GU Cancers Symposium

The updated data sustained the previous radiographic progression-free survival benefit observed with the niraparib combination and showed that the combination also met several secondary end points.

"[This is] a group of patients that there are few treatments available for, and we're excited about the data," says Daniel P. Petrylak, MD.

"Looking at the effect of the darolutamide on docetaxel, we didn't see much of a difference in dose reduction, dose modification, or dose hold for docetaxel, telling you that darolutamide didn't really affect the dosing of docetaxel," says Arash Rezazadah Kalebasty, MD.

Baseline findings showed that patients treated with first-line platinum-based chemotherapy prior to avelumab maintenance experienced a complete response rate of 13% and a partial response rate of 68% to chemotherapy.

The real-world data were presented at the 2023 American Society of Clinical Oncology Genitourinary Cancers Symposium.

"We're trying to understand where these new therapeutic agents might fit into our paradigms of care," says John L. Gore, MD, MS.

"This trial did not require a biomarker for entry in, so patients were treated with combination therapy or standard care, which would have been the abiraterone alone, to see if there was a benefit," says Michael S. Cookson, MD, MMHC.

Median progression-free survival in the intent-to-treat population by blinded independent central review was 16.6 months (95% CI, 12.8-19.8) with nivolumab plus cabozantinib vs 8.4 months (95% CI, 7.0-9.7) with sunitinib (HR, 0.58; 95% CI, 0.48-0.71).

The median progression-free survival (PFS) was 16.9 months (95% CI, 11.5-not estimable) with cabozantinib vs 11.3 months (95% CI, 7.7-14.0) with placebo in the PFS intention-to-treat population.

Data from the 3-month analysis showed that the cabozantinib elicited an objective response rate of 29.5% (95% CI, 20.3%-40.2%) in the total population (n = 88), which comprised a complete response rate of 1.2% and a partial response rate of 30.5%.

At a median follow-up of 13.4 months, 336 (75%) OS events occurred with atezolizumab plus platinum and gemcitabine and 310 (78%) occurred with placebo plus platinum and gemcitabine.

An exploratory analysis of the IMvigor130 study failed to show an improvement in overall survival with atezolizumab, compared with placebo plus platinum-based chemotherapy and gemcitabine in patients with untreated locally advanced or metastatic urothelial cancer.

“The effect size for adjuvant nivolumab versus placebo across primary, secondary, and exploratory endpoints is all remarkably stable,” says Matthew D. Galsky, MD.

Treatment with nivolumab in patients with high-risk muscle-invasive urothelial carcinoma continued to improve survival, supporting its use as a standard of following radical resection.

In cohort B of the phase 2 Keynote-057 trial, pembrolizumab led to antitumor activity in patients with BCG-unresponsive, papillary high-risk non–muscle-invasive bladder cancer.

Treatment with rucaparib reduced risk of imaging-based progression or death by half in men with BRCA-altered metastatic castration-resistant prostate cancer.

Of note, 55% of patients received a full course (6 injections) of radium-223 injections, and 67% received 5 of the 6 injections.

"The median survival of the combination arm was 16.1 months versus 13.4 months in the standard chemo arm," says Enrique Grande, MD.

“These data support further evaluation of sacituzumab govitecan—alone or in combination—in patients with metastatic urothelial carcinoma who progressed after prior CPI therapy,” says Daniel P. Petrylak, MD.

The ORR for patients was 47%. Of note, ORRs were higher in patients with specific alterations compared with wild type including ERBB2 (67% vs. 44%, respectively; P = .05) and TSC1 (68% vs. 25%; P = .04).

The combination use of niraparib plus abiraterone and prednisone continued to improve outcomes in patients with metastatic, castration-resistant prostate cancer and HRR gene alterations.

In the the phase 2 HCRN GU 16-257 trial, 33 patients with muscle-invasive bladder cancer were eligible to forego cystectomy and continue 240-mg maintenance nivolumab monotherapy every 2 weeks for 8 cycles followed by surveillance.

“There are a number of trials that we're interested in to develop potentially combining chemotherapy and neoadjuvant immunotherapy,” says Joshua J. Meeks, MD, PhD.

"The MMAI model had significantly improved accuracy and prognostication to discriminate which patients would develop distant metastasis or die from prostate cancer," says Daniel E. Spratt, MD.

“This represents one of the largest reported in the phase 3 trials in first-line mCRPC,” says investigator Noel W. Clarke, MBBS, FRCS, ChM.

"We found that if the patient has normal IsoPSA, he has only 1% of risk of developing clinically significant prostate cancer in a median follow-up time of 18 months," says Nour Abdallah, MD.

Data showed that treatment with talazoparib plus enzalutamide resulted in a 37% reduction in the risk of progression or death as assessed by blinded independent central review.

By the data cut-off date of January 31, 2023, investigators reported that 30% of patients with nonmetastatic castration-resistant prostate cancer had received darolutamide for at least 4 years, and 24% of were still receiving the agent.

Results of the ARASENS trial (NCT02799602) demonstrated that darolutamide plus ADT and docetaxel prolonged overall survival regardless of disease volume or risk.

Investigators compared 3 second-generation androgen receptor inhibitors to determine real-world utilization of the drugs and examine the incidence of adverse events.