Benzinga - by Vandana Singh, Benzinga Editor.
On Sunday, Johnson & Johnson (NYSE:JNJ) ) released updated results from an open-label, multicenter, multi-cohort Phase 1 study of TAR-210 in patients with non–muscle-invasive bladder cancer (NMIBC) with select FGFR alterations.
TAR-210 is an intravesical targeted releasing system designed to provide sustained, local release of erdafitinib into the bladder.
These data were featured at the 2024 American Urological Association (AUA) Annual Meeting.
Results featured updated data from Cohort 1 (C1), patients with recurrent, Bacillus Calmette-Guérin (BCG)–unresponsive high-risk (HR) NMIBC (high-grade Ta/T1; papillary only) who refused or were ineligible for radical cystectomy and Cohort 3 (C3), patients with recurrent, intermediate-risk NMIBC (Ta/T1) low-grade papillary disease left in situ as tumor marker lesions.
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At the data cutoff of March 22, 2024, 64 patients had been treated with TAR-210 across the 2 cohorts.
Of the 21 patients in C1 with HR-NMIBC, the 12-month recurrence-free (RF) survival rate was 90%. In C3, 31 patients were efficacy evaluable with a complete response (CR) rate of 90%.1
Friday, Johnson & Johnson reported updated results from Cohort 2 of the Phase 2b SunRISe-1 study of TAR-200 monotherapy in patients with BCG-unresponsive high-risk non–muscle-invasive bladder cancer (HR-NMIBC) with carcinoma in situ, who are ineligible for, or decline, radical cystectomy.
The results included an evaluation of 85 patients.
The estimated 1-year duration of response (DOR) rate is 74.6%, with a median follow-up in responders of 29.9 weeks; 41 of 48 responders (85%) remain in complete response (CR) at data cutoff as of January 2, 2024, and none of the responders progressed to muscle-invasive bladder cancer or metastasis.
98% (47 of 48) of CRs were achieved at the first disease assessment at week 12, and four of five patients who have completed two years of treatment remain in CR.
The investigator-assessed confirmed CR rate correlated strongly with central results.
On Friday, Johnson & Johnson also announced results from the open-label, single-arm Phase 2 Apa-RP study evaluating adjuvant treatment with Erleada (apalutamide) and androgen deprivation therapy (ADT) in patients with high-risk localized prostate cancer (HRLPC) who have undergone radical prostatectomy (RP).
Following RP, patients who received the treatment regimen showed a 100% biochemical recurrence (BCR)–free rate at 24 months.
The study met its primary endpoint, showing that patients who received 12 months of Erleada plus ADT adjuvant to RP experienced no confirmed biochemical recurrence after 12 additional months of follow-up.
The treatment regimen demonstrated a serum testosterone recovery (≥150 ng/dL) rate of 76.4% at 12 months.
Price Action: JNJ shares are down 0.50% at $148.52 at last check Monday.
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