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Clinical Trial News

AstraZeneca's Imfinzi Improves Survival in Bladder Cancer Patients

  • AstraZeneca's Imfinzi, an anti-PD-L1 checkpoint inhibitor, significantly improved survival rates in patients with muscle-invasive bladder cancer.
  • The Imfinzi regimen, administered before and after surgery, reduced the risk of death by 25% compared to chemotherapy alone.
  • The trial also demonstrated a reduction in the risk of disease recurrence by approximately one-third with the Imfinzi treatment.
  • These results from the Phase 3 NIAGARA trial could transform the standard of care for this aggressive form of bladder cancer.

Anlotinib and Penpulimab Combination Shows Promise in Advanced Hepatocellular Carcinoma

• The Phase III APOLLO trial demonstrated that anlotinib combined with penpulimab significantly improved progression-free survival (PFS) in patients with advanced hepatocellular carcinoma (aHCC). • The combination therapy showed a median PFS of 6.9 months compared to 2.8 months with sorafenib, a long-established aHCC treatment, indicating a substantial clinical benefit. • Overall survival (OS) also improved in the anlotinib plus penpulimab arm, with a median OS of 16.5 months versus 13.2 months in the sorafenib arm. • The safety profile of the anlotinib and penpulimab combination was manageable, with fewer treatment-related adverse events compared to sorafenib.

Pfizer's Ponsegromab Shows Promise in Treating Cancer Cachexia in Phase 2 Trial

  • Pfizer's ponsegromab met its primary endpoint, demonstrating a statistically significant increase in body weight compared to placebo in cancer cachexia patients.
  • The highest dose of ponsegromab (400 mg) led to a 5.6% mean increase in body weight at 12 weeks, along with improvements in appetite and physical activity.
  • The Phase 2 study included patients with non-small cell lung cancer, pancreatic cancer, or colorectal cancer, showing the drug was generally safe and well-tolerated.
  • Pfizer plans to initiate registration-enabling studies in 2025 based on these positive results, potentially offering a new treatment option for cachexia.

AstraZeneca's Imfinzi Demonstrates Improved Survival in Muscle-Invasive Bladder Cancer

  • AstraZeneca's Imfinzi, combined with chemotherapy, significantly improved event-free survival in patients with muscle-invasive bladder cancer (MIBC).
  • The NIAGARA Phase III trial showed a 32% reduction in disease progression, recurrence, or death compared to chemotherapy alone.
  • The Imfinzi regimen reduced the risk of death by 25%, with 82.2% of patients alive at two years versus 75.2% in the chemotherapy arm.
  • These results could transform the standard of care for MIBC, offering a curative-intent regimen and improving cure rates.

Pazopanib and Bevacizumab Combination Doubles Progression-Free Survival in Metastatic Kidney Cancer

  • A novel treatment regimen combining pazopanib and bevacizumab has demonstrated a significant improvement in progression-free survival (PFS) for patients with metastatic kidney cancer.
  • The phase 1/2 clinical trial showed a median PFS of 23.3 months with the combination therapy, compared to 11.1 months with pazopanib alone.
  • The study suggests that alternating pazopanib with bevacizumab is a promising treatment strategy, particularly for patients in the International Metastatic Renal Cell Carcinoma Database (IMDC) Favorable Risk group.
  • The combination therapy demonstrated comparable or superior efficacy to immunotherapy combinations and improved safety compared to immunotherapy in the Favorable Risk group.

PSMA PET-CT Criteria Show Promise for Early Prostate Cancer Progression Detection

  • New criteria for PSMA PET-CT show high inter-reader agreement in detecting prostate cancer progression, with a kappa value of 0.9 for progression vs. no progression.
  • PSMA PET-CT detected progression earlier than PCWG3 criteria, while still correlating well with overall survival in the PRINCE trial.
  • The proposed criteria include a response category, allowing for the identification of complete responses based on the disappearance of lesions.
  • Further validation is planned using data from multiple clinical trials to ensure robustness and correlation with overall survival before widespread implementation.

Disitamab Vedotin Plus Pembrolizumab Shows Promise in HER2-Expressing Urothelial Cancer

• Disitamab vedotin combined with pembrolizumab demonstrates a 75% response rate in treatment-naive metastatic urothelial cancer patients with HER2 expression. • The combination shows activity in both HER2-positive and HER2-low tumors, suggesting a broad potential application in urothelial cancer. • The safety profile of disitamab vedotin plus pembrolizumab differs from enfortumab vedotin plus pembrolizumab, potentially offering a distinguishing factor. • An international phase III study is underway, comparing the combination to platinum-based chemotherapy to further evaluate its efficacy.

New Zealand Expands Access to Pembrolizumab and Nivolumab for Multiple Cancers

  • Pembrolizumab (Keytruda) will be funded from October 1, 2024, for advanced triple-negative breast cancer, head and neck cancer, colorectal cancer, bladder cancer, and Hodgkin lymphoma in New Zealand.
  • Nivolumab (Opdivo) will be funded from November 1, 2024, for eligible patients with kidney cancer, offering a new treatment option for this patient population.
  • The expanded access is expected to benefit approximately 1,000 people in the first year, increasing to 4,500 over five years, improving survival and quality of life.
  • Funding has also been approved for posaconazole and voriconazole for individuals at high risk of invasive fungal infections, such as those undergoing cancer treatment or organ transplants.

3D Systems and Smith & Nephew Gain FDA Clearance for Personalized Total Ankle Replacement Solution

  • 3D Systems received FDA clearance for its patient-matched guides designed for Smith & Nephew's Salto Talaris and Cadence total ankle replacement systems.
  • The collaboration provides surgeons with a comprehensive solution integrating 3D-printed instruments for personalized ankle replacement procedures.
  • The new system aims to enhance surgical precision and improve patient outcomes through increased efficiency and accuracy in total ankle replacement.
  • Both companies showcased the new systems at the American Orthopaedic Foot and Ankle Society Annual Meeting from September 11-14.

Amivantamab Plus Chemotherapy Shows Promise in Metastatic Colorectal Cancer

• RYBREVANT® (amivantamab) combined with chemotherapy demonstrated a 49% overall response rate in patients with RAS/BRAF wild-type metastatic colorectal cancer. • The median duration of response was 7.4 months, and the median progression-free survival was 7.5 months in the study population. • Notably, 21% of patients were able to undergo curative-intent surgery due to the treatment's strong antitumor activity. • The safety profile of the combination was manageable, with no new safety signals observed beyond those of the individual components.
NCT05663866Active, Not RecruitingPhase 2
Janssen Research & Development, LLC
Posted 5/18/2023
NCT04606381Active, Not RecruitingPhase 1
Janssen Research & Development, LLC
Posted 11/10/2020

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