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“These findings reinforce isodose MHFRT as the standard of care, offering the same cancer control as conventional treatment but with fewer side effects than dose-escalated MHFRT,” says Amar U. Kishan, MD. 

Data reinforce isodose MHFRT as standard of care radiotherapy regimen

“Our study identifies that men who were invited for screening, but do not attend screening appointments are at significantly higher risk of dying from prostate cancer compared to men who were not offered screening or accepted an invitation for screening,” says Renée Leenen MD.

Avoidance of prostate cancer screening linked to increased risk of PCSM

Calyxo has identified a new risk of injury when the CVAC System is used in patients with high viscosity fluid in their kidneys at the start of the procedure.

FDA reports Urgent Device Field Correction notice for CVAC Aspiration System

"If you determine you can invest in a volatile environment, the best approach is to do so over a period of time," writes Jeff Witz, CFP.

Money Matters: How to cope with market volatility in 2025

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"The preliminary results of that study, which is a phase 1/2 dose escalation and dose expansion trial, were presented by Professor Ben Tran last year at the ENA meeting1 and showed a very favorable toxicity profile compared to erdafitinib," says Gopa Iyer, MD.

Gopa Iyer, MD, highlights SURF301 trial of TYRA-300 in mUC

“There are plans now to continue the dose optimization to identify the exact dose for a further expansion,” says Gopa Iyer, MD. 

Gopa Iyer, MD, highlights findings from FORAGER-1 in metastatic urothelial carcinoma

"The median progression-free survival and median overall survival continue to be almost double what we see with chemotherapy," says Gopa Iyer, MD.

Gopa Iyer, MD, on durable efficacy of EV/pembrolizumab in urothelial carcinoma

Dr. De La Cerda provides an overview of a patient case involving a 68 year-old male presenting with severe back pain, with an analysis of the clinical presentation, workup, and medical history.

Bone Predominant mCRPC Patient Case

Video content above is prompted by the following:

What are your initial impressions of the case?

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The FDA has accepted a Biologics License Application (BLA) seeking approval of nivolumab (Opdivo) co-formulated with Halozyme’s proprietary recombinant human hyaluronidase (rHuPH20), or subcutaneous nivolumab, for the treatment of patients with all previously approved solid tumor indications for nivolumab as a monotherapy, monotherapy maintenance following completion of combination therapy with nivolumab plus ipilimumab (Yervoy), or in combination with chemotherapy or cabozantinib (Cabometyx).

Nivolumab is currently approved under several indications, including in combination with ipilimumab for the first-line treatment of patients with intermediate- or poor-risk advanced renal cell carcinoma (RCC), in combination with cabozantinib for the first-line treatment of patients with advanced RCC, for the treatment of patients with advanced RCC who have received prior anti-angiogenic therapy, and in combination with cisplatin and gemcitabine for the first-line treatment of patients with unresectable or metastatic urothelial carcinoma.

The FDA is set to have a decision regarding the subcutaneous nivolumab formulation on or by December 29, 2024.

 According to a news release from Bristol Myers Squibb,

 approval of the formulation would make it the first and only subcutaneously administered PD-1 inhibitor.

“We believe subcutaneous nivolumab has the potential to make a significant difference in the lives of patients, which is reinforced by the FDA’s acceptance of our application,” said Gina Fusaro, PhD, vice president, global program lead, Bristol Myers Squibb, in the news release.

 “Opdivo is a foundational PD-1 inhibitor approved for many different types of cancer, and our continued investment in research that puts patients first remains a priority. If approved by the FDA, the subcutaneous administration of nivolumab would provide patients and their physicians with a new option that delivers the same well-known benefits as IV Opdivo but with the improved convenience of an injection administered in 3 to 5 minutes rather than a 30-to-60-minute infusion.”

The BLA submission is supported by findings from the phase 3 CheckMate-67T trial (NCT04810078), in which subcutaneous nivolumab met the study’s co-primary end points by demonstrating noninferiority to intravenous (IV) nivolumab regarding time average nivolumab serum concentration over 28 days (C

; geometric mean ratio [GMR}, 2.098; 90% CI, 2.001-2.200) and minimum serum concentration at a steady state (C

Data from the study, which were presented at the 2024 American Society of Clinical Oncology Genitourinary Cancers Symposium in San Francisco, California,

 also showed that subcutaneous nivolumab demonstrated noninferiority to IV nivolumab in the key powered secondary end point of objective response rate (ORR). Specifically, the subcutaneous arm demonstrated an ORR of 24.2% (95% CI, 19.0-30.0) per blinded independent central review (BICR), compared with 18.2% (95% CI, 13.6-23.6) in the IV arm.

The safety profile for subcutaneous nivolumab was consistent with that of the IV formulation. Among patients who received the subcutaneous formulation, 8.1% experienced injection-site reactions, with all being low-grade and transient. Deaths due to study drug toxicity occurred in 3 patients in the subcutaneous arm and 1 patient in the IV arm. Most deaths that occurred during the study were due to disease progression.

In total, the phase 3, open-label CheckMate-67T trial enrolled 495 patients with advanced or metastatic ccRCC who had received prior systemic therapy. Patients were randomly assigned 1:1 to receive 1200 mg subcutaneous nivolumab plus rHuPH20 every 4 weeks (n = 248) or to 3 mg/kg IV nivolumab every 2 weeks (n = 247) for up to 2 years of treatment or until disease progression, unacceptable toxicity, withdrawal, or death.

The co-primary pharmacokinetic end points for noninferiority testing were C

 of subcutaneous nivolumab vs IV nivolumab. The key secondary end point was ORR per BICR.

Final completion of the CheckMate-67T study is expected in January 2026.

1. U.S. Food and Drug Administration accepts Bristol Myers Squibb’s application for subcutaneous nivolumab (nivolumab and hyaluronidase). News release. Bristol Myers Squibb. May 6, 2024. Accessed May 7, 2024. https://news.bms.com/news/corporate-financial/2024/U.S.-Food-and-Drug-Administration-Accepts-Bristol-Myers-Squibbs-Application-for-Subcutaneous-Nivolumab-nivolumab-and-hyaluronidase/default.aspx

2. Bristol Myers Squibb announces updated action date by the U.S. Food and Drug Administration for subcutaneous nivolumab (nivolumab and hyaluronidase). News release. Published online and accessed May 21, 2024. https://investors.bms.com/iframes/press-releases/press-release-details/2024/Bristol-Myers-Squibb-Announces-Updated-Action-Date-by-the-U.S.-Food-and-Drug-Administration-for-Subcutaneous-Nivolumab-nivolumab-and-hyaluronidase/default.aspx

3. George S, Bourlon TB, Chacon MR, et al. Subcutaneous nivolumab (NIVO SC) vs intravenous nivolumab (NIVO IV) in patients with previously treated advanced or metastatic clear cell renal cell carcinoma (ccRCC): Pharmacokinetics (PK), efficacy, and safety results from CheckMate 67T. 

4. A study of subcutaneous nivolumab versus intravenous nivolumab in participants with previously treated clear cell renal cell carcinoma that is advanced or has spread (CheckMate-67T). ClinicalTrials.gov. Last updated March 1, 2024. Accessed May 7, 2024. https://clinicaltrials.gov/study/NCT04810078

The FDA is set to have a decision regarding the subcutaneous nivolumab formulation on or by December 29, 2024. 

News

FDA accepts BLA for subcutaneous nivolumab in solid tumors

The use of blue light cystoscopy (BLC) was associated with a reduced risk of recurrence among patients with non–muscle invasive bladder cancer (NMIBC), according to findings from the BRAVO study, published in 

According to the authors, this study is the largest real-world data comparison of 2 distinct retrospective cohorts.

In total, the study included 626 patients from the Veterans Affairs health care system. A 1:1 propensity score matching algorithm was used to compose 2 cohorts—patients who underwent BLC and patients who only underwent white light cystoscopy (WLC)—with 313 patients in each arm. Across both cohorts, the median age at diagnosis was 71 years, and 61% of patients had high-risk NMIBC. The median follow-up was 3.7 years.

Overall, 159 patients experienced a recurrence, of whom 64 (20%) were in the BLC arm and 95 (30%) were in the WLC arm. The risk of recurrence was significantly lower in the BLC arm, with a 3-year recurrence-free survival of 74.9% in the BLC arm vs 66.9% in the WLC arm (HR, 0.62; 95% CI, 0.45-0.86; 

According to the authors, “There was no association between risk of recurrence and receipt of intravesical BCG or intravesical chemotherapy.”

However, high-risk disease (HR, 2.25; 95% CI, 1.53-3.32) and older age (HR for every 10 years, 1.31; 95% CI, 1.09-1.59) were associated with a greater risk of recurrence.

Additionally, 38 patients experienced a bladder cancer progression, of whom 17 (5%) were in the BLC arm and 21 (7%) were in the WLC arm. The risk of disease progression on univariable analysis was not significantly different between the 2 arms (HR, 0.80; 95% CI, 0.42-1.51).

The authors noted, “In a multivariable adjusted analysis, patients who underwent BLC had a reduced risk of bladder cancer progression with a HR of 0.71 (95% CI, 0.37-1.38); however, statistical significance was not achieved.”

The authors found no association between progression and the receipt of intravesical BCG or intravesical chemotherapy. There was also no association between disease progression and age, sex, race, ethnicity, or smoking status. However, patients with high-risk disease had a 4-times increased risk of progression compared with those without high-risk disease (HR, 4.44; 95% CI, 1.49-13.25).

Patients in the BLC group were more likely to receive intravesical BCG therapy or intravesical chemotherapy. Specifically, 61% of patients in the BLC arm received intravesical BCG therapy, compared with 43% of patients in the WLC arm (

 < .01). Similarly, 48% of patients in the BLC arm received intravesical chemotherapy, compared with 27% of patients in the WLC arm (

 < .01). There was no significant difference in the rates of definitive treatment, with 8% of patients in the BLC arm and 6% of patients in the WLC arm receiving either radical cystectomy, radiation therapy, and/or systemic chemotherapy (

In a subanalysis, BLC detected higher grade NMIBC in 33 patients, compared with 9 patients for WLC (adjusted HR, 1.92; 95% CI, 1.23-3.02).

According to the authors, these findings support improved oncologic outcomes with BLC.

"Bladder cancer detection plays an important role in preventing cancer recurrence and optimizing appropriate treatment pathways, as previous research has shown that WLC alone may not comprehensively detect all NMIBCs,” concluded senior author Stephen B. Williams, MD, MBA, MS, FACS, FACHE, professor and chief of urology at the University of Texas-Medical Branch, in a news release on the findings.

 “In this propensity-score matched cohort study, we found that the use of BLC vs. WLC alone was associated with significantly decreased 38% risk of recurrence. Our results are in line with the recent Cochrane review of nearly 3,000 patients across 15 randomized trials, where the authors found that that BLC may reduce the risk of bladder cancer recurrence by 34%.

 These data support current AUA/SUO guidelines recommending BLC usage in patients with NMIBC to increase detection and decrease recurrence.”

1. Nasrallah AA, Das S, Evans C, et al. Oncologic outcomes of blue light cystoscopy in an equal access setting: results of the BRAVO Study. 

. 2025;3(3):e00017. doi:10.1097/JU9.0000000000000260

2. New BRAVO study publication reinforces clinical benefits of BLC in reducing risk of bladder cancer recurrence. News release. Photocure. March 14, 2025. Accessed March 19, 2025. https://www.prnewswire.com/news-releases/new-bravo-study-publication-reinforces-clinical-benefits-of-blc-in-reducing-risk-of-bladder-cancer-recurrence-302401805.html

3. Maisch P, Koziarz A, Vajgrt J, Narayan V, Kim MH, Dahm P. Blue versus white light for transurethral resection of non-muscle invasive bladder cancer. 

. 2021;12(12):CD013776. doi:10.1002/14651858.CD013776.pub2

"These data support current AUA/SUO guidelines recommending BLC usage in patients with NMIBC to increase detection and decrease recurrence," says Stephen B. Williams, MD, MBA, MS, FACS, FACHE.

Real-world data reaffirm oncologic benefits of BLC for NMIBC

Lu)-rhPSMA-10.1 injection showed encouraging radiation dosimetry results in patients with metastatic castration-resistant prostate cancer (mCRPC), according to final results from a phase 1 study (NCT05413850), shared in a news release by Blue Earth Therapeutics.

In the trial, radiation dosimetry was performed for up to 3 cycles of treatment with 

Lu-rhPSMA-10.1 injection. The study included 13 patients with mCRPC. Overall, the results demonstrated a favorable ratio between radiation doses absorbed in the tumor vs the dose delivered to key healthy organs, such as the kidneys and salivary glands.

Specifically, the mean tumor-to-kidney ratio was 32, and the mean tumor-to-salivary gland ratio was 73. The mean absorbed radiation dose to tumors was 8.9 Gy for each GBq administered radioactivity, compared with 0.27 Gy/GBq in the kidneys and 0.13 Gy/GBq in the salivary glands.

Additionally, the mean biological half-life in tumors was 338 hours. According to the company, “When paired with the 6.7-day physical half-life of 

Lu, this gives an effective mean half-life of 91.4 hours. This allows delivery of radiation to tumors over many days: one and a half to twice the reported data for established agents in this class.”

“The phase 1 data provides strong validation of the innovative approach taken on optimizing radioligand therapy by Blue Earth Therapeutics and the inventors of the rhPSMA technology,” said David Gauden, DPhil, CEO of Blue Earth Therapeutics, in the news release.

 “The relative ratios of tumor to healthy organ absorbed radiation doses are key metrics in establishing a better profile of the risks and potential benefits of radioligand therapies. With radioligand therapies, normal organ toxicity considerations gate the total amount of radioactivity that can be administered, so the more of the radioactivity that accumulates in tumors, the better. Our goal is to substantially increase the potential for [patients with] prostate cancer to benefit compared to available radioligand therapy, and completion of this study moves us closer to making that goal a reality."

The phase 2 portion of the phase 1/2 study is set to commence this quarter, the company reported. According to Blue Earth, the phase 2 portion will assess:

“Administration of significantly higher overall injected radioactivity in comparison to recent phase 3 clinical trials of other PSMA-targeted radioligand therapies;

Front loading of administered radioactivity in early cycles; and

Extending the duration of administration of radioactivity beyond 36 weeks to provide longer time on treatment.”

The phase 2 portion will enroll patients through clinical trial sites across the US and the Netherlands.

To be eligible for enrollment, patients must have a serum testosterone level below 50 ng/dL, an ECOG performance score of 0 to 2, a life expectancy of at least 6 months, and adequate bone marrow reserve and organ function, among other measures.

The phase 2 portion will include 2 cohorts: those in the post-chemotherapy setting and those who have not yet received taxane-based chemotherapy. The primary outcome measure is the number of patients with an antitumor response, defined as at least a 50% reduction in prostate-specific antigen from baseline.

Completion of the trial is expected in October 2026.

1. Blue Earth Therapeutics reports key results from Lutetium (177Lu) rhPSMA-10.1 injection phase 1 clinical trial. News release. Blue Earth Therapeutics Ltd. March 13, 2025. Accessed March 13, 2025. https://www.prnewswire.com/news-releases/blue-earth-therapeutics-reports-key-results-from-lutetium-177lu-rhpsma-10-1-injection-phase-1-clinical-trial-302400601.html

2. Anti-tumour activity of (177Lu) RhPSMA-10.1 injection. ClinicalTrials.gov. Last updated November 22, 2024. Accessed March 13, 2025. https://clinicaltrials.gov/study/NCT05413850

The mean absorbed radiation dose to tumors was 8.9 Gy/GBq, compared with 0.27 Gy/GBq in the kidneys and 0.13 Gy/GBq in the salivary glands. 

Radioligand therapy shows promising safety in patients with mCRPC

A 35-year-old male from Sudan was hospitalized with a right obstructing 1-cm ureteral stone seen on KUB. The KUB also revealed curvilinear calcification in the bladder wall. The patient was taken to the operating room for ureteroscopy and laser lithotripsy.

During cystoscopy, a rim of calcification was seen along the right ureteric ridge (figure 1a). A biopsy of this area was taken with the pathology shown in figure 1b.

B. Squamous cell carcinoma of the bladder

A 35-year-old male from Sudan presented with a 1-cm obstructing ureteral stone and curvilinear calcification in the bladder wall, as seen on KUB imaging. The patient underwent ureteroscopy and laser lithotripsy. During cystoscopy, calcification was observed along the right ureteric ridge. A biopsy was performed on this area to further investigate the pathology. The findings from the biopsy are crucial for understanding the underlying condition contributing to the calcification and obstruction, which may have implications for the patient's treatment and management.

A 35-year-old male from Sudan was hospitalized with a right obstructing 1-cm ureteral stone seen on KUB. The KUB also revealed curvilinear calcification in the bladder wall. The patient was taken to the operating room for ureteroscopy and laser lithotripsy. During cystoscopy, a rim of calcification was seen along the right ureteric ridge. What is the diagnosis?

Residents Corner

Quiz: Sandy patch on cystoscopy

Real-world data indicate a significantly lower incidence of all-cause bowel disorders in patients with prostate cancer who received radiotherapy treatment along with placement of a polyethylene glycol-based hydrogel spacer (spaceOAR) vs patients who did not receive a spacer.

®, Michael R. Folkert, MD, PhD, explained, “What we were doing with this study is we were trying to look at real-world data for spacer use. We have a lot of prospective data to guide us in in our care of patients, but it's nice to see what happens when you actually apply it to real patients.” Folkert is a professor of radiation oncology at the University of Washington School of Medicine, Seattle.

For the study, Folkert and his colleagues evaluated data on patients from 4 separate data sets: Medicare 5% Standard Analytic Files, Medicare 100% Standard Analytic Files, Merative MarketScan Commercial Database, and Premier Healthcare Database. Patients with prostate cancer who were treated with radiotherapy between 2015 and 2021 were included in the analysis.

“From those data sets, we were able to extract a range of codes for disorders and procedures that were related to bowel complaints to bowel disorders, and then conducted an analysis to probe associations between these codes and the use of rectal spacers, and then a comparison also of disorders and procedures the same sets of disorders and procedures related to bowel complaints and disorders on an age-matched general population that didn't have prostate cancer, to kind of ground the that experience in a general population,” Folkert said.

Regarding their findings, “4 years following radiation therapy, there is a 25% lower hazard of bowel disorders and a 46% lower hazard of related procedures [in patients who received a spacer],” Folkert said.  

1. Folkert MR, Sato R, Yu JB, et al. Bowel disorder incidence and rectal spacer use in patients with prostate cancer undergoing radiotherapy. 

. 2025;8(3):e250491. doi:10.1001/jamanetworkopen.2025.0491

"4 years following radiation therapy, there is a 25% lower hazard of bowel disorders and a 46% lower hazard of related procedures [in patients who received a spacer],” says Michael R. Folkert, MD, PhD.

Gopa Iyer, MD

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