MedPath

Clinical Trial News

Pfizer's Sasanlimab-BCG Combination Shows Significant Improvement in High-Risk Bladder Cancer Trial

  • Pfizer's phase III CREST trial demonstrated that sasanlimab, an anti-PD-1 monoclonal antibody, in combination with BCG therapy significantly improved outcomes in patients with high-risk non-muscle invasive bladder cancer.
  • The combination therapy was evaluated as both induction therapy and with maintenance treatment in BCG-naïve patients, showing promising results for this difficult-to-treat patient population.
  • This development follows similar positive results from AstraZeneca's POTOMAC trial, where Imfinzi (durvalumab) plus BCG therapy showed statistically significant improvement in disease-free survival compared to BCG alone.

Neoadjuvant Chemohormonal Therapy Before Radical Prostatectomy for High-Risk Prostate Cancer

A study evaluated the feasibility and safety of neoadjuvant chemohormonal therapy (NCHT) before radical prostatectomy (RP) for Japanese patients with high-risk localized prostate cancer (PCa). The study found NCHT to be safe and feasible, with a significant difference in biochemical progression-free survival (bPFS) between very high-risk (VHR) and not very high-risk (nVHR) groups. However, more extensive treatment modalities are needed to improve outcomes, especially in VHR patients.

Controversy Surrounds FDA Approval of Pembrolizumab for High TMB Solid Tumors

A recent analysis has sparked controversy over the FDA's accelerated approval of pembrolizumab for treating solid tumors with a high tumor mutational burden (TMB), citing concerns over the broadness of the approval criteria and the neglect of survival data in certain tumor types. The approval was based on the KEYNOTE-158 study, which showed a 29% overall response rate in patients with TMB greater than 10 mutations per megabase, but critics argue it overlooks more meaningful clinical endpoints like survival and quality of life.

Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-158/KEYNOTE-158)

NCT02628067RecruitingPhase 2
Merck Sharp & Dohme LLC
Posted 12/18/2015

Advancements in PSMA-Targeted Radionuclide Therapy for Metastatic Prostate Cancer

  • PSMA-PET imaging with small molecule delivery of radionuclides is effective for defining intra-prostatic and metastatic prostate cancer, especially at low PSA levels.
  • 177Lu-PSMA-617 has shown promising results in mCRPC treatment, with studies reporting significant PSA decline and manageable toxicities.
  • The TheraP study demonstrated that 177Lu-PSMA-617 achieved a higher PSA response rate compared to cabazitaxel chemotherapy in mCRPC patients.
  • The ongoing phase III VISION trial is evaluating 177Lu-PSMA-617 plus standard of care versus standard of care alone for radiographic progression-free and overall survival in mCRPC.

Use of an Experimental Radiopharmaceutical (131I-MIP-1095) in Men With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

NCT03030885CompletedPhase 1
Memorial Sloan Kettering Cancer Center
Posted 1/19/2017

In Men With Metastatic Prostate Cancer, What is the Safety and Benefit of Lutetium-177 PSMA Radionuclide Treatment in Addition to Chemotherapy

NCT04343885Active, Not RecruitingPhase 2
Peter MacCallum Cancer Centre, Australia
Posted 4/21/2020

Phase I Dose-escalation Study of Fractionated 177Lu-PSMA-617 for Progressive Metastatic CRPC

NCT03042468Active, Not RecruitingPhase 1
Weill Medical College of Cornell University
Posted 12/1/2016

Shingrix Label Updated with Guillain-Barré Syndrome Warning Following FDA Review

  • The FDA has mandated a label update for Shingrix, a shingles vaccine, to include a warning about the potential risk of Guillain-Barré Syndrome (GBS).
  • Postmarketing studies revealed an elevated risk of GBS within 42 days following Shingrix vaccination, particularly after the first dose, in adults aged 65 and older.
  • The FDA emphasizes that while an association between Shingrix and GBS was observed, the available evidence is insufficient to establish a definitive causal relationship.
  • Healthcare professionals in Hong Kong will be informed, and the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.

UK PM's 'Greed' Comments Spark Controversy Amid Global Vaccine Distribution Debate

  • Boris Johnson faced immediate backlash after attributing UK's COVID-19 vaccination success to "capitalism" and "greed" during a Conservative MP Zoom call, later attempting to retract his comments.
  • The controversial remarks came during a sensitive period marking one year of UK lockdown restrictions and amid escalating tensions between the EU and UK over vaccine supply chains.
  • The UK's successful vaccination program has delivered first doses to 28 million people, while EU countries have administered 55 million doses total, highlighting the disparity in distribution.

Gamification Emerges as Powerful Tool in Healthcare: From Patient Care to Medical Education

  • Gamification is revolutionizing healthcare delivery by improving patient adherence in chronic disease management, with studies showing nearly 50% of chronic disease patients currently not taking medicines as prescribed.
  • Digital therapeutics incorporating game elements are gaining significant traction among pharmaceutical companies and healthcare providers, particularly when combined with VR and AR technologies for rehabilitation.
  • Medical education is being transformed through gamification, with research indicating improved learning outcomes for healthcare professionals through structured gameplay elements and innovative teaching approaches.

CDK4/6 Inhibitors Show Trend Toward Benefit in Early Breast Cancer, Meta-Analysis Finds

  • A meta-analysis of over 12,000 patients with early HR+/HER2- breast cancer showed a trend towards improved invasive disease-free survival with adjuvant CDK4/6 inhibitors.
  • The study did not find a statistically significant improvement in distant relapse-free survival with the addition of CDK4/6 inhibitors to endocrine therapy.
  • Adjuvant CDK4/6 inhibitors were associated with a significantly increased incidence of adverse events, including neutropenia, anemia, and diarrhea.
  • The findings highlight the need for longer follow-up and better patient selection to optimize the use of CDK4/6 inhibitors in early breast cancer.

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

Adjuvant Ribociclib With Endocrine Therapy in Hormone Receptor+/HER2- High Risk Early Breast Cancer

NCT03078751CompletedPhase 2
Novartis Pharmaceuticals
Posted 6/20/2017

Palbociclib for HR Positive / HER2-negative Isolated Locoregional Recurrence of Breast Cancer

NCT03820830Active, Not RecruitingPhase 3
ETOP IBCSG Partners Foundation
Posted 8/27/2019

Savana Leverages AI to Transform EHR Data into Actionable Clinical Insights

  • Savana's AI-powered platform analyzes unstructured electronic health record data across 14 countries in five languages, enabling unprecedented access to real-world clinical evidence.
  • The company's technology has demonstrated significant value during COVID-19 pandemic through the BigCOVIData study, revealing key insights about disease characteristics and predictive factors.
  • Using advanced Natural Language Processing and privacy-preserving techniques, Savana helps pharmaceutical companies and researchers unlock previously inaccessible clinical data while maintaining patient confidentiality.

Libtayo (Cemiplimab) Monotherapy Demonstrates Overall Survival Benefit in Advanced Cervical Cancer

• A Phase 3 trial of Libtayo (cemiplimab) monotherapy in patients with recurrent or metastatic cervical cancer was halted early due to positive overall survival results. • The trial showed a 31% reduction in the risk of death compared to chemotherapy, regardless of PD-L1 status, marking the first immunotherapy to improve survival in this setting. • Libtayo monotherapy led to a median survival of 12.0 months versus 8.5 months with chemotherapy, with regulatory submissions planned for 2021. • The study included women with squamous cell carcinoma or adenocarcinoma, showing survival benefits in both subtypes, with a median age of 51 years.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.