SUNRISE-1 STUDY DESIGN
INLEXZO™ was evaluated in Cohort 2 of SunRISe-11
SunRISe-1 was a single-arm, multi-center study of patients with BCG-unresponsive NMIBC with CIS, with or without papillary tumors (T1 or high-grade Ta) following transurethral resection1
POPULATION1
- BCG-unresponsive NMIBC
- CIS, with or without papillary tumors
- Ineligible for or had elected not to undergo radical cystectomy
POPULATION1
- BCG-unresponsive NMIBC
- CIS, with or without papillary tumors
- Ineligible for or had elected not to undergo radical cystectomy
Every 3 weeks for up to
6 months, then once every
12 weeks for up to 18 months
or until unacceptable toxicity, persistence or recurrence of CIS and/or high-grade papillary disease, or progression1
Reinduction was not included in the study design.2
MAJOR EFFICACY OUTCOME MEASURES1
- Complete response (CR) rate at any time*
- Duration of response (DoR)†
Assessments
- Tumor status was assessed every 12 weeks during the initial two years of treatment, after which cystoscopy was performed at least every 24 weeks
- Mandatory biopsies were performed 24 and 48 weeks after treatment initiation
Reinduction was not included in the study design.2
| Characteristics | INLEXZO™ (N=83) |
|---|---|
| Median age (range) | 71 years (40-88 years) |
| Gender | |
| Gender | |
| Male | 80% |
| Female | 20% |
| Race | |
| Race | |
| White | 87% |
| Asian | 10% |
| Black or African American | 2.4% |
| Race not reported | 1.2% |
| Ethnicity | |
| Ethnicity | |
| Hispanic or Latino | 10% |
| Not Hispanic or Latino | 89% |
| Ethnicity unknown or not reported | 1.2% |
| ECOG Performance Status | |
| ECOG Performance Status | |
| 0 | 92% |
| 1 | 8% |
| Tumor pattern at study entry | |
| Tumor pattern at study entry | |
| CIS only | 67% |
| CIS with high-grade Ta only | 22% |
| CIS with T1 | 11% |
| Median number of prior instillations of BCG (range) | 12 (7-42) |
| Characteristics | INLEXZO™ (N=83) |
|---|---|
| Median age (range) | 71 years (40-88 years) |
| Gender | |
| Male | 80% |
| Female | 20% |
| Race | |
| White | 87% |
| Asian | 10% |
| Black or African American | 2.4% |
| Race not reported | 1.2% |
| Ethnicity | |
| Hispanic or Latino | 10% |
| Not Hispanic or Latino | 89% |
| Ethnicity unknown or not reported | 1.2% |
| Characteristics | INLEXZO™ (N=83) |
|---|---|
| ECOG Performance Status | |
| 0 | 92% |
| 1 | 8% |
| Tumor pattern at study entry | |
| CIS only | 67% |
| CIS with high-grade Ta only | 22% |
| CIS with T1 | 11% |
| Median number of prior instillations of BCG (range) | 12 (7-42) |
BCG, Bacillus Calmette–Guérin; CIS, carcinoma in situ; NMIBC, non–muscle invasive bladder cancer.
BCG-unresponsive NMIBC CIS was defined as persistent or recurrent CIS alone or with Ta/T1 disease within 12 months of adequate BCG therapy.1
Adequate BCG therapy was defined as a minimum administration of at least 5 of 6 doses of an initial induction course plus either of: at least 2 of 3 doses of maintenance therapy or at least 2 of 6 doses of a second induction course.1
*CR rate at any time was defined as negative results for cystoscopy (with transurethral resection of bladder tumor [TURBT] and centrally reviewed biopsies as applicable) and centrally reviewed
urine cytology.1†DoR was defined from the time of first CR achieved to first evidence of recurrence, progression, or death due to any cause (whichever was earlier) for participants who achieved a CR.3
MAJOR EFFICACY OUTCOME MEASURES
INLEXZO™ delivers a powerful complete and durable response
COMPLETE RESPONSE RATE‡
82%
(68/83)
(95% CI, 72%-90%)
CR was achieved
without reinduction3§‖
Durable response‖§
51%
(35/68) of patients
maintained a CR ≥12 months
(range: 0-44+ months)
‡CR rate at any time was defined as negative results for cystoscopy (with TURBT and centrally reviewed biopsies as applicable) and centrally reviewed urine cytology.1
§Reinduction was not included in the study design.2
‖Based on patients (n=68) that achieved a CR at any time. DoR was defined from the time of first CR achieved to first evidence of recurrence, progression, or death due to any cause (whichever was earlier) for participants who achieved a CR.1,3
‡CR rate at any time was defined as negative results for cystoscopy (with TURBT and centrally reviewed biopsies as applicable) and centrally reviewed urine cytology.1
§Based on patients (n=68) that achieved a CR at any time. DoR was defined from the time of first CR achieved to first evidence of recurrence, progression, or death due to any cause (whichever was earlier) for participants who achieved a CR.1,3
‖Reinduction was not included in the study design.2
ADDITIONAL DATA
INLEXZO™ is designed for patients seeking bladder preservation
92%
(76/83) of evaluable patients did not progress to MIBC (≥T2)1
- 8% (7/83) of evaluable patients experienced progression to MIBC (≥T2)
- 3.5% (3/83) had progression determined at cystectomy, with a median of 94 days between persistent/recurrent CIS or T1 and MIBC
84%
(57/68) of patients
who achieved a
CR did not have an RC4
- Delaying cystectomy can lead to the development of metastatic bladder cancer, which can be lethal
- Disclaimer: This exploratory analysis is not in the Prescribing Information. It is being provided for descriptive purposes; results require cautious interpretation, as RC may have occurred after patient discontinuation
- Median follow-up time in responders: 20.2 months (range: 5-48 months)
CIS, carcinoma in situ; MIBC, muscle invasive bladder cancer; RC, radical cystectomy.
References: 1. INLEXZO™ [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 2. Jacob JM, Guerrero-Ramos F, Necchi A, et al. TAR-200 monotherapy in patients with bacillus Calmette–Guérin–unresponsive high-risk non–muscle-invasive bladder cancer carcinoma in situ: 1-year durability and patient-reported outcomes from SunRISe-1. Presented at: 120th American Urological Association Annual Meeting; April 26-29, 2025; Las Vegas, NV. 3. Janssen Research & Development, LLC. Phase 2b clinical study evaluating efficacy and safety of TAR-200 in combination with cetrelimab, TAR-200 alone, or cetrelimab alone in participants with high-risk non-muscle invasive bladder cancer (NMIBC) unresponsive to intravesical Bacillus Calmette-Guerin (BCG) who are ineligible for or elected not to undergo radical cystectomy. October 4, 2024. Accessed September 2, 2025. https://ascopubs.org/doi/suppl/10.1200/JCO-25-01651/suppl_file/
protocol1_JCO-25-01651.pdf 4. Data on file. Janssen Biotech, Inc.