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Clinical Trial News

Pembrolizumab Shows Sustained Survival Benefit in Advanced Melanoma After 10-Year Follow-up

  • Ten-year follow-up data from the KEYNOTE-006 study demonstrates pembrolizumab's continued superiority over ipilimumab in unresectable stage III/IV melanoma.
  • Patients receiving pembrolizumab experienced a median overall survival of 32.7 months compared to 15.9 months with ipilimumab, with 10-year OS rates of 34% and 23.6%, respectively.
  • A second course of pembrolizumab in patients who initially responded showed promising efficacy, with a median modified PFS of 51.8 months.
  • The findings support pembrolizumab as a standard-of-care treatment, providing long-term benefits for patients with advanced melanoma.

Study to Evaluate the Safety and Efficacy of Two Different Dosing Schedules of Pembrolizumab (MK-3475) Compared to Ipilimumab in Participants With Advanced Melanoma (MK-3475-006/KEYNOTE-006)

NCT01866319CompletedPhase 3
Merck Sharp & Dohme LLC
Posted 8/28/2013

Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab (MK-3475) Study (MK-3475-587/KEYNOTE-587)

NCT03486873RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 8/21/2018

Olaparib/Cediranib Combination Fails to Improve Survival in Relapsed Ovarian Cancer

  • The phase 3 ICON9 trial investigated olaparib plus cediranib versus olaparib alone as maintenance therapy for relapsed platinum-sensitive ovarian cancer.
  • The combination of olaparib and cediranib did not significantly improve progression-free survival compared to olaparib monotherapy (HR = 0.84; 95% CI, 0.65-1.07; P = .24).
  • Overall survival was also not significantly different between the two arms, with median OS of 37.8 months for olaparib and 37.2 months for the combination (HR = 0.92; 95% CI, 0.67-1.26; P = .81).
  • The safety profile of the combination was consistent with the known toxicities of each agent, with slightly higher rates of certain grade 3 or higher adverse events.

Study Evaluating the Efficacy of Maintenance Olaparib and Cediranib or Olaparib Alone in Ovarian Cancer Patients

NCT03278717Unknown StatusPhase 3
University College, London
Posted 6/15/2018

TAR-200 Demonstrates High Complete Response Rate in BCG-Unresponsive Bladder Cancer

  • Johnson & Johnson's TAR-200 showed an 83.5% complete response rate in patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk non-muscle-invasive bladder cancer (HR-NMIBC).
  • The study demonstrated durable complete responses without reinduction, with 82% of patients maintaining response after a median follow-up of 9 months.
  • An estimated 12-month complete response rate of 57.4% was observed, based on Kaplan-Meier curve analysis, indicating sustained efficacy over time.
  • The risk-benefit profile favors TAR-200 monotherapy in this patient population, offering a promising treatment option.

Enhertu Shows Promise in HER2+ Breast Cancer with Brain Metastases

• Enhertu (trastuzumab deruxtecan) demonstrates a 61.6% 12-month median progression-free survival in metastatic breast cancer patients with brain metastases. • The DESTINYBreast-012 trial reveals a 79% overall response rate for central nervous system metastases with Enhertu treatment. • Enhertu maintains a 90.3% 12-month overall survival rate in patients with active breast cancer brain metastases, indicating a significant clinical benefit. • Analysts predict Enhertu will dominate the ADC market, reaching $11.2 billion in global sales by 2030, surpassing Kadcyla and Tukysa.

MediLink's YL201 Demonstrates Promising Activity in Small Cell Lung Cancer and Other Solid Tumors

  • MediLink Therapeutics presented Phase I clinical data for YL201, a B7H3-targeting antibody-drug conjugate, at ESMO 2024, showcasing its potential in treating advanced solid tumors.
  • In patients with extensive-stage small cell lung cancer (ES-SCLC), YL201 achieved an overall response rate (ORR) of 68.1% and a median progression-free survival (mPFS) of 6.2 months.
  • A global clinical trial collaboration with Amgen will evaluate YL201 in combination with Amgen's IMDELLTRA™ for ES-SCLC, exploring a novel synergistic mechanism of action.
  • YL201 monotherapy has demonstrated encouraging efficacy in ES-SCLC, prompting MediLink to actively prepare for Phase 3 studies in SCLC and nasopharyngeal carcinoma (NPC).

A Study YL201 in Patients With Selected Advanced Solid Tumors

NCT06057922RecruitingPhase 1
MediLink Therapeutics (Suzhou) Co., Ltd.
Posted 9/22/2023

A Study of YL201 in Patients with Advanced Solid Tumors

NCT05434234RecruitingPhase 1
MediLink Therapeutics (Suzhou) Co., Ltd.
Posted 5/25/2022

Neoadjuvant Immunotherapy Solidifies as Standard of Care in Stage III Melanoma

  • Updated data from the NADINA trial demonstrates that neoadjuvant ipilimumab plus nivolumab significantly improves event-free and distant metastasis-free survival compared to adjuvant nivolumab in resectable stage III melanoma.
  • An updated pooled analysis from the International Neoadjuvant Melanoma Consortium (INMC) confirms the long-term benefits of neoadjuvant immunotherapy, particularly with combination checkpoint inhibition.
  • Major pathologic response (MPR) is identified as a strong prognostic marker, with patients achieving MPR showing significantly improved recurrence-free survival rates.
  • Neoadjuvant BRAF/MEK targeted therapy is shown to be less effective than neoadjuvant immunotherapy and equivalent to adjuvant BRAF/MEK therapy.

Tiragolumab Plus Atezolizumab Versus Atezolizumab in the Treatment of Stage II Melanoma Patients Who Are ctDNA-positive Following Resection

NCT05060003TerminatedPhase 2
Washington University School of Medicine
Posted 11/8/2022

Substudy 02C: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab Alone in Participants With Stage III Melanoma Who Are Candidates for Neoadjuvant Therapy (MK-3475-02C/KEYMAKER-U02)

NCT04303169Active, Not RecruitingPhase 1
Merck Sharp & Dohme LLC
Posted 6/26/2020

Vemurafenib, Cobimetinib, Atezolizumab, and Tiragolumab in Treating Patients With High-Risk Stage III Melanoma

NCT03554083Active, Not RecruitingPhase 2
Mayo Clinic
Posted 10/5/2018

Oklahoma Entrepreneur Launches Yni.Fit Device for Urinary Incontinence

  • Allison Watkins, an Edmond, Oklahoma entrepreneur, has launched Yni.Fit, a novel insertion device designed to combat urinary incontinence in women.
  • After clinical trials and FDA approval, Yni.Fit was launched in Oklahoma this summer, addressing a need for millions of women suffering from bladder leakage.
  • Watkins, driven by her own experiences, aims to expand Yni.Fit nationally next year, offering a solution developed from patient insight and entrepreneurial spirit.

GSK and iTeos' Belrestotug Shows Promise in NSCLC Trial, Offering Hope for TIGIT Therapies

• Belrestotug, an anti-TIGIT antibody from GSK and iTeos, demonstrated a higher objective response rate (ORR) when combined with GSK's Jemperli (dostarlimab) in PD-L1-positive NSCLC patients. • The GALAXIES Lung-02 phase 2 trial showed a dose-response relationship with belrestotug, with the highest dose achieving a 76.7% ORR compared to 28.1% for Jemperli alone. • While side effects were generally manageable, the combination therapy had higher treatment discontinuation rates and some treatment-related deaths, warranting careful safety monitoring. • A phase 3 trial, GALAXIES-Lung-301, is planned using the 400mg dose of belrestotug in combination with Jemperli, comparing it to Keytruda plus placebo in first-line NSCLC patients.

Durvalumab Perioperative Regimen Significantly Improves Survival in Muscle-Invasive Bladder Cancer

  • AstraZeneca's durvalumab in combination with chemotherapy demonstrated a statistically significant improvement in event-free survival (EFS) in MIBC patients.
  • The IMFINZI perioperative regimen reduced the risk of disease progression, recurrence, or death by 32% compared to chemotherapy alone.
  • Overall survival (OS) also saw a significant boost, with a 25% reduction in the risk of death with the durvalumab regimen.
  • The study marks the first immunotherapy regimen to demonstrate a statistically significant overall survival improvement in this setting.

Perioperative Durvalumab Shows Significant Benefit in Muscle-Invasive Bladder Cancer

  • A perioperative regimen including durvalumab significantly reduced the risk of recurrence by 32% in patients with muscle-invasive bladder cancer (MIBC).
  • The same regimen also demonstrated a 25% reduction in the risk of death compared to neoadjuvant chemotherapy alone in the NIAGARA Phase III trial.
  • Durvalumab's addition to neoadjuvant chemotherapy did not compromise patients' ability to complete surgery, maintaining a consistent safety profile.
  • These findings support durvalumab's potential as a new standard of care in the perioperative treatment of MIBC, addressing a critical unmet need.

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