The approval was based on results from cohort A of the phase 2\/3 QUILT-3.032 (NCT03022825) trial assessing 77 patients with BCG-unresponsive high-risk NMIBC with CIS with or without Ta\/T1 papillary disease after transurethral resection. Administration of nogapendekin alfa inbakicept was given as induction via intravesical instillation with BCG and followed by maintenance therapy for up to 37 months. <\/p>\n
Topline efficacy data include complete responses (CR) determined by cystoscopy, urine cytology, and biopsy. The CR rate was 62% (95% CI, 51%-73%). Of note, 58% of patients had a CR with a duration of response (DOR) of 12 months or more, and 40% had a CR with a DOR of 24 months or more. <\/p>\n
The recommended dose is 400 mcg given intravesically with BCG once a week for 6 weeks as induction therapy. If a patient has residual CIS and\/or high grade Ta tumor at month 3, a second induction course may be given. <\/p>\n
Maintenance after induction will be given at the 400 mcg recommended dose given intravesically with BCG once a week for 3 weeks at months 4, 7, 10, 13, and 19. This will continue for a total of 15 doses. If patients have no evidence of high-grade disease at month 25 and later, maintenance instillations with BCG may be given once a week for 3 weeks at months 25, 31, and 37 for a maximum of 9 instillations. <\/p>\n
The most common adverse effects included laboratory test abnormalities and consisted of increased creatinine, dysuria, hematuria, urinary frequency, and micturition urgency. <\/p>\n
Reference<\/p>\n
FDA approves an expanded indication for nogapendekin alfa inbakicept-pmln for BCG-unresponsive non-muscle invasive bladder cancer. News release. FDA. October 14, 2026. Accessed October 14, 2026. https:\/\/tinyurl.com\/38cp583x<\/p>\n","protected":false},"excerpt":{"rendered":"The approval was based on results from cohort A of the phase 2\/3 QUILT-3.032 (NCT03022825) trial assessing 77…\n","protected":false},"author":2,"featured_media":630552,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[10],"tags":[134,111,139,69],"class_list":["post-630551","post","type-post","status-publish","format-standard","has-post-thumbnail","category-health","tag-health","tag-new-zealand","tag-newzealand","tag-nz"],"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/nz\/wp-json\/wp\/v2\/posts\/630551","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/nz\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/nz\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/nz\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/nz\/wp-json\/wp\/v2\/comments?post=630551"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/nz\/wp-json\/wp\/v2\/posts\/630551\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/nz\/wp-json\/wp\/v2\/media\/630552"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/nz\/wp-json\/wp\/v2\/media?parent=630551"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/nz\/wp-json\/wp\/v2\/categories?post=630551"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/nz\/wp-json\/wp\/v2\/tags?post=630551"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}