated patients, particularly in germ cell, gastric/esophageal, and non-small cell lung cancers.
  • The ongoing trial will determine the maximum tolerated dose and recommended dose for expansion, further evaluating DS-9606 in CLDN6-expressing advanced solid tumors.

Nivolumab and Ipilimumab Combo Shows Long-Term Survival Benefit in Advanced Melanoma

  • A decade-long study reveals that the combination of nivolumab and ipilimumab significantly extends survival in patients with advanced melanoma, offering a potential long-term solution.
  • The trial demonstrated that patients who were progression-free after three years had a high likelihood of remaining alive and disease-free at the 10-year mark.
  • The immunotherapy regimen did not show any increase in long-term adverse effects, confirming its safety profile over the extended study period.
  • Researchers suggest that these findings can shift patient expectations towards hope and optimism, potentially reducing the need for frequent oncologist visits.

Kisqali Demonstrates Sustained Benefit in Early Breast Cancer

• Updated analysis of the NATALEE trial shows Kisqali plus endocrine therapy reduces recurrence risk by 28.5% in stage II and III HR+/HER2- early breast cancer. • The invasive disease-free survival benefit of Kisqali was consistent across all pre-specified patient subgroups, including node-negative disease. • Secondary endpoints, including distant disease-free survival, also showed consistent results, with a trend for improved overall survival. • The safety profile of Kisqali remains consistent with previous reports, showing a well-tolerated profile with generally low-grade 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

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.

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