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“We can now see that we can find a proportion of those men that have an elevated STHLM3 tests that actually have a quite substantial risk of biochemical recurrence after the radical prostatectomy,” says Tobias Nordström, MD, PhD. 

Tobias Nordström, MD, on follow-up data from the STHLM3 trial

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

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

1:52:57 Pathophysiological differences of overactive bladder (OAB) in men vs women

1:55:17 Distinguishing OAB from symptoms of benign prostatic hyperplasia (BPH)

1:56:51 Engaging the patient in the diagnostic process

2:04:28 Long-term clinical implications of delayed diagnosis and treatment in OAB

2:11:26 Patient advocacy for managing OAB

2:14:42 Educational outreach for OAB awareness

2:27:12 Role of primary care providers in management of OAB

2:30:22 Bladder health screening and diagnostics

Overactive bladder (OAB) presents distinct pathophysiological differences between men and women, often complicating diagnosis due to symptom overlap with benign prostatic hyperplasia (BPH) in men. Engaging patients in the diagnostic process is crucial for accurate identification and management. Delayed diagnosis and treatment can significantly impact patients' quality of life and lead to adverse long-term clinical outcomes. Patient advocacy and educational outreach are essential for raising awareness and improving management strategies. Primary care providers play a pivotal role in OAB management, emphasizing the importance of bladder health screening and diagnostics.

Experts discuss overactive bladder and the impacts on quality of life, distinguishing OAB from BPH, and how a delayed diagnosis can worsen symptoms.  

Episode 1 Podcast: Understanding Overactive Bladder (OAB): Pathophysiology, Diagnosis, and Management in Older Adults

Gal Wald, MD, shares the background and rationale for the study, “Initial Results Of A Phase II Trial Of Bacillus Calmette-Guérin (BCG) And Intravesical Gemcitabine For Patients With BCG-Exposed High-Grade Non-Muscle Invasive Bladder Cancer (NCT04179162),” 

Gal Wald, MD, on the rationale for trial of BCG plus gemcitabine in NMIBC

, shares the background and rationale for the study, “Initial Results Of A Phase II Trial Of Bacillus Calmette-Guérin (BCG) And Intravesical Gemcitabine For Patients With BCG-Exposed High-Grade Non-Muscle Invasive Bladder Cancer (NCT04179162),” which he presented at the 

Society of Urologic Oncology 25th Annual Meeting

 in Dallas, Texas. Wald is a fourth year urology resident at Weill Cornell Medicine in New York, New York.

These are preliminary results for a phase 2 multi-center trial for intravesical gemcitabine and BCG for BCG-exposed non–muscle-invasive bladder cancer. BCG-exposed patients represent a population with an unmet need. More than half of patients who initially respond to BCG monotherapy relapse within 5 years. These patients are typically given another course of BCG, but they tend to have even lower response rates. So, combination therapies have now become the forefront of our field, and we are trying to do better to avoid BCG-unresponsive disease, as well as progression to either muscle-invasive or metastatic disease. The current landscape of BCG and in combination with other therapies is quite heterogeneous. We have BCG with immune checkpoint blockade. However, that has an unacceptable toxicity profile for the majority of non–muscle-invasive bladder cancer patients. And it's quite expensive; it costs approximately a quarter million dollars per year per patient.

We have other recently FDA approved medications, BCG with IL-15 super agonist. That does not have single agent activity, and it's even more cost prohibitive. It's approximately half a million dollars per year per patient. So, intravesical chemo immunotherapy represents a whole other treatment paradigm for patients. Prior RCTs and meta-analyses have shown that combination therapy is more efficacious than BCG alone. But a lot of these trials have used mitomycin, which is a known vesicant and has significant urinary side effects.

When you compare gemcitabine to mitomycin, we've shown that in the BCG-exposed space, for example, it is more efficacious. It's also generally more tolerable with a favorable toxicity profile as it's not as strong of a vesicant. And it's less cost prohibitive. Not to mention that gemcitabine also has immunomodulatory effects. So, there's a biological rationale. It can reduce immunosuppressive cellular populations, including model derived suppressor cells, regulatory T-cells. It can prime the immune system. In preclinical animal models, we have shown that the combination of these 2 therapies is more efficacious than either therapy alone, which suggests either an additive or a synergistic effect. We've previously reported the final results of phase 1 showing that the combination of gemcitabine and BCG is very well tolerated. In that trial, there are no grade 3 to 5 adverse events.

This transcript was AI generated and edited by human editors for clarity.

The study explores a phase II trial combining intravesical gemcitabine and BCG for patients with BCG-exposed high-grade non-muscle invasive bladder cancer. BCG-exposed patients often relapse, necessitating alternative treatments. Combination therapies are emerging as a solution to prevent disease progression. Current BCG combinations, like those with immune checkpoint inhibitors, have high toxicity and cost. Gemcitabine, compared to mitomycin, offers better efficacy, tolerability, and cost-effectiveness. It also has immunomodulatory effects, enhancing the immune response. Phase I results showed the gemcitabine-BCG combination is well-tolerated with no severe adverse events.

"Combination therapies have now become the forefront of our field, and we are trying to do better to avoid BCG-unresponsive disease, as well as progression to either muscle-invasive or metastatic disease," says Gal Wald, MD.

Kara L. Watts, MD, recaps her session on focal ablation from the Society of Urologic Oncology 25th Annual Meeting in Dallas, Texas

Kara Watts, MD, recaps SUO 2024 session on salvage focal ablation

, outlines her session on focal ablation from the 

 in Dallas, Texas. Watts is an associate professor of urology and the director of the Prostate Screening Program at Albert Einstein College of Medicine and Montefiore Medical Center in Bronx, New York.

The talk this year is on focal ablation for radiorecurrent localized prostate cancer. There's actually 3 talks in the session focusing on salvage radical prostatectomy, salvage radiation therapy, and salvage focal ablation. So really, the main points that I intend to cover this afternoon are what the options are in terms of salvage ablation focal modalities, and what some of the medium-term outcomes are in terms of oncologic cancer control compared to salvage radical prostatectomy and also salvage radiation therapy. I think the highlights are the functional outcomes after a salvage focal ablation are favorable, definitely, compared to salvage radical prostatectomy, but the studies are quite limited in terms of real salvage focal ablation. And we're going to see more emerging over time, similar to what we're seeing in the primary treatment setting as well.

Focal ablation for radiorecurrent localized prostate cancer was a key topic at the Society of Urologic Oncology's annual meeting. The session included discussions on salvage radical prostatectomy, salvage radiation therapy, and salvage focal ablation. Focal ablation offers favorable functional outcomes compared to salvage radical prostatectomy, though studies on its efficacy remain limited. As research progresses, more data on salvage focal ablation is expected to emerge, paralleling trends seen in primary treatment settings. The session aimed to elucidate current options and medium-term oncologic outcomes for these salvage therapies.

"I think the highlights are the functional outcomes after a salvage focal ablation are favorable, definitely, compared to salvage radical prostatectomy, but the studies are quite limited in terms of real salvage focal ablation," says Kara L. Watts, MD. 

Kara Watts, MD, outlines SUO 2024 session on salvage focal ablation

, discusses the study “Primary chemoablation of recurrent low-grade intermediate-risk non-muscle-invasive bladder cancer with UGN-102: A single-arm, open-label, phase 3 trial (ENVISION; NCT05243550),”

 in Dallas, Texas. Prasad is a physician at Morristown Medical Center in Atlantic Health System and Garden State Urology in New Jersey.

Could you describe the background and the design of the ENVISION trial?

ENVISION is the third study investigating a novel agent called UGN-102 (mitomycin). UGN-102 is a new paradigm in treating bladder cancer; specifically, low-grade, intermediate-risk, non–muscle invasive bladder cancer. These are low-grade tumors that generally recur frequently, that are large or multifocal. For urologists, these are the types of tumors that recur rapidly, recur frequently, put patients through a number of procedures, and generally carry a significant morbidity because of their repetitive nature. The idea of UGN-102 is to use a topical, non-surgical approach to treating bladder tumors, which is completely different than what we’ve done over time. Historically, we've always resected or fulgurated these tumors. In general, we've never had a non-surgical option to manage tumors primarily.

ENVISION was the third study investigating UGN-102 as primary treatment for low-grade, intermediate-risk, non–muscle invasive bladder cancer. The first study was OPTIMA (NCT03558503). It was a phase 2b study. The second was ATLAS (NCT04688931). It was a phase 3 randomized controlled trial between UGN-102 and [transurethral resection of the bladder tumor] (TURBT), the standard of care. ENVISION was the third study, and the one that is preceding the application for FDA approval.

ENVISION is a single-arm study; all patients received UGN-102. The medication is given intravesically, so similar to the way in which we administer most of our treatments for bladder cancer via a simple urethral catheter. Patients who had a tumor present that was recurrent—meaning they had had a tumor within the past year and that was low grade and characterized as intermediate-risk disease—were given UGN-102 via catheter once a week for 6 weeks. Then we followed up with the cystoscopy to assess for treatment response. Again, [this is] a single-arm, phase 3 study [with] 240 participants. All the participants received the study drug and then were evaluated initially for complete response following treatment. For those patients who were complete responders, they were followed for a minimum of 12 months to assess the durability of response. Remember, [this trial included] patients who had previously recurred within a year; [we] follow them up for a full year and see how those patients that were complete responders did.

What were the key findings that were presented at SUO?

At the SUO we presented both the complete response rate and, for the first time, the 12-month durability of response rate. Again, every patient received the study drug once a week for 6 weeks, and these patients were assessed with cystoscopy, biopsy for cause, [and] urinary cytology. What we found was that 79.6% of patients were complete responders. So, almost 4 out of 5 patients who had no TURBT, had a tumor left in the bladder, [and were] treated with a topical instillation of UGN-102, when we look back 3 months later, had no tumor that was visible. That was the first and key finding was the 3-month complete response rate.

For those patients who were complete responders, we then followed those patients for 12 months. Patients had cystoscopies every 3 months, and then we assessed the durability of response by Kaplan-Meier analysis at 12 months. That's a standard approach for assessing durability of response for these types of studies. What we found is that [per] Kaplan-Meier estimate, for patients who achieved a complete response at 3 months, [there] was a likelihood of remaining in complete response of 82.3% at 12 months. The durability response for these patients was impressive given the fact that these patients were those who, by definition and by inclusion criteria, were recurrent within a year at [baseline]. Again, taking a highly recurrent patient population and treating them, almost 80% of patients [achieved] a complete response and then [there was] an estimated durability of response of over 80%. I think the study investigators are really pleased to find that this appeared to be a viable alternative to TURBT.

Importantly, the investigators felt that these were really efficacious numbers, both in terms of complete response rate and durability of response rate that most of us in clinical practice would [find] meaningful. The second component, of course, is safety. We looked to see what the treatment-related adverse events were in the study to make sure this was a safe and appropriate treatment to administer to patients. Overall, the rates of adverse events were very low. There were only 2 out of 240 patients that had a [serious] treatment-related adverse event. One was urinary retention; the other was urethral stenosis. These are both things that urologists frequently see and are able to manage, and both of these were actually self-resolved. So, we found that the safety profile also met what the investigators felt was appropriate.

UroGen, the company that sponsors UGN-102 has submitted the drug for FDA application. I imagine that that application will be assessed sometime in either Q2 or Q3 of 2025. For urologists looking for potential non-surgical alternatives for TURBT in a patient population that is fairly recurrent with low-grade disease, I hope that we'll be hearing news about the future of UGN-102 in a positive way sometime in the next 6 to 12 months.

Taking these findings together, what is the key take-home message for urologists?

As urologists, we're always looking for additional tools to help us with recurrence in bladder cancer. It's the critical issue, especially in low-grade patients, where tumors rarely metastasize and invade, but they frequently recur. These are not necessarily fatal tumors, but they're ones that cause significant morbidity to patients. The average age for a bladder cancer patient is 75. [For] many of our patients, the risk factor they had was smoking, and therefore many also have concomitant cardiopulmonary disease. Taking these patients to the operating room repetitively often involves risk for these patients that have baseline health issues. Many of my patients who have low-grade, intermediate-risk disease are on blood thinners, also because of their cardiac issues. For these patients, we have to take them off their blood thinners to do a TURBT, [which] puts them at risk for issues like heart attack and stroke, and then we have to re-engage blood thinners after resection, which can lead to issues like bleeding down the road, readmissions, catheters, etc. Again, although the disease is not so aggressive that it requires removing the bladder or any significant treatments, the reality of recurrent and repetitive TURBT has been shown to be harmful to patients and increases their overall mortality over time by just simple discontinuation of blood thinners. I think as urologists, we should all welcome a new tool to be able to use in patients that is non-operative.

Urologists will determine where this fits in the best. Is this a frontline treatment that may replace TURBT? Is this to use alongside TURBT in certain patients—older patients, more frail patients, patients on blood thinners, perhaps patients with multiple lesions that recur frequently, where, historically, our TURBTs haven't worked out well? Or is this something that urologists keep in their back pocket to know is available in those particular patients where they don't want to address them with TURBT? I think any additional non-surgical tool for anything we do is extremely advantageous, so I would encourage urologists to learn more about the drug. We'll wait to see if the drug is approved and if approved, I think there's a really nice opportunity to potentially change the way in which we manage bladder cancer, which is an incredibly exciting opportunity to change disease management in an essentially fundamental way.

Could you expand on how you foresee this agent changing the treatment paradigm if it were to be approved?

The traditional management for low-grade, intermediate-risk, non–muscle invasive bladder cancer is TURBT. There are some patients who have small lesions, and these can often be fulgurated, but these are typically low-risk, low-grade patients, [with] small lesions, single lesions. When we begin to talk about multifocal lesions, larger lesions, and patients who recur, we often find that fulguration is not the easiest way to address these types of patients.

We found that [there were] about 2% of patients in the study that investigators felt could be managed with fulguration. So, that was always our non-TURBT option for patients where we didn't want to take them to the operating room. We've discussed a little bit about what some of those risk factors may be: being on a blood thinner, being older, being more frail, and having issues and risks that are associated with general anesthesia. I think urologists are going to find those types of patients first. Those may have been patients where they were addressing them with fulguration even though that may not have been a really great option, but it was the best option that was available to avoid anesthesia. Now we have a completely non-surgical option, potentially, to be able to address those patients. I think that's going to be the first place that almost all urologists will begin to adopt this agent.

But I think that the other way to look at it is that we have a non-surgical option that works in over 79% of patients and is durable. The estimated durability is over 80% in patients. Those are very high numbers to me. I think there will be some urologists who will say this should basically be the first-line therapy, and we should administer UGN-102 to all patients who have bladder cancer that is low-grade and intermediate-risk. Then for those 1 out of 5 patients that are not complete responders, to then address those patients with TURBT. It's possible that as we go over time, this may completely flip the order in which we do things. Currently, it's always TURBT first, maybe wash the bladder with chemotherapy or something else afterwards to see if we can prevent recurrence. We may completely flip that on its head, where we're using these types of gel instilled chemotherapeutic options like UGN-102 first, and then use TURBT if needed in that small subset of patients that may not be complete responders.

Is there anything else you’d like to add?

We're trying our best to be able to share these novel findings with our urologic community. We're very grateful to the SUO for the opportunity to present these data in the fall. We have 2 abstracts accepted at [the Genitourinary Cancers Symposium], which will be in February. We'll be able to present those to our broader urologic community that includes our radiation oncologists and medical oncologists, as well as our urologic oncologists who attend that meeting. Then we'll be submitting additional abstracts for the [American Urological Association] to again approach our general urologic community, because these types of tumors, low-grade tumors, intermediate, recurrent, large, and multifocal tumors, are taken care of by every single urologist. This is not something that just affects a subset or a fellowship-trained component of urologic surgeons. This is something that every single urologist takes care of and manages. It's important for us to do our part to share these new and exciting data with the entire urologic community.

1. Prasad SM, Shishkov D, Mihaylov NV, et al. Primary chemoablation of recurrent low-grade intermediate-risk non-muscle-invasive bladder cancer with UGN-102: A single-arm, open-label, phase 3 trial (ENVISION). Presented at: Society of Urologic Oncology 25th Annual Meeting. December 4-6, 2024. Dallas, Texas. Abstract 121. Accessed December 10, 2024. https://suo-abstracts.secure-platform.com/a/gallery/rounds/21/details/3652

The ENVISION trial investigated UGN-102, a novel intravesical chemoablative agent, as a primary treatment for recurrent low-grade, intermediate-risk non-muscle-invasive bladder cancer. The study demonstrated a 79.2% complete response rate at three months and an 82.3% durability of response at 12 months. The trial's safety profile was favorable, with minimal adverse events. UGN-102 offers a promising non-surgical alternative to TURBT, potentially altering the treatment paradigm for this patient population. The drug is under FDA review, with potential approval anticipated in 2025, which could significantly impact bladder cancer management.

"The durability response for these patients was impressive given the fact that these patients were those who, by definition and by inclusion criteria, were recurrent within a year at [baseline]," says Sandip M. Prasad, MD. 

Tobias Nordström, MD, PhD

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