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Enfortumab Vedotin Plus Pembrolizumab Shows Consistent Benefits in Urothelial Carcinoma Regardless of Nectin-4 Levels

  • The combination of enfortumab vedotin and pembrolizumab demonstrates superior progression-free survival (PFS), overall survival (OS), and overall response rate (ORR) compared to chemotherapy in urothelial carcinoma.
  • An exploratory analysis of the EV-302 trial reveals that the benefits of enfortumab vedotin plus pembrolizumab are consistent across all Nectin-4 expression subgroups.
  • The study suggests that Nectin-4 expression levels do not significantly impact the efficacy of enfortumab vedotin plus pembrolizumab in treating locally advanced or metastatic urothelial carcinoma.
  • These findings further establish enfortumab vedotin plus pembrolizumab as a standard of care for first-line treatment, irrespective of PD-L1 or Nectin-4 expression.

Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer

NCT04223856Active, Not RecruitingPhase 3
Astellas Pharma Global Development, Inc.
Posted 3/30/2020

New Drug Target Discovered for Aggressive Prostate Cancer

Scientists have identified the BCL2 protein as a key factor in aggressive prostate cancer, offering a new target for treatment and a way to predict resistance to hormone therapy. A clinical trial combining the BCL2 inhibitor venetoclax with hormone therapy has begun, aiming to improve outcomes for patients with high BCL2 levels.

Eli Lilly's Lutetium Zadavotide Guraxetan Shows Promise in Metastatic Castration-Resistant Prostate Cancer

  • Eli Lilly's 177Lu-PNT2002 demonstrated efficacy in chemotherapy-naïve mCRPC patients progressing on ARPIs, with a median rPFS of 9.5 months, compared to 6 months for ARPIs.
  • The overall survival analysis showed a hazard ratio of 1.14, but adjusted for crossover, the HR was reduced to 0.68, suggesting a potential survival benefit.
  • 177Lu-PNT2002 offers a more patient-friendly dosing schedule compared to Novartis' Pluvicto, with lower dosage, longer intervals, and fewer cycles.
  • Despite negative OS results, the FDA may view 177Lu-PNT2002 favorably due to the high crossover rate, similar to Pluvicto's approval circumstances.

Tislelizumab Approved in Israel for Advanced Esophageal Squamous Cell Carcinoma

  • The Israeli Ministry of Health has approved tislelizumab (Tevimbra) as monotherapy for unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy.
  • Approval was based on the phase 3 RATIONALE 302 trial, which demonstrated a statistically significant improvement in overall survival (OS) compared to chemotherapy.
  • In the RATIONALE-302 trial, tislelizumab showed a median OS of 8.6 months versus 6.3 months with chemotherapy, with a hazard ratio of 0.70 (P = .0001).
  • This approval marks a significant step in providing a new treatment option for ESCC patients in Israel, potentially improving outcomes for this challenging malignancy.

A Study of Tislelizumab (BGB-A317) Versus Chemotherapy as Second Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma

NCT03430843CompletedPhase 3
BeiGene
Posted 1/26/2018

Boehringer Ingelheim's Nintedanib Demonstrates Positive Phase III Results in Idiopathic Pulmonary Fibrosis

  • Boehringer Ingelheim's nintedanib has shown statistically significant results in a Phase III trial for treating idiopathic pulmonary fibrosis (IPF).
  • The trial marks the first successful Phase III outcome in IPF treatment in a decade, offering new hope for patients.
  • Nintedanib aims to slow disease progression, addressing a critical unmet need in IPF management and improving patient outcomes.

Oral Obesity Pill Race Heats Up with New Data from Novo, Roche, and Terns

  • Novo Nordisk's oral amycretin demonstrated a 4% placebo-adjusted weight loss after four weeks, showing potential in glucose control and appetite regulation.
  • Roche's CT-996 led with a 6.1% placebo-adjusted weight loss but raised tolerability concerns due to high rates of gastrointestinal adverse events.
  • Terns Pharmaceuticals' TERN-601 achieved a 4.9% placebo-adjusted weight loss, with analysts noting a unique approach that could balance efficacy and tolerability.

Digital Breast Tomosynthesis Shows Superior Breast Cancer Detection Over Mammography in 10-Year Study

  • A decade-long study reveals that digital breast tomosynthesis (DBT) enhances breast cancer detection rates compared to standard digital mammography.
  • DBT demonstrates a significant reduction in the detection of advanced-stage cancers, suggesting earlier diagnosis and intervention.
  • The research indicates that DBT has a lower recall rate for additional testing, reducing unnecessary follow-up procedures for patients.
  • Findings suggest DBT's improved performance could encourage wider adoption of this technology in breast cancer screening programs.

Atezolizumab Switch After Targeted Therapy Shows Survival Trend in BRAF+ Melanoma

  • Patients with BRAF V600–positive melanoma showed a trend towards improved overall survival with early switch to atezolizumab after vemurafenib/cobimetinib run-in.
  • The phase 2 ImmunoCobiVem trial explored the efficacy of switching to atezolizumab versus continuing targeted therapy in this patient population.
  • Median overall survival was 49.6 months in the atezolizumab arm compared to 40.2 months in the continuous targeted therapy arm.
  • Progression-free survival was longer with continuous targeted therapy, but subsequent crossover to the alternative treatment showed potential benefits.

Evaluating the Efficacy and Safety of a Sequencing Schedule of Cobimetinib Plus Vemurafenib Followed by Immunotherapy With an Anti- PD-L1 Antibody in Patients With Unresectable or Metastatic BRAF V600 Mutant Melanoma

NCT02902029CompletedPhase 2
University Hospital, Essen
Posted 11/1/2016

Pfizer Advances Anamorelin to Phase III for Cancer-Related Weight Loss

  • Pfizer is set to initiate a Phase III clinical trial for anamorelin, a ghrelin receptor agonist, aimed at addressing weight loss in cancer patients.
  • Anamorelin is designed to stimulate appetite and increase muscle mass, potentially improving outcomes for cancer patients experiencing cachexia.
  • The decision to move forward with Phase III trials follows promising results from earlier studies demonstrating anamorelin's efficacy in promoting weight gain.
  • This late-stage development underscores the need for effective treatments for cancer-related anorexia and cachexia syndrome (CACS), a condition with limited therapeutic options.

CPS Technologies Awarded $1.1 Million DOE Contract for Radiation Shielding

  • CPS Technologies Corp. secures a $1.1 million Phase II SBIR contract from the U.S. Department of Energy for developing modular radiation shielding.
  • The 24-month project aims to optimize lightweight materials effective against gamma and neutron radiation for microreactor transportation and use.
  • Building on successful Phase I results, Phase II will focus on scaling manufacturing processes for commercialization, with NETCO as a subcontractor.
  • This award marks CPS's second Phase II SBIR contract in 2024, bringing their total SBIR funding to over $3 million, highlighting government interest.

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