TAR-200 Monotherapy Shows Greater Than 80% Complete Response Rate in Patients With High-risk Non-muscle-invasive Bladder Cancer
TAR-200 Monotherapy Shows Greater Than 80% Complete Response Rate in Patients With High-risk Non-muscle-invasive Bladder Cancer
New data from Phase 2b SunRISe-1 study show rapid achievement of complete response (CR) with 98% achieving a CR within 12 weeks
來自2b期Sunrise-1研究的新數據顯示，快速實現完全反應（CR），98％的人在12周內達到了CR
TAR-200 provides durable CRs in patients with Bacillus Calmette-Guérin (BCG)–unresponsive high-risk non–muscle-invasive bladder cancer (NMIBC) with carcinoma in situ – a disease area with limited treatment options for patients
TAR-200 爲 Bacillus Calmette-Gue'rin (BCG) 患者提供耐用的 CR—反應遲鈍的高風險不—伴有原位癌的肌肉浸潤性膀胱癌（NMIBC）——患者治療選擇有限的疾病區域
SAN ANTONIO, May 3, 2024 /PRNewswire/ -- Johnson & Johnson announced today updated results from Cohort 2 of the Phase 2b SunRISe-1 study evaluating the efficacy and safety of investigational 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. These data were featured today in a plenary session (Abstract #P2-01) at the 2024 American Urological Association Annual Meeting (AUA) taking place May 3-6, 2024, in San Antonio, Texas.
聖安東尼奧，2024 年 5 月 3 日 /PRNewswire/ — 強生公司今天公佈了 2b 期 Sunrise-1 研究第 2 組的最新結果，該研究評估了正在研究的 TAR-200 單一療法對伴有原位癌的 BCG 無反應的高危非肌肉浸潤性膀胱癌 (HR-NMIBC) 患者的療效和安全性，這些患者沒有資格或拒絕進行根治性膀胱切除術。這些數據今天在2024年5月3日至6日在德克薩斯州聖安東尼奧市舉行的2024年美國泌尿外科學會年會（AUA）的全體會議（摘要 #P2 -01）上公佈。
"The high complete response rate and durability of these responses observed in patients treated with TAR-200 underscores the potential of this treatment approach for patients with BCG-unresponsive HR-NMIBC," said Joseph Jacob,* M.D., M.S., Department of Urology, Upstate Medical University, presenting author. "These results address an area of high unmet need for bladder sparing therapies in this patient population."
主持作者上州醫科大學泌尿外科系*醫學博士、碩士約瑟夫·雅各布說：“在接受 TAR-200 治療的患者中觀察到的這些反應的高完全緩解率和持久性凸顯了這種治療方法對BCG無反應HR-NMIBC患者的潛力。”“這些結果解決了該患者群體對膀胱保留療法的高需求未得到滿足的領域。”
Results included an evaluation of 85 patients (median age of 71 years old: range 40-88; 32.9% with concurrent papillary disease) who received TAR-200 monotherapy. The centrally confirmed complete response (CR) rate was 82.8% by urine cytology and/or biopsy (95% confidence interval [CI], 70.6-91.4). The study protocol did not allow retreatment for nonresponders, consistent with U.S. Food and Drug Administration (FDA) guidance. The estimated 1-year duration of response (DOR) rate is 74.6% (95% CI, 49.8-88.4), with median follow-up in responders of 29.9 weeks (range, 14-140); 41 of 48 responders (85%) remain in CR at data cutoff as of January 2, 2024, and none of the responders progressed to muscle-invasive bladder cancer or metastasis. Ninety-eight percent (47 of 48) of CRs were achieved at 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.1
結果包括對85名接受 TAR-200 單一療法的患者（中位年齡爲71歲：介於40-88歲之間；32.9％同時患有乳頭狀疾病）的評估。通過尿液細胞學和/或活檢，中心確認的完全緩解（CR）率爲82.8％（95％的置信區間 [CI]，70.6-91.4）。根據美國食品藥品監督管理局（FDA）的指導方針，該研究方案不允許對無反應者進行再治療。估計的1年緩解持續時間（DOR）率爲74.6％（95％置信區間，49.8-88.4），受訪者的隨訪中位數爲29.9周（範圍爲14-140）；截至2024年1月2日，48名受訪者中有41名（85％）在數據截止時仍在CR中，沒有一個反應者進展爲肌肉浸潤性膀胱癌或轉移。百分之九十八（48例中的47例）是在第12周進行首次疾病評估時獲得的，在完成兩年治療的五名患者中，有四名仍在CR。研究人員評估的證實CR率與中心結果密切相關。1
Interim results from the SunRISe-1 study were featured at the European Society for Medical Oncology 2023 Congress and shared at AUA 2023. These results were also presented at the European Association of Urology 2024 Congress.
Sunrise-1研究的中期結果已在歐洲腫瘤內科學會2023年大會上公佈，並在AUA 2023年上進行了分享。這些結果也在2024年歐洲泌尿外科協會大會上公佈。
Treatment-related adverse events (TRAEs) occurred in 61 patients (71.8%). The most common (≥10%) were pollakiuria (35.3%), dysuria (29.4%), micturition urgency (15.3%), and urinary tract infections (15.3%). Seven patients (8.2%) had Grade 3 or higher TRAEs and four patients (4.7%) had one or more serious TRAEs. Four patients (4.7%) had TRAEs leading to discontinuation and no deaths were reported.
61名患者（71.8％）發生了與治療相關的不良事件（TRAE）。最常見的（≥10％）是尿頻（35.3％）、排尿困難（29.4％）、尿急（15.3％）和尿路感染（15.3％）。七名患者（8.2％）患有3級或更高的TRAE，四名患者（4.7％）患有一種或更多嚴重的TRAE。四名患者（4.7%）的TRAE導致停藥，沒有死亡報告。
"These study results mark a significant step in our mission to bring new treatment options to patients that focus on bladder preservation and long-term survival," said Christopher Cutie, M.D., Vice President, Disease Area Leader, Bladder Cancer, Johnson & Johnson Innovative Medicine. "These results reinforce the potential of TAR-200 to transform the treatment landscape and our ongoing dedication to address unmet needs for patients facing this challenging disease."
強生創新醫學副總裁兼膀胱癌疾病領域負責人克里斯托弗·庫蒂醫學博士說：“這些研究結果標誌着我們向着重於膀胱保存和長期存活的患者提供新的治療選擇的使命邁出了重要一步。”“這些結果增強了 TAR-200 改變治療格局的潛力，以及我們爲解決面臨這種挑戰性疾病的患者未滿足的需求所做的持續努力。”
TAR-200 is an investigational targeted releasing system designed to provide extended local release of gemcitabine into the bladder. It is installed in a physician's office setting during a 3- to 5-minute procedure with no anesthesia. In December 2023, the FDA granted TAR-200 Breakthrough Therapy Designation (BTD) for the potential future treatment of patients with BCG-unresponsive HR-NMIBC, who are ineligible for or elected not to undergo radical cystectomy (surgical removal of the bladder).
TAR-200 是一種研究中的靶向釋放系統，旨在延長吉西他濱局部釋放到膀胱的時間。在 3 到 5 分鐘的手術過程中，它安裝在醫生的辦公室環境中，無需麻醉。2023 年 12 月，美國食品藥品管理局授予 TAR-200 突破性療法稱號 (BTD)，用於未來可能治療沒有資格或選擇不接受根治性膀胱切除術（手術切除膀胱）的 BCG 無反應 HR-NMIBC 患者。
Bladder cancer is the sixth most common cancer in the U.S., with more than 83,000 patients diagnosed each year, with NMIBC accounting for about 75-85% of all newly diagnosed bladder cancers.2,3 Although BCG immunotherapy has been accepted as the standard of care for nearly five decades, 30-40% of patients do not respond to BCG and experience disease recurrence or progression.4 In such scenarios, radical cystectomy (removal of the bladder and neighboring structures and organs) emerges as the primary treatment option. This major abdominal procedure requires a urinary diversion to be created to collect and store urine.5
膀胱癌是美國第六大最常見的癌症，每年診斷出超過83,000名患者，NMIBC約佔所有新診斷的膀胱癌的75-85％。2,3 儘管卡介苗免疫療法已被視爲標準護理已有近五十年，但30-40％的患者對卡介苗沒有反應，會出現疾病復發或進展。4 在這種情況下，根治性膀胱切除術（切除膀胱和鄰近的結構和器官）成爲主要的治療選擇。這種主要的腹部手術需要開設尿路來收集和儲存尿液。5
About SunRISe-1
SunRISe-1 (NCT04640623) is a randomized, parallel-assignment, open-label Phase 2 clinical study evaluating the safety and efficacy of TAR-200 in combination with cetrelimab, TAR-200 alone, or cetrelimab alone for BCG-unresponsive HR-NMIBC carcinoma in situ (CIS) patients who are ineligible for, or elected not to undergo, radical cystectomy. Participants are randomized to 1 of 4 cohorts: treatment with TAR-200 in combination with cetrelimab (Cohort 1), TAR-200 alone (Cohort 2), cetrelimab alone (Cohort 3), or TAR-200 alone with papillary disease only (Cohort 4). The primary endpoint is CR rate at any time point. Secondary endpoints include DOR, overall survival, pharmacokinetics, quality of life, safety and tolerability. Cohorts 1 and 3 were closed to further enrollment effective June 1, 2023.
關於 Sunrise-1
Sunrise-1（NCT04640623）是一項隨機、平行分配、開放標籤的 2 期臨床研究，評估 TAR-200 與西曲利單抗、單獨使用 TAR-200 或單獨使用西曲利單抗對沒有資格或選擇不接受根治性膀胱切除術的 BCG 無反應的 HR-NMIBC 原位癌（CIS）患者的安全性和有效性。參與者被隨機分爲 4 個隊列中的 1 個：使用 TAR-200 與西曲利單抗聯合治療（隊列 1）、單獨使用 TAR-200（隊列 2）、單獨使用 cetrelimab（隊列 3），或單獨使用 TAR-200 治療乳頭狀疾病（隊列 4）。主要終點是任何時間點的 CR 率。次要終點包括DOR、總存活率、藥代動力學、生活質量、安全性和耐受性。自 2023 年 6 月 1 日起，第 1 組和第 3 組已停止進一步註冊。
About TAR-200
TAR-200 is an investigational targeted releasing system, enabling controlled release of gemcitabine into the bladder, increasing the amount of time the drug delivery system spends in the bladder and sustaining local drug exposure. The safety and efficacy of TAR-200 are being evaluated in Phase 2 and Phase 3 studies in patients with muscle-invasive bladder cancer in SunRISe-2 and SunRISe-4, NMIBC in SunRISe-1, SunRISe-3 and SunRISe-5.
關於 TAR-200
TAR-200 是一種在研的靶向釋放系統，它可以控制吉西他濱進入膀胱的釋放，增加藥物輸送系統在膀胱中的停留時間並維持局部藥物暴露。Sunrise-2 和 Sunrise-4 的肌肉浸潤性膀胱癌患者、Sunrise-1、Sunrise-3 和 Sunrise-5 中的 NMIBC 患者的 2 期和 3 期研究正在評估 TAR-200 的安全性和有效性。
About Cetrelimab
Administered intravenously, cetrelimab is an investigational programmed cell death receptor-1 (PD-1) monoclonal antibody being studied for the treatment of bladder cancer, prostate cancer, melanoma, and multiple myeloma as part of a combination treatment. Cetrelimab is also being evaluated in multiple other combination regimens across the Janssen Oncology portfolio.
關於西曲利單抗
西曲利單抗是一種研究中的程序性細胞死亡受體-1（PD-1）單克隆抗體，作爲聯合治療的一部分，正在研究用於治療膀胱癌、前列腺癌、黑色素瘤和多發性骨髓瘤。西曲利單抗還在楊森腫瘤學產品組合的其他多種組合方案中接受評估。
About High-Risk Non–Muscle-Invasive Bladder Cancer
High-risk non–muscle-invasive bladder cancer (HR-NMIBC) is a type of non-invasive bladder cancer that is more likely to recur or spread beyond the lining of the bladder, called the urothelium, and progress to invasive bladder cancer compared to low-risk NMIBC.6,7 HR-NMIBC makes up 15-44% of patients with NMIBC and is characterized by a high-grade, large tumor size, presence of multiple tumors, and CIS. Radical cystectomy is currently recommended for NMIBC patients who fail BCG therapy, with over 90% cancer-specific survival if performed before muscle-invasive progression.8,9 Given that NMIBC typically affects older patients, many may be unwilling or unfit to undergo radical cystectomy.10 The high rates of recurrence and progression can pose significant morbidity and distress for these patients.6,10
關於 High-無風險—肌肉浸潤性膀胱癌
高風險非肌肉浸潤性膀胱癌（HR-NMIBC）是一種非侵入性膀胱癌，與低風險的NMIBC相比，它更有可能復發或擴散到膀胱內膜以外，稱爲尿路上皮，並發展爲浸潤性膀胱癌。6,7 HR-NMIBC佔NMIBC患者的15-44％，其特徵是腫瘤級別高、體積大、存在多個腫瘤和CIS腫瘤。目前建議對卡介苗治療失敗的NMIBC患者進行根治性囊腫切除術，如果在肌肉侵入性進展之前進行癌症特異性存活率，則癌症特異性存活率超過90％。8,9 鑑於NMIBC通常影響老年患者，許多人可能不願意或不適合接受根治性膀胱切除術。10 高複發率和進展率可能給這些患者帶來嚴重的發病率和痛苦。6,10
About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at or at . Follow us at @JanssenUS and @JNJInnovMed. Janssen Research & Development, LLC and Janssen Biotech, Inc., are both Johnson & Johnson companies.
關於強生公司
在強生，我們相信健康就是一切。我們在醫療保健創新方面的實力使我們能夠建立一個可以預防、治療和治癒複雜疾病、治療更智能、侵入性更小、解決方案個性化的世界。憑藉我們在創新醫學和醫療技術方面的專業知識，我們在當今的全方位醫療解決方案中處於獨特的地位，能夠實現未來的突破，並對人類的健康產生深遠影響。要了解更多信息，請訪問或訪問。通過 @JanssenUS 和 @JNJInnovMed 關注我們。Janssen Research & Development, LLC和Janssen Biotech, Inc. 都是強生公司。
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of TAR-200 or cetrelimab. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, Janssen Biotech, Inc., and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 31, 2023, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, or on request from Johnson & Johnson. None of Janssen Research & Development, LLC, Janssen Biotech, Inc., nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
有關前瞻性陳述的注意事項
本新聞稿包含1995年《私人證券訴訟改革法》中定義的 “前瞻性陳述”，內容涉及產品開發以及 TAR-200 或西曲利單抗的潛在益處和治療影響。提醒讀者不要依賴這些前瞻性陳述。這些陳述基於當前對未來事件的預期。如果基本假設證明存在不準確或已知或未知的風險或不確定性，則實際結果可能與Janssen Research & Development, LLC的預期和預測存在重大差異， Janssen Biotech, Inc. 和/或強生。風險和不確定性包括但不限於：產品研發固有的挑戰和不確定性，包括臨床成功和獲得監管批准的不確定性；商業成功的不確定性；競爭，包括技術進步、新產品和競爭對手獲得的專利；專利挑戰；醫療保健產品和服務購買者行爲和支出模式的變化；包括全球醫療改革在內的適用法律和法規的變化；以及發展趨勢控制醫療保健成本。這些風險、不確定性和其他因素的更多清單和描述可以在強生截至2023年12月31日財年的10-K表年度報告中找到，包括標題爲 “關於前瞻性陳述的警示說明” 和 “第1A項” 的章節。風險因素”，以及強生公司隨後向美國證券交易委員會提交的10-Q表季度報告和其他文件中。這些文件的副本可在網上查閱 www.sec.gov， 或應強生公司的要求。Janssen Research & Development, LLC、Janssen Biotech, Inc. 和強生均不承諾根據新信息或未來事件或事態發展更新任何前瞻性陳述。
*Dr. Jacob has not been paid for any media work.
*雅各布博士沒有因任何媒體工作獲得報酬。
1 Necchi A, Daneshmand S, Simone G, Xylinas E, Morris DS, Zainfeld D, et al. P2-01 TAR-200 in patients with Bacillus Calmette-Guérin-unresponsive high-risk non–muscle-invasive bladder cancer: results from SunRISe-1 study. Journal of Urology. 2024;211.
2 Key statistics for bladder cancer. American Cancer Society. Accessed April 1, 2024.
3 Deng S, Meng F, Wang L, et al. Global research trends in non–muscle invasive bladder cancer: bibliometric and visualized analysis. Front Oncol. 2022;12:1044830. Published 2022 Nov 17. doi:10.3389/fonc.2022.1044830
4 Zlotta AR, Fleshner NE, Jewett MA. The management of BCG failure in non-muscle-invasive bladder cancer: an update. Can Urol Assoc J. 2013;3(6-S4):199.
5 Bladder removal surgery: What is a radical cystectomy? Bladder Cancer Advocacy Network. Accessed April 1, 2024.
6 Grab-Heyne K, Henne C, Mariappan P, et al. Intermediate and high-risk non–muscle-invasive bladder cancer: an overview of epidemiology, burden, and unmet needs. Front Oncol. 2023;13:1170124.
7 Lieblich A, Henne C, Mariappan P, Geiges G, Pöhlmann J, Pollock RF. The management of non–muscle-invasive bladder cancer: A comparison of European and UK guidelines. J Clin Urol. 2018;11(2):144-148.
8 Brooks NA, O'Donnell MA. Treatment options in non–muscle-invasive bladder cancer after BCG failure. Indian J Urol. 2015;31(4):312-319. doi:10.4103/0970-1591.166475
9 Guancial EA, Roussel B, Bergsma DP, et al. Bladder cancer in the elderly patient: challenges and solutions. Clin Interv Aging. 2015;10:939-949.
10 Chamie K, Litwin MS, Bassett JC, et al. Recurrence of high-risk bladder cancer: A population-based analysis. Cancer. 2013;119(17):3219-3227.
1 Necchi A、Daneshmand S、Simone G、Xylinas E、Morris DS、Zainfeld D 等。P2-01 TAR-200 用於無反應的高風險非肌肉浸潤性膀胱癌患者：Sunrise-1 研究的結果。 泌尿外科雜誌。 2024; 211。
2 膀胱癌的關鍵統計數據。美國癌症協會。於 2024 年 4 月 1 日訪問。
3 鄧S，孟飛，王力，等非肌肉浸潤性膀胱癌的全球研究趨勢：文獻計量和可視化分析。 Front Oncol。 2022年; 12:1044830。發佈於 2022 年 11 月 17 日。doi: 10.3389/fonc.2022.1044830
4 阿肯色州茲洛塔，內布拉斯納州，馬薩諸塞州朱維特。非肌肉浸潤性膀胱癌中卡介苗衰竭的管理：最新情況。 Can Urol Assoc J. 2013; 3 (6-S4): 199。
5 膀胱切除手術：什麼是根治性膀胱切除術？膀胱癌倡導網絡。於 2024 年 4 月 1 日訪問。
6 Grab-Heyne K、Henne C、Mariappan P 等中等和高風險的非肌肉浸潤性膀胱癌：流行病學、負擔和未滿足的需求概述。 Front Oncol。 2023; 13:1170124.
7 Lieblich A、Henne C、Mariappan P、Geiges G、Polhlmann J、Pollock RF。非肌肉浸潤性膀胱癌的管理：歐洲和英國指南的比較。 J Clin Urol。 2018; 11 (2): 144-148。
8 北美布魯克斯，馬薩諸塞州奧唐納。卡介苗失敗後的非肌肉浸潤性膀胱癌的治療選擇。 印度人 J Urol。 2015; 31 (4): 312-319. doi: 10.4103/0970-1591.166475
9 Guancial EA、Roussel B、Bergsma DP 等老年患者的膀胱癌：挑戰和解決方案。 臨床訪談老化。 2015; 10:939-949。
10 Chamie K、Litwin MS、Bassett JC 等高危膀胱癌的復發：基於人群的分析。 癌症。 2013; 119 (17): 3219-3227。
|
Media contacts: Ania DiAntonio +1 215 620-0717 |
Investor contact: U.S. Medical Inquiries +1 800 526-7736 |
|
媒體聯繫人： 阿尼亞·迪安東尼 +1 215 620-0717 |
投資者聯繫人： 美國醫療查詢 +1 800 526-7736 |
SOURCE Johnson & Johnson
來源：強生公司
譯文內容由第三人軟體翻譯。