On Sunday, Johnson & Johnson JNJ ) released up to date outcomes from an open-label, multicenter, multi-cohort Part 1 research of TAR-210 in sufferers with non–muscle-invasive bladder most cancers (NMIBC) with choose FGFR alterations.
TAR-210 is an intravesical focused releasing system designed to supply sustained, native launch of erdafitinib into the bladder.
These information have been featured on the 2024 American Urological Affiliation (AUA) Annual Assembly.
Outcomes featured up to date information from Cohort 1 (C1), sufferers with recurrent, Bacillus Calmette-Guérin (BCG)–unresponsive high-risk (HR) NMIBC (high-grade Ta/T1; papillary solely) who refused or have been ineligible for radical cystectomy and Cohort 3 (C3), sufferers with recurrent, intermediate-risk NMIBC (Ta/T1) low-grade papillary illness left in situ as tumor marker lesions.
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On the information cutoff of March 22, 2024, 64 sufferers had been handled with TAR-210 throughout the 2 cohorts.
Of the 21 sufferers in C1 with HR-NMIBC, the 12-month recurrence-free (RF) survival price was 90%. In C3, 31 sufferers have been efficacy evaluable with an entire response (CR) price of 90%.1
Friday, Johnson & Johnson reported up to date outcomes from Cohort 2 of the Part 2b SunRISe-1 research of TAR-200 monotherapy in sufferers with BCG-unresponsive high-risk non–muscle-invasive bladder most cancers (HR-NMIBC) with carcinoma in situ, who’re ineligible for, or decline, radical cystectomy.
The outcomes included an analysis of 85 sufferers.
The estimated 1-year length of response (DOR) price is 74.6%, with a median follow-up in responders of 29.9 weeks; 41 of 48 responders (85%) stay in full response (CR) at information cutoff as of January 2, 2024, and not one of the responders progressed to muscle-invasive bladder most cancers or metastasis.
98% (47 of 48) of CRs have been achieved on the first illness evaluation at week 12, and 4 of 5 sufferers who’ve accomplished two years of therapy stay in CR.
The investigator-assessed confirmed CR price correlated strongly with central outcomes.
On Friday, Johnson & Johnson additionally announced outcomes from the open-label, single-arm Part 2 Apa-RP research evaluating adjuvant therapy with Erleada (apalutamide) and androgen deprivation remedy (ADT) in sufferers with high-risk localized prostate most cancers (HRLPC) who’ve undergone radical prostatectomy (RP).
Following RP, sufferers who acquired the therapy routine confirmed a 100% biochemical recurrence (BCR)–free price at 24 months.
The research met its main endpoint, displaying that sufferers who acquired 12 months of Erleada plus ADT adjuvant to RP skilled no confirmed biochemical recurrence after 12 extra months of follow-up.
The therapy routine demonstrated a serum testosterone restoration (≥150 ng/dL) price of 76.4% at 12 months.
Worth Motion: JNJ shares are down 0.50% at $148.52 eventually test Monday.
Picture through Wikimedia Commons
