GU Cancers 2021 | BTCRC-GU15-023: DUART plus adjuvant durvalumab in bladder cancer
Monika Joshi, MD, MRCP, Penn State Cancer Institute, Hershey, PA, shares an update on the primary results from the Phase II BTCRC-GU15-023 trial (NCT02891161) of concurrent durvalumab and radiation therapy (DUART) followed by adjuvant durvalumab in patients with localized urothelial cancer of the bladder. 26 patients with urothelial bladder cancer who were unfit for surgery, were cisplatin ineligible, or whose tumor was unresectable, were enrolled in the study. DUART followed by adjuvant durvalumab demonstrated promising efficacy in these patients. This interview took place during the 2021 Genitourinary Cancers Symposium.
Transcript (edited for clarity)
This is a very exciting and interesting Phase II study in locally advanced and muscle invasive bladder cancer patients who were unfit for surgery, or unresectable or cisplatin-ineligible. And this is a Big Ten Cancer Research Consortium study.
We enrolled 26 patients and we evaluated the efficacy of combining durvalumab, the checkpoint inhibitor, with radiation therapy followed by adjuvant durvalumab...
This is a very exciting and interesting Phase II study in locally advanced and muscle invasive bladder cancer patients who were unfit for surgery, or unresectable or cisplatin-ineligible. And this is a Big Ten Cancer Research Consortium study.
We enrolled 26 patients and we evaluated the efficacy of combining durvalumab, the checkpoint inhibitor, with radiation therapy followed by adjuvant durvalumab. So, in this cohort of patients, we observed that the only efficacy endpoint, and that was one of the secondary endpoints for this study, which was evaluated post-completion of two doses of durvalumab along with seven weeks of radiation. And we saw a complete response rate of about 79.1% and a disease control rate of about 91.7%.
What we’re presenting in our ASCO GU meeting is the long-term endpoints or the primary endpoints for this study, which were to disease control rate, post-adjuvant therapy, as well as progression-free survival at one year. And in this cohort, we observed that complete responses post-adjuvant therapy was 54.5%. And we also observe disease control rate of 72.7%. One-year PFS probability was 70.3%, and it was exciting to see that one year overall survival probability was around 83.8%. So overall the treatment was well tolerated by these patients and it’s exciting to see promising efficacy in this small single-arm, Phase II study.
Read more...
Disclosures
Monika Joshi, MBBS, MSc, MD, FRCP, has received research support from AstraZeneca, Pfizer and Eisai and has participated in advisory boards with Sanofi and Bayer.
