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“It encompasses and contains the miTNM, PROMISE, PRIMARY, RECIP, PSMA-RADS, and E-PSMA concept and criteria all together,” says Jeremie Calais, MD, PhD.

Jeremie Calais, MD, on development of a prostate cancer imaging reporting template

"But as you get out of expert centers and academic sites that did it for years under research protocols, the level of the quality of the reads decreases," says Jeremie Calais, MD, PhD. 

Jeremie Calais, MD, on rationale for reporting template for PSMA-PET scans

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 approved nivolumab (Opdivo) plus hyaluronidase-nvhy (Qvantig) for subcutaneous injection across most 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 was previously approved under several indications in renal cell carcinoma (RCC) and urothelial carcinoma. 

The approval is supported by findings from the phase 3 CheckMate-67T trial (NCT04810078), in which subcutaneous nivolumab plus hyaluronidase-nvhy met the study’s co-primary end points by demonstrating noninferiority to IV nivolumab regarding time average nivolumab serum concentration over 28 days (C

For both pharmacokinetic end points, the predefined acceptance margin was met, with the lower boundary of the 90% confidence interval of geometric mean ratios not reaching less than 0.8.

Data from the study, which were presented earlier this year 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, patients in 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) among patients in the IV arm.

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 hyaluronidase-nvhy 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.

 of subcutaneous nivolumab vs IV nivolumab. The key secondary end point was ORR per BICR.

The CheckMate-67T remains ongoing, with final completion expected in January 2026.

Subcutaneous nivolumab plus hyaluronidase-nvhy are approved across most previously approved adult solid tumor indications for nivolumab, including several in RCC and urothelial carcinoma.

In RCC, subcutaneous nivolumab is approved for the first-line treatment of patients with intermediate- or poor-risk advanced RCC following treatment with intravenous (IV) nivolumab and ipilimumab combination therapy, in combination with cabozantinib for the first-line treatment of patients with advanced RCC, and in the treatment of patients with advanced RCC who have received prior anti-angiogenic therapy. Subcutaenous nivolumab is not approved in combination with ipilimumab for the treatment of patients with RCC. 

In urothelial carcinoma, the subcutaneous nivolumab formulation is indicated for the treatment of patients with urothelial carcinoma who are at high risk of recurrence following radical tumor resection, in locally advanced or metastatic urothelial carcinoma in patients that have progressed during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy, and  in combination with cisplatin and gemcitabine for the first-line treatment of patients with unresectable or metastatic urothelial carcinoma.

1. FDA approves nivolumab and hyaluronidase-nvhy for subcutaneous injection. News release. Published online and accessed December 27, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-and-hyaluronidase-nvhy-subcutaneous-injection

2. 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. 

3. 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 December 27, 2024. https://clinicaltrials.gov/study/NCT04810078

4. U.S. Food and Drug Administration approves Opdivo

Qvantig (nivolumab and hyaluronidase-nvhy) injection, for subcutaneous use in most previously approved adult, solid tumor Opdivo (nivolumab) indications. News release. Bristol Myers Squibb. Published online and accessed December 27, 2024. https://www.businesswire.com/news/home/20241218841283/en/U.S.-Food-and-Drug-Administration-Approves-Opdivo-Qvantig%E2%84%A2-nivolumab-and-hyaluronidase-nvhy-Injection-for-Subcutaneous-Use-in-Most-Previously-Approved-Adult-Solid-Tumor-Opdivo%C2%AE-nivolumab-Indications12

The FDA has approved the combination of nivolumab and hyaluronidase-nvhy for subcutaneous injection across all previously approved solid tumor indications for nivolumab. This approval is based on the phase 3 CheckMate-67T trial, which demonstrated noninferiority of subcutaneous administration compared to intravenous administration in terms of pharmacokinetics and objective response rate. The safety profile of the subcutaneous formulation was consistent with the intravenous version, with low-grade injection-site reactions. The trial enrolled 495 patients with advanced or metastatic clear cell renal cell carcinoma and remains ongoing.

The approval is supported by data from the phase 3 CheckMate-67T trial.

FDA approves subcutaneous nivolumab for solid tumors, including RCC

Advancements in genetic testing have opened new doors in the diagnosis and management of prostate cancer.

A key focus of the 2023 Canadian Urological Association (CUA) guideline on genetic testing in prostate cancer is the role of germline genetic testing. This testing offers critical insights into hereditary cancer risk, helping to identify individuals who may benefit from enhanced surveillance, risk-reducing strategies, or tailored therapies.

The updated guideline provides a comprehensive framework for determining who should undergo germline testing, which genes should be analyzed, and how results can influence clinical decision-making. 

In this quiz, the first in a series of 3 based on the guideline, we explore the recommendations for germline genetic testing in prostate cancer management, offering an opportunity to test your understanding of this essential topic!

Editor’s note: This quiz was composed with the aid of artificial intelligence tools

1. Rendon RA, Selvarajah S, Wyatt AW, et al. 2023 Canadian Urological Association guideline: Genetic testing in prostate cancer. 

2023;17(10):314–325. doi:10.5489/cuaj.8588
 

The 2023 Canadian Urological Association guideline emphasizes the importance of germline genetic testing in prostate cancer management. This testing provides valuable insights into hereditary cancer risks, aiding in identifying individuals who may benefit from enhanced surveillance, risk-reducing strategies, or personalized therapies. The guideline offers a detailed framework for determining candidates for germline testing, specifying which genes to analyze, and how the results can guide clinical decisions. This approach aims to optimize patient outcomes through tailored management strategies based on genetic insights.

Test your knowledge of this quiz on the Canadian Urological Association's recommendations for germline genetic testing in prostate cancer management.

Quiz: CUA guidelines on germline genetic testing in prostate cancer

In the era of precision medicine, genomic profiling of tumors has become a cornerstone of advanced cancer care.

The 2023 CUA guideline, titled “2023 Canadian Urological Association guideline: Genetic testing in prostate cancer”, highlights the importance of genomic profiling in prostate cancer, emphasizing its role in informing treatment decisions and prognosis. According to the document, which cites 90 reference documents, by analyzing tumor-specific alterations, genomic profiling allows clinicians to tailor therapies to the unique molecular characteristics of a patient’s disease.

This quiz, our second in a series of 3 on the guideline, will focus on the CUA’s guidance on the use of genomic profiling in prostate cancer, including indications, recommended methodologies, and interpretation of findings. Join us to evaluate your grasp of this pivotal tool in modern oncology!

 2023;17(10):314–325. doi:10.5489/cuaj.8588

Test your knowledge of this quiz on the Canadian Urological Association's recommendations for genomic profiling of tumors in prostate cancer.

Quiz: What CUA guidelines say about genomic profiling of tumors in prostate cancer

Jeremie Calais, MD, PhD, highlights the key components of the report, “Standardized template for clinical reporting of PSMA PET/CT scans.” 

Jeremie Calais, MD, highlights key elements of PSMA-PET reporting template

, highlights the key components of the report, “Standardized template for clinical reporting of PSMA PET/CT scans.” Calais is a nuclear medicine physician at the University of California, Los Angeles.

It's a table, basically, with boxes. It encompasses and contains the miTNM, PROMISE, PRIMARY, RECIP, PSMA-RADS, and E-PSMA concept and criteria all together. On this you have the relevant prostate cancer history, the indication for the scan, primary staging, BCR, PSMA expression assessment before PSMA targeted therapy, some technical parameters that are important, date of scan, the comparison to prior scans, the treatments the patient is on at the time of the scan, [and] how the CT was made. Then some measurement in the salivary glands, in the liver for tumor to background ratio assessments. Then you go by TNM staging. So, you start from the prostate. Both sides, we divided by left, right, apex, midline-based, anterior, posterior. You can check boxes wherever you see uptake or you find suspicious uptake. Number of lesions, seminal vesicles, then the pelvic lymph nodes, extra pelvic lymph nodes, bone metastasis, 1- 2- 3- oligo vs poly, visceral metastasis, the presence or absence of PSMA-negative lesion noted on CT. All that are all summarized into a table that I personally find quite nice to use. These are the main parameters that you can find in these templates.

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

“It encompasses and contains the miTNM, PROMISE, PRIMARY, RECIP, PSMA-RADS, and E-PSMA concept and criteria all together,” says Jeremie Calais, MD, PhD. 

Jeremie Calais, MD, PhD

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