Johnson & Johnson on Friday unveiled updated data from its Phase IIb SunRISe-1 study, which found that its investigational drug-device combination TAR-200 can induce rapid complete response in patients with high-risk non-muscle invasive bladder cancer.

强生公司周五公布了其IIb期SunRISe-1研究的最新数据，该研究发现其研究药物组合TAR-200可以在高危非肌肉浸润性膀胱癌患者中诱导快速完全反应。

Friday’s readout, which was presented at the American Urological Association’s annual meeting, came from 85 patients with high-risk non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ and who are either ineligible for or decline radical cystectomy. Results demonstrated a centrally confirmed complete response rate of 82.8%, as quantified by biopsies or urine cytology..

周五在美国泌尿外科协会年会上公布的数据来自85例高危非肌层浸润性膀胱癌（NMIBC）原位癌患者，这些患者要么不符合根治性膀胱切除术的资格，要么拒绝根治性膀胱切除术。结果显示，通过活组织检查或尿细胞学定量，中央确认的完全缓解率为82.8%。。

Almost all incidences of complete response were achieved within 12 weeks of treatment, according to J&J.

据J＆J称，几乎所有完全缓解的发生率都在治疗后12周内达到。

SunRISe-1 also had an estimated 1-year duration of response of 74.6%, with 85% of all responders still showing complete treatment response as of the data cutoff on January 2, 2024. None of the responders progressed to muscle-invasive or metastatic disease.

SunRISe-1的估计1年反应持续时间为74.6%，截至2024年1月2日的数据截止，所有反应者中有85%仍显示出完全的治疗反应。没有反应者进展为肌肉浸润性或转移性疾病。

Christopher Cutie, J&J’s vice president and disease area leader for bladder cancer, in a statement called these findings “a significant step” in the pharma’s quest to provide patients with new treatment options focused on “bladder preservation and long-term survival.”

强生公司副总裁兼膀胱癌疾病领域负责人克里斯托弗·库蒂（ChristopherCutie）在一份声明中称，这些发现是该制药公司寻求为患者提供以“膀胱保存和长期生存”为重点的新治疗选择的“重要一步”

“These results reinforce the potential of TAR-200 to transform the treatment landscape” in NMIBC, Cutie said.

Cutie说，“这些结果增强了TAR-200改变NMIBC治疗环境的潜力”。

Designed to be easily installed, TAR-200 is an investigational targeted drug releasing system that allows for the controlled dosing of gemcitabine into the bladder. The drug-device system prolongs the exposure of the bladder to the anti-cancer drug. TAR-200’s installation procedure only takes three to five minutes and can be completed in a physician’s office without anesthesia..

TAR-200设计易于安装，是一种研究性靶向药物释放系统，可将吉西他滨控制剂量注入膀胱。药物装置系统延长了膀胱暴露于抗癌药物的时间。TAR-200的安装过程只需三到五分钟，无需麻醉即可在医生办公室完成。。

In SunRISe-1, J&J is testing TAR-200 as a monotherapy or in combination with the intravenous PD-1 blocker cetrelimab. The trial has so far enrolled 200 patients and is designed to evaluate complete response as its primary endpoint. Key secondary outcomes include duration of response, overall survival and quality of life..

在SunRISe-1中，强生公司正在测试TAR-200作为单一疗法或与静脉注射PD-1阻滞剂西曲单抗联合使用。该试验迄今已招募了200名患者，旨在评估完全缓解作为其主要终点。关键的次要结果包括反应持续时间，总生存期和生活质量。。

J&J is also running the Phase III SunRISe-3 and SunRISe-5 studies of TAR-200 in NMIBC, as well as SunRISe-2 and SunRISe-4 in muscle-invasive bladder cancer.

强生公司还在NMIBC进行TAR-200的III期SunRISe-3和SunRISe-5研究，以及肌肉浸润性膀胱癌的SunRISe-2和SunRISe-4研究。

Friday’s readout adds another bladder cancer victory for J&J. In January 2024, the pharma won the FDA’s approval for its FGF kinase inhibitor Balversa (erdafitinib) for locally advanced or metastatic urothelial carcinoma.

周五的读数为强生公司赢得了另一场膀胱癌胜利。2024年1月，该制药公司获得了FDA批准，其FGF激酶抑制剂Balversa（erdafitinib）用于局部晚期或转移性尿路上皮癌。

The regulator also recently approved ImmunityBio’s first-in-class IL-15 superagonist Anktiva (nogapendekin alfa inbakicept-pmln), in combination with Bacillus Calmette-Guérin, for NMIBC.

监管机构最近还批准ImmunityBio的第一批IL-15超促性腺激素Anktiva（nogapendekin alfa inbakicept pmln）与卡介苗（Bacillus Calmette-Guérin）联合用于NMIBC。