{"id":1230,"date":"2020-12-24T02:01:00","date_gmt":"2020-12-24T02:01:00","guid":{"rendered":"https:\/\/aceoncology.org\/intravesical-gene-therapy-for-non-muscle-invasive-bladder-cancer"},"modified":"2021-03-05T04:57:11","modified_gmt":"2021-03-05T04:57:11","slug":"intravesical-gene-therapy-for-non-muscle-invasive-bladder-cancer","status":"publish","type":"post","link":"https:\/\/aceoncology.org\/zh-hans\/intravesical-gene-therapy-for-non-muscle-invasive-bladder-cancer\/","title":{"rendered":"Intravesical Gene Therapy for Non-Muscle Invasive Bladder Cancer"},"content":{"rendered":"\n

Around 75% of patients with bladder cancer are diagnosed with non-muscle invasive bladder cancer (NMIBC). The standard of care for high-risk NMIBC (carcinoma in situ, high-grade Ta or T1 tumors) after transurethral resection (TUR) of the bladder tumor is intravesical therapy, such as Bacillus Calmette-Guerin (BCG). Although the majority of patients achieve complete response (CR) to BCG induction therapy, many eventually develop BCG-unresponsive disease, which is challenging and difficult to treat. While radical cystectomy may be curative in more than 80% of patients, some are ineligible for this procedure due to comorbidities, or a preference for bladder-sparing approaches, such as intravesical chemotherapy, or more recently systemic immunotherapy. However, the efficacy of intravesical chemotherapy is suboptimal and while systemic immunotherapy with the immune checkpoint inhibitor pembrolizumab<\/a> is effective, treatment may be associated with systemic immune-related adverse events. Thus, there is a critical unmet clinical need for an alternative intravesical therapy that is effective, safe, and induces durable responses.<\/p>\n\n\n\n

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Innovative intravesical therapy, nadofaragene firadenovec, is a replication-deficient recombinant adenovirus vector-based gene therapy that delivers a copy of the human interferon alfa-2b gene into urothelial cells. Based on preclinical data, and promising efficacy and safety in phase 1\/2 clinical trials, a multicenter, single-arm, open-label, repeat-dose phase 3 study<\/a> in BCG-unresponsive NMIBC was conducted. After TUR of all visible bladder tumors, 157 eligible patients received a single intravesical dose (75mL) of nadofaragene firadenovec (3×1011<\/sup> viral particles per mL) repeated at 3, 6 and 9 months. Patients were enrolled into two cohorts by diagnosis: carcinoma in situ, with or without concomitant high-grade Ta or T1 NMIBC (carcinoma in situ cohort), and high-grade Ta or T1 tumors without concomitant carcinoma in situ (high-grade Ta\/T1 cohort). They were evaluated every 3 months for recurrence with urine cytology and cystoscopy (with biopsy, if warranted). Efficacy assessment at 12 months included biopsy from 5 sites in the bladder. The primary endpoint was CR in the carcinoma in situ cohort at any time within 12 months after the first dose of nadofarogene firadenovec. Median follow-up was 19.7 months for the carcinoma in situ cohort and 20.2 months for the Ta\/T1 cohort. Intravesical administration of nadofaragene firadenovec resulted in CR in 53.4% of patients in the carcinoma in situ cohort, all within 3 months of the first dose. Median duration of CR was 9.7 months. At 12 months, 24.3% of patients in the carcinoma in situ cohort remained free of high-grade recurrence. In the Ta\/T1 cohort, 72.9% of patients were free of high-grade recurrence at month 3, and 43.8% at month 12. Median duration of high-grade recurrence-free survival (RFS) in this group was 12.4 months. In the entire population, recurrences of any stage were reported in 69% of evaluable patients; most were high-grade NMIBC recurrences while progression to muscle invasive bladder cancer was rare (5%). High grade RFS at 1 year for the entire population was 30.5%. By the month 12 cutoff, 29% of patients in the carcinoma in situ cohort and 21% in the high-grade Ta\/T1 cohort had undergone cystectomy, with a median time to cystectomy of 8.9 and 8.3 months, respectively. At 24 months, cystectomy-free survival was 64.5% for the total study population, and OS was 91.2% in the carcinoma in situ cohort and 93.5% in the high-grade Ta\/T1 cohort. The most frequent drug-related AEs were discharge around the catheter during installation, fatigue, bladder spasms and micturition urgency. Grade 3\/4 AEs occurred in 18% of all patients, and only 4% were considered as study-drug related. Only 3 patients stopped treatment, and there were no treatment related deaths.<\/p>\n\n\n\n

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The authors conclude that nadofaragene firadenovec is an effective gene therapy for patients with BCG-unresponsive NMIBC, with a favorable dosing schedule and manageable safety profile, and thus represents a new treatment option. In a commentary<\/a> published alongside the study report, the trial investigators are commended for conducting a well-designed study, and nadofarogene firadenovec is acknowledged as having the potential to become the new gold standard treatment for patients with BCG-unresponsive NMIBC.<\/p>\n\n\n\n

<\/div>\n\n\n\n

References<\/strong><\/p>\n\n\n\n

Boorjian SA, et al. Lancet Oncol. <\/em>2020; Nov 27. [Online ahead of print].<\/p>\n\n\n\n

Kulkarni GS. Lancet Oncol. <\/em>2020; Nov 27 [Online ahead of print].<\/p>\n","protected":false},"excerpt":{"rendered":"

Around 75% of patients with bladder cancer are diagnose […]<\/p>\n","protected":false},"author":434,"featured_media":663,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[2],"tags":[],"class_list":["post-1230","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-2"],"acf":[],"yoast_head":"\nIntravesical Gene Therapy for Non-Muscle Invasive Bladder Cancer - ACE Oncology<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/aceoncology.org\/zh-hans\/intravesical-gene-therapy-for-non-muscle-invasive-bladder-cancer\/\" \/>\n<meta property=\"og:locale\" content=\"zh_CN\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Intravesical Gene Therapy for Non-Muscle Invasive Bladder Cancer - ACE Oncology\" \/>\n<meta property=\"og:description\" content=\"Around 75% of patients with bladder cancer are diagnose […]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/aceoncology.org\/zh-hans\/intravesical-gene-therapy-for-non-muscle-invasive-bladder-cancer\/\" \/>\n<meta property=\"og:site_name\" content=\"ACE Oncology\" \/>\n<meta property=\"article:published_time\" content=\"2020-12-24T02:01:00+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2021-03-05T04:57:11+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/aceoncology.org\/wp-content\/uploads\/2020\/12\/file-1608725421950-Picture-Blog-Post-32_BladderCancer.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1250\" \/>\n\t<meta property=\"og:image:height\" content=\"834\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Pascha Paularin\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@ace_oncology\" \/>\n<meta name=\"twitter:site\" content=\"@ace_oncology\" \/>\n<meta name=\"twitter:label1\" content=\"\u4f5c\u8005\" \/>\n\t<meta name=\"twitter:data1\" content=\"Pascha Paularin\" \/>\n\t<meta name=\"twitter:label2\" content=\"\u9884\u8ba1\u9605\u8bfb\u65f6\u95f4\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 \u5206\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/aceoncology.org\/zh-hans\/intravesical-gene-therapy-for-non-muscle-invasive-bladder-cancer\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/aceoncology.org\/zh-hans\/intravesical-gene-therapy-for-non-muscle-invasive-bladder-cancer\/\"},\"author\":{\"name\":\"Pascha Paularin\",\"@id\":\"https:\/\/aceoncology.org\/#\/schema\/person\/d8f6edf15a20f14b3b57d44c6be51e33\"},\"headline\":\"Intravesical Gene Therapy for Non-Muscle Invasive Bladder Cancer\",\"datePublished\":\"2020-12-24T02:01:00+00:00\",\"dateModified\":\"2021-03-05T04:57:11+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/aceoncology.org\/zh-hans\/intravesical-gene-therapy-for-non-muscle-invasive-bladder-cancer\/\"},\"wordCount\":655,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\/\/aceoncology.org\/#organization\"},\"image\":{\"@id\":\"https:\/\/aceoncology.org\/zh-hans\/intravesical-gene-therapy-for-non-muscle-invasive-bladder-cancer\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/aceoncology.org\/wp-content\/uploads\/2020\/12\/file-1608725421950-Picture-Blog-Post-32_BladderCancer.jpg\",\"articleSection\":[\"\u6587\u7ae0\u7cbe\u8981\"],\"inLanguage\":\"zh-Hans\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\/\/aceoncology.org\/zh-hans\/intravesical-gene-therapy-for-non-muscle-invasive-bladder-cancer\/#respond\"]}]},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/aceoncology.org\/zh-hans\/intravesical-gene-therapy-for-non-muscle-invasive-bladder-cancer\/\",\"url\":\"https:\/\/aceoncology.org\/zh-hans\/intravesical-gene-therapy-for-non-muscle-invasive-bladder-cancer\/\",\"name\":\"Intravesical Gene Therapy for Non-Muscle Invasive Bladder Cancer - 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