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"The updated results from CLEAR trial confirming that the amount of tumor shrinkage correlates with prognosis through overall survival, PFS, as well as through IMDC prognostic scoring should add further weight to lenvatinib and pembrolizumab being a go-to standard of care in this setting," says Thomas E. Hutson, DO, PharmD.

CLEAR trial analyses reaffirm benefit of lenvatinib/pembrolizumab in aRCC

 is compliance officer and medical director of coding and reimbursement, United Urology Group and Chesapeake Urology, in Towson, Maryland.

"With the requirements for an E/M code as noted above, we agree with you that the supporting documentation, if appropriately documented, would support a level 3 outpatient visit for a visit regarding counseling for contraception or family planning," write Jonathan Rubenstein, MD, and Mark Painter.

Level of service for vasectomy prompts coding confusion

The designation is supported by preliminary data from the ongoing phase 1/2a SECuRE trial. 

FDA grants fast track designation to 67Cu-SAR-bisPSMA for mCRPC

According to ImmunityBio, shipments of rBCG are set to begin immediately via the EAP. 

FDA approves expanded access program to provide alternative source of BCG

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“Although the future of AI within science is uncertain, disclosure of the use of AI is an excellent first step to balance academic integrity with disruptive innovation,” the authors write. 

Artificial intelligence is the new ghost author in urological research

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

Findings from WOLVERINE, a global meta-analysis of several randomized trials, suggest that metastasis-directed therapy (MDT) confers benefits in several survival-related outcomes in oligometastatic prostate cancer.

“Although there exists more prospective randomized data for oligometastatic prostate cancer, the data investigating metastasis-directed therapy is limited to generally several smaller phase 2 trials. Much has been hypothesized regarding patient subgroups who do or do not benefit from metastasis-directed therapy, but these analyses are limited. Finally, the current phase 2 randomized trials that do exist have spanned several eras in metastatic prostate cancer imaging and treatment. Thus, we sought to pool the existing data in the X-MET collaboration, which is meant to amalgamate all randomized investigating oligometastatic solid tumors,” explained Chad Tang, MD, BS, MS, associate professor of radiation oncology at the University of Texas MD Anderson Cancer Center in Houston, at the 2025 American Society of Clinical Oncology Genitourinary Cancers Symposium in San Francisco, California.

Tang and his colleagues identified all published trials that randomly assigned patients with oligometastatic prostate cancer (fewer than 5 metastases) to MDT and standard of care (SOC) vs SOC alone. Individual patient data were pooled, with progression-free survival (PFS), radiographic PFS (rPFS), castration-resistance free survival (CRFS), and overall survival (OS) harmonized across studies. The investigators conducted 2 parallel analyses: a meta-analysis using common and random effect models to calculate pooled HRs and a Cox regression that incorporated individual patients who were stratified by trial enrollment.

Contributing studies included ARTO (NCT03449719), STOMP (NCT01558427), COMET (NCT01446744), EXTEND (intermittent and continuous cohorts, NCT03599765), and ORIOLE (NCT02680587). A total of 472 patients with oligometastatic prostate cancer were included. Median follow-up was 41 months. Patients were randomly assigned to MDT plus SOC (n = 248) or SOC alone (n = 224). A total of 125 (50%) patients in the MDT plus SOC group received a second-generation androgen receptor pathway inhibitor compared with 134 (60%) patients in the SOC alone group. Fifty-two (21%) patients in the MDT plus SOC group received androgen deprivation therapy alone compared with 40 (18%) in the SOC alone group. Median number of metastases was 2 for each group.

Regarding PFS, in the trial-level analysis, the HR was 0.44 (95% CI, 0.35-0.57; 

< .0001). Median PFS was 35 months in the MDT plus SOC group vs 21 months in the SOC alone group. In the Cox regression analysis, the HR was 0.45 (95% CI, 0.35-0.58; 

< .0001). For rPFS, the HR for trial-level analysis was 0.60 (95% CI, 0.43-0.85; 

= .0039), the HR for the Cox regression analysis was 0.59 (95% CI, 0.46-0.76; 

< .0001). For CRFS, the HR for the trial-level analysis was 0.58 (95% CI, 0.37-0.92; 

= .019), and the HR for the Cox regression analysis was 0.58 (95% CI, 0.37-0.91; 

= .020). Median CRFS was 72 months in the MDT plus SOC group vs 63 months in the SOC alone group. For OS, the HR for the trial-level analysis was 0.63 (95% CI, 0.39-1.004; 

= .051), and the HR for the Cox regression analysis was 0.64 (95% CI, 0.40-1.01; 

= .057). The 48-month OS was 87% in the MDT plus SOC group vs 75% in the group receiving SOC alone.

“In summary, across the different end points, the pooled analysis of all published trials randomizing oligometastatic prostate cancer to MDT vs not in addition to standard of care systemic therapy or observation reveal an improvement in [PFS] and later end points…MDT benefit was maintained across subgroups, including patients who had do novo presentations and thus untreated primaries, independent of the different staging modalities used across studies, independent of castration-sensitive and resistant status, and independent of whether the patient was treated with or without ADT,” Tang said.

1. Tang C, Sherry AD, Hwang H, et al. World-wide oligometastatic prostate cancer (omPC) meta-analysis leveraging individual patient data (IPD) from randomized trials (WOLVERINE): an analysis from the X-MET collaboration. 

 2025;43(suppl 5). Abstract 15. doi:10.1200/JCO.2025.43.5_suppl.15

A global meta-analysis, WOLVERINE, evaluated the impact of metastasis-directed therapy (MDT) on oligometastatic prostate cancer, revealing significant benefits in survival outcomes. The study pooled data from several randomized trials, comparing MDT plus standard of care (SOC) to SOC alone. Results showed improved progression-free survival (PFS), radiographic PFS, and castration-resistance free survival (CRFS) with MDT. The analysis included 472 patients, with a median follow-up of 41 months. The findings suggest MDT's efficacy across various patient subgroups, regardless of staging modalities or androgen deprivation therapy (ADT) use.

Median PFS was 35 months in the MDT plus SOC group vs 21 months in the SOC alone group. 

WOLVERINE findings highlight benefits of MDT in oligometastatic prostate cancer

The FDA has authorized an expanded access program (EAP) to provide an alternative source of BCG, recombinant BCG (rBCG), to patients across the US, ImmunityBio announced in a news release.

According to the company, the hope is that this program will help to address the ongoing shortage of TICE BCG in the US. The shortage, which ramped up in 2019, has posed challenges for the treatment of patients with non–muscle invasive bladder cancer (NMIBC), for which BCG has been the standard of care since 1977. In the release, ImmunityBio cited a recent survey of 100 urologists, of which 57% reported they were unable to treat patients in the previous 12 months due to a lack of access to TICE BCG.

There is currently only one manufacturer of TICE BCG in the US. For this EAP, ImmunityBio has partnered with the Serum Institute of India, which develops rBCG, to provide an alternative source across the country. According to the news release, these shipments are set to begin immediately.

“With the increasing threat of supply shortages of essential medicines, the biopharmaceutical industry must innovate and secure new means of ensuring uninterrupted access to vital therapeutics,” said Patrick Soon-Shiong, MD, founder, executive chairman, and global chief scientific and medical officer of ImmunityBio, in the news release.

 “Our collaboration with the FDA and Serum Institute to ensure a reliable supply of this vital drug for bladder cancer patients underscores ImmunityBio’s commitment to addressing critical access issues that affect so many patients.”

Following the FDA's approval of nogapendekin alfa inbakicept-pmln (Anktiva) in April 2024, ImmunityBio announced the collaboration with the Serum Institute of India to supply the company with standard BCG, as well as rBCG, to be used in combination with Anktiva in its approved indication.

 The supply of BCG through this partnership is now available through the EAP across the US.

The rBCG vaccine (VPM1002BC) has been evaluated in phase 1/2 clinical trials in Europe as an immunotherapy in patients with NMIBC.

 According to ImmunityBio, rBCG has 2 gene modifications that enable improved immunogenicity and safety vs other formulations of BCG. In clinical trials, the rBCG vaccine has already shown favorable safety and tolerability as well as enhanced immunogenicity in driving CD8+ and CD4 T cells compared with earlier strains of BCG, the company reported.

Specifically, the phase 1/2 trial of the therapy, conducted in patients with NMIBC who had failed conventional BCG, showed that 49.3% (95% CI, 32.1-64.4%) of patients treated with VPM1002BC remained recurrence-free at 1 year following treatment.

At 2- and 3-year follow-up, the recurrence-free rates were 47.4% (95% CI, 30.4-62.6%) and 43.7% (95% CI 26.9-59.4%), respectively.  

The therapy was also found to be safe and generally well tolerated. Grade 1, 2, and 3 treatment-related adverse events occurred in 14.3%, 54.8%, and 4.8% of patients, respectively. No grade 4 adverse events were reported. In total, 2 of 42 patients were not able to complete 5 or more instillations during the induction period.

Data on rBCG is also available from studies assessing it as a tuberculosis (TB) vaccine. These studies include 2 trials in healthy adult participants, 1 in healthy newborn infants, and a trial in HIV-unexposed and HIV-exposed, BCG-naive newborn infants. Studies have also been conducted to assess “the effect of rBCG vaccination on TB recurrence and on the susceptibility or severity of respiratory diseases during the severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2) pandemic,” ImmunityBio noted.

1. FDA authorizes ImmunityBio to provide recombinant BCG (rBCG) to urologists to address TICE BCG shortage. News release. ImmunityBio. February 19, 2025. Accessed February 19, 2025. https://ir.immunitybio.com/news-releases/news-release-details/fda-authorizes-immunitybio-provide-recombinant-bcg-rbcg

2. ImmunityBio, Serum Institute of India agree on an exclusive arrangement for global supply of Bacillus Calmette-Guerin (BCG) across all cancer types. News release. ImmunityBio. May 2, 2024. Accessed February 19, 2025. https://ir.immunitybio.com/news-releases/news-release-details/immunitybio-serum-institute-india-agree-exclusive-arrangement

3. Rentsch CA, Bosshard P, Mayor G, et al. Results of the phase I open label clinical trial SAKK 06/14 assessing safety of intravesical instillation of VPM1002BC, a recombinant mycobacterium Bacillus Calmette Guérin (BCG), in patients with non-muscle invasive bladder cancer and previous failure of conventional BCG therapy. 

. 2020;9(1):1748981. doi:10.1080/2162402X.2020.1748981

4. Rentsch CA, Thalmann GN, Lucca I, et al. A phase 1/2 single-arm clinical trial of recombinant Bacillus Calmette-Guérin (BCG) VPM1002BC immunotherapy in non-muscle-invasive bladder cancer recurrence after conventional BCG therapy: SAKK 06/14. 

. 2022;5(2):195-202. doi:10.1016/j.euo.2021.12.006

The FDA has approved ImmunityBio's Expanded Access Program to provide recombinant BCG (rBCG) as an alternative to TICE BCG, addressing the US shortage impacting non–muscle invasive bladder cancer (NMIBC) treatment. ImmunityBio collaborates with the Serum Institute of India to distribute rBCG, which has shown improved immunogenicity and safety in clinical trials. The partnership also supports the use of rBCG with Anktiva, following its FDA approval. Ongoing trials continue to evaluate rBCG's efficacy in bladder cancer and other conditions, including tuberculosis.

Treatment Strategies to Tackle NMIBC Heterogeneity

Panelists examine disease heterogeneity in NMIBC and discuss a balanced treatment approach that prioritizes patient quality of life and surgery effectiveness.

Episode 3 Video: Treatment Strategies to Tackle NMIBC Heterogeneity

The first reporting of real-world data for nadofaragene firadenovec-vncg (Adstiladrin) indicate that the non–muscle invasive bladder cancer (NMIBC) treatment yields positive efficacy and safety outcomes, investigators reported at the 2025 

American Society of Clinical Oncology Genitourinary Cancers Symposium

Nadofaragene firadenovec was FDA approved in 2022 for the treatment of patients with high-risk BCG-unresponsive NMIBC with carcinoma in situ (CIS) with or without papillary tumors.

“However, real-world post-marketing efficacy or safety data remain lacking,” wrote the authors in their abstract.

For their study, the investigators conducted a retrospective analysis of patients with BCG-unresponsive NMIBC who received treatment with nadofaragene firadenovec at 3 Mayo Clinic sites between November 2023 and December 2024. Complete response (CR) rate, duration of response (DOR), high-grade recurrence-free survival (HGRFS), cystectomy-free survival (CFS), and adverse events (AEs) comprised the study outcomes.  

A total of 46 patients received treatment with nadofaragene firadenovec during the study; 3 of these patients had not yet undergone follow-up cystoscopy. “Thus 43 patients were efficacy-evaluable, [whereas] 46 were evaluable for safety/AEs,” the authors wrote in their poster.

In the 43 efficacy-evaluable patients, the median age was 71.0 years (interquartile range [IQR], 67.0-77.5 years), median Elixhauser Comorbidity index was 5 (IQR, 3-6), and median number of prior BCG instillations was 12 (IQR, 9-15). Of the patients, 63% had received prior intravesical chemotherapy, and 26% had received prior pembrolizumab. Median time to NMIBC diagnosis to nadofaragene firadenovec instillation was 33.0 months (IQR, 17.5-56.0 months).

The investigators reported that there were 24 evaluable patients with CIS with/without papillary disease, of whom 79% had a CR at 3 months. The median DOR was not reached. In addition, at a median follow-up of 7.3 months, 16 of 19 patients (84%) still had CRs. The Kaplan-Meier-estimated DOR at 6 months was 100% and at 9 months was 75%.

Thirteen of 19 (68%) patients with papillary disease were recurrence free at 3 months. Ten of 13 (77%) patients remained recurrence free at a median follow-up of 8.9 months, the investigators reported. CFS was 95% at an overall median follow-up of 8.2 months, and OS was 100% at the same follow-up.

Three patients experienced progression: 1 progressed from Ta to T1, 1 progressed from CIS to T2, and 1 progressed from Ta to metastatic.

The investigators reported that the most common AEs included grade 1-2 bladder spasms (61%) and failure to retain nadofaragene firadenovec for a full hour (33%). A total of 4 patients experienced a grade 3 AE. No grade 4-5 AEs were reported, and no patients discontinued nadofaragene firadenovec treatment due to AEs.

In the 43 efficacy-evaluable patients, 79% (95% CI, 68-92), 66% (95% CI, 53-82), and 51% (95% CI, 36-72) were free from high-grade recurrence at month 3, 6, and 9, respectively.

“Understanding real-world outcomes in patients with BCG-unresponsive NMIBC is essential for informing how we approach treatment and deliver care. These initial encouraging post-marketing results provide valuable insights into the benefits of using Adstiladrin in everyday clinical practice, allowing providers to make more informed decisions and deliver the best possible care for patients,” said study principal investigator Mark D. Tyson II, MD, MPH, urologic oncologist and associate professor, Mayo Clinic, Scottsdale, Arizona, in a news release about the study.

1. Moyer JA, Durant A, Nguyen M, et al. Real-world outcomes of nadofaragene firadenovec in BCG-unresponsive non-muscle invasive bladder cancer. 

 2025;43(suppl 5). Abstract 70. doi:10.1200/JCO.2025.43.5_suppl.716

2. First real-world outcomes data for Adstiladrin (nadofaragene firadenovec-vncg) to be presented at 2025 ASCO Genitourinary Cancers Symposium. News release. Ferring Pharmaceuticals. February 12, 2025. Accessed February 14, 2025. https://www.businesswire.com/news/home/20250211294420/en/First-Real-World-Outcomes-Data-for-ADSTILADRIN%C2%AE-nadofaragene-firadenovec-vncg-to-be-Presented-at-2025-ASCO-Genitourinary-Cancers-Symposium

Real-world data for nadofaragene firadenovec (Adstiladrin) in treating BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) show promising efficacy and safety outcomes. Conducted at three Mayo Clinic sites, the study involved 46 patients, with 43 being efficacy-evaluable. Results indicated a high complete response rate, with 79% of patients with carcinoma in situ achieving complete response at three months. The treatment demonstrated a favorable safety profile, with no grade 4-5 adverse events reported. These findings provide valuable insights for clinical practice in managing NMIBC.

The investigators reported that there were 24 evaluable patients with CIS with/without papillary disease, of whom 79% had a CR at 3 months.  

Tyler Bergeron, BS

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