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"Perhaps the biggest Medicare reform concern for urologists is the potential for provider reimbursements cuts, a threat that has continued to loom over the health care community for some time," writes the AACU's Ally Lopshire.

Tax law may threaten Medicare, provider pay

While drug importation may sound like a good option to reduce drug costs, the potential can of worms it could create isn’t worth it, the AACU’s Ally Lopshire writes.

Drug importation: Shortsighted and ineffective

Two topics of particular relevance at the 2017 Joint Advocacy Conference were IPAB repeal and medical liability reform, both of which have legislative initiatives currently gaining momentum in Congress.

JAC 2017: IPAB repeal, liability reform see renewed focus

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?

Video Series

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

The FDA has granted 510(k) clearance to EUROIMMUN’s automated chemiluminescence-based immunoassay (ChLIA) test for the quantitative measurement of free testosterone levels in serum or plasma, Revvity, Inc, announced in a news release.

It is the first test of its kind to receive FDA approval for the measurement of free testosterone, the company noted. The ChLIA test also has European CE mark approval.

According to Revvity, the test can provide results in 48 minutes for diagnostic insights for conditions such as hypogonadism, impotence, polycystic ovarian syndrome, and other androgenital syndromes. The FDA clearance is for an assay range of 0.40 pg/mL to 60.00 pg/mL.

The test is processed using the company’s iSYS or i10 instruments and incorporates highly specific monoclonal antibodies to ensure accurate and reproducible results. EUROIMMUN's ChLIA tests "use magnetic particles coated with antibodies or antigens as a solid phase to detect specific antigens or antibodies in patient samples by means of chemiluminescence signals," the company explained.

"Laboratory customers have been asking for a user-friendly FDA-cleared test, on a random-access platform, for direct measurement of free testosterone," said Jonathan Friend, general manager at Revvity’s EUROIMMUN US, in the news release.

 "This clearance reinforces our commitment to expanding the FDA-cleared menu for the EUROIMMUN family of ChLIA automation solutions with assays that serve diverse patient populations across all demographics.”

This test adds to EUROIMMUN’s suite of reproductive testing options, which includes an automated assay for the quantitative measurement of total testosterone.

The total testosterone test has been granted CE mark approval in Europe and can be used in the diagnosis and treatment of conditions such as primary and secondary hypogonadism, delayed or precocious puberty, impotence in males, hirsutism and virilization in females due to tumors, polycystic ovaries, and adrenogenital syndromes. The test has not been granted FDA clearance in the US.

1. Revvity announces FDA clearance for first automated free testosterone test. News release. Revvity Inc. January 10, 2025. Accessed January 10, 2025. https://news.revvity.com/press-announcements/press-releases/press-release-details/2025/Revvity-Announces-FDA-Clearance-for-First-Automated-Free-Testosterone-Test/default.aspx

2. Endocrine reproductive. Immunodiagnostic Systems. Accessed January 10, 2025. https://www.idsplc.com/disease-areas/endocrinology/endocrine-reproductive/

3. Free testosterone. Immunodiagnostic Systems. Accessed January 10, 2025. https://www.idsplc.com/products/free-testosterone/

4. ChLIA. EUROIMMUN. Accessed January 10, 2025. https://www.euroimmun.us/techniques/chlia/

5. Total testosterone. Immunodiagnostic Systems. Accessed January 10, 2025. https://www.idsplc.com/products/total-testosterone/

The FDA has granted 510(k) clearance to EUROIMMUN's automated chemiluminescence-based immunoassay (ChLIA) test for measuring free testosterone levels in serum or plasma. This test, which provides results in 48 minutes, aids in diagnosing conditions like hypogonadism and polycystic ovarian syndrome. It operates within an assay range of 0.40 pg/mL to 60.00 pg/mL using iSYS or i10 instruments. The test has also received European CE mark approval. EUROIMMUN's suite includes a total testosterone test, approved in Europe but not yet FDA-cleared in the US.

The test can provide results in 48 minutes for diagnostic insights for conditions such as hypogonadism, impotence, polycystic ovarian syndrome, and other androgenital syndromes. 

FDA clears chemiluminescence-based immunoassay for free testosterone

, discusses the need to increase diversity in clinical trials, specifically focusing on studies in prostate cancer. He also highlights the recent Northwestern-led course, “Enhancing Recruitment of Ethnic Minorities in Cancer Clinical Trials,” which took place on February 16, 2024. Murphy is a urologist at Northwestern University Feinberg School of Medicine in Chicago, Illinois.

During the discussion, Murphy provides some advice for researchers looking to increase diversity in their trials. He also references a study in which 64% of Black patients indicated that they would be willing to discuss clinical trials in prostate cancer, compared with 82% of White patients.

 While there is a difference, Murphy notes that the percentage of more than half of Black patients being willing to discuss clinical trials is not insignificant, and the data supports the idea of clinicians continuing to make the ask to their patients in order to help increase diversity in prostate cancer trials.

Murphy ends the discussion by sharing some of his thoughts on future work building on the Northwestern-led course, such as a session focused on mock recruitments with patients who have previously enrolled in clinical trials.

Don’t forget to subscribe to Speaking of Urology® on 

, or anywhere that podcasts are available.

1. Senft N, Hamel LM, Manning MA, et al. Willingness to discuss clinical trials among Black vs White men with prostate cancer. 

. 2020;6(11):1773-1777. doi:10.1001/jamaoncol.2020.3697

In this podcast episode, Adam B. Murphy, MD, MBA, MSCI, discusses the need to increase diversity in clinical trials, specifically focusing on studies in prostate cancer.

Dr. Murphy on increasing diversity in cancer clinical trials 

Dr. Adam Murphy discusses a genomics assay study during an interview at SUO

Dr. Murphy highlights a genomics assay study in prostate cancer

, highlights how to create successful inclusive clinical trials based on the study, “Impact of genomic testing on urologists’ treatment preference in favorable risk prostate cancer: A randomized trial,” for which he served as the senior author. Murphy is an assistant professor of urology at Northwestern University in Chicago, Illinois.

So, in yesterday's session, they were asking about how we did our investigator-initiated studies. Mine was interesting in that we paired it with a DOD-funded grant from the outset. The company provided a letter of support for our grant, and when it got funded, they decided to provide the cost of all the assays that they produced for free. In exchange, we did some additional analyses for them. So, that was one of the angles, that they were going down to teach new investigators, new trialists how to get involved. The other angle that we had was about how we completed a clinical trial on a clinical utility study for the Oncotype DX genomics assay. The genomics assay was using biopsy tissue to help patients make decisions for the treatment choices. We also tested the effect of the assay on provider choice.

So, it's a unique assay where we recruited 200 men from 3 safety net hospitals: Cook County Health, Jesse Brown VA, and the University of Illinois in Chicago, which are minority-serving institutions, with a 70% of African American, or Black, population. Only about 12% of the men were privately insured or college educated. So, it was a very underserved population we were getting. The idea is how do we get these men in trial without dropping out and completing the end points? I gave them several points. One, we had a team of 2 leaders, Dr. Peter Gann and myself, who both had experience with comparative effectiveness evaluation, prostate cancer biomarkers, and also working across multiple institutions. The team came with some expertise, leaders in urology, either the chairs or are championing urologic oncologists.

We also had stellar research coordinators who've been experienced with patient care. Since a couple of them were nurses, they were used to minority interaction, so they were used to working with diverse populations. There were 3 females, 1 was African American, 1 was Ukrainian, and 1 was American White. I made a joke that they also were able to field marriage proposals from some of the veterans. They knew how to set their own boundaries and not feel overwhelmed. And they also felt comfortable. They were socially justice minded, and they knew that it was important for us to increase our enrollment of minorities into prostate cancer trials.

An additional thing that we talked about was just the fact that we had trained these coordinators to act as patient navigators. They did a lot of reminder phone calls. They also did a lot of education for the patients, so they were aware of what was going on. They would shift appointment times if patients called and said, "I can't make it to the next visit". They also worked well with a very busy pathology department to make sure that our samples of tissue cores went out to the company so that we could get the results back in time for them to be used for their treatment discussions for their prostate cancer. I think some other things were that we aligned our incentives with the company because they wanted urologists to use their test more and show that it was accurate and it impacted treatment decisions. So, that was their angle; we wanted to make sure that we knew the effect on actual patients' and providers' choice. We were worried that these assays that were thought to increase the uptake of active surveillance, in some populations may not have the same effect, [such as] in an African American heavy population or a population in safety net hospitals where the risk is higher. So, it could be shifting them more towards surgery or radiation, and less towards adoption of active surveillance. And we actually found that.

This transcription has been edited for clarity.

"The genomics assay was using biopsy tissue to help patients make decisions for the treatment choices. We also tested the effect of the assay on provider choice," says Adam B. Murphy, MD, MBA, MSCI.  

Ally Lopshire

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