{"id":50730,"date":"2022-11-10T19:02:22","date_gmt":"2022-11-10T18:02:22","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/cg-oncology-presents-new-phase-2-data-with-cg0070-in-combination-with-keytruda-pembrolizumab-in-non-muscle-invasive-bladder-cancer-unresponsive-to-bacillus-calmette-guerin\/"},"modified":"2022-11-10T19:02:22","modified_gmt":"2022-11-10T18:02:22","slug":"cg-oncology-presents-new-phase-2-data-with-cg0070-in-combination-with-keytruda-pembrolizumab-in-non-muscle-invasive-bladder-cancer-unresponsive-to-bacillus-calmette-guerin","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/cg-oncology-presents-new-phase-2-data-with-cg0070-in-combination-with-keytruda-pembrolizumab-in-non-muscle-invasive-bladder-cancer-unresponsive-to-bacillus-calmette-guerin\/","title":{"rendered":"CG Oncology Presents New Phase 2 Data With CG0070 in Combination With KEYTRUDA\u00ae (pembrolizumab) in Non-Muscle Invasive Bladder Cancer Unresponsive to Bacillus Calmette-Gu\u00e9rin"},"content":{"rendered":"<div>\n<p class=\"bwalignc\">\n&#8211; 88% (n=28\/32) of Evaluable Patients Achieved Complete Response at the Initial 3-Month Timepoint from the Phase 2 Clinical Trial of CG0070 in Combination with KEYTRUDA<sup>\u00ae<\/sup> (pembrolizumab) for NMIBC Unresponsive to BCG &#8211;\n<\/p>\n<p class=\"bwalignc\">\n&#8211; CG0070 in Combination with KEYTRUDA Was Well Tolerated with Promising Efficacy and Safety Data &#8211;\n<\/p>\n<p>IRVINE, Calif.&#8211;(BUSINESS WIRE)&#8211;<a href=\"https:\/\/twitter.com\/hashtag\/SITC2022?src=hash\" target=\"_blank\" rel=\"noopener\">#SITC2022<\/a>&#8212;<a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.cgoncology.com&amp;esheet=52964846&amp;newsitemid=20221110005069&amp;lan=en-US&amp;anchor=CG+Oncology%2C+Inc.&amp;index=1&amp;md5=2228383bdcd375d7ff118ef839e6f144\" rel=\"nofollow noopener\" shape=\"rect\">CG Oncology, Inc.<\/a>, an oncolytic immunotherapy company focused on developing novel therapeutics for patients with urologic cancers, today announced new updated data from its global Phase 2 study (CORE1) of CG0070 in combination with Merck\u2019s anti-PD-1 therapy KEYTRUDA<sup>\u00ae<\/sup> (pembrolizumab), for the treatment of patients with non-muscle invasive bladder cancer (NMIBC) unresponsive to Bacillus Calmette-Gu\u00e9rin (BCG).\n<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20221110005069\/en\/1630986\/5\/CG_Logo_color.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20221110005069\/en\/1630986\/21\/CG_Logo_color.jpg\"><\/a><\/p>\n<p>\nThe results were announced in an oral presentation at the Society for Immunotherapy of Cancer (SITC) Annual Meeting, held virtually and in person in Boston, MA.\n<\/p>\n<p>\n\u201cWe\u2019re excited to present these results, which continue to support CG0070\u2019s promise in patients with bladder cancer unresponsive to BCG, a difficult-to-treat patient population,\u201d said Arthur Kuan, Chief Executive Officer, CG Oncology. \u201cWe are seeing continued positive results for CG0070 in combination with pembrolizumab in NMIBC patients unresponsive to BCG. Enrollment in this study is now completed, and data readout on all patients through a minimum of 12 months is expected in 2023.\u201d\n<\/p>\n<p>\n<b>Summary of Interim Clinical Results<\/b>\n<\/p>\n<p>\n<b>Abstract #666 &#8211; Phase 2, Single Arm Study of CG0070 Combined with Pembrolizumab in Patients with Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG)<\/b>\n<\/p>\n<p>\nThe new data for CORE1 adds to that <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.businesswire.com%2Fnews%2Fhome%2F20220604005004%2Fen%2FCG-Oncology-Presents-New-Clinical-Data-on-Two-Ongoing-Programs-at-The-American-Society-of-Clinical-Oncology-ASCO-2022-Annual-Meeting&amp;esheet=52964846&amp;newsitemid=20221110005069&amp;lan=en-US&amp;anchor=presented+at+the+ASCO+2022+Annual+Meeting&amp;index=2&amp;md5=8520c145a37ccdc0ac6e48a07e0048a2\" rel=\"nofollow noopener\" shape=\"rect\">presented at the ASCO 2022 Annual Meeting<\/a> earlier this year and continues to show both promising early anti-tumor activity and tolerability of CG0070 in combination with pembrolizumab for patients with BCG-unresponsive NMIBC.\n<\/p>\n<ul class=\"bwlistdisc\">\n<li>\nAs of the interim analysis, based on a data cutoff on October 10, 2022, 32 patients were evaluable for efficacy with a minimum of 3-month follow up.\n<\/li>\n<\/ul>\n<ul class=\"bwlistdisc\">\n<li>\n88% of patients evaluable for efficacy (n=28\/32) have achieved complete response (CR) at the initial 3-month timepoint. Of those patients evaluable for CR at additional timepoints, 88% (n=23\/26) have also maintained a CR through 6 months, 86% (n=18\/21) through 9 months and 73% (n=11\/15) at the 12-month assessment.\n<\/li>\n<\/ul>\n<ul class=\"bwlistdisc\">\n<li>\nCG0070 in combination with pembrolizumab has been generally well tolerated with the adverse event profile consistent with that observed in prior studies of each agent alone. The most common treatment-related adverse events reported include transient grade 1-2 local genitourinary symptoms.\n<\/li>\n<\/ul>\n<p>\n\u201cThere is a critical unmet need for efficacious bladder-sparing therapies for patients with BCG-unresponsive bladder cancer,\u201d said Roger Li, MD, lead study investigator and urologic oncologist at Moffitt Cancer Center. \u201cCG0070 has continued to show very promising results, more than doubling CR rates previously seen with immune checkpoint inhibitors. With a unique dual-mechanism of action that first engages an immune response and then amplifies that response with immune checkpoint blockade, this novel combination of CG0070 with pembrolizumab could potentially change the outlook for patients with BCG-unresponsive bladder cancer.\u201d\n<\/p>\n<p>\n<b>About the CORE1 Study<\/b>\n<\/p>\n<p>\nUnder a previously announced clinical collaboration with Merck (known as MSD outside the US and Canada) relating to the investigation of CG0070 in combination with pembrolizumab, CORE1, which has completed enrollment of 35 total patients, is to evaluate the safety and efficacy of CG0070 plus pembrolizumab for the treatment of NMIBC unresponsive to BCG.\n<\/p>\n<p>\nMore information about the study can be found at <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.clinicaltrials.gov&amp;esheet=52964846&amp;newsitemid=20221110005069&amp;lan=en-US&amp;anchor=www.clinicaltrials.gov&amp;index=3&amp;md5=5c79bbeba5d97f28b5e18606055b7752\" rel=\"nofollow noopener\" shape=\"rect\">www.clinicaltrials.gov<\/a> (NCT04387461).\n<\/p>\n<p>\nKEYTRUDA<sup>\u00ae<\/sup> is a registered trademark of Merck Sharp &amp; Dohme LLC, a subsidiary of Merck &amp; Co., Inc., Rahway, NJ, USA.\n<\/p>\n<p>\n<b>About CG0070<\/b>\n<\/p>\n<p>\nOur lead candidate, CG0070, is an intravesically delivered oncolytic immunotherapy agent in a Phase 3 trial for the treatment of BCG-unresponsive non-muscle invasive bladder cancer. CG0070 is also in a Phase 2 study in combination with KEYTRUDA<sup>\u00ae<\/sup> (pembrolizumab) in the same indication. Other types of bladder cancer are being evaluated with CG0070 in combination with OPDIVO<sup>\u00ae<\/sup> (nivolumab).\n<\/p>\n<p>\n<b>About CG Oncology<\/b>\n<\/p>\n<p>\nCG Oncology is an oncolytic immunotherapy company focused on developing bladder-saving therapeutics for patients with urologic cancer. At CG Oncology, we see a world where urologic cancer patients can benefit from our innovative therapies to live and work with dignity and an enhanced quality of life. To learn more, visit <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.cgoncology.com&amp;esheet=52964846&amp;newsitemid=20221110005069&amp;lan=en-US&amp;anchor=www.cgoncology.com&amp;index=4&amp;md5=202f57564d84b9dadb437eda3aa186b7\" rel=\"nofollow noopener\" shape=\"rect\">www.cgoncology.com<\/a>. Follow us on Twitter @cgoncology.\n<\/p>\n<p> <b>Contacts<\/b> <\/p>\n<p>\nBing Kung<br \/>\n<br \/>Vice President, Business Development<br \/>\n<br \/>CG Oncology<br \/>\n<br \/><a target=\"_blank\" href=\"&#x6d;&#x61;&#105;l&#x74;&#x6f;&#58;&#98;d&#x40;&#x63;&#103;&#111;n&#x63;&#x6f;&#108;og&#x79;&#x2e;&#99;o&#x6d;\" rel=\"nofollow noopener\" shape=\"rect\">&#98;&#100;&#x40;c&#103;&#x6f;&#x6e;c&#111;&#x6c;&#x6f;g&#121;&#x2e;&#x63;o&#109;<\/a>\n<\/p>\n<p>\nMedia<br \/>\n<br \/>Kimberly Ha<br \/>\n<br \/>KKH Advisors<br \/>\n<br \/>(917) 291-5744<br \/>\n<br \/><a target=\"_blank\" href=\"&#109;&#x61;&#105;&#x6c;t&#111;&#x3a;&#107;&#x69;m&#x62;e&#114;&#x6c;&#121;&#x2e;h&#x61;&#x40;&#107;&#x6b;h&#x61;d&#118;&#x69;&#115;&#x6f;r&#x73;&#46;&#99;&#x6f;&#109;\" rel=\"nofollow noopener\" shape=\"rect\">k&#105;&#x6d;&#x62;e&#114;&#108;&#x79;&#x2e;h&#97;&#64;&#x6b;&#x6b;h&#97;&#x64;&#x76;&#x69;s&#111;&#x72;&#x73;&#46;&#99;&#111;&#x6d;<\/a>\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>&#8211; 88% (n=28\/32) of Evaluable Patients Achieved Complete Response at the Initial 3-Month Timepoint from the Phase 2 Clinical Trial of CG0070 in Combination with KEYTRUDA\u00ae (pembrolizumab) for NMIBC Unresponsive to BCG &#8211; &#8211; CG0070 in Combination with KEYTRUDA Was Well Tolerated with Promising Efficacy and Safety Data &#8211; IRVINE, Calif.&#8211;(BUSINESS WIRE)&#8211;#SITC2022&#8212;CG Oncology, Inc., an &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/cg-oncology-presents-new-phase-2-data-with-cg0070-in-combination-with-keytruda-pembrolizumab-in-non-muscle-invasive-bladder-cancer-unresponsive-to-bacillus-calmette-guerin\/\">[Read more&#8230;]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-50730","6":"format-standard","7":"category-industry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>CG Oncology Presents New Phase 2 Data With CG0070 in Combination With KEYTRUDA\u00ae (pembrolizumab) in Non-Muscle Invasive Bladder Cancer Unresponsive to Bacillus Calmette-Gu\u00e9rin - Pharma Trend<\/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:\/\/pharma-trend.com\/en\/cg-oncology-presents-new-phase-2-data-with-cg0070-in-combination-with-keytruda-pembrolizumab-in-non-muscle-invasive-bladder-cancer-unresponsive-to-bacillus-calmette-guerin\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"CG Oncology Presents New Phase 2 Data With CG0070 in Combination With KEYTRUDA\u00ae (pembrolizumab) in Non-Muscle Invasive Bladder Cancer Unresponsive to Bacillus Calmette-Gu\u00e9rin - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"&#8211; 88% (n=28\/32) of Evaluable Patients Achieved Complete Response at the Initial 3-Month Timepoint from the Phase 2 Clinical Trial of CG0070 in Combination with KEYTRUDA\u00ae (pembrolizumab) for NMIBC Unresponsive to BCG &#8211; &#8211; CG0070 in Combination with KEYTRUDA Was Well Tolerated with Promising Efficacy and Safety Data &#8211; IRVINE, Calif.&#8211;(BUSINESS WIRE)&#8211;#SITC2022&#8212;CG Oncology, Inc., an ... 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