Hannah Clarke

Associate Editor at MJH Life Sciences

Associate Editor, MJH Life Sciences | MPH candidate at Johns Hopkins University | views expressed are my own

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Articles

Durvalumab plus BCG significantly improves DFS in NMIBC

6 days ago | urologytimes.com | Benjamin P. Saylor |Hannah Clarke

Treatment for 1 year with durvalumab (Imfinzi) plus standard-of-care BCG induction and maintenance therapy was associated with a statistically significant and clinically meaningful improvement in disease-free survival (DFS) high-risk non–muscle invasive bladder cancer (NMIBC) vs BCG induction and maintenance alone, AstraZeneca announced.1 According to the company, although the phase 3 POTOMAC trial (NCT03528694) was statistically powered to formally evaluate overall survival, “a descriptive...
AUA 2025 recap: Urologic oncology trials in progress

1 week ago | urologytimes.com | Hannah Clarke

The 2025 American Urological Association (AUA) Annual Meeting in Las Vegas, Nevada featured several sessions on ongoing clinical trials in urologic oncology. These spanned several up-and-coming agents in the non–muscle invasive bladder cancer (NMIBC) space, as well as potential practice-informing studies in both prostate and kidney cancer. Take a look through some of the notable studies that were spotlighted during this year’s meeting.
FDA issues refusal to file letter on sBLA for nogapendekin alfa inbakicept

1 week ago | urologytimes.com | Hannah Clarke

The FDA has issued a refusal to file (RTF) letter to ImmunityBio in regard to their supplemental biologics license application (sBLA) for use of nogapendekin alfa inbakicept-pmln (NAI; Anktiva) in combination with BCG for BCG-unresponsive non–muscle invasive bladder cancer (NMIBC) in the papillary indication, the company announced in a news release.1 According to ImmunityBio, this letter comes after receiving unanimous guidance to submit the sBLA from leadership at the agency during an...
Hugo robot-assisted surgery system shows promise for urologic procedures

1 week ago | urologytimes.com | Hannah Clarke

The Expand URO IDE study met its primary efficacy and safety end points, supporting the use of the Hugo robot-assisted surgery system in patients undergoing urologic procedures, according to data presented at the 2025 American Urological Association (AUA) Annual Meeting in Las Vegas, Nevada.1The results were shared by Michael R. Abern, MD, an associate professor of urology at Duke University School of Medicine in Durham, North Carolina.
TAR-200 elicits unprecedented complete response rate in BCG-unresponsive NMIBC

1 week ago | urologytimes.com | Hannah Clarke

Treatment with TAR-200 yeilded an 82.4% complete response (CR) rate among patients with BCG-unresponsive high-risk non–muscle invasive bladder cancer (NMIBC), which is the highest single-agent CR reported to date, the authors noted.1These data, collected from cohort 2 of the SunRISe-1 trial (NCT04640623), were presented at the 2025 American Urological Association (AUA) Annual Meeting in Las Vegas, Nevada.
Phase 3 trial of capivasertib in mCRPC discontinued following IDMC recommendation

1 week ago | urologytimes.com | Hannah Clarke

The phase 3 CAPItello-280 trial (NCT05348577) has been terminated following a recommendation from the Independent Data Monitoring Committee (IDMC), AstraZeneca announced in a news release.1The study was assessing the safety and efficacy of adding capivasertib (Truqap) to docetaxel and androgen deprivation therapy (ADT) for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC).
CISTO: Radical cystectomy has key role in recurrent high-grade NMIBC

2 weeks ago | urologytimes.com | Hannah Clarke

Radical cystectomy should continue to have an important role in the management of patients with recurrent high-grade non–muscle invasive bladder cancer (NMIBC), according to 12-month results from the CISTO study (NCT03933826).1The findings were presented during the 2025 American Urological Association (AUA) Annual Meeting in Las Vegas, Nevada by John L. Gore, MD, MS, an adjunct professor of surgery at the Fred Hutchinson Cancer Center at the University of Washington in Seattle.
FDA updates in urology: April 2025

2 weeks ago | urologytimes.com | Hannah Clarke

Welcome to Urology Times’® monthly FDA update! Last month, key developments included the clearance of a wireless, catheter-free urodynamics system for lower urinary tract dysfunction (LUTD) and a submission for an expanded indication of nogapendekin alfa inbakicept-pmln (NAI, Anktiva) for papillary non–muscle invasive bladder cancer (NMIBC). Stay informed with our FDA recap, delivered during the first week of each new month.
TAR-200 boasts impressive DFS rates in papillary disease-only NMIBC

2 weeks ago | urologytimes.com | Hannah Clarke

TAR-200 monotherapy poses a promising emerging option for patients with BCG-unresponsive papillary disease-only high-risk non–muscle invasive bladder cancer (NMIBC), according to results from cohort 4 of the SunRISe-1 trial (NCT04640623) presented at the 2025 American Urological Association (AUA) Annual Meeting in Las Vegas, Nevada.1TAR-200 is a novel intravesical drug releasing system.
Jason Hafron, MD, outlines AUA 2025 session on clinical trial recruitment

2 weeks ago | urologytimes.com | Jason M. Hafron |Hannah Clarke

OpinionVideoApril 26, 2025Author(s):,In an interview with Urology Times®, Jason M. Hafron, MD, CMO, discusses his talk, “Barriers in Recruiting and Running Effective Clinical Trials in Independent Practices,” which was presented at the 2025 American Urological Association (AUA) Annual Meeting in Las Vegas, Nevada. Hafron is the chief medical officer and director of clinical research at Michigan Institute of Urology.