- |||||||||| Adstiladrin (nadofaragene firadenovec-vncg) / Ferring, Keytruda (pembrolizumab) / Merck (MSD)
Review, Journal, PD(L)-1 Biomarker, IO biomarker: Advancements in the Diagnosis, Treatment, and Risk Stratification of Non-Muscle Invasive Bladder Cancer. (Pubmed Central) - Mar 31, 2025
Future directions highlight the need for biomarker-driven models to refine treatment paradigms, reduce overtreatment, and improve long-term outcomes. Continued clinical trials are essential to validate these approaches and address unmet needs in NMIBC care.
- |||||||||| Adstiladrin (nadofaragene firadenovec-vncg) / Ferring
Review, Journal: Practical use of nadofaragene firadenovec-vncg for pharmacists. (Pubmed Central) - Feb 18, 2025
Pharmacists are positioned to be key contributors to the care team regarding the effective use of nadofaragene firadenovec. Further awareness and education will continue to optimize the clinical use of nadofaragene firadenovec in the high-risk BCG-unresponsive NMIBC setting.
- |||||||||| Adstiladrin (nadofaragene firadenovec-vncg) / Ferring, Keytruda (pembrolizumab) / Merck (MSD), Anktiva (nogapendekin alfa inbakicept-pmln) / ImmunityBio
Review, Journal, HEOR, Cost-effectiveness, Cost effectiveness: Unmet Need in Non-muscle-invasive Bladder Cancer Failing Bacillus Calmette-Gu (Pubmed Central) - Feb 12, 2025
In the rapidly evolving landscape of urothelial cancer, some of these treatment strategies might be cost effective and improve patients' quality of life. The findings of our review highlight the need for novel, more effective therapeutic strategies.
- |||||||||| Review, Journal: New Treatment Options for Non-Muscle-Invasive Bladder Cancer. (Pubmed Central) - Feb 11, 2025
Additionally, immune checkpoint inhibitors such as pembrolizumab and durvalumab have demonstrated potential for systemic treatments in BCG-unresponsive NMIBC and may show even more promise in combinations...For low-grade NMIBC, efforts are underway to de-escalate care through active surveillance and novel adjuvant therapies, reducing the need for repeated TURBT procedures. Together, these advancements highlight a promising shift toward personalized, bladder-preserving strategies that prioritize patient quality of life while addressing unmet needs in NMIBC management.
- |||||||||| Adstiladrin (nadofaragene firadenovec-vncg) / Ferring, cretostimogene grenadenorepvec (CG0070) / CG Oncology
Review, Journal: Integrating gene therapy into the treatment paradigm for non-muscle invasive bladder cancer. (Pubmed Central) - Feb 2, 2025
Significant differences in trial design limit comparability of agents across trials, highlighting the need for critical assessment of published findings. While initial investigations were in high-risk patients who recur despite frontline therapy with Bacillus Calmette-Guerin (BCG), there is growing interest in BCG-na
- |||||||||| Adstiladrin (nadofaragene firadenovec-vncg) / Ferring, Keytruda (pembrolizumab) / Merck (MSD), Anktiva (nogapendekin alfa inbakicept-pmln) / ImmunityBio
Review, Journal: Bladder-sparing Therapy for Bacillus Calmette-Gu (Pubmed Central) - Dec 12, 2024
Data are median (IQR) or % [95% CI]. The IBCG consensus recommendations provide practical guidance on BST for BCG-U NMIBC.
- |||||||||| Adstiladrin (nadofaragene firadenovec-vncg) / Ferring, Keytruda (pembrolizumab) / Merck (MSD)
Review, Journal: Bacillus Calmette-Gu (Pubmed Central) - Nov 18, 2024
The last years have been exciting regarding new developments in this field after a long period of stagnation. Unfortunately, data available on some alternative therapies are mainly limited mainly to Phase I or II studies with a lack of robust evidence, but a clear trend in future treatments has just been drawn.
- |||||||||| Adstiladrin (nadofaragene firadenovec-vncg) / Ferring
Enrollment closed: Safety and Efficacy of FE 999326 Administered Intravesically to Japanese Subjects With High-grade, BCG Unresponsive, Non-muscle Invasive Bladder Cancer (NMIBC) (clinicaltrials.gov) - Nov 15, 2024
P3, N=25, Active, not recruiting,
Unfortunately, data available on some alternative therapies are mainly limited mainly to Phase I or II studies with a lack of robust evidence, but a clear trend in future treatments has just been drawn. Recruiting --> Active, not recruiting
- |||||||||| Journal: Novel intravesical therapies and delivery systems for the management of bladder cancer. (Pubmed Central) - Oct 8, 2024
The armamentarium for the treatment of bladder cancer patients is expanding, notably with HIVEC, hydrogels, drug-RIS and novel therapies. However, accurate patients' selection is key to prevent disease progression in any bladder-sparing strategy, and radical cystectomy remains the gold-standard to date.
- |||||||||| Adstiladrin (nadofaragene firadenovec-vncg) / Ferring, Keytruda (pembrolizumab) / Merck (MSD), Anktiva (nogapendekin alfa inbakicept-pmln) / ImmunityBio
Review, Journal: Recent Advances in Drug Delivery Strategies for High-Risk BCG-Unresponsive Non-Muscle Invasive Bladder Cancer: A Brief Review from 2018 to 2024. (Pubmed Central) - Sep 29, 2024
This review focuses on high-risk BCG-unresponsive NMIBC therapies that have been or are currently being investigated in clinical trials, offering a broad overview of the delivery system designs and up-to-date clinical outcomes that have been reported as of July 2024. It aims to inform the development of future drug delivery systems for second-line therapies in high-risk BCG-unresponsive NMIBC.
- |||||||||| Adstiladrin (nadofaragene firadenovec-vncg) / Ferring, GemRIS (gemcitabine-releasing intravesical system) / J&J
P2 data, Journal: Radiotherapy Combined with a Radiosensitizer for Bacillus Calmette-Gu (Pubmed Central) - Sep 26, 2024
P2
The study will measure the proportion of patients remaining recurrence free at 6 mo and thereafter. It will also evaluate the safety of the treatment and its impact on quality of life.
- |||||||||| Adstiladrin (nadofaragene firadenovec-vncg) / Ferring
Review, Journal: Clinical use of nadofaragene firadenovec-vncg. (Pubmed Central) - Sep 24, 2024
Implementation of these recommendations will ensure efficient real-world use of nadofaragene firadenovec and the development of useful training materials and relevant standard operating procedures to help support a clinic's treatment for patients with BCG-unresponsive NMIBC with CIS. Video Abstract https://vimeo.com/user17898099/review/953723559/e18af7ec43.
- |||||||||| Adstiladrin (nadofaragene firadenovec-vncg) / Ferring
Review, Journal: The Evolution of Nadofaragene Firadenovec: A Review and the Path Forward. (Pubmed Central) - Aug 12, 2024
Nadofaragene leverages the cytotoxic, anti-angiogenic, and immune-modulatory roles of interferon to effectively treat NMIBC that is resistant to BCG. Ongoing studies of resistance mechanisms and prognostic biomarkers have been promising; these will ultimately improve patient selection and allow for the modulation of factors in the tumor or immune microenvironment to further increase therapeutic response.
- |||||||||| Adstiladrin (nadofaragene firadenovec-vncg) / Ferring
Enrollment open: ABLE-42: A Trial to Evaluate Efficacy of Reinduction With Nadofaragene Firadenovec in Subjects With CIS (clinicaltrials.gov) - Jul 24, 2024
P4, N=25, Recruiting,
Ongoing studies of resistance mechanisms and prognostic biomarkers have been promising; these will ultimately improve patient selection and allow for the modulation of factors in the tumor or immune microenvironment to further increase therapeutic response. Not yet recruiting --> Recruiting
- |||||||||| Anktiva (nogapendekin alfa inbakicept-pmln) / ImmunityBio
Journal: In brief: Anktiva for bladder cancer. (Pubmed Central) - Jun 21, 2024
No abstract available No abstract available
- |||||||||| Oncofid-P (paclitaxel-hyaluronic acid conjugate) / Fidia Farmaceutici
A PHASE III, SINGLE-ARM STUDY TO EVALUATE THE EFFICACYAND SAFETY OF PACLITAXEL-HYALURONIC ACID CONJUGATE ADMINISTERED INTRAVESICALLY TO PATIENTS WITH BCG-UNRESPONSIVE CARCINOMA IN SITU OF THE BLADDER WITH OR WITHOUT TA-T1 PAPILLARY DISEASE (ORION-BC STUDY) () - May 8, 2024 - Abstract #AUA2024AUA_4230;
P3
InJanuary 2020, the Food and Drug Administration (FDA) approvedpembrolizumab (Keytruda, Merck&Co) for the systemic treatment ofpatients with BCGeunresponsive, high-risk NMIBC with CIS, with orwithout papillary tumors, who are ineligible for or choose not to undergoRC...In 2022 intravesical Adstiladrin (Ferring), which acts bystimulating immune responses, was approved by the FDA based onefficacy on 50 subjects out of 107 enrolled [51% (95% CI: 41%, 61%)]who experienced a CR at the first disease assessment three monthsafter initial treatment...gemcitabine and docetaxel, Milbar 2017)...Up to 146 patients will be enrolled: up to now 9 patientswere enrolled and treated. The first DSMB meeting is scheduled end of January 2024.
- |||||||||| Adstiladrin (nadofaragene firadenovec-vncg) / Ferring
Cost effectiveness analysis of nadofaragene firadenovec for the treatment of high-risk, bacillus Calmette-Guerin (Hall A; Poster Bd #: 293) - Apr 24, 2024 - Abstract #ASCO2024ASCO_1763;
P2, P3
At 60 months, Nadofaragene firadenovec-vncg allowed bladder preservation in nearly half of the patients and proved to be a safe option for BCG-unresponsive NMIBC. The analysis suggests that nadofaragene firadenovec is cost-effective compared to pembrolizumab for the treatment of high-risk, BCG unresponsive NMIBC with CIS
- |||||||||| Review, Journal: Revolutionizing Treatment: Breakthrough Approaches for BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer. (Pubmed Central) - Apr 13, 2024
Other, less researched therapeutic possibilities are also included, namely: N-803 immunotherapy, TAR-200 and TAR-210 intravesical delivery systems and combined Cabazitaxel, Gemcitabine and Cisplatin chemotherapy. Conservative treatment and delaying radical cystectomy would greatly benefit patients' quality of life; it is undoubtedly the future of BCG-unresponsive NMIBC.
- |||||||||| Adstiladrin (nadofaragene firadenovec-vncg) / Ferring
Efficacy of Nadofaragene Firadenovec-vncg for Patients With Bacillus Calmette-Gu (304A) - Mar 12, 2024 - Abstract #AUA2024AUA_2979;
P3
These data will help identify mechanisms to improve patient selection and therapeutic efficacy of Ad-IFN?. Nadofaragene firadenovec provided nearly half of participants with bladder preservation at 60 months and represents a safe intravesical treatment option for patients with BCG-unresponsive CIS
- |||||||||| Adstiladrin (nadofaragene firadenovec-vncg) / Ferring, Keytruda (pembrolizumab) / Merck (MSD)
Review, Journal: BCG and Alternative Therapies to BCG Therapy for Non-Muscle-Invasive Bladder Cancer. (Pubmed Central) - Feb 27, 2024
Moreover, recent logistic issues with BCG production caused a worldwide BCG shortage, re-sparking interest in alternative BCG treatments including mitomycin C, sequential gemcitabine with docetaxel, and others. This review encompasses both the historic and current role of BCG in the treatment of non-muscle-invasive bladder cancer, revisiting BCG alternative therapies and reviewing the novel therapeutics that were approved for the BCG-unresponsive stage or are under active investigation.
- |||||||||| Adstiladrin (nadofaragene firadenovec-vncg) / Ferring
Trial completion date, Trial primary completion date, Real-world evidence, Real-world: ABLE-41: ADSTILADRIN Early Utilization and Outcomes in the Real World Setting (clinicaltrials.gov) - Feb 15, 2024
P=N/A, N=800, Recruiting,
This review encompasses both the historic and current role of BCG in the treatment of non-muscle-invasive bladder cancer, revisiting BCG alternative therapies and reviewing the novel therapeutics that were approved for the BCG-unresponsive stage or are under active investigation. Trial completion date: Dec 2026 --> Dec 2025 | Trial primary completion date: Dec 2026 --> Dec 2025
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