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The European Commission must issue a decision on the application on or by June 2, 2025.

Subcutaneous nivolumab under review in EU for solid tumors

The approval is supported by results from the phase 3 NIAGARA trial.

FDA approves durvalumab/chemo for muscle–invasive bladder cancer

The approval is supported by positive data from the phase 3 PSMAfore trial.

FDA approves expanded label for 177Lu-PSMA-617 in mCRPC

The test can deliver diagnostic results for chlamydia, gonorrhea, and trichomoniasis.

FDA grants marketing authorization to at-home diagnostic test for STIs

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Cycling has multiple benefits, and steps can be taken to prevent genitourinary injury.

Bicycle riding: Good or bad for men’s health?

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

Today, March 28, 2025, the FDA approved neoadjuvant durvalumab (Imfinzi) in combination with gemcitabine and cisplatin, followed by adjuvant durvalumab monotherapy following radical cystectomy, for adult patients with muscle invasive bladder cancer (MIBC).

“This approval for the durvalumab-based perioperative regimen is a major breakthrough for people with muscle-invasive bladder cancer, nearly half of whom see their cancer return despite chemotherapy and surgery with curative-intent," said Matthew D. Galsky, MD, of the Icahn School of Medicine at Mount Sinai in New York, in a news release.

 "This durvalumab regimen significantly extended patients’ lives in the NIAGARA trial and has the potential to transform care.”

The approval is supported by results from the phase 3 NIAGARA trial (NCT03732677), which showed that perioperative durvalumab plus neoadjuvant chemotherapy extended event-free survival (EFS) and overall survival (OS) vs neoadjuvant chemotherapy alone.

At 24 months, the estimated EFS was 67.8% (95% CI, 63.6 to 71.7) in the durvalumab arm vs 59.8% (95% CI, 55.4 to 64.0) in the control arm (HR, 0.68; 95% CI, 0.56 to 0.82; 

 < .001). The median EFS was not reached in the durvalumab arm and was 46.1 months (95% CI: 32.2, NR) in the chemotherapy arm. At a median follow-up of 42.3 months, 35.1% of patients in the durvalumab arm and 46.4% of patients in the control arm experienced an EFS event.

The estimated 24-month OS was 82.2% (95% CI, 78.7 to 85.2) in the durvalumab arm vs 75.2% (95% CI, 71.3 to 78.8) in the control arm (HR, 0.75; 95% CI, 0.59 to 0.93; 

 = .01). The median OS was not reached in either arm.

Pathological complete response (pCR), the trial’s second primary end point, was not significantly different between both arms. Specifically, the pCR rate was 33.8% (95% confidence interval [CI], 29.8 to 38.0) in the durvalumab arm vs 25.8% (95% CI, 22.2 to 29.8) in the control arm (RR, 1.30; 95% CI, 1.09 to 1.56; 

Regarding safety, adverse events (AEs) were comparable between both arms.

Grade 3-4 AEs occurred in 69.4% of patients I nthe durvalumab arm and 67.5% of patients in the control arm. Grade 3-4 treatment-related AEs were reported in 40.6% and 40.9% of patients, respectively.

The authors also reported, “Radical cystectomy was performed in 88.0% of the patients in the durvalumab group and in 83.2% of those in the comparison group.”

In total, the open-label NIAGARA trial enrolled 1063 adult patients with cisplatin-eligible MIBC who were candidates for radical cystectomy and had not received prior systemic therapy for bladder cancer. Participants were randomly assigned 1:1 to receive neoadjuvant durvalumab plus gemcitabine-cisplatin every 3 weeks for 4 cycles followed by radical cystectomy and adjuvant durvalumab every 4 weeks for 8 cycles (n = 533) or to receive neoadjuvant gemcitabine-cisplatin followed by radical cystectomy alone (n = 530).

The dual primary end points were EFS and pathological complete response. OS was a key secondary end point.

In the news release on the approval, the FDA advised, "The recommended durvalumab dose for patients with a body weight of 30 kg [or greater] is 1,500 mg every 3 weeks with chemotherapy (neoadjuvant treatment) and 1,500 mg as a single agent every 4 weeks (adjuvant treatment). The recommended durvalumab dose for patients with a body weight [less than] 30 kg is 20 mg/kg with chemotherapy every 3 weeks (neoadjuvant treatment) and 20 mg/kg as a single agent every 4 weeks (adjuvant treatment). Treatment should continue until disease progression that precludes definitive surgery, recurrence, or unacceptable toxicity or a maximum of 8 cycles after surgery."


1. FDA approves durvalumab for muscle invasive bladder cancer. News release. US Food & Drug Administration. Published online and accessed March 28, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-muscle-invasive-bladder-cancer

2. IMFINZI (durvalumab) approved in the US as first and only perioperative immunotherapy for patients with muscle-invasive bladder cancer. News release. AstraZeneca. Published online and accessed March 31, 2025. https://www.astrazeneca-us.com/media/press-releases/2025/IMFINZI-durvalumab-approved-in-the-US-as-first-and-only-perioperative-immunotherapy-for-patients-with-muscle-invasive-bladder-cancer.html

3. Powles T, Catto JWF, Galsky MD. Perioperative durvalumab with neoadjuvant chemotherapy in operable bladder cancer. 

. 2024;391:1773-1786. doi:10.1056/NEJMoa2408154

The FDA has approved the use of neoadjuvant durvalumab in combination with gemcitabine and cisplatin, followed by durvalumab alone as adjuvant therapy, for adults with muscle invasive bladder cancer (MIBC) post-radical cystectomy. This decision is based on the phase 3 NIAGARA trial, which demonstrated that the combination therapy significantly improved event-free survival (EFS) and overall survival (OS) compared to chemotherapy alone. The approval marks a significant advancement in the treatment options available for MIBC, offering a new therapeutic strategy to enhance patient outcomes.

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

A study evaluated the impact of polyethylene glycol-based hydrogel spacers on bowel disorder incidence in prostate cancer patients undergoing radiotherapy. Using real-world data from multiple databases, researchers found that patients with spacers experienced significantly lower rates of bowel disorders and related procedures compared to those without spacers. Specifically, there was a 25% reduction in the hazard of bowel disorders and a 46% reduction in related procedures four years post-radiotherapy. This study highlights the potential benefits of spacer use in reducing bowel complications in prostate cancer treatment.

"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.

Michael R. Folkert, MD, PhD, discusses real-world outcomes with spacer in prostate cancer

Updated data from the phase 3 BOND-003 trial (NCT04452591) continue to support the efficacy, safety, and tolerability of cretostimogene grenadenorepvec in patients with high-risk BCG-unresponsive non–muscle invasive bladder cancer (NMIBC).

The data were presented by Trinity J. Bivalacqua, MD, PhD, at the 40th Annual European Association of Urology Congress in Madrid, Spain.

Overall, updated efficacy data showed a complete response (CR) rate at any time point of 75.5% (95% CI, 66.3-83.2%). The 12-month landmark CR rate was 46% (95% CI, 36.9-56.1). There are also 30 confirmed CRs that have reached the 24-month time point. Per Kaplan-Meier estimate, the 12- and 24-month CR rates are 50% (95% CI, 39.6-58.9%) and 41% (95% CI, 30.4-50.8%), respectively. The CR rate was consistent across patient subgroups.

Additionally, at 12 months, 97.3% of patients were free from progression to muscle-invasive bladder cancer, and the cystectomy-free survival was 90.0%.

Data also showed a sustained duration of response (DOR) in these patients. The estimated DOR was 63.7% (95% CI, 51.8-73.3%) at 12 months and 58.7% (95% CI, 46.4-69.0%) at 24 months. The median DOR has not been reached but exceeds 28 months (95% CI, 14.3-NE). The median follow-up is 22.3 months.

Bivalacqua noted during the presentation, “What this demonstrates very clearly is that patients that have a durable response at 12 months continue with a durable response at [24] months. We can hypothesize that this may relate to the innate to adaptive switching with immunogenic memory. However, this has never been proven.”

Cretostimogene was also generally well-tolerated, with the majority of adverse events (AEs) being grade 1 or 2. In total, 64.3% of patients experienced any grade treatment-related AE (TRAE). The most common TRAEs (reported in more than 10% of patients) included bladder spasms (25%), pollakiuria (20.5%), urgency (19.6%), dysuria (15.2%), and hematuria (13.4%). The median time to TRAE resolution was 1 day. There were no grade 3 or higher TRAEs, treatment-related discontinuations, or deaths.

Bivalacqua then outlined translational data on cretostimogene. Data collected in the induction period showed that levels of creto titer and GM-CSF in the urine both peaked following instillation and were sustained locally for 4 to 5 days. According to Bivalacqua, these data suggest that there is effective payload delivery.

In the maintenance phase, Bivalacqua noted, “We see similar pharmacokinetics with a peak and trough pattern as previously showed. And the titers are present throughout the maintenance period.”

Cretostimogene also demonstrates stable and robust antibody and anti-tumor response. Antibody response was shown to be associated with clinical outcomes.

There were no creto levels detected systemically, with concentration remaining in the bladder even with repeat dosing. Based on these findings, the investigators concluded that post-cretostimogene close contact precautions are not needed.

In total, cohort C of the BOND-003 study included 112 patients with high-risk BCG-unresponsive NMIBC with CIS. Patients enrolled in the study received an induction course of weekly cretostimogene for 6 weeks. For nonresponders, a second 6-week induction course was given. Patients then received a maintenance course of 3 weekly treatments every 12 weeks for year 1 and then every 6 months for years 2 and 3.

Bivalacqua noted, “Another important point to delineate between multiple trials in this disease space is the fact that this trial had mandatory biopsy at 12 months, which allows us to better detect the effectiveness of any therapeutic agent.”

Among those enrolled in the study, the majority of patients were male (74%), White (62%), and over 65 years of age (83%). This was also a heavily pretreated population; the median number of prior BCG instillations was 12 (range, 7 to 66).

The primary end point for the trial was CR rate at any time point. Secondary end points include CR at 12 months, DOR, recurrence-free survival, progression-free survival, cystectomy-free survival, and safety.

Cretostimogene currently has FDA breakthrough therapy and fast track designations for high-risk BCG-unresponsive NMIBC with CIS with or without papillary tumors.

 These designations were awarded in December 2023 based on initial findings from BOND-003.

“Cretostimogene’s strong safety and efficacy profile, combined with its best-in-class durability, address an unmet need for my non-muscle invasive bladder cancer patients,” concluded Bivalacqua, a professor of urology and oncology at the Perelman Center for Advanced Medicine at the University of Pennsylvania, in a news release on the findings.

 “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.”

1. Bivalacqua T, Tyson MD, Uchio EM, et al. Updated clinical & translational results: BOND-003 Cohort C- A phase 3, single-arm study of intravesical cretostimogene grenadenorepvec for high-risk BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ. Presented at: 40

 Annual European Association of Urology Congress; March 21-24, 2025; Madrid, Spain. Abstract LB12.

2. Study of cretostimogene given in patients with non-muscle invasive bladder cancer, unresponsive to Bacillus-Calmette-Guerin (BOND-003). ClinicalTrials.gov. 

pdated January 6, 2025. Accessed March 25, 2025. https://clinicaltrials.gov/study/NCT04452591

3. CG Oncology receives both FDA fast track and breakthrough therapy designation for cretostimogene grenadenorepvec in high-risk BCG-unresponsive non-muscle invasive bladder cancer. News release. CG Oncology. December 5, 2023. Accessed March 25, 2025. https://cgoncology.com/cg-oncology-receives-both-fda-fast-track-and-breakthrough-therapy-designation-for-cretostimogene-grenadenorepvec-in-high-risk-bcg-unresponsive-non-muscle-invasive-bladder-cancer/

4. Cretostimogene grenadenorepvec data continues to demonstrate best-in-class durability of response as well as consistent and compelling safety and efficacy. News release. GC Oncology, Inc. March 24, 2025. Accessed March 25, 2025. https://ir.cgoncology.com/news-releases/news-release-details/cretostimogene-grenadenorepvec-data-continues-demonstrate-best

Updated data from the phase 3 BOND-003 trial underscore the efficacy, safety, and tolerability of cretostimogene grenadenorepvec in high-risk BCG-unresponsive NMIBC patients. The trial demonstrated a complete response rate of 75.5% at any time point, with a 12-month CR rate of 46% and a 24-month CR rate of 41%. The treatment was well-tolerated, with most adverse events being mild. Translational data indicated effective payload delivery and robust antibody responses. Cretostimogene has received FDA breakthrough therapy and fast track designations, highlighting its potential as a significant advancement in bladder cancer treatment.

"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 addition of durvalumab (Imfinzi) to neoadjuvant chemotherapy did not affect the rate or timing of radical cystectomy and did not lead to an increased rate of surgical complications in patients with cisplatin-eligible muscle-invasive bladder cancer (MIBC), according to additional data from the phase 3 NIAGARA trial (NCT03732677).

The data were presented by James W.F. Catto, MBChB, PhD, FRCS, at the 40th Annual European Association of Urology (EAU) Congress in Madrid, Spain.

Initial data from the NIAGARA trial were shared at the 2024 European Society for Medical Oncology Congress in Barcelona, Spain and published in the

Overall, data showed that the addition of durvalumab to neoadjuvant chemotherapy prior to radical cystectomy significantly improved overall survival (24-month OS, 82.2% vs 75.2%; 

 = .0106) and event-free survival (24-month EFS, 67.8% vs 59.8%; 

< .0001) compared with neoadjuvant chemotherapy alone. The combination also led to a 10% improvement in pathological complete response rate (37.3% vs 27.5%; 

In the presentation at the EAU Congress, Catto began by stating, “It's an honor to be here talking about NIAGARA, which is the first prospective randomized trial to show an overall survival benefit in muscle-invasive bladder cancer with neoadjuvant treatment. We can't underestimate the importance of that.”

The current analyses focused on the impact that adding durvalumab had on surgical outcomes, as well as neoadjuvant safety data with the combination.

Overall, the addition of durvalumab did not appear to affect the rate of surgical completion. In the durvalumab plus chemotherapy arm, 469 patients (88%) underwent radical cystectomy compared with 441 patients (83%) in the chemotherapy alone arm.

Tumor characteristics were well balanced between both arms. In total, 60% of patients in both arms had higher than T2N0 disease.

Catto added, “[Overall,] 60% of people and 70% of people had a hysterectomy and an oophorectomy, but the new EAU guidelines are much more about organ-preserving approaches in women, so perhaps we'll see a pullback toward more organ preservation.”

The median time from the last dose of neoadjuvant chemotherapy to radical cystectomy was 5.6 weeks (range, 1.1-16.9 weeks) in the combination arm vs 5.4 weeks (range, 1.7-47.6 weeks) in the chemotherapy arm. In the durvalumab arm, 90% and 96% of patients had cystectomy within 56 days and 70 days following the last dose of neoadjuvant chemotherapy, respectively. In the chemotherapy alone arm, 90% and 95% of patients had undergone cystectomy within 56 and 70 days following the last dose of chemotherapy, respectively.

The proportion of patients with surgical complications was also comparable between both study arms. Approximately 16% of patients in each arm experienced a complication of grade 3 or higher.

Similarly, 93% of patients in each arm experienced a treatment-related adverse event (TRAE) during the neoadjuvant study period. TRAEs of grades 3 or 4 were reported in 38% of patients in the combination arm vs 41% of patients in the comparator arm.

The most common (10% or higher) AEs during the neoadjuvant study period included nausea (51% durvalumab/chemotherapy vs 46% chemotherapy), neutropenia (40% vs 45%), and fatigue (33% vs 30%).

Catto noted, “Neutropenia was the most concerning issue, but that's being driven by the chemotherapy.”

Additionally, immune-mediated AEs in the combination arm were generally low grade and consistent with previously reported safety data on durvalumab. These AEs were primarily driven by hypothyroid (3%) and hyperthyroid (2%) events. The median time to onset was 73 days (range, 29-141) for the hypothyroid events and 38 days (range, 22-112) for the hyperthyroid events.

In total, the NIAGARA trial enrolled 1063 patients with cisplatin-eligible MIBC. Patients were randomly assigned 1:1 to receive durvalumab plus chemotherapy (n = 533) or to chemotherapy alone (n = 530) followed by radical cystectomy. In the combination arm, patients also received 8 cycles of adjuvant durvalumab.

The primary end points for the study were event-free survival and pathological complete response. Overall survival was a key secondary end point. Safety end points include immune-mediated AEs.

Catto concluded during the presentation, “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. It gives us a very safe signal for that approach for our patients. The immune-mediated adverse events aren’t new. They're rare, and apart from thyroid function, they're mostly happening before they come to a urologist. I think we can feel reassured by that.”

1. Catto JWF, Al-Ahmadie H, van der Heijden MS, et al. Surgical outcomes and neoadjuvant safety with perioperative durvalumab for muscle-invasive bladder cancer (NIAGARA). Presented at: 40

 Annual European Association of Urology Congress; March 21-24, 2025; Madrid, Spain. Abstract GC2.

2. Powles TB, van der Heijden MS, Galsky MD, et al. A randomized phase III trial of neoadjuvant durvalumab plus chemotherapy followed by radical cystectomy and adjuvant durvalumab in muscle-invasive bladder cancer (NIAGARA). Presented at: 2024 European Society for Medical Oncology Annual Congress; September 13-17, 2024; Barcelona, Spain. Abstract LBA5.

3. Powles T, Catto JWF, Galsky MD. Perioperative durvalumab with neoadjuvant chemotherapy in operable bladder cancer. 

The phase 3 NIAGARA trial evaluated the addition of durvalumab to neoadjuvant chemotherapy in patients with cisplatin-eligible muscle-invasive bladder cancer. Results showed that durvalumab did not affect the rate or timing of radical cystectomy or increase surgical complications. The combination improved overall survival and event-free survival compared to chemotherapy alone. Surgical outcomes and adverse events were comparable between both arms, with neutropenia being the most concerning issue. Immune-mediated adverse events were low grade and consistent with previous safety data on durvalumab.

“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.

Austin Lee

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