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"Now with the new translational data indicating that post-treatment close contact precautions are unnecessary, I am confident that cretostimogene will represent a breakthrough in bladder cancer treatment, if approved by the FDA," says Trinity J. Bivalacqua, MD, PhD. 

Cretostimogene grenadenorepvec continues to show favorable efficacy, safety in NMIBC

The mean change in IPSS from baseline to 3 months was 12.9 in the Aquablation arm vs 13.1 in the LEP arm.

WATER III: Aquablation achieves comparable outcomes to laser enucleation for BPH

“The addition of the durvalumab did not make treatment more morbid than chemotherapy alone, and it didn't change or increase the surgical complications you saw in the ward," says James W.F. Catto, MBChB, PhD, FRCS.

Additional NIAGARA data reinforce benefit of perioperative durvalumab in MIBC

“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

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“The primary end point is progression-free survival, and the secondary end points are overall survival, objective response rates, duration of response, and safety.”

Francesca Jackson-Spence, MBChB, details the ongoing SAMETA trial in papillary renal cancer

“Interestingly, the confirmed response rate in the intention to treat population was 32%, but this increases to 53% in the MET driven subset,” says Francesca Jackson-Spence, MBChB, BMedSc, MRCP. 

Francesca Jackson-Spence, MRCP, on efficacy of savolitinib/durvalumab in papillary renal cancer

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

Both isodose and dose-escalated moderately hypofractionated radiotherapy (MHFRT) showed comparable efficacy to conventionally-fractionated radiotherapy (CFRT) in patients with prostate cancer, though dose-escalated MHFRT was associated with greater odds of bowel toxicity, according to data from a recent meta-analysis published in 

With isodose MHFRT, there was no added risk of urinary or bowel toxicity compared with CFRT.

“We believe these data strongly support that isodose MHFRT should become the preferred standard of care MHFRT regimen for prostate cancer,” said co-lead author Amar U. Kishan, MD, executive vice chair of radiation oncology at the David Geffen School of Medicine at UCLA, in a news release on the findings.

 “More broadly, there appears to be little reason to consider conventional radiotherapy over MHFRT for the types of patients enrolled in these trials given these results.”

In total, the study assessed outcomes from 7 phase 3 trials that compared MHFRT with CFRT. Of these, 3 studies compared isodose MHFRT with CFRT (n = 3454; median follow-up, 5.4 years) and 4 studies compared dose-escalated MHFRT with CFRT (n = 2426; median follow-up, 7.1 years).

In the studies comparing isodose MHFRT with CFRT, progression-free survival (PFS) was not statistically significant different between the 2 cohorts (HR, 0·92; 95% CI, 0·81–1·05; 

 = .21). Specifically, the estimated 5-year PFS was 77.0% (95% CI, 74.9%-77.0%) with MHFRT vs 75.6% (95% CI, 73.5%-75.6%) with CFRT.

The authors added, “There were also no significant differences in overall survival (HR, 0.83; 95% CI, 0.68–1.01; 

 = .06) or in progression-free survival detected after stratification by NCCN risk classification.”

Regarding safety, isodose MHFRT was not associated with an increased odds of 5-year late grade 2 or higher physician-scored genitourinary toxicity (OR, 1.16; 95% CI, 0.86–1.57; 

 = .32) nor late grade 3 or higher physician-scored genitourinary toxicity (OR, 1·15; 95% CI, 0.89–1.49; 

 = .27) compared with CFRT. Similarly, isodose MHFRT was not associated with an increased odds of late grade 2 or higher physician-scored gastrointestinal toxicity (OR, 1.30; 95% CI, 0.59–2.87; 

 = .51) or late grade 3 or higher gastrointestinal toxicity (OR, 0.89; 95% CI, 0.43–1.87; 

Additionally, patients in the isodose MHFRT arm did not experience an increased risk of 2x the minimally important clinical difference (MCID) in patient-reported urinary (OR, 1.03; 95% CI, 0.51–2.09; 

 = .93) or bowel (OR, 0.76; 95% CI, 0.40–1.43; 

 = .39) quality of life decrement compared with CFRT.

In the studies comparing dose-escalated MHFRT and CFRT, there was not statistically significant difference in PFS between the 2 arms, with an estimated 5-year PFS of 82.7% (95% CI, 80.5-84.9%) in the MHFRT arm vs 82.7% (95% CI, 80.5-84.9%) in the CFRT arm (HR, 0.94; 95% CI, 0.82–1.09; 

 = .43). The authors also noted no difference in overall survival nor PFS by National Comprehensive Cancer Center risk group.

Regarding safety, dose-escalated MHFRT was not associated with an increased odds of late grade 2 or higher physician-scored genitourinary toxicity (OR, 1.20; 95% CI, 0.95–1.51; 

 = .13), but was linked to a higher risk for grade 3 or higher genitourinary toxicity (OR, 1.53; 95% CI, 1.07–2.20; 

 = .021). Patients who received dose-escalated MHFRT also had an increased risk of late grade 2 or higher gastrointestinal toxicity (OR, 1.48; 95% CI, 1.14–1.92; 

 = .0035) and late grade 3 gastrointestinal toxicity (OR, 1.80; 95% CI, 1.08–3·00; 

Patients in the dose-escalated MHFRT also had significantly increased odds of experiencing a 2xMCID in bowel quality of life decrement vs patients who received CFRT (OR, 1.68; 95% CI, 1.07–2.61; 

 = .023). However, dose-escalated MHFRT was not associated with an increased odds of 2xMCID in urinary quality of life decrement (OR, 1.57; 95% CI, 0.87–2.85; 

“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,” said Kishan, who is also a researcher in the UCLA Health Jonsson Comprehensive Cancer Center. “Patients can safely opt for a shorter treatment schedule without compromising their outcomes, ensuring they receive effective care with fewer visits and minimal added risk. Less time in treatment can still mean the best possible results.”

1. Kishan AU, Sun Y, Tree AC, et al. Hypofractionated radiotherapy for prostate cancer (HYDRA): an individual patient data meta-analysis of randomised trials in the MARCAP consortium. 

. 2025. doi: 10.1016/S1470-2045(25)00034-8

2. Study confirms safety and efficacy of higher-dose-per-day radiation for early-stage prostate cancer. News release. University of California, Los Angeles (UCLA), Health Sciences. March 18, 2025. Accessed March 20, 2025. https://www.newswise.com/articles/study-confirms-safety-and-efficacy-of-higher-dose-per-day-radiation-for-early-stage-prostate-cancer

Isodose and dose-escalated moderately hypofractionated radiotherapy (MHFRT) demonstrate comparable efficacy to conventionally-fractionated radiotherapy (CFRT) in prostate cancer treatment. Isodose MHFRT does not increase urinary or bowel toxicity risks, supporting its use as a standard care regimen. Dose-escalated MHFRT, however, is linked to higher bowel toxicity odds. The meta-analysis of seven phase 3 trials shows no significant differences in progression-free or overall survival between MHFRT and CFRT. Isodose MHFRT offers effective cancer control with fewer side effects, allowing shorter treatment schedules without compromising patient outcomes.

A subanalysis from the European Randomized study of Screening for Prostate Cancer (ERSPC) showed that participants who failed to attend a prostate cancer screening session despite being invited faced an increased risk of prostate cancer-specific mortality (PCSM).

Conversely, those who did attend a screening session demonstrated a 23% reduced risk of PCSM. The data were presented at the 40

 Annual European Association of Urology Congress in Madrid, Spain.

“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,” explained lead author, Renée Leenen MD, a PhD researcher at the Erasmus MC Cancer Institute, in a news release on the findings.

 “We need to better understand who these men are, why they choose not to attend appointments, and how to motivate them. This will help us to design population-based prostate cancer screening programs that encourage higher rates of informed participation. Tackling attendance rates in this way could be a big factor in the long-term success of a national prostate screening program.”

Overall, the ERSPC included men aged 55 to 69 years who were randomly assigned to the screening arm (n = 72,460) or to the control arm (n = 88,920). Participants were recruited across Finland, the Netherlands, Italy, Sweden, Switzerland, Belgium, and Spain. Follow-up was conducted over 20 years.

Participants in the screening arm who did not attend any of the screening rounds offered were considered non-attenders. In total, 12,401 (17%) participants in the study were non-attenders.

Data showed a rate ratio (RR) of 1.39 (95%CI 1.18-1.63) when comparing non-attenders vs the control arm and 0.77 (95%CI 0.69-0.85) when comparing attenders with the control arm. In other words, compared to the control group, non-attenders demonstrated a 39% increased risk of PCSM, while attenders demonstrated a 23% lower risk.

The authors noted, “Sensitivity analysis showed no stat. sig. differences between pre- or post-randomization consent (sHR, 0.71; 95% CI, 0.46-1.29).”

When comparing the attenders vs the non-attenders, those who attended a screening session demonstrated a 45% (RR, 0.55; 95% CI, 0.47-0.65) decreased odds of PCSM.

According to Tobias Nordström, MD, PhD, of the Karolinska Institute in Sweden, these data suggest that the benefit of screening may be greater than previously assumed.

“For countries around Europe that are planning to introduce a national prostate screening program, this analysis focusing on attendance shows that men who participate in screening have a much-improved long-term benefit than what we’ve seen from previous studies,” he said in the news release.

However, in the non-responders arm, these findings may point to a group of men who need extra attention. According to Leenen, the choice to not participate in screening may reflect overall behaviors of care avoidance, which may explain why non-attenders demonstrated a higher risk of PCSM vs the control arm.

“It may be that men who opted not to attend a screening appointment are care avoiders, meaning they’re less likely to engage in healthy behaviors and preventative care in general. This is the opposite behavior of people who are perhaps more health conscious and are more likely to attend a screening appointment.”

The authors warn that non-attendance may be the greatest barrier to successful implementation of a population-based screening program. Thus, these data “emphasize the urgent need to address awareness, informed participation and inequalities in access,” the authors write.

“But it highlights a group of men who need our attention, as they’re more at risk of developing advanced prostate cancer and dying from it,” Nordström added. “We need to better understand why these men might actively choose not to participate in screening, despite being invited to attend, and how this behavior is linked to worse outcomes when they get a diagnosis.”

Full results from the ERSPC subanalysis are expected to be published later this year.

1. Leenen RCA, Mulder E, Remmers S, et al. Prostate cancer mortality in men not attending a population-based screening program: The good, the bad, and the ugly after 20-year follow-up in the European Randomized study of Screening for Prostate Cancer. Presented at the 40

 Annual European Association of Urology Congress. Madrid, Spain. March 21-24, 2025. Abstract A0279

2. Worse outcomes for men who avoid prostate cancer screening. News release. European Association of Urology. March 20, 2025. Accessed March 21, 2025. https://www.eurekalert.org/news-releases/1077327

A subanalysis from the ERSPC revealed that men who skipped prostate cancer screening despite being invited had a higher risk of prostate cancer-specific mortality (PCSM). Attendees of the screening showed a 23% reduced risk of PCSM. The study highlighted the need to understand and motivate non-attenders, as their behavior may reflect broader care avoidance tendencies. The findings suggest that non-attendance is a significant barrier to effective population-based screening programs, emphasizing the importance of addressing awareness, informed participation, and access inequalities to improve screening outcomes.

“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 sent an Urgent Device Field Correction notice to urologists on February 19, 2025, providing updated instructions on the use of their CVAC Aspiration System, the FDA reported.

Specifically, Calyxo had identified a new risk of injury when the CVAC Aspiration System is used in patients with high viscosity (thick) fluid in their kidneys at the start of the procedure. This can reduce fluid outflow, leading to excessive pressure in the kidneys that may result in injury or death.

At the time of the release, 1 death had been reported in relation to this issue.

Specifically, Calyxo shared the following instructions with affected health care professionals:

“Do not continue to provide fluid inflow in the presence of unresolved slow or absent fluid outflow. Doing so can create an intrarenal pressure imbalance, which may result in serious injury or death.

If a patient has cloudy, opaque (turbid), or suspected thick (high-viscosity) fluid observed in the kidney’s collecting system, stop irrigation immediately using the three-way stopcock.

If visibility within the collecting system is completely obscured by opaque fluid, do not use the CVAC Aspiration System in the procedure.

Diagnostic or therapeutic ureteroscopy is contraindicated in patients with untreated urinary tract infection. Patients with coagulation disorders, severe cardiopulmonary insufficiency, or uncontrolled diabetes should be managed appropriately.

If drainage through the access sheath is desired, use a 13/15 Fr or larger Ureteral Access Sheath. The CVAC Aspiration System is compatible with 12/14 Fr Ureteral Access Sheaths and will provide limited outflow, which may over-pressure the kidney.

Confirm your equipment is set up properly for use with the CVAC Aspiration System to monitor fluid outflow when low outflow is suspected. If there is a suspected slowing or lack of fluid outflow from the CVAC Aspiration System, stop irrigation inflow using the three-way stopcock.

If visibility is sufficient to proceed, follow the evacuation procedure to clear the fluid in the kidney.”

These instructions specifically apply to the following device: Calyxo REF Number CVC127020-1 and User Manual L00018 Rev C (UDI-DI: 00860005357710).

The FDA noted that they are monitoring the situation and will continue to update the public on any significant new information. Health care professionals who experience an adverse reaction or quality issue related to these devices may contact 

MedWatch: The FDA Safety Information and Adverse Event Reporting Program

The CVAC Aspiration System is used to “establish a channel during endoscopic urological procedures for the treatment and removal of urinary stones,” according to the agency.

Calyxo received FDA clearance for their redesigned CVAC System in March 2024.

 According to the company, the redesign was initiated following 2 years of real-world use in order to further enhance the steerable ureteroscopic renal evacuation (SURE) procedure. Specifically, Calyxo explained that the updated system includes “direct visualization with dedicated irrigation channels and a large aspiration lumen.”

1. Early alert: Aspiration System issue from Calyxo. News release. US Food & Drug Administration. Last updated March 20, 2025. Accessed March 21, 2025. https://www.fda.gov/medical-devices/medical-device-recalls/early-alert-aspiration-system-issue-calyxo

2. Calyxo announces FDA Clearance for new, redesigned CVAC System. News release. Calyxo. March 26, 2024. Accessed March 21, 2025. https://calyxoinc.com/calyxo-news/calyxo-fda-approved-cvac-system-kidney-stones/

Calyxo issued an urgent notice to urologists regarding the CVAC Aspiration System, highlighting a new risk of injury when used in patients with high-viscosity kidney fluid. This can lead to excessive pressure and potential injury or death, with one death reported. Updated instructions emphasize stopping fluid inflow if outflow is slow or absent and avoiding use in certain conditions. The FDA is monitoring the situation. The CVAC System, cleared by the FDA in 2024, is designed for urinary stone removal with enhanced features for improved procedures.

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

The markets have certainly been a roller coaster lately. After a solid start to the year, the US markets have been upended by the will-they-or-won’t-they Trump administration tariffs, sticky inflation, and interest rates unlikely to drop significantly anytime soon. This volatility is not unexpected when a stock market setting new record highs suddenly experiences significant headwinds. Economic indicators also show signs of an economic slowdown. Unemployment has been creeping up, and new hires have been trending down. However, overall, the US economy continues to look fairly strong. Despite this, the stock markets have been jumping up and down from one day to another.

For investors, it is critical not to overreact. You need to block out the surrounding noise and follow your investment strategy in the face of volatile markets. Actions based on emotion and fear can cause you to make mistakes that can harm your long-term investment performance. In 2020, I wrote an article during another period of high volatility (the COVID-19 shutdown) and provided some insights for investing in these environments.

• Fight the impulse to sell your holdings if the markets are dropping. Selling after drops can make temporary losses permanent and difficult to recover. Although it can be difficult emotionally, sticking to your investment strategy may be healthier for your portfolio. It is important to continue monitoring your investments, but remember the long-term reasons the investment is in your portfolio. What role is it playing? If it is still a good fit, holding the investment may be the better long-term strategy.

• Remember that you are investing for the long term. Markets have always fluctuated up and down, and during your lifetime, you are likely to experience several significant declines. Investors should ignore the noise and stay disciplined in their designed investment strategy, which was created specifically to avoid these pitfalls.

• Review your risk tolerance. Risk you took on years ago may no longer make sense given your current circumstances and stage of life.

• Make sure your portfolio is well diversified. Volatile markets have a way of exposing improperly diversified portfolios.

"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.

Francesca Jackson-Spence, MBChB, BSc

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