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“The trial is meant to define or test this agent in this population for which currently there's not an established standard of care,” says Robert Svatek, MD. 

Robert Svatek, MD, discusses the design of the PIVOT-006 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

Guatam Jayram, MD, highlights key agents coming down the pike in bladder cancer. 

Gautam Jayram, MD, on key bladder cancer agents to keep an eye on 

, highlights key agents coming down the pike in bladder cancer. Jayram presented the session “Five things urologists need to know now about bladder and kidney cancer in 2025,” at the 

 in Chicago, Illinois. Jayram is a urologic oncologist and director of the Advanced Therapeutics Center at Urology Associates of Nashville in Tennessee.

There's a lot of trial activity going on with immunotherapy. Specifically with immunotherapy, we have BCG combination trials: BCG plus sasanlimab, BCG plus durvalumab, with a couple trials that are going to read out in the next 12 months. That's going to be really exciting to see if the BCG-naïve population can benefit from combination treatment, and who would benefit the most.

Then the other side of it are some of these other agents. So, cretostimogene [grenadenorepvec] has a really robust trial platform, and that's intravesical gene therapy as well. That has really good data and has a lot of interesting applications, I think, in patients with both intermediate-risk disease and BCG-unresponsive disease in patients with carcinoma in situ. I think that those trials are continuing to improve as we gain more information.

Then you have other players that are in a little bit earlier stages: Protara with lyophilized strep pyogenes, which is an intravesical agent. You have enGene, which is a non-viral vector, intravesical agent that has a lot of promise and could be really easy to give for a community center. Those studies are still accruing; that data is still being accumulated. But there's a ton of activity in this space, and I think every 6 to 12 months, we're going to keep getting these boluses of information that's going to help us.

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

Emerging therapies in bladder cancer are showing promise, with significant trial activity in immunotherapy and gene therapy. BCG combination trials, such as BCG plus sasanlimab and BCG plus durvalumab, are anticipated to provide insights into treatment benefits for BCG-naïve populations. Intravesical gene therapy, like cretostimogene, shows potential for intermediate-risk and BCG-unresponsive patients. Early-stage agents, including Protara's lyophilized strep pyogenes and enGene's non-viral vector, are under investigation. Continuous advancements in these areas are expected to yield valuable data every 6 to 12 months.

"There's a ton of activity in this space, and I think every 6 to 12 months, we're going to keep getting these boluses of information that's going to help us," says Gautam Jayram, MD. 

Siamak Daneshmand, MD, highlights data on the safety and tolerability of TAR-200 monotherapy in patients with non–muscle-invasive bladder cancer

Siamak Daneshmand, MD, on safety/tolerability data from SunRISe-1

, highlights data on the safety and tolerability of TAR-200 monotherapy in patients with non–muscle-invasive bladder cancer (NMIBC), which were shared at the 

Society of Urologic Oncology 25th Annual Meeting

 in Dallas, Texas. Daneshmand is a professor of urology and director of clinical research at the Keck School of Medicine of the University of Southern California, Los Angeles.

Could you describe the background/design of the SunRISe-1 trial?

TAR-200 is an intravesical gemcitabine releasing system. This has been a very exciting trial. This is for non–muscle invasive-bladder cancer that's unresponsive to BCG. Initially, there were 3 cohorts. One was cetrelimab, which is a PD-1 inhibitor, alone. Cohort 2 [was] TAR-200 alone, and cohort 3 [was] TAR-200 plus cetrelimab. Later, there was a cohort 4 that was added for papillary disease only. But these are basically patients [with] BCG-unresponsive CIS with or without papillary disease. The idea was to see what the efficacy of this gemcitabine releasing system was for these patients. We concentrated mostly on the TAR-200 alone arm. There was data released from the cetrelimab alone arm, which had about a 37% complete response rates, which are in line with what we've seen with other PD-1 inhibitors in the past. So, one of the objectives was, of course, to see the efficacy—that was the main objective—but at the same time to see safety and tolerability of this device. We'd seen the safety in the previous phase 1 studies, and it seemed to be very tolerable. But this was obviously a much larger global scale clinical trial.

What were the key findings on safety and tolerability?

As we get mature data, everyone's interested in how well these devices are tolerated. At the end of the day, this is a device that's in the bladder that's floating in there for 3 weeks at a time, so it's of great interest to know how patients are tolerating it. These side effects and AEs and profiles were very meticulously annotated throughout the trial. It turns out, it is actually very well tolerated. Most of the AEs are grade 1 and 2 [and were] things that we're completely used to as urologists with intravesical therapies of all kinds for treatment of non–muscle-invasive bladder cancer.

We wanted to know how many patients discontinued therapy. There were 85 patients, and 5 patients discontinued therapy because of side effects. So, very low number that had the device removed for side effects. I mentioned that most of the AEs were grade 1 and 2. These consisted of frequency, urgency, UTIs—again, things we're very used to with intravesical therapies. These are the risks of all intravesical therapies. There were very few grade 3 AEs, or 9% of the patients had grade 3 AEs, consisting of infections, UTI, urinary retention, and things like that. Again, hematuria is another one that we see often with any kind of intravesical therapy. Most of it is related to probably catheter insertion. But overall, again, very well tolerated. The vast majority of patients were able to maintain the device in for 3 weeks and went on to continue therapy. This is a therapy that's being given every 3 weeks for the first 6 months, and then after that, it's quarterly. So, we're very happy to see both its continued efficacy results as well as the low AEs.

TAR-200, an intravesical gemcitabine-releasing system, was evaluated in the SunRISe-1 trial for its safety and tolerability in patients with BCG-unresponsive non–muscle-invasive bladder cancer (NMIBC). The trial included multiple cohorts, focusing on TAR-200 alone. The device demonstrated a favorable safety profile, with most adverse events (AEs) being grade 1 or 2, such as frequency, urgency, and UTIs. Only 5 out of 85 patients discontinued due to side effects. The trial confirmed TAR-200's tolerability and potential efficacy in NMIBC treatment.

"Most of the AEs were grade 1 and 2. These consisted of frequency, urgency, UTIs—again, things we're very used to with intravesical therapies," says Siamak Daneshmand, MD. 

, details a case study on the use of trastuzumab deruxtecan-nxki (Enhertu) in a patient with Human Epidermal Growth Factor Receptor (HER) 2-positive prostate cancer.

 Jain is an oncologist at the Washington DC VA Medical Center and an associate professor of medicine at George Washington University.

Could you provide some background on this case and describe the rationale for turning to this treatment option?

This is a 59-year-old, currently 60-year-old veteran who had been seen by other large academic centers in the Washington, DC area, and had been coming to see me for the past few years as a third opinion. It turned out that his prostate cancer was extremely aggressive. After undergoing several treatments, it can be converted or changed to what they call neuroendocrine prostate cancer, which tends to be extremely aggressive. Patients usually have less than a year to live. His cancer had gone to the neck and brain, and he had it resected at an academic university in the area in October/November. He came back in January and had mentioned to me that the cancer had grown back in the neck and brain. So, he had disease in the brain, neck, abdomen and all over his bones. At the other hospitals, they had basically told his wife and him that they had ran out of standard-of-care options. He came in [to see me] and was fatigued and withdrawn and had a poor performance status. That's when I talked to him about using this drug off-label.

Things that people need to recognize is we do not check protein expression or immunohistochemistry expression in prostate cancer. We check it in breast cancer and a lot of other solid tumors, but not in prostate cancer. We rely on next-generation sequencing to get a tumor profile of the tumor. What's interesting about this particular target of HER2 in prostate cancer is you cannot see it in the next-generation sequencing; you have to be able to check it using immunohistochemistry. At the other hospitals, they had checked next-generation sequencing, but had not seen this biomarker. The reason we were doing biomarker research that led to HER2 was we have a minority cohort at the Washington DC VA Medical Center, and we wanted to look at certain targets using immunohistochemistry. When these data came out 2 years ago [and were] very promising in breast cancer, we thought to re-look at HER2 in prostate cancer. Before that veteran had come and saw me, I had known that his HER2 expression was high. I had checked it in his tumor, knowing that this could be a relevant pathway and we have an upcoming clinical trial. We knew he was positive. So, when he came and saw me in February, we knew this was a potential area or target to treat.

What was the patient’s response to treatment?

He started therapy in February of this year, and within 2 to 3 cycles of treatment, he had a dramatic improvement in his fatigue and his appetite. His energy had increased because his hemoglobin had increased. There was a huge tumor on his left side of his neck, and that had decreased so you could no longer palpate it. He no longer had bone pain. The tumor was on his neck, so he couldn’t swallow that well on that side, and his vision was impaired on the left side. A lot of those symptoms went away within a few months. It's very dramatic. I mean, he failed 7-8 lines of therapy.

The family gets very emotional. There was a trip that they wanted to go on, a mission trip. They were going to go to the west coast to Utah. He has 5 sons and a daughter. They were not sure that they were going to be able to go on this trip, because of all the news that they heard in January/February. When he had that dramatic improvement from the trastuzumab deruxtecan, he was able to go on this trip in June. And he's still doing well.

What's amazing about this therapy is his prior lines of therapy only worked for 3 to 4 months. He's been on this therapy from February to now November, and he's still doing well. So, he's been on it now for almost 9 months. Even though he has a very aggressive prostate cancer [that] involved the neck and brain, and his prior lines worked 3 to 4 months, this therapy has been working for 9 months and he's doing well. There was 1 lesion in the brain that they were a little concerned whether it was responding to trastuzumab deruxtecan, [but] the rest of his disease was doing well. So, they resected it at an academic institution in our area, and a few days afterwards, which just happened last week, he was like, “When can I resume my trastuzumab deruxtecan?” He actually wanted to come in last week because he was doing that well. I feel like it's an incredible turn-around from February to now. Like I said, he's been on it for 9 months. I feel in my heart he might be on it beyond a year, which is incredible, being so late-stage and having such an aggressive cancer.

Given this patient’s response to therapy, are there plans to explore this treatment option in prostate cancer?

We had our concept endorsed to our pharma sponsor, Daiichi Sankyo. We have an upcoming trial called the CaRPET trial (NCT06610825). It's a multi-VA site trial between us and 6 other VAs and then our academic affiliate, George Washington University. Our hope is to start this trial in December of this year. What we're looking at in that trial is different levels of HER2 expression. In some of the other solid tumors, this drug worked very well if you had higher expression, like IHC 2+ and IHC 3+. We will have arms of IHC 3+, IHC 2+, and IHC 1+, just to stratify response to therapy. Our hope [is] that the majority of the patients respond, but bare minimum, that they respond in the higher expressing group, the IHC 2+ and the IHC 3+. We're going to try to see, by different levels of immunohistochemistry, who responds in this trial. We're very excited about it. It's a 60-patient trial.

Could you touch on the importance of HER2 expression testing?

In April of this year, the trastuzumab deruxtecan got an FDA pan-tumor approval that [says that] anybody that is IHC 3+ can go on this drug.

 That pan-tumor approval and this patient case really highlight that in prostate cancer, we should be checking HER2 by immunohistochemistry so that we can identify patients to get this treatment, either by participating in the clinical trial or getting trastuzumab deruxtecan based on the pan-tumor FDA approval.

I will make a note that some people in prostate cancer use a breast scoring system or a gastric scoring system. Based on how we score it using our institution scoring system, we scored him as an IHC 3+. But if you use the breast or gastro scoring system, he would not have been IHC 3+. That would have meant that if the pan-tumor approval was there and somebody had seen him and done immunohistochemistry, he would have not been scored IHC 3+. Therefore, he would not have been able to benefit from that pan-tumor approval. Another thing that we're trying to illustrate in the case is not only to test for HER2 by immunohistochemistry, but also to consider an alternative scoring schema that takes into consideration the morphology that you see in prostate cancer. We're utilizing that scoring schema in our clinical trial. By no means are we saying that this is the right scoring schema, we're just saying that we should just not be using a breast scoring schema or another solid tumor schema and applying it in prostate. That is our argument.

Is there anything else that you wanted to add?

It's a very incredible drug. It's an antibody drug conjugate, so it's linked to topoisomerase inhibitor. As long as there's expression of HER2 in prostate cancer, or any other solid tumor, then the drug will work, because it kills that target and the neighboring cancer cells. I feel like we're a little bit behind [in prostate cancer]; we have data on all the other solid tumors. You could say to yourself, with such a common cancer in men, why are we starting the trial now?

The reason for that is they tried other HER2-directed drugs like herceptin [trastuzumab] and lapatinib [Tykerb] in the past, and it didn't work in prostate cancer. Because it's not a mutation or amplification you can't use a signal transduction inhibitor. You need to focus on this low level of expression.

Where this antibody drug conjugate comes into play is as long as there's expression in the cancer cells, there's a chance that this could work. Because prior drugs in prostate cancer utilizing HER2 did not work, maybe that is why in prostate cancer we are the last major solid tumor to have this checked on. In breast there's an approval, gyn, lung, upper GI, and even in the pan-tumor trial, they included pancreatic—they included everybody. So, why did they not include prostate? I think it was just because it's a low level of expression, and the prior therapies on HER2 did not work.

1. Lap CJ, Rajendran R, Martin JM, et al. Response of Human Epidermal Growth Factor Receptor 2-expressing prostate cancer to trastuzumab deruxtecan. 

2. FDA grants accelerated approval to fam-trastuzumab deruxtecan-nxki for unresectable or metastatic HER2-positive solid tumors. News release. US Food & Drug Administration. April 5, 2024. Accessed December 3, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-fam-trastuzumab-deruxtecan-nxki-unresectable-or-metastatic-her2

A case study highlights the use of trastuzumab deruxtecan-nxki in a patient with HER2-positive prostate cancer, demonstrating significant clinical improvement. The patient, previously unresponsive to multiple therapies, showed marked symptom relief and tumor reduction after treatment. This success has prompted the initiation of the CaRPET trial to explore HER2 expression levels in prostate cancer. The trial aims to stratify responses based on immunohistochemistry scores. The study underscores the importance of HER2 testing in prostate cancer and suggests alternative scoring systems for accurate assessment.

"That pan-tumor approval and this patient case really highlight that in prostate cancer, we should be checking HER2 by immunohistochemistry," says Maneesh R. Jain, MD.

The potential of HER2 targeting in prostate cancer: A case study with trastuzumab deruxtecan

Ellen Cahill, MD, discusses what to consider when incorporating chaperones for genitourinary exams

Ellen Cahill, MD, on chaperone use for genitourinary exams

 discusses what to consider when incorporating chaperones for genitourinary exams. She presented the study “The Use of Chaperones for Genitourinary Exams: A Survey of Society for the Study of Male Reproduction (SSMR) Members,” at the 2024 Sexual Medicine Society of North American Fall Scientific Meeting in Scottsdale, Arizona. Cahill is a urology resident at Yale School of Medicine in New Haven, Connecticut.

What factors should be considered when developing standardized guidelines for chaperone use in sexual medicine? How can these guidelines be implemented effectively to ensure consistency and improve the patient-physician experience?

I think it would be really nice if we did have standardized guidelines on who could serve as a chaperone. Like I said, our study showed that there are wide variations. At Yale, we only allow for nurses and techs to be chaperones. We don't allow another physician to be a chaperone, a medical student, a scribe, anything like that. But it really varied in our survey. You also want to consider what exam needs a chaperone. At Yale, we use them for any rectal exam, genitourinary exam, breast exam, any really sensitive exam. And we don't give patients a choice. It's just a policy that we have. Sometimes patients do say, "Do we really need this? Do I have to have this done?" And typically, by just saying, "This is our policy," we don't have issues with that, but it's something that should be considered. Are you going to give the patients a choice, or are you going to have that be your standardized policy, and then just making sure to work it into the workflow, talk to the clinic staff, and figure out how this is going to be implemented by who, and just making sure there's buy-in from everybody.

Standardized guidelines for chaperone use in genitourinary exams are essential to ensure consistency and improve the patient-physician experience. Variations exist in who can serve as a chaperone, with some institutions like Yale allowing only nurses and techs. The decision to use chaperones should consider the type of exam and whether patients have a choice. Effective implementation requires integrating the policy into clinical workflows and securing buy-in from all staff members to ensure smooth operation and adherence to the guidelines.

"I think it would be really nice if we did have standardized guidelines on who could serve as a chaperone," says Ellen Cahill, MD.

Vikram M. Narayan, MD, discusses an ongoing study to evaluate the use of augmented reality to simulate surgical procedures for resident training.

Vikram Narayan, MD, on the use of augmented reality to assist in resident training

, discusses an ongoing study to evaluate the use of augmented reality to simulate surgical procedures for resident training. Narayan is an assistant professor of urology at Emory University and the director of urological oncology at Grady Memorial Hospital in Atlanta, Georgia. 

One of the roles that I have here at Emory is to help train the next generation of surgeons. I think the importance is how best to get those surgeons ready for their own independent practice. Historically, in surgical education, simulation has been a big area of interest and focus. I don't think we, to date, have a surgical simulator that matches the fidelity or realism of being at a patient's bedside.

One of the things that we are exploring here at Emory is the use of augmented and mixed reality and potentially virtual reality to try and help educate some of our resident surgeons. We have a recently approved, IRB approved study that I'm doing together with my colleague in the department of radiology, Dr. Elias Kikano, to use Apple Vision Pro to essentially do 3D simulation with imaging as well as review of surgical videos in an immersive space so as to try and improve the pre-operative and post-operative experience that a resident has, essentially trying to think through the best way to help augment their education. Put another way, with Apple Vision Pro, what we're hoping to do is have our residents be able to put on a headset and walk through a case before they actually walk into an operating room.

This is very important because right now, the way we do that is through didactic teachings. We'll have videos that are on a 2-dimensional screen, that don't necessarily capture the depth of being at a patient's bedside. We're hoping that with these sorts of tools, we'll be able to improve the comfort and readiness that a resident has by the time they show up in the operating room to assist in a case. It's very early days, but some of the things that we're doing are, with our residents, sitting them down, having them be in headset, in a vision Pro headset—which is a very new technology; it was only released earlier this year in February. So, we're very excited to have this IRB approved study to look at ways in which an attending physician can walk a resident through a case in headset and then figure out the next steps in terms of performance evaluation, that sort of thing.

Pictured in the video: Vikram M. Narayan, MD, Assistant Professor of Urology, and Donald Fedrigon, MD, PGY-5, reviewing 3D robotic surgery footage in Apple Vision Pro as part of a pre-procedure planning and didactics. October 29, 2024.

Augmented reality is being explored for surgical training at Emory University, led by Dr. Vikram M. Narayan. The study, in collaboration with Dr. Elias Kikano, utilizes Apple Vision Pro to create 3D simulations and immersive surgical video reviews. This approach aims to enhance the pre-operative and post-operative educational experiences of resident surgeons, moving beyond traditional didactic methods. The goal is to improve residents' comfort and readiness for real surgeries. The study is in its early stages, focusing on performance evaluation and educational augmentation.

“Put another way, with Apple Vision Pro, what we're hoping to do is have our residents be able to put on a headset and walk through a case before they actually walk into an operating room,” says Vikram M. Narayan, MD. 

Robert Svatek, MD

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