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"The findings from this study will help us understand sunobinop’s potential as a possible new treatment option for this chronic disorder,” said Craig Landau, MD.

Study progresses of sunobinop for interstitial cystitis/bladder pain syndrome

The goal of the trial is to improve quality of life by identifying patients who can safely reduce or avoid treatment with hormone therapy.

Phase 3 trial launches of ArteraAI Prostate test for treatment selection 

"Considering that almost all patients in the combined treatment group achieved testosterone recovery at 1 year, the results support that this short term (intermittent) combined approach is an optimal option in selected patients with metachronous oligorecurrent hormone-sensitive prostate cancer," the authors wrote. 

Adding ADT to SBRT improves progression-free survival in oligorecurrent HSPC

“Five years after telehealth suddenly became a routine part of care for most Americans, we show that it has not led to runaway utilization or spending. This kind of in-depth analysis can inform its future," says Chad Ellimoottil, MD, MS. 

Data refute concerns about telehealth as Congress weighs legislation 

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University Hospitals Urology Institute is excited to announce that this coming fall, the department is hosting 2 educational courses in cutting-edge urologic specialties: female sexual health and gender care.

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The device helps reduce unintentional side effects of prostate cancer therapy.

University Hospitals Cleveland Medical Center named first SpaceOAR Hydrogel Center of Excellence

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

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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

Use of the prostate-specific membrane antigen (PSMA) agent piflufolastat F 18 (

F-DCFPyL PET/CT, Pylarify) in patients with biochemically recurrent prostate cancer was associated with a high detection rate in patients with low prostate-specific antigen (PSA) levels, according to data presented at the 2025 American Society of Clinical Oncology Genitourinary Cancers Symposium in San Francisco, California.

In outlining the background for the study, the authors, led by Ida Sonni, MD, of the University of California, Los Angeles, explained that PSMA PET imaging has shown high sensitivity and specificity in the biochemically recurrent setting and “There is growing interest in using PSMA PET/CT for detecting and localizing [biochemical recurrence] in patients with low PSA levels (<0.5 ng/mL).” They also noted the paucity of literature regarding detection rates of PSMA PET radiotracers in the biochemical recurrent setting. To this end, the investigators sought to evaluate detection rates of 

F-DCFPyL in patients with biochemically recurrent prostate cancer who showed “minimally detectable serum PSA levels.”

The investigators conducted a pooled retrospective analysis of patients drawn from investigator-initiated trials at West Los Angeles Veterans Affairs and the phase 3 CONDOR trial (NCT03739684) who had serum PSA levels of 0.5 ng/mL or lower. For the analysis, patients with rising PSA levels following definitive treatment for their prostate cancer underwent 

F-DCFPyL PET/CT and were placed in 1 of 2 groups: low PSA (0.2 ng/mL- ≤0.5 ng/mL) or ultralow PSA (0 ng/mL-<0.2 ng/mL). The automated deep learning-enabled Prostate Cancer Molecular Imaging Standardized Evaluation platform was used to aid in 

F-DCFPyL PET/CT reads. The investigators defined detection rate as “the number of patients with positive PSMA lesions relative to total number of patients.”

The investigators included 129 patients in the study; 93 were in the low-PSA group, and 36 were in the ultralow PSA group. Total detection rate was 36% (13/36) in the ultralow PSA group and 51% (47/93) in the low-PSA group. Findings in the prostate bed were identified in 8% (3 patients) of the ultralow PSA group and 4% (4 patients) of the low-PSA group. Lymph node-only findings were identified in 14% (5 patients) of the ultralow PSA group and 31% (29 patients) of the low-PSA group. Lymph node and bone findings were identified in 33% (12 patients) of the ultralow PSA group and 42% (39 patients) of the low-PSA group. Bone-only findings were identified in 22% (8 patients) of the ultralow PSA group and 15% (14 patients) of the low-PSA group. Visceral (lung or liver) findings were identified in 3% (1 patient) in the ultralow PSA group and 11% (10 patients) in the low-PSA group. Total mean standard uptake value was 3.8 in the ultralow PSA group and 4.2 in the low-PSA group. Total maximum standard update value was 10.9 in the ultralow PSA group and 12.4 in the low-PSA group. Mean total disease volume was 4.9 mL in the ultralow PSA group and 1.9 mL in the low-PSA group.

F-DCFPyL PET/CT demonstrates a significant detection rate for recurrent prostate cancer in patients with minimally detectable PSA levels. Our findings highlight the potential of 

F-DCFPyL PET/CT in the early identification of metastatic disease. Current thresholds for initiating PSMA PET/CT in patients with [biochemical recurrence] may need reconsideration,” the authors wrote in their conclusion.

1. Sonni I, Nickols NG, Niknam K, et al. Early detection of recurrent prostate cancer using 18F-DCFPyL PET/CT PET/CT in patients with minimal PSA levels.

 2025;43(suppl 5). Abstract 344. doi:10.1200/JCO.2025.43.5_suppl.344

The use of the PSMA agent piflufolastat F 18 (18F-DCFPyL PET/CT) in patients with biochemically recurrent prostate cancer shows a high detection rate, even at low PSA levels. A study presented at the 2025 ASCO Genitourinary Cancers Symposium analyzed 129 patients with PSA levels ≤0.5 ng/mL. Detection rates were 36% in the ultra-low PSA group and 51% in the low-PSA group. The findings suggest that 18F-DCFPyL PET/CT could be valuable for early identification of metastatic disease, potentially prompting a reevaluation of current PSMA PET/CT initiation thresholds.

Total detection rate was 36% (13/36) in the ultralow PSA group and 51% (47/93) in the low-PSA group. 

Piflufolastat F18 yields high detection rate even at low PSA levels for prostate cancer

Preliminary findings from the PYLARIFY registry (NCT05712473) highlight the real-world clinical utility of piflufolastat F18 and the impact of scans on a clinician’s treatment management decisions.

Piflufolastat F18 was approved by the FDA in May 2021 for PET imaging of prostate-specific membrane antigen (PSMA)-positive lesions in men with prostate cancer.

Data from the registry, which is collecting findings on the real-world clinical utility of the agent, were presented at the 

2025 American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium

The results encompassed the first 100 patients enrolled in the study. Of these, 40 patients had newly diagnosed prostate cancer and had not yet received any treatment (cohort 1), and 60 patients were undergoing scans for biochemical recurrence (cohort 2). The median age of participants was 70.7 years and 71.3 years, respectively.

In total, 10% of patients in cohort 1 and 77% of patients in cohort 2 received at least 1 conventional imaging procedure prior to piflufolastat F18. The average number of conventional imaging procedures per patient was 1 and 1.58 in each cohort, respectively. The most common conventional imaging modalities used prior to piflufolastat F18 across both cohorts were CT (80%), skeletal scintigraphy (72%), and PET (26%).

In cohort 1, those who underwent both piflufolastat F18 and conventional imaging had an added 28 days to the length of their diagnostic journey compared with those who only underwent piflufolastat F18.

Data also showed the impact of piflufolastat F18 imaging on management plans. In cohort 1, piflufolastat F18 scans led to treatment escalation in 30% of patients, treatment de-escalation in 15% of patients, and no change in 55% of patients. In cohort 2, piflufolastat F18 scans led to treatment escalation in 57% of patients, treatment de-escalation in 17% of patients, and no change in 27% of patients.

Overall, 96% of clinicians strongly agreed (53%) or agreed (43%) that piflufolastat F18 improved their confidence in their treatment decision-making. The remaining respondents neither agreed nor disagreed with the statement.

In total, the multicenter, prospective, observational PYLARIFY registry plans to enroll up to 500 patients in the US across both cohorts.

 To be eligible for enrollment, patients need to be at least 21 years of age and eligible for a PSMA/PET scan. Participants must also have histopathological-confirmed prostate adenocarcinoma and a life expectancy of at least 6 months. Follow-up for each patient will occur for up to 5 years.

Among the first 100 patients enrolled in the study, 35% in cohort 1 and 26% in cohort 2 were Gleason grade 8 or higher at the time of diagnosis. Additionally, 90% of patients in cohort 1 and 74% of patients in cohort 2 were classified as being in the intermediate-to-high Gleason group at diagnosis. At diagnosis, 98% of patients in cohort 1 and 95% of patients in cohort 2 presented with non-metastatic hormone-sensitive prostate cancer.

Overall, 38% of patients in cohort 1 and 32% in cohort 2 were current or former smokers.

Data collection in the registry remains ongoing, with final completion expected in June 2029.

1. Shore ND, O’Donnell L, Wilson B, Dave SS, Kashyap A, Lazarou N. The role of conventional imaging and piflufolastat F18 in newly diagnosed and recurrent prostate cancer patients: preliminary observations from the PYLARIFY registry. 

. 2025;43(suppl 5). Abstract 41. doi:10.1200/JCO.2025.43.5_suppl.41

2. An observational registry assessing the impact of PYLARIFY (piflufolastat F18) PET in patients with prostate cancer. ClinicalTrials.gov. Updated February 3, 2023. Accessed February 20, 2025. https://clinicaltrials.gov/study/NCT05712473

Preliminary findings from the PYLARIFY Registry underscore the clinical utility of piflufolastat F18 in prostate cancer management. The study, involving 100 patients, revealed that piflufolastat F18 scans significantly influenced treatment decisions, with notable treatment escalations and de-escalations in both newly diagnosed and recurrent cases. Clinicians reported increased confidence in treatment planning due to these scans. The registry aims to enroll 500 patients, with ongoing data collection until 2029. The study highlights the potential of piflufolastat F18 to refine diagnostic and therapeutic strategies in prostate cancer care.

The results encompassed the first 100 patients enrolled in the registry.

Real-world data show impact of piflufolastat F18 on prostate cancer management 

Dose-dense MVAC plus nivolumab (Opdivo) yielded an 84% metastases-free rate in an intent-to-treat (ITT) cohort of patients with muscle-invasive bladder cancer, according to interim data from the RETAIN-2 trial.

American Society of Clinical Oncology Genitourinary Cancers Symposium

 in San Francisco, California, by Pooja Ghatalia, MD, an associate professor of hematology/oncology at Fox Chase Cancer Center/Temple Health in Philadelphia, Pennsylvania.

Patients were included in the study if they had clinical T2-T3 N0 disease, predominant urothelial carcinoma of the bladder, and ECOG performance status 0 or 1. Study participants received 3 cycles of neoadjuvant dose-dense MVAC plus nivolumab.

“While getting neoadjuvant treatment, their pretreatment tissue was sequenced to assess for alterations in previously validated biomarkers signatures that have correlated with chemotherapy response,” Ghatalia said in her presentation.

Following the completion of neoadjuvant treatment, the investigators conducted clinical restaging using cystoscopy biopsies, urine cytology, and CT imaging. Active surveillance was offered to patients who had clinical T0 disease and at least 1 genetic mutation. Intervention (intravesical therapy, chemotherapy/radiation therapy, or cystectomy) was recommended to patients who had residual disease of lacked mutations.

“The primary end point of this trial is 2-year metastasis-free survival [MFS], which has not yet been reached,” Ghatalia said.

Of a total of 80 patients who received patients, 9 were not evaluable. Median age was 69 years (range, 68-86 years). Fifty-five (77%) patients were men, and 16 (23%) patients were women. ECOG performance status was 0 in 57 (80%) patients and 1 in 14 (20%) patients. Histology was pure urothelial carcinoma in 48 (68%) patients and urothelial and carcinoma/variant histology in 23 (32%) patients. Forty-one (58%) patients had cT2 disease, and 30 (42%) patients had cT3 disease. Thirty-one (44%) patients were mutation-positive, and 40 (56.3%) were mutation-negative.

Of the ITT population of 71 patients, 47 were assigned to intervention and 23 were assigned to active surveillance. Crossover occurred with 3 patients assigned to intervention who chose active surveillance, and 4 patients assigned to active surveillance who elected to undergo cystectomy. This resulted in 48 patients undergoing intervention and 22 patients undergoing active surveillance.

Ghatalia reported a 19% incidence of grades 3 and 4 treatment-related adverse events, along with 2 deaths following 3 cycles of dose-dense MVAC/nivolumab, one related to multiorgan failure and the other to acute kidney injury.

“There was 1 death in a patient receiving chemoradiation, likely due to pneumonitis,” Ghatalia reported.

Out of the 45 patients in the intervention group, 35 underwent cystectomy, 3 received BCG, and 10 underwent chemotherapy/radiation therapy. A total of 7 patients developed metastases. The ypT0 rate was 40% in the patients undergoing cystectomy.

For the 19 patients who ultimately accepted active surveillance, 2 patients required delayed cystectomy, and 1 patient required delayed chemotherapy/radiation therapy. Three patients developed metastases. For 3 patients, intervention was recommended but the patients opted for active surveillance. Two of these patients underwent delayed cystectomy, and 1 patient developed metastases.

“Among active surveillance patients, 82% are metastases-free, and 60% were metastases-free and had an intact, unradiated bladder,” Ghatalia said.

Median follow-up was 21.7 months (25th-75th percentile, 13.6-30.3 months). In the ITT population, interim 2-year MFS was 77.4%, and interim 2-year overall survival was 93%.

“In conclusion, at the time of interim analysis, dose-dense and MVAC and nivolumab was associated with a metastases-free rate of 84.2% in [the] ITT [population] and 82% in the active surveillance arm…Compared to RETAIN-1, the ypT0 rate was higher at 40%, and so was the rate of ypT0 plus clinical CR of 54%, suggesting [an] additive benefit of adding nivolumab to dose-dense MVAC,” Ghatalia said.

1. Ghatalia P, Ross EA, Zibelman MR, et al. A phase 2 trial of risk enabled therapy after neoadjuvant chemo-immunotherapy for muscle-invasive bladder cancer (RETAIN-2). 

 2025;43(suppl 5). Abstract 815. doi:10.1200/JCO.2025.43.5_suppl.815

Interim data from the RETAIN-2 trial demonstrated an 84% metastases-free rate in patients with muscle-invasive bladder cancer treated with dose-dense MVAC plus nivolumab. The study included patients with clinical T2-T3 N0 disease and ECOG Performance Status 0-1. Following neoadjuvant treatment, patients were either placed under active surveillance or received further intervention based on clinical restaging and genetic mutations. The trial reported a 19% incidence of grade 3-4 treatment-related adverse events. Interim 2-year metastasis-free survival was 77.4%, and overall survival was 93%.

“Among active surveillance patients, 82% are metastases-free, and 60% were metastases-free and had an intact, unradiated bladder,” said Pooja Ghatalia, MD.

RETAIN-2 interim data promising for dose-dense MVAC plus nivolumab in MIBC

Cu-SAR-bisPSMA was effective in detecting prostate cancer lesions in patients with biochemical recurrence and negative or equivocal standard of care (SOC) imaging, according to findings from the phase 1/2 COBRA trial (NCT05249127).

In total, the COBRA study enrolled 52 patients, of whom 50 had evaluable PET imaging results. 

Cu-SAR-bisPSMA was delivered at 200 MBq, and PET/CT imaging was performed on day 0 (1-4 hours post-dose) and day 1 (24±6 hours post-dose). Scans were compared against a reference standard.

Cu-SAR-bisPSMA detected lesions in up to 80% of patients. According to the authors, “Histopathology confirmed the presence of [prostate cancer] in lesions identified by 

Cu-SAR-bisPSMA in up to 78% of cases in which biopsies were performed.”

The detection rate across all 3 readers ranged from 44% to 58% (95% CI, 30%-71.8%) on day 0 and increased to 58% to 80% (95% CI, 43.2%-90%) on day 1.

The correct detection rate (CDR; proportion of true positive patients out of all patients who had at least 1 reference standard datapoint) also increased on next-day imaging, ranging from 19% to 26.2% (95% CI, 8.6%-42.0%) on day 0 and 26.2% to 33.3% (95% CI, 13.9%-49.5%) on day 1. When assessing the CDR against the gold standard of histopathology as the reference standard, the CDR was notably higher, ranging from 44.4% to 55.6% on day 0 and 55.6% to 77.8% on day 1 (n = 9).

According to the authors, “This highlights the limitations of using less sensitive methods (eg, current SOC imaging) to verify the 

Overall, the agent identified 53 to 80 lesions on day 0 vs 82 to 153 on day 1. The mean number of lesions per patient with a positive 

Cu-SAR-bisPSMA scan ranged from 2.4 to 2.8 on day 0 and 2.8 to 4.1 on day 1.

Cu-SAR-bisPSMA imaging led to a change in treatment plans in 48% (24 of 50) of patients.

Cu-SAR-bisPSMA was granted a fast track designation from the FDA in January 2025 for PET imaging of prostate-specific membrane antigen (PSMA)-positive lesions in patients with biochemical recurrence of prostate cancer following initial definitive therapy.

 The agent also has a fast track designation in patients with suspected metastasis of prostate cancer who are candidates for initial definitive therapy.

The agent is being further assessed in the ongoing phase 3 AMPLIFY trial.

The company announced plans to launch the AMPLIFY trial in October 2024.

 Overall, the nonrandomized, single-arm, open-label, multicenter trial will further evaluate the ability of 

Cu-SAR-bisPSMA PET/CT to detect prostate cancer lesions among patients with biochemical recurrence. Efficacy will be assessed on both same-day imaging (day 1, day of administration) and next-day imaging (day 2, approximately 24 hours post-administration).

The study plans to enroll approximately 220 patients who have rising or detectable prostate-specific antigen levels following initial definitive treatment for prostate cancer.

Clarity Pharmaceuticals noted in the news release, “As a pivotal trial, the final study results are intended to provide sufficient evidence to support an application to the FDA for approval of 

Cu-SAR-bisPSMA as a new diagnostic imaging agent in prostate cancer in patients with BCR.”

1. Nordquist L, Lengyelova E, Saltzstein D, et al. COBRA: Assessment of the efficacy of 

Cu-SAR-bisPSMA using histopathology as reference standard in patients with biochemical recurrence of prostate cancer following definitive therapy. 

. 2025;43 (suppl 5). Abstract 44. doi:10.1200/JCO.2025.43.5_suppl.44

2. Clarity receives U.S. FDA fast track designation for Cu-64 SAR-bisPSMA in biochemical recurrence of prostate cancer. News release. Clarity Pharmaceuticals. January 24, 2025. Accessed March 6, 2025. https://www.claritypharmaceuticals.com/news/ftd-2/

The investigational PET imaging agent 64Cu-SAR-bisPSMA demonstrated efficacy in detecting prostate cancer lesions in patients with biochemical recurrence, particularly when standard imaging was negative or equivocal. The COBRA trial showed that the agent identified lesions in up to 80% of patients, with histopathology confirming prostate cancer in 78% of biopsied cases. The detection rate improved on next-day imaging, influencing treatment plans in 48% of patients. The agent, granted fast track designation by the FDA, is undergoing further evaluation in the phase 3 AMPLIFY trial.

The detection rate ranged from 44% to 58% on day 0 and 58% to 80% on day 1.

University Hospitals

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