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"The list of methods and biomarkers to help patients and physicians decide whether to perform biopsy is continuously evolving," writes Sigrid Carlsson, MD, PhD, MPH.

Novel method in the diagnostic arsenal for prostate cancer

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

Regarding your article on the Medicare proposed fee schedule rules for 2025,

 can you further explain how the practice expense (PE) relative value unit (RVU) is changing for the cystoscopy? I’m not familiar with the cystoscopy packs that are mentioned in the article or how they affect an in-office cystoscopy.

In the article you are referring to, we stated that several urology codes will see their PE valuation change due to updates in supply valuation. A practitioner is reimbursed by the total RVU of a procedure, which consists of the sum of the work RVU, the PE RVU, and the malpractice RVU. In the case of cystoscopy procedures, the work RVU is unchanged. However, the Centers for Medicare & Medicaid Services (CMS) felt that the reimbursement for some of the supplies and equipment involved in some cystoscopy procedures was incorrectly valued. Many cystoscopy procedures have PE valuation that includes either drapes for cystoscopy (supply code SA045) or a full cystoscopy kit (supply 

code SA058), which includes several items such as drapes and other equipment necessary for the procedure to be performed. Medicare felt that the cost and, therefore, reimbursement of these packs was greater than the sum of its components. Therefore, with the help of the Relative Value Update Committee (RUC), these packs were revalued, with the SA045 dropping from $17.33 to $14.99 and SA058 dropping from $113.70 to $37.63. These updates will result in a reduction in the PE RVU portion of the total RVU; therefore, the reimbursement for the procedure will similarly be reduced. Please note that in the Medicare final rule, it was determined that SA058 changes would be phased in over 4 years to allow practices to adjust to the changes. As a result of the changes and the programmed phase-in of the changes, the cystoscopy code total RVU for the office setting will be 8% lower in 2025 than the current value. It is important to note that the kit packs and their corresponding numbers are not reported to Medicare separately and instead are used by CMS and the RUC in the process of developing the RVUs for these procedures.

Send coding and reimbursement questions to Jonathan Rubenstein, MD, and Mark Painter c/o

The information in this column is designed to be authoritative, and every effort has been made to ensure its accuracy at the time it was written. However, readers are encouraged to check with their individual carrier or private payers for updates and to confirm that this information conforms to their specific rules.

"As a result of the changes and the programmed phase-in of the changes, the cystoscopy code total RVU for the office setting will be 8% lower in 2025 than the current value," write Jonathan Rubenstein, MD, and Mark Painter.

What’s changing with reimbursement for cystoscopy packs

The marriage process requires careful thought about several financial situations many couples will likely face. With financial disagreements being a leading cause of marital problems, why not tackle them ahead of time? This may include reaching out to your financial planner and other legal and tax advisers well in advance of the nuptials.

The starting point is to have a candid discussion with your fiance/fiancee about your overall finances

For example, how much debt is each of you bringing to the marriage? What about savings? How is each of your credit ratings? What are your income and tax circumstances going to look like? The older you are, the more (good and bad) financial baggage you're likely to bring to the partnership.

Next, from a banking standpoint, you’ll need to decide if you will be combining accounts or keeping them separate.Your financial adviser can walk you through how to combine your individual checking, savings, and money market accounts. He or she can also advise you about adding or changing beneficiaries on your individual retirement accounts and other retirement plans. Even if you decide to maintain separate accounts, it may be helpful to have at least one joint account to pay for shared expenses, such as mortgage or car payments, rent, household expenses, and insurance premiums. This account is meant strictly for household needs, and it allows you both to keep track of how you are spending money. A joint account can also help avoid complications in the event a spouse dies. When there are separate accounts and a spouse or common-law partner dies, the survivor will be excluded from the separate accounts if the estate goes into probate. A probate settlement could take months and add additional expenses due to court and attorney fees.

If you are both employed, you must take time to review and coordinate your employee benefits. You might save money by eliminating duplicate health care, for example. This process also allows you to determine, and then make any changes to, the beneficiary designations on retirement plans and insurance policies held through your employers.

Next, sit down and identify your financial goals as a couple

 Start by creating an annual budget, as well as a contingency plan in case a spouse gets laid off or becomes disabled. Make sure you have an emergency cash reserve equal to several months of income. Designate who will be responsible for paying the bills. Also look beyond your current financial situation. For example, discuss what you envision retirement will look like, and whether your current retirement account contributions are sufficient to achieve your long-term goals.

People who have been previously married may bring additional financial complications to the table, especially if they have children and/or are required to pay alimony, child support, or insurance premiums under the terms of a divorce settlement agreement. Also consider whether your remarriage will nullify any entitlements to assets from a former spouse. For example, getting remarried could invalidate your right to claim an inheritance or other financial interest. Meet with your advisers to address these issues whenever you are considering blending your finances.

Marriage is also a good time to meet with an estate planning attorney and get a plan in place. Estate planning is often pushed aside because it deals with a question most couples don’t want to discuss: “What happens if one of us dies?” However, it is important to have those conversations and formulate a plan. A will may be a good first step, or it may not be necessary depending on the type and value of the assets owned. An estate planning attorney will be able to provide specific guidance. Having health care and durable powers of attorney in place is always a smart idea in the event you are incapacitated. Depending on your assets, certain trusts may also play an important role in accomplishing your estate planning goals.

Remember that whether or not it's your first time down the aisle, marriage is a celebration. Don't let all the financial and administrative details that go along with your special day spoil it. Meet with your financial, tax, and legal advisers to establish a budget and tackle other financial and legal issues head-on. A little planning can alleviate potential stress well beyond your wedding day.

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MEDIQUS Asset Advisors, Inc. does not provide tax, legal or accounting advice. This material has been prepared for informational purposes only, and is not intended to provide, and should not be relied on for, tax, legal or accounting advice. You should consult your own tax, legal and accounting advisors before engaging in any transaction.

"Remember that whether or not it's your first time down the aisle, marriage is a celebration. Don't let all the financial and administrative details that go along with your special day spoil it," writes Jeff Witz, CFP.

Money Matters: Financial considerations when getting married

Treatment with capivasertib (Truqap) in combination with abiraterone acetate (Zytiga) and androgen deprivation therapy (ADT) significantly extended radiographic progression-free survival (rPFS) vs placebo with abiraterone plus ADT in patients with PTEN-deficient de novo metastatic hormone-sensitive prostate cancer (mHSPC), according to topline data from the phase 3 CAPItello-281 trial (NCT04493853).

AstraZeneca also reported that there was a trend toward an improvement in overall survival (OS), although the data were still immature at the time of data report. The trial remains ongoing to assess this secondary end point.

“Patients with this aggressive form of prostate cancer with tumor PTEN deficiency currently face a particularly poor prognosis, and there is an urgent need for new treatments that improve upon current therapies,” explained principal investigator Karim Fizazi, MD, PhD, Institut Gustave Roussy, and University of Paris Saclay in Villejuif, France, in a news release on the data.

“The results seen with capivasertib in combination with abiraterone-prednisone and androgen deprivation therapy in the CAPItello-281 trial represent a step forward for these patients.”

Safety data from the trial has been consistent with the known profiles for each agent. According to AstraZeneca, these data will be presented at an upcoming medical meeting and shared with global regulatory authorities.

“These results show for the first time, that adding an AKT inhibitor to a standard-of-care therapy can provide benefit to patients with a biomarker of PTEN-deficient metastatic hormone-sensitive prostate cancer,” said Susan Galbraith, executive vice president of Oncology R&D at AstraZeneca, in the news release.

 “By targeting a key driver of the disease, we have been able to improve upon current therapies and demonstrate the potential role of this combination in an area of critical unmet need. It will be important to see greater maturity in key secondary end points including overall survival.”

In total, the double-blind, randomized, placebo-controlled study enrolled 1012 adult patients with mHSPC and PTEN loss.

To be eligible for enrollment, patients needed to have histologically confirmed de novo mHSPC, PTEN deficiency, an ECOG score of 0 to 1, and ongoing ADT. Patients were excluded if they had prior radical prostatectomy or definitive radiotherapy with therapeutic intent, major surgery within 4 weeks of study start, brain metastases or spinal cord compression, past interstitial lung disease, or any of the pre-specified cardiac criteria.

For the trial, patients were randomly assigned 1:1 to receive 400 mg capivasertib BD on days 1 to 4 of a 28-day treatment cycle or to matching placebo, each in combination with 1000 mg abiraterone daily plus ADT. Treatment is continued until disease progression or unacceptable toxicity.

The primary end point for the study is rPFS, assessed for up to approximately 55 months. Secondary end points include OS, time to the start of first subsequent therapy, symptomatic skeletal event-free survival, and time to pain progression, among other measures.

Final study completion is anticipated for March 2027.

In addition to the CAPItello-281 trial, the phase 3 CAPItello-280 trial is also assessing capivasertib in combination with docetaxel vs placebo plus docetaxel in patients with metastatic castration-resistant prostate cancer. Completion of the study is expected in December 2026.

1. Truqap combination in PTEN-deficient metastatic hormone-sensitive prostate cancer demonstrated statistically significant and clinically meaningful improvement in radiographic progression-free survival in CAPItello-281 phase III trial. News release. AstraZeneca. Published online and accessed November 25, 2024. https://www.astrazeneca.com/media-centre/press-releases/2024/truqap-improved-rpfs-in-advanced-prostate-cancer.html

2. Capivasertib+abiraterone as treatment for patients with metastatic hormone-sensitive prostate cancer and PTEN deficiency (CAPItello-281). ClinicalTrials.gov. Last updated July 23, 2024. Accessed November 25, 2024. https://clinicaltrials.gov/study/NCT04493853

3. Study of capivasertib + docetaxel vs placebo + docetaxel as treatment for metastatic castration resistant prostate cancer (mCRPC) (CAPItello280). ClinicalTrials.gov. Last updated October 8, 2024. Accessed November 25, 2024. https://clinicaltrials.gov/study/NCT05348577

Capivasertib combined with abiraterone acetate and androgen deprivation therapy (ADT) significantly improved radiographic progression-free survival (rPFS) in patients with PTEN-deficient metastatic hormone-sensitive prostate cancer (mHSPC) compared to placebo, according to the phase 3 CAPItello-281 trial. While overall survival (OS) data remains immature, the trial continues to evaluate this secondary endpoint. Safety profiles were consistent with known data. The study enrolled 1012 patients, with final completion expected in March 2027. Another trial, CAPItello-280, is assessing capivasertib with docetaxel in metastatic castration-resistant prostate cancer.

Data from the CAPItello-281 trial also showed a trend toward an improvement in overall survival. 

Capivasertib plus abiraterone extends rPFS in PTEN-deficient mHSPC

The first patient has been dosed in the phase 2 CELLVX-230 trial (NCT06636682), exploring the potential of the personalized immunotherapy FK-PC101 to delay or prevent prostate cancer recurrence following radical prostatectomy, Theragent announced in a news release.

According to the company, FK-PC101 utilizes patients’ own tumor cells collected during surgery, which are then irradiated to make them incompetent for replication and delivered as an autologous cellular vaccine. Theragent recently produced the first batch of these agents, allowing for the first patient dosing in CellVax’s phase 2 trial.

"Despite recent improvements in radiation, surgeries, and other therapies, up to 30% of patients may still experience recurrent prostate cancer after prostatectomy," said CellVax CEO Fernando Kreutz in the news release.

 "Further, after such recurrence, the current standard of care is salvage radiotherapy and/or androgen deprivation therapy (ADT), both of which may lead to poorer health-related quality of life for patients. FK-PC101 could delay the necessity for such treatments, if not prevent them entirely."

The phase 2 CELLVX-230 trial is being conducted through a collaboration with the Society of Urologic Oncology Clinical Trials Consortium. The study’s principal investigator is Scott Eggener, MD, who is the vice chair of urology and director of the high risk and advanced prostate cancer clinic at theUniversity of Chicago in Illinois.

In total, the multicenter, adaptive trial plans to enroll 100 patients with high-risk prostate cancer following radical prostatectomy.

 Participants will be enrolled across 3 clinical trial sites in the United States.

To be eligible for enrollment, patients need to have localized high-risk or very high-risk prostate cancer, no evidence of distant metastases, 3 or more prostate biopsy cores with at least 50% tumor involvement, a prostate-specific antigen level greater than 4 ng/mL within 28 days prior to enrollment, and a life expectancy of more than 5 years. Additionally, patients need to be a candidate for radical prostatectomy and have no prior history of nor plans to receive neoadjuvant radiation therapy, ADT, or any other anticancer therapy.

For the study, patients will be randomly assigned 1:1 to either the vaccine cohort or to a standard-of-care control cohort. Those assigned to receive the vaccine will receive up to 7 intradermal doses between day 1 and day 180. In both cohorts, BCG will be given concurrently with dose 1 (day 1) and dose 2 (day 8).

Upon disease recurrence, patients may be treated with other prostate cancer therapies that are deemed appropriate. Patients in the control group will be eligible to receive the vaccine following disease recurrence within 1 year of radical prostatectomy.

The primary outcome measure is disease-free survival, defined as free from local prostate cancer recurrence, distant metastatic prostate cancer recurrence, biochemical recurrence, or death from any cause. Secondary outcome measures include the time to next treatment, metastasis-free survival, immune response to FK-PC101, and safety and tolerability. An additional outcome measure is overall survival. All end points will be assessed for up to 22 months.

Final completion of the CELLVX-230 trial is anticipated for May 2027.

1. Theragent and CellVax Therapeutics announce first manufacturing batch in phase 2 trial of FK-PC101, a novel personalized cancer immunotherapy. News release. Theragent. November 11, 2024. Accessed November 27, 2024. https://www.prnewswire.com/news-releases/theragent-and-cellvax-therapeutics-announce-first-patient-dosed-in-phase-2-trial-of-fk-pc101-a-novel-personalized-cancer-immunotherapy-302300746.html

2. FK-PC101 as adjuvant therapy for men with high-risk prostate cancer. ClinicalTrials.gov. Last updated October 21, 2024. Accessed November 27, 2024. https://clinicaltrials.gov/study/NCT06636682

The phase 2 CELLVX-230 trial investigates FK-PC101, a personalized immunotherapy, to delay or prevent prostate cancer recurrence post-radical prostatectomy. FK-PC101 uses patients' irradiated tumor cells as an autologous vaccine. The trial, in collaboration with the Society of Urologic Oncology Clinical Trials Consortium, aims to enroll 100 high-risk prostate cancer patients across three U.S. sites. Participants are randomized to receive either the vaccine or standard care, with disease-free survival as the primary outcome. Completion is expected by May 2027, with secondary outcomes including metastasis-free survival and immune response.

The phase 2 CELLVX-230 trial is exploring the potential of FK-PC101 to delay or prevent prostate cancer recurrence following prostatectomy.

Phase 2 trial launches of autologous prostate cancer vaccine 

Updated data from the phase 1a ENGAGER-PSMA-01 trial (NCT05519449) showed safety and encouraging anti-tumor activity of the PSMA-targeting TRACTr JANX007 in the treatment of patients with metastatic-castration resistant prostate cancer (mCRPC), Janux Therapeutics announced in a news release.

Based on these results, the investigators have selected 2 once-weekly step dose regimens for further investigation in the phase 1b expansion trial in patients who have not yet received lutetium Lu 177 vipivotide tetraxetan (Pluvicto) as their second- or third-line treatment.

“These clinical data show substantial activity with JANX007 in 5L [mCRPC] patients and provide compelling support for the doses we’ve selected for expansion trials directed at pre-PLUVICTO 2L and 3L patients,” said David Campbell, PhD, president and CEO of Janux Therapeutics, in the news release.

 “We look forward to rapidly advancing JANX007 into second and third-line therapy where a substantial unmet need remains and where we believe JANX007’s highly differentiated profile could allow for broad usage, if approved. This is an exciting day for Janux, but more importantly the prostate cancer patients we serve.”

Overall, the ENGAGER-PSMA-01 study is assessing the safety, tolerability, pharmacokinetic, pharmacodynamic, and preliminary efficacy of JANX007 monotherapy in patients with mCRPC.

As of the data cutoff date of November 15, 2024, 16 pre-PLUVICTO patients were treated in the study. Each patient received once-weekly target doses ranging from 2 mg to 9 mg via IV in a 21- or 28-day cycle. Participants enrolled had a median of 4 prior lines of therapy.

Data showed that 100% of patients achieved a prostate-specific antigen (PSA) decline of at least 50% (PSA50), 63% of patients achieved a PSA decline of at least 90% (PSA90), and 31% of patients achieved a PSA decline of at least 99%. At target doses of 2 mg or higher, 75% of patients maintained a PSA50 decline and 50% maintained a PSA90 decline for 12 weeks or more.

According to the company, “Deep and durable PSA responses were observed irrespective of resistance driver aberration status, or prior treatments with a taxane or ARPi.”

Additionally, 50% (4 of 8) of RECIST-evaluable patients achieved a confirmed or unconfirmed partial response. The disease control rate was 63% (5 of 8 patients).

Regarding safety, JANX007 was generally well-tolerated. Cytokine release syndrome (CRS), CRS-related adverse events, and treatment-related adverse events not associated with CRS were generally grade 1 and 2 and primarily occurred in the first treatment cycle. The maximum tolerable dose for the TRACTr had not yet been established at the time of data report.

In total, the open-label phase 1 study plans to enroll 105 adult patients across 16 clinical trial sites in the US and Australia.

To be eligible for enrollment, patients need to have histologically or cytologically confirmed adenocarcinoma of the prostate, mCRPC that progressed following at least 1 novel anti-androgen therapy and at least 1 taxane-containing regimen, and adequate organ function.

The primary outcome measures are the incidence of dose-limiting toxicities, adverse events, and serious adverse events. Secondary outcome measures include overall response rate, PSA response, duration of response, radiographic progression-free survival, and overall survival.

Janux expects to provide additional updated data from the trial in 2025. Final completion of the study is anticipated for December 2026.

1. Janux announces doses selected for phase 1b expansion trials supported by encouraging efficacy and safety profile observed in phase 1a dose escalation for JANX007 in mCRPC. News release. Janux Therapeutics. December 2, 2024. Accessed December 3, 2024. https://www.businesswire.com/news/home/20241202674893/en/Janux-Announces-Doses-Selected-for-Phase-1b-Expansion-Trials-Supported-by-Encouraging-Efficacy-and-Safety-Profile-Observed-in-Phase-1a-Dose-Escalation-for-JANX007-in-mCRPC

2. Study of JANX007 in subjects with metastatic castration-resistant prostate cancer (ENGAGER-PSMA-01). ClinicalTrials.gov. Last updated September 23, 2024. Accessed December 3, 2024. https://clinicaltrials.gov/study/NCT05519449

The phase 1a ENGAGER-PSMA-01 trial demonstrated the safety and promising anti-tumor activity of JANX007, a PSMA-targeting TRACTr, in metastatic castration-resistant prostate cancer (mCRPC) patients. Investigators have chosen two once-weekly dosing regimens for further phase 1b trials in patients who have not received lutetium Lu 177 vipivotide tetraxetan. The trial showed significant PSA declines and disease control, with JANX007 being well-tolerated. The study aims to enroll 105 patients, with primary outcomes focusing on safety and secondary outcomes on efficacy. Further data is expected in 2025.

Data showed that all patients achieved a PSA decline of at least 50%. 

Sigrid Carlsson, MD, PhD, MPH

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