{"id":949400,"date":"2026-04-07T09:27:52","date_gmt":"2026-04-07T13:27:52","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/corbus-pharmaceuticals-announces-broad-alignment-with-fda-on-registration-path-for-crb-701-in-second-line-hnscc-and-cervical-cancer\/"},"modified":"2026-04-07T09:27:52","modified_gmt":"2026-04-07T13:27:52","slug":"corbus-pharmaceuticals-announces-broad-alignment-with-fda-on-registration-path-for-crb-701-in-second-line-hnscc-and-cervical-cancer","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/corbus-pharmaceuticals-announces-broad-alignment-with-fda-on-registration-path-for-crb-701-in-second-line-hnscc-and-cervical-cancer\/","title":{"rendered":"Corbus Pharmaceuticals Announces Broad Alignment with FDA on Registration Path for CRB-701 in Second-Line HNSCC and Cervical Cancer"},"content":{"rendered":"<div class=\"mw_release\">\n<p align=\"center\">\n        <em>FDA feedback enables Corbus to proceed with proposed registrational study design and endpoints to support potential accelerated approval in second-line HNSCC and cervical cancer<\/em>\n      <\/p>\n<p align=\"center\">\n        <em>Updated CRB-701 monotherapy data accepted for presentation at ASCO 2026<\/em>\n      <\/p>\n<p align=\"center\">\n        <em>Dr. Dominic Smethurst to step down as Corbus&#8217; Chief Medical Officer on June 30, 2026<\/em>\n      <\/p>\n<p>NORWOOD, Mass., April  07, 2026  (GLOBE NEWSWIRE) &#8212; Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP), a clinical-stage company focused on promising new therapies in oncology and obesity, today announced broad alignment with the U.S. Food and Drug Administration (FDA) on the registration path for CRB-701, the Company\u2019s next-generation, highly stable Nectin-4 targeting ADC, in head and neck squamous cell carcinoma (HNSCC) and cervical cancer. Corbus also announced that Dr. Dominic Smethurst, MA, MRCP is stepping down from his role as Chief Medical Officer; his last day with the company will be June 30, 2026.<\/p>\n<p>The agreed upon second-line registrational study designs for CRB-701 include:<\/p>\n<ul type=\"disc\">\n<li>HNSCC: a single, randomized controlled study exploring the efficacy and safety of CRB-701 compared to physicians\u2019 choice chemotherapy with potential accelerated approval using objective response rate (ORR) as the primary endpoint and potential full approval granted on overall survival (OS) benefit.<\/li>\n<li>Cervical cancer: a single, randomized controlled study exploring the efficacy and safety of CRB-701 compared to physicians\u2019 choice of chemotherapy or Tivdak\u00ae with potential accelerated approval using ORR as the primary endpoint and potential full approval granted on OS benefit.<\/li>\n<li>Continued interactions with the FDA planned to finalize the protocols and statistical analysis plans for the registrational studies.\n<\/li>\n<\/ul>\n<p>Updated clinical data from the Phase 1\/2 study of CRB-701 in both HNSCC and cervical cancer will be presented at the upcoming 2026 American Society of Clinical Oncology (ASCO) Annual Meeting to be held May 29 \u2013 June 2 in Chicago. Data will include clinical response durability as well as HNSCC patient subgroup analysis. Corbus previously presented dose optimization data from the study, including encouraging efficacy and safety findings, at the 2025 European Society for Medical Oncology Congress (ESMO 2025). The company also anticipates reporting data with CRB-701 in combination with Keytruda<sup>\u00ae<\/sup> in first-line HNSCC patients in Q4 2026 to support potential further registration-enabling trials.<\/p>\n<p>\u201cWe\u2019re pleased to share this important regulatory update as we continue to progress CRB-701 as a novel oncology therapeutic to address unmet medical needs for patients. We look forward to sharing updated monotherapy data on CRB-701 at ASCO and expect to initiate a registrational study for CRB-701 in second-line HNSCC in mid-2026,\u201d said Yuval Cohen, Ph.D., Chief Executive Officer of Corbus.<\/p>\n<p>Dr. Cohen continued, \u201cThis milestone marks an important transition from clinical proof of concept to pending late-stage registrational development and the potential for regulatory submission of CRB-701. This year we will be adding several key new senior leaders to best prepare us for this critical next phase. We are very grateful for Dr. Smethurst\u2019s contributions to advance our pipeline programs through early development, well positioning Corbus for continued success.\u201d<\/p>\n<p>\n        <strong>About CRB-701<\/strong><br \/>\n        <br \/>CRB-701 (SYS6002) is a next-generation antibody drug conjugate (ADC) targeting Nectin-4, that contains a site-specific, cleavable linker and a homogenous drug antibody ratio of 2, using MMAE as the payload. Nectin-4 is a clinically validated, tumor-associated antigen in urothelial cancer. The FDA has granted two Fast Track designations to CRB-701 in HNSCC and cervical cancer. CRB-701 is licensed from CSPC Megalith Biopharmaceutical Co. Ltd. China.<\/p>\n<p>\n        <strong>About Corbus<\/strong><br \/>\n        <br \/>Corbus Pharmaceuticals Holdings, Inc. is a clinical-stage company focusing on promising new therapies in oncology and obesity and is committed to helping people defeat serious illness by bringing innovative scientific approaches to well understood biological pathways. Corbus\u2019 pipeline includes CRB-701, a next-generation antibody drug conjugate for the treatment of Nectin-4-expressing tumors, and CRB-913, an orally delivered highly peripherally restricted CB1 inverse agonist for the treatment of obesity. Corbus is headquartered in Norwood, Massachusetts. For more information on Corbus, visit <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=8RnRBM_3UhQn7iSW5TsQakYJE1EuiE0nRTWi4GS9y9C1p1x2-DCGrl7VEXZHX0DtZjL-CGfJsV4BiWwWIWNTT9taOb3Q9x63xPlFJ1ob7CdR96fOK7ZH0nQPYVpb7nj7Q2u1QT1qfx1g0iwhFR1o71mm7Z3WV1OUDZq2shQhGZYMYNVUnsIktUpdcyN7M3eEvUeICeYm6M61fswE_k3CVQw8l9vxFq8WLccLbiKUfGGPpWYHPXmnEjPV_sQjq6FIOH9BRYdN_0v3Chk3zyJ52yx3mZ4XOi82LEhPcaJLSSH8uKmqm4s2a-XfK5xhhtRXHwAtmPeTCy9fvUYuExzfW_NNbURPeSA1JkguXj0OEu0rUBGAXJsLcp4wFziIz0Klv0H094A5Rjnd5EuQKTezQRuYPUTf-G3DsR2nL_kgrHK_1k0V4tmsEYH1xjoccfPtceW8zOoSTHYtM-9Tu1y7gSw4JVY1ejwgbJVcOOZAhK0=\" rel=\"nofollow\" target=\"_blank\">corbuspharma.com<\/a>. Connect with us on <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=dJkQcEKQ1FC_c_Extba-uucPKug1NzyaC3k6Khl4P_e9pmVJ_vCucmYHxAPJOF4TkQJHRm9zYpu0e5UspzR9VlP-4bx4hRzrOwjnW4frtIHeHE-J_i-GlDYQoyOtLq-3NdUiCKDEhB7sIsBKODSFGoaUSPhGNGLmZR8PUB99iCn9bltSxYFmUhPO4p_FMjj634KBoumeYvrx8UlLkwsdGYdo-rYG7FeQKnVuPcToVjuIbfUGGciCK58uET8qQMz7MGwDQEaBc9MEWF6ydG9LgPn3is4oZnBRtv3ibCugAavhcPo73D4gwUU4UCMB1ZmDYhZJZMiz3ZQl_maaRKMvB1GCSdG9oTLqsADc8ib-D_TFDi_XoWa5cJOIBAVcpe8n\" rel=\"nofollow\" target=\"_blank\">X<\/a>, <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=lGRhexNQM-dh8yWGlpa5E_FoTVjDH3gHzxNdX9uAekQuEvY7ZgbG-SsbsGITC0jZNU7M1dnj2lYOrLlejKR035NMvPqI2GrOSyKrUkYEOXSkcUqjUMeKxIAXnGd9JniGRaB5JPC5wk9ctaodPvYjUU9PPC1vEP32ccTyVmowIafAxMmXeu0Pnwyur0T5XGOGm1r4ywfucpwB841qjp47uVDevN3XbU109Cwwwvj01CeoXxy5f_VBIKnKZ4DiNFx7DkBExAPeq-g2FF31l8oE7h4G26MmIpGFevvnXPiI2Pj-ndibavWr2ItLQ0udCXedVW2xybMhgBX_NwKoVaP6B6N9Pjqvky36_gkvyl9ctD_XKMtFzshxxtXE9WBfDHOqyEGtDnOR2vJP0RaWJPHWJs-NW-lTpsqZ4h4VX9VR8V0JgPqsESuvOKzHr1R2NTYvyfkTqw2FfBs95lEmlHZaaxrCqklRQIWDzgW39XOSbDQ=\" rel=\"nofollow\" target=\"_blank\">LinkedIn<\/a> and <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=g2Mtoq8RJz6UVFjWfYJht9JgiOMZmenVO_skdPErLQo6sgZP0kd_rsTaOO6dWPpgswK9dJigxO9xQKoGsj7FPoMn-jGzNjTB4IEMebM3qvDTFjA1YYjFZTFO7E6LNsHzVk733AzcSdm2RGegbTZ1pYguSQ2i_PR1pOxnaVbzkc_tpmF-Qhtmlsm5rjDXHdLlT1JmfoVv85Jj-Zji-2tz5uSCEs6CDG6mvOi6bPV8edlYGWYifBrzRp_D1kicDE5n9uXZFiN2fw2sjxy4DZdQ7eH-mDsxKIWz60u7RjNacaWtClLKJ10G5EuEUCjmqYgHfaOOH6YVF34n_6El8lc0trE6gLFJvnKBypY6Jb1HpcMidN68VLSX6HSkAutVEXIBei4tUcWyCU-6QBhScZhCjkuyro5EZNMETUQ27fpsmEcUt6-MnSu16d3mjGKTpLXU\" rel=\"nofollow\" target=\"_blank\">Facebook<\/a>.<\/p>\n<p>\n        <strong>Forward-Looking Statements<br \/><\/strong>This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company\u2019s trial results, product development, clinical and regulatory timelines, including timing for completion of trials and presentation of data, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statement that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management\u2019s current beliefs and assumptions.<\/p>\n<p>These statements may be identified by the use of forward-looking expressions, including, but not limited to, \u201cexpect,\u201d \u201canticipate,\u201d \u201cintend,\u201d \u201cplan,\u201d \u201cbelieve,\u201d \u201cestimate,\u201d \u201cpotential,\u201d \u201cpredict,\u201d \u201cproject,\u201d \u201cshould,\u201d \u201cwould\u201d and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors on our operations, clinical development plans and timelines, which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company\u2019s filings with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.<\/p>\n<p>\n        <strong>INVESTOR CONTACTS:<\/strong><br \/>\n        <br \/>Sean Moran<br \/>Chief Financial Officer<br \/>Corbus Pharmaceuticals<br \/><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=HnNuS4C2SbSuD-ie9smidu8hwMySI2_dgwGNNayqnAPjkDTmOpXUA-VE5Z8y9ZwFaPjgVKdvNCOQLAk59Ltq4YkHQ8WvC3_C9wPJqMVZKpR-9AyvIEs6jqm_9E_gMW7x\" rel=\"nofollow\" target=\"_blank\">smoran@corbuspharma.com<\/a><\/p>\n<p>Dan Ferry<br \/>Managing Director<br \/>LifeSci Advisors, LLC<br \/><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=3u1-V4CrW8KtLny6rPej2Xc8FQMxPl8GE-sO-U4TBJ2DGyaxc3sS1epWYFYlPYC2WkEfPp8pHpIgOBSj38Mk6NcUE4t5CIOaoSh_cYKrwz9kwYkyq2AMbnQSV2021J-HU-4Wuo5nnVnA0zu4nmwSCq9b4HC0nxxRX8oahUN-dDp6Cn2qMTec5Ay9A6HDQHmmDPiWaJ5OH79eXrezpD4Xlg9olgS6CI5rlYYvxpqUXHKgBQqGvO96_dym88twKXf9o1LOvnyOaLyh0FztfxkS2Ni0ZcwHLVaBV5FCKy6zlNh3Ib-6a-DTaZZvNs11YY6V\" rel=\"nofollow\" target=\"_blank\">daniel@lifesciadvisors.com<\/a><\/p>\n<p>\n        <strong>MEDIA CONTACT:<\/strong><br \/>\n        <br \/>Liz Melone<br \/>Founder &amp; Principal<br \/>Melone Communications, LLC<br \/><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=ZstX7ID0ZL0Y5nEUczJUmwMO6HKRnTkgvMlgWRovLH8vi9GP28cYf8lnVZG25--xUTqeCcFC0Q_xzkK8Trc1J2EC2wwgCGvT8eR3cja6Rdc=\" rel=\"nofollow\" target=\"_blank\">liz@melonecomm.com<\/a><\/p>\n<p>      <img decoding=\"async\" alt=\"\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTY4NDk5NyM3NTIxOTAxIzUwMDExODg0MA==\" \/><br \/>\n      <br \/>\n      <img decoding=\"async\" alt=\"\" src=\"https:\/\/ml.globenewswire.com\/media\/NmJhOGNkNjktYmVmYy00YWY3LTkxYjgtYzJmNTEwMDBmNjliLTUwMDExODg0MC0yMDI2LTA0LTA3LWVu\/tiny\/Corbus-Pharmaceuticals-Holding.png\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>FDA feedback enables Corbus to proceed with proposed registrational study design and endpoints to support potential accelerated approval in second-line HNSCC and cervical cancer Updated CRB-701 monotherapy data accepted for presentation at ASCO 2026 Dr. Dominic Smethurst to step down as Corbus&#8217; Chief Medical Officer on June 30, 2026 NORWOOD, Mass., April 07, 2026 (GLOBE NEWSWIRE) &#8212; Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP), a clinical-stage company focused on promising new therapies in oncology and obesity, today announced broad alignment with the U.S. Food and Drug Administration (FDA) on the registration path for CRB-701, the Company\u2019s next-generation, highly stable Nectin-4 targeting ADC, in head and neck squamous cell carcinoma (HNSCC) and cervical cancer. Corbus also announced that Dr. Dominic Smethurst, MA, &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/corbus-pharmaceuticals-announces-broad-alignment-with-fda-on-registration-path-for-crb-701-in-second-line-hnscc-and-cervical-cancer\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Corbus Pharmaceuticals Announces Broad Alignment with FDA on Registration Path for CRB-701 in Second-Line HNSCC and Cervical Cancer&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-949400","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Corbus Pharmaceuticals Announces Broad Alignment with FDA on Registration Path for CRB-701 in Second-Line HNSCC and Cervical Cancer - Market Newsdesk<\/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:\/\/www.marketnewsdesk.com\/index.php\/corbus-pharmaceuticals-announces-broad-alignment-with-fda-on-registration-path-for-crb-701-in-second-line-hnscc-and-cervical-cancer\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Corbus Pharmaceuticals Announces Broad Alignment with FDA on Registration Path for CRB-701 in Second-Line HNSCC and Cervical Cancer - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"FDA feedback enables Corbus to proceed with proposed registrational study design and endpoints to support potential accelerated approval in second-line HNSCC and cervical cancer Updated CRB-701 monotherapy data accepted for presentation at ASCO 2026 Dr. Dominic Smethurst to step down as Corbus&#8217; Chief Medical Officer on June 30, 2026 NORWOOD, Mass., April 07, 2026 (GLOBE NEWSWIRE) &#8212; Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP), a clinical-stage company focused on promising new therapies in oncology and obesity, today announced broad alignment with the U.S. Food and Drug Administration (FDA) on the registration path for CRB-701, the Company\u2019s next-generation, highly stable Nectin-4 targeting ADC, in head and neck squamous cell carcinoma (HNSCC) and cervical cancer. Corbus also announced that Dr. Dominic Smethurst, MA, &hellip; Continue reading &quot;Corbus Pharmaceuticals Announces Broad Alignment with FDA on Registration Path for CRB-701 in Second-Line HNSCC and Cervical Cancer&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/corbus-pharmaceuticals-announces-broad-alignment-with-fda-on-registration-path-for-crb-701-in-second-line-hnscc-and-cervical-cancer\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2026-04-07T13:27:52+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTY4NDk5NyM3NTIxOTAxIzUwMDExODg0MA==\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"5 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/corbus-pharmaceuticals-announces-broad-alignment-with-fda-on-registration-path-for-crb-701-in-second-line-hnscc-and-cervical-cancer\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/corbus-pharmaceuticals-announces-broad-alignment-with-fda-on-registration-path-for-crb-701-in-second-line-hnscc-and-cervical-cancer\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Corbus Pharmaceuticals Announces Broad Alignment with FDA on Registration Path for CRB-701 in Second-Line HNSCC and Cervical Cancer\",\"datePublished\":\"2026-04-07T13:27:52+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/corbus-pharmaceuticals-announces-broad-alignment-with-fda-on-registration-path-for-crb-701-in-second-line-hnscc-and-cervical-cancer\\\/\"},\"wordCount\":948,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/corbus-pharmaceuticals-announces-broad-alignment-with-fda-on-registration-path-for-crb-701-in-second-line-hnscc-and-cervical-cancer\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=OTY4NDk5NyM3NTIxOTAxIzUwMDExODg0MA==\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/corbus-pharmaceuticals-announces-broad-alignment-with-fda-on-registration-path-for-crb-701-in-second-line-hnscc-and-cervical-cancer\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/corbus-pharmaceuticals-announces-broad-alignment-with-fda-on-registration-path-for-crb-701-in-second-line-hnscc-and-cervical-cancer\\\/\",\"name\":\"Corbus Pharmaceuticals Announces Broad Alignment with FDA on Registration Path for CRB-701 in Second-Line HNSCC and Cervical Cancer - 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(NASDAQ: CRBP), a clinical-stage company focused on promising new therapies in oncology and obesity, today announced broad alignment with the U.S. Food and Drug Administration (FDA) on the registration path for CRB-701, the Company\u2019s next-generation, highly stable Nectin-4 targeting ADC, in head and neck squamous cell carcinoma (HNSCC) and cervical cancer. 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