Journal article
A Clinical Trial of the Intradermal TLR2 Agonist CADI-05 for BCG Recurrent and Unresponsive Non-Muscle Invasive Bladder Cancer
Bladder cancer, Vol.5(2), pp.171-180
01/01/2019
DOI: 10.3233/BLC-190211
Abstract
Background: CADI-05, a TLR-2 agonist, induces Th1 immune response following intradermal administration and has been found useful in management of lung cancer and melanoma.
Objective: To evaluate CADI-05 in patients with BCG recurrent and unresponsive Non-muscle invasive bladder cancer (NMIBC) for 15-months recurrence free survival (RFS) rate.
Methods: In BCG unresponsive (BU) or recurrent (BR) NMIBC, CADI-05 was administered intradermally every two weeks for 3 months followed by every month for 3 months and subsequently every 2 months for 6 months following transurethral resection (TUR) in a single arm study (ClinicalTrials.gov: NCT00694798). Cystoscopy, cytology, and sonography were performed for the presence/recurrence of NMIBC at 3, 6, 9, 12, 15 months and beyond and confirmed by biopsy. Evaluation of preoperative biopsy for Desmocollin-3 (DSC3) expression and tumor infiltrating lymphocytes (TIL) was optional.
Results: Twenty patients with NMIBC received intradermal CADI-05. RFS at 15 and 30 months was 35% (7/20) patients. The median RFS was also better for BU compared to BR group (HR, 0.329; 95% CI, 0.071 to 1.532). DSC3 expression was present in 68.8% (11/16) patients. TIL and RFS beyond 30 months were seen 2.3 times and 2.8 times more often in DSC3 expressing NMIBC respectively. No grade IV or V adverse events occurred. Local site reactions were the most common adverse event.
Conclusion: Intradermal CADI-05 following TUR is associated with 35% RFS at 30 months.
Details
- Title: Subtitle
- A Clinical Trial of the Intradermal TLR2 Agonist CADI-05 for BCG Recurrent and Unresponsive Non-Muscle Invasive Bladder Cancer
- Creators
- Michael A. O'Donnell - Univ Iowa Hosp & Clin, Iowa City, IA 52242 USASharwan Singh - Post Graduate Institute of Medical Education and ResearchRajeev Sood - Dr. Ram Manohar Lohia HospitalJitendra Amlani - Uro Care HospitalH. Krishnamoorthy - Lourdes HospitalKetan Shukla - Aarogyam Specialty Hospital, Ahmedabad, IndiaNayan Mohanty - Saket City Hospital, New Delhi, IndiaSushil Bhatia - Choithram Hospital and Research CentreBhaswat Chakraborty - Nirma UniversityNirav Desai - Cadila PharmaceuticalsRajiv Modi - Cadila PharmaceuticalsChandreshwar Shukla - Cadila PharmaceuticalsKapil Vachhani - Cadila PharmaceuticalsRashmi Patel - Institute of Transplantation SciencesAnup Kundu - Institute of Post Graduate Medical Education and ResearchBakulesh Khamar - Cadila Pharmaceuticals
- Resource Type
- Journal article
- Publication Details
- Bladder cancer, Vol.5(2), pp.171-180
- Publisher
- Ios Press
- DOI
- 10.3233/BLC-190211
- ISSN
- 2352-3727
- eISSN
- 2352-3727
- Number of pages
- 10
- Grant note
- Cadila Pharmaceuticals Limited, Ahmedabad, India VI-D7P/159/06-07/TDT / Department of Science & Technology (DST), Government of India; Department of Science & Technology (India)
- Language
- English
- Date published
- 01/01/2019
- Academic Unit
- Urology
- Record Identifier
- 9984320076102771
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