Durvalumab and Radiation Therapy Show Promising Efficacy in Urothelial Cancer

Strategic Insights -

Patients with urothelial bladder cancer who are ineligible for cisplatin or have unresectable disease have limited treatment options. Researchers from Pennsylvania State University (Penn State) Cancer Institute aimed to evaluate the safety and efficacy of durvalumab (durva) and radiation therapy (RT) in combination with adjuvant durva in localized urothelial cancer patients with comorbidities. The study showed promising results, with a 71.5% progression-free survival rate at 1 year and a 83.8% overall survival rate at 1 year.

Key Takeaways:

  • The phase II study enrolled 26 patients with pure or mixed urothelial bladder cancer (T2-4 N0-2 M0) who were unfit for surgery or cisplatin ineligible.
  • Patients received durva concurrently with RT for 7 weeks, followed by adjuvant durva for 1 year.
  • The primary endpoints were progression-free survival at 1 year and disease control rate post-adjuvant durva.
  • The study found that durva with RT followed by adjuvant durva was safe and had promising efficacy in localized urothelial cancer patients with comorbidities, including node-positive patients.
  • Larger randomized studies, such as S1806 and EA8185, are needed to evaluate the efficacy of combining immunotherapy and RT in BC.
  • The study's results showed that patients with complete response or partial response had an increase in naive CD4 T cells and a decrease in PD-1+CD4 T cells at baseline.

Statistics:

  • 71.5% progression-free survival rate at 1 year
  • 83.8% overall survival rate at 1 year
  • 54.5% complete response rate post-adjuvant durva
  • 72.7% disease control rate post-adjuvant durva
  • 21.8 months median progression-free survival
  • 30.8 months median overall survival
  • 62.5% complete response rate at 8 weeks post-durvaRT
  • Grade 3 treatment-related adverse events: anemia, high lipase/amylase, immune-nephritis, transaminitis, dyspnea (grade 4-COPD/immune), fatigue, rash, diarrhea, and scleritis

Sources:

  • NewsRx. Pennsylvania State University (Penn State) Cancer Institute Researchers Highlight Research in Urothelial Cancer [Concurrent durvalumab and radiation therapy (DUART) followed by adjuvant durvalumab in patients with localized urothelial cancer of ...]. Immunotherapy Weekly. March 15, 2023; p 914.
  • Concurrent durvalumab and radiation therapy (DUART) followed by adjuvant durvalumab in patients with localized urothelial cancer of bladder: results from phase II study, BTCRC-GU15-023. Journal for ImmunoTherapy of Cancer, 2023,11(2). (Journal for ImmunoTherapy of Cancer - http://www.immunotherapyofcancer.org/).
  • Hong Zheng, Junjia Zhu, Monika Joshi, Mark Stein, Alexander Sankin, Deepak Kilari, Yousef Zakharia, Joseph Drabick, Ralph Hauke, Hamid Emamekhoo, Todd Schell, Leonard Tuanquin, Vonn Walter, Matthew Kaag, Jiangang Liao, Sheldon L Holder, Suzzane Merrill, Joshua Warrick, Benjamin Gartrel, and David J Degraff. Pennsylvania State University (Penn State) Cancer Institute.