{"id":10733,"date":"2025-04-29T13:48:56","date_gmt":"2025-04-29T17:48:56","guid":{"rendered":"https:\/\/lifescivoice.com\/?p=10733"},"modified":"2025-04-29T13:48:56","modified_gmt":"2025-04-29T17:48:56","slug":"pfizers-pd-1-inhibitor-shows-mixed-results-in-bladder-cancer-trial","status":"publish","type":"post","link":"https:\/\/lifescivoice.com\/pfizers-pd-1-inhibitor-shows-mixed-results-in-bladder-cancer-trial\/","title":{"rendered":"Pfizer\u2019s PD-1 Inhibitor Shows Mixed Results in Bladder Cancer Trial"},"content":{"rendered":"<p>Pfizer has announced detailed results from its Phase 3 trial evaluating sasanlimab, a subcutaneous PD-1 inhibitor, in combination with Bacillus Calmette-Gu\u00e9rin (BCG) as a first-line treatment for high-risk, non-muscle invasive bladder cancer. The data, presented at the 2025 American Urological Association Annual Meeting, revealed a 32% reduction in the risk of disease-related events. However, the study did not meet all its secondary objectives and showed an increased rate of serious adverse events in the sasanlimab treatment arm.<br \/>\nThe primary endpoint of event-free survival (EFS), defined by recurrence of high-grade disease, progression, persistence of carcinoma in situ, or death from any cause, favored the sasanlimab plus BCG induction and maintenance regimen. At 36 months, 82.1% of patients receiving the combination were free from events compared to 74.8% in the control cohort.<br \/>\n<script async=\"\" src=\"https:\/\/pagead2.googlesyndication.com\/pagead\/js\/adsbygoogle.js?client=ca-pub-3812572458252831\" crossorigin=\"anonymous\"><\/script> <ins class=\"adsbygoogle\" style=\"display: block; text-align: center;\" data-ad-layout=\"in-article\" data-ad-format=\"fluid\" data-ad-client=\"ca-pub-3812572458252831\" data-ad-slot=\"7669348015\"><\/ins> <script>\n     (adsbygoogle = window.adsbygoogle || []).push({});\n<\/script><br \/>\nDespite achieving the primary EFS endpoint, other findings tempered the overall outcome. In a third cohort where patients received sasanlimab and BCG induction but no maintenance doses, event-free survival outcomes were not superior to the standard of care. This result indicated the necessity of maintaining BCG as a part of the regimen if sasanlimab is incorporated into treatment protocols.<br \/>\nKey secondary endpoints revealed further limitations. Specifically, sasanlimab did not improve overall survival (OS) compared to the standard treatment. These results were collected after a median follow-up period of 40.9 months, with final analysis still pending.<br \/>\nThe safety profile of sasanlimab in combination with BCG was reported as generally consistent with previous data. Nonetheless, a notable difference was seen in the incidence of serious treatment-related adverse events. The rate was 17.7% in the sasanlimab plus BCG induction and maintenance group, compared to 1.4% in the control group. Hepatitis and pancreatitis emerged as the most common grade 3 or 4 immune-mediated adverse events among patients treated with sasanlimab, although most cases were managed effectively with thyroid hormone supplementation.<br \/>\n<script async=\"\" src=\"https:\/\/pagead2.googlesyndication.com\/pagead\/js\/adsbygoogle.js?client=ca-pub-3812572458252831\" crossorigin=\"anonymous\"><\/script> <ins class=\"adsbygoogle\" style=\"display: block; text-align: center;\" data-ad-layout=\"in-article\" data-ad-format=\"fluid\" data-ad-client=\"ca-pub-3812572458252831\" data-ad-slot=\"7669348015\"><\/ins> <script>\n     (adsbygoogle = window.adsbygoogle || []).push({});\n<\/script><br \/>\nPfizer has submitted the trial results to health authorities to support potential regulatory filings. If approved, sasanlimab could become the first PD-1 inhibitor authorized for first-line treatment of high-risk, non-muscle invasive bladder cancer. Currently, Merck &#038; Co.\u2019s Keytruda holds approval only for patients unresponsive to BCG. Regulatory approval of sasanlimab could also facilitate Pfizer\u2019s broader plans to integrate the drug with its antibody-drug conjugate therapies.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Pfizer has announced detailed results from its Phase 3 trial evaluating sasanlimab, a subcutaneous PD-1 inhibitor, in combination with Bacillus Calmette-Gu\u00e9rin (BCG) as a first-line treatment for high-risk, non-muscle invasive bladder cancer. The data, presented at the 2025 American Urological Association Annual Meeting, revealed a 32% reduction in the risk of disease-related events. However, the [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":10734,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[35],"tags":[],"class_list":{"0":"post-10733","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-clinical"},"_links":{"self":[{"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/posts\/10733","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/comments?post=10733"}],"version-history":[{"count":2,"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/posts\/10733\/revisions"}],"predecessor-version":[{"id":10740,"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/posts\/10733\/revisions\/10740"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/media\/10734"}],"wp:attachment":[{"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/media?parent=10733"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/categories?post=10733"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/tags?post=10733"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}