Benjamin P. Saylor, Strategic Content Lead

The primary end point—12-month DFS rate—was 80% (40/50 evaluable patients; 95% CI, 0.67-0.89), with 2 patients pending assessment and 3 not evaluable.

PSA50 response rates were 58.8% overall in Group A (72.7% at 10 MBq), 85.2% overall in Group B (100% at 10 MBq), and 52.5% overall in Group C (56.3% at 10 MBq).

"Together with the efficacy and safety results, these PRO findings support the overall benefit-risk profile of perioperative EV plus [pembrolizumab] as the new standard of care in this patient population," said Peter H. O'Donnell, MD.

The FDA approved cefepime and zidebactam for adult complicated UTI after ENHANCE-1 showed an 89.0% response rate at test of cure.

"Compared to placebo [plus] ADT, apalutamide [plus] ADT showed 9 times more pCR/MRD, a 20% improved MFS, a 29% reduction in prostate cancer recurrence, and a 3-year improvement in time to subsequent therapy," said Mary-Ellen Taplin, MD, FASCO.

Study investigator Gopa Iyer, MD, concluded that LY4052031 represents a promising next-generation Nectin-4 ADC with a distinct payload mechanism that may overcome EV resistance in mUC.

"These data help inform patient decision-making regarding adjuvant therapy and also point to a possible need for supportive services to help survivors after treatment," said Ronald C. Chen, MD, MPH, FASCO, FASTRO.

"There is some evidence here, supported by our statistical analysis plan, that the classifier predicted the postulated benefits of adding docetaxel to ADT and enzalutamide," said Christopher Sweeney, MBBS, DHS.

At a median follow-up of 42.8 months, median OS was 33.6 months (95% CI, 26.6–39.8) with EV+P (240 events/442 patients) vs 15.9 months (95% CI, 13.6–18.3) with chemotherapy (329 events/444 patients).

"Twenty-seven of 40 patients achieved a pCR amounting to a rate of 68%. Therefore, the null hypothesis could be rejected," said Richard Cathomas, MD.

Although the primary end point was not met, Rana R. McKay, MD, highlighted a notable divergence in OS curves after 1 year that she described as a signal warranting further investigation.

Patients in the enzalutamide combination group were most likely to achieve a treatment suspension lasting a least 2 years.

The lower bound of the 95% CI (57.6%) exceeded the prespecified noninferiority effectiveness performance goal of 50.9%, thereby meeting the primary effectiveness end point.

Extended follow-up data from a phase 3 randomized trial show that aglatimagene besadenovec plus valacyclovir combined with radiotherapy produced a 39% improvement in prostate cancer-specific disease-free survival vs placebo plus standard-of-care radiotherapy in men with intermediate- to high-risk localized prostate cancer.

"I think these data clearly support one year of durvalumab in combination with induction maintenance BCG as a potential new treatment for patients with BCG high-risk NMIBC with the appropriate shared decision-making conversation," said Neal D. Shore, MD, FACS.

Darolutamide plus ADT also significantly delayed time to mCRPC (HR 0.26; 95% CI 0.18–0.38; P <.001) and rPFS (HR 0.30; 95% CI 0.19–0.48; P <.001) vs ADT.

The agency simultaneously approved the Signatera CDx as a companion diagnostic to identify patients with ctDNA MRD who are eligible for treatment.

The OPTIMUM randomized trial demonstrated that microultrasonography-guided biopsy is noninferior to MRI fusion-guided biopsy for detecting clinically significant prostate cancer, with a streamlined in-office workflow, a manageable learning curve, and substantially lower cost that may help address diagnostic access gaps worldwide.

"The CR rates in both arms are compelling, being higher than 50% with both strategies…BI-EFS rates in participants at week 18 CR assessment were comparable between arms and were higher than 80% in both arms," said Andrea Necchi, MD.

"Belzutifan plus lenvatinib addresses an unmet clinical need and represents a potential new treatment option for patients with RCC that progressed after PD 1 or-L1 therapy,” said Robert J. Motzer, MD.

“After 28 months’ follow-up, the combination of pembrolizumab and belzutifan resulted in a statistically significant and clinically meaningful improvement in disease-free survival over pembrolizumab single agent,” said Toni K. Choueiri, MD.

"Tokyo BCG is noninferior to TICE. This means that the BCG shortage could be mitigated with the Tokyo strain," said Robert Svatek, MD, MSCI.

“When we looked at ctDNA dynamics, patients who had baseline and postneoadjuvant ctDNA negativity had the best outcomes," said Pooja Ghatalia, MD.

“Neoadjuvant and adjuvant EV/pembro significantly improved event-free survival, overall survival, and path CR rate vs neoadjuvant gem/cis in patients with muscle-invasive bladder cancer who are eligible for cisplatin-based chemotherapy and radical cystectomy," said Matthew D. Galsky, MD.

“Biochemical responses were seen at all dose levels, with an overall PSA50 response of 62% and a PSA90 response of 40%," according to Fred Saad, CQ, MD, FRCS, FCAHS.

Karim Fizazi, MD, PhD, reported that the 9-year prostate cancer-specific survival rate was 90% (95% CI, 86-94) in patients receiving cabazitaxel vs 89% (95% CI, 84-93) in patients not receiving cabazitaxel.

"Capivasertib in combination with abiraterone represents a potential first-in-class targeted treatment for patients with this now PTEN-defined metastatic APMN,” said Daniel J. George, MD.

"Enzalutamide plus radium-223 is an option in first-line treatment for mCRPC patients with bone metastases," said Enrique Gallardo, MD.

Median OS was 28 months (95% CI, 13-NR) in arm 1, 37 months (95% CI, 26-NR) in arm 2, and 68 months (95% CI, 38-NR) in arm 3.

Data from the pivotal BREEZE study indicated a mean IPSS improvement of 37% in patients receiving the system.