SYS-6002

32 Abstracts and Presentations Showcase Cutting-Edge Research at the 2026 ASCO® Annual Meeting 2026 ASCO® Annual Meeting abstracts featuring FCS research: 1073, 1094, 1530, 2629, 3013, 3078, 3088, 3146, 4213, 5511, 5565, 5580, 6062, 7023, 7029, 7532, 7565, 9564, e13044, e16400, TPS11202, TPS2668, TPS2680, TPS3155, TPS3160, TPS3167, TPS3179, TPS5139, TPS5628, TPS5647, TPS8134, TPS8136 FORT MYERS, Fla., May 28, 2026 /PRNewswire/ -- Findings from 32 abstracts and presentations conducted at Florida Cancer Specialists & Research Institute, LLC (FCS) are among the groundbreaking scientific advances in cancer care that will be featured as oncology professionals from around the world gather this week at the 2026 American Society of Clinical Oncology (ASCO®) Annual Meeting in Chicago. Continue Reading Florida Cancer Specialists & Research Institute (FCS) will present findings from 32 abstracts and presentations at the 2026 ASCO® Annual Meeting, showcasing innovative clinical trials, targeted therapies and precision oncology research led by FCS physicians and researchers across Florida. Thirteen physicians and leaders from the statewide practice will present the outcomes of early and late-phase clinical trials performed at FCS Phase 1 Drug Development Units and clinics throughout Florida. Research conducted at FCS is made possible through valuable relationships with Sarah Cannon Research Institute (SCRI), one of the world's leading oncology research organizations conducting community-based clinical trials, Paradigm Health, an AI-enabled clinical trial matching and recruitment platform, and other independent clinical trial programs. FCS Assistant Managing Physician, David Wenk, MD, said, "Our extensive research program is a defining strength of FCS and a vital part of our mission to provide patients with convenient access to world-class cancer care close to home." "The research being presented highlights both innovative treatment strategies and cutting-edge targeted therapies," said FCS Director of Drug Development Manish R. Patel, MD. "Through our ongoing clinical research efforts, we are generating new scientific insights that are advancing precision oncology for patients with a wide range of cancers, including rare and advanced disease." The following FCS principal investigators are first authors on ten abstracts that will be presented throughout the meeting: Lucio Gordan, MD, FCS president & managing physician, Ashley Hernandez, Amanda Warner and Christian Okitondo Patient characteristics, treatment patterns, social determinants of health, and safety in patients prescribed nivolumab and hyaluronidase-nvhy by early adopters. Lowell Hart, MD (Retired) (RW) post-progression outcomes after first-line (1L) treatment with ribociclib + an aromatase inhibitor (AI) vs AI alone in US patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2–) metastatic breast cancer (MBC). Maen Hussein, MD, FCS director of value-based care and Kristin Boykin, FCS senior director, pharmacy operations Evaluating the impact of a statewide intervention on multiple myeloma bispecific T-cell engaging antibody (BsAb) therapy uptake in Florida (FL). Management of chemotherapy-induced adverse events in patients with metastatic pancreatic ductal adenocarcinoma: A US-based modified Delphi consensus. Bradley Monk, MD, FACOG, FACS A pragmatic, hybrid observational study evaluating the effectiveness of trastuzumab deruxtecan (T-DXd) in patients with human epidermal growth factor receptor 2 (HER2) immunohistochemistry (IHC) 3+ solid tumors: DESTINY-PanTumor04. Efficacy prediction for progression-free survival (PFS) and overall survival (OS) by genomic instability score (GIS) cutoffs in patients (pts) with advanced ovarian cancer (aOC): Post hoc results from the phase 3 PRIMA/ENGOT-OV26/GOG-3012 trial. Manish R. Patel, MD A phase 1/2, first-in-human study of AVZO-021, a selective cyclin-dependent kinase 2 inhibitor (CDK2i), as monotherapy and in combination for patients with advanced solid tumors, including hormone receptor–positive (HR+)/human epidermal growth factor receptor 2–negative (HER2−) breast cancer (BC) and cyclin E1 (CCNE1)–amplified solid tumors: Updated safety and efficacy results. A phase 1, first-in-human study of DS9051, a novel targeted protein degradation molecule, in patients with advanced/metastatic adrenocortical carcinoma (ACC) or metastatic castration-resistant prostate cancer (mCRPC). Judy Wang, MD, FCS associate director of drug development, Sarasota Drug Development Unit A first-in-human study of ATX-295, an oral inhibitor of KIF18A, in patients with advanced or metastatic solid tumors, including ovarian cancer. Judy Wang, MD and Cesar Augusto Perez, MD, FCS director of drug development, SCRI at Lake Nona Drug Development Unit Phase 1 dose escalation of CTX-8371, a novel PD-1×PD-L1 bispecific antibody, in patients with advanced malignancies post checkpoint inhibition. The following FCS principal investigators have co-authored 22 additional abstracts and publications of research results and other clinical findings featured throughout the annual meeting: Lucio N. Gordan, MD Real-world patient characteristics, outcomes, and resource utilization of chimeric antigen receptor (CAR) T cell therapy across Foundation for the Accreditation of Cellular Therapy (FACT) and non-FACT treatment centers in large B-cell lymphoma (LBCL).* Lowell Hart, MD (Retired) (RW) post-progression outcomes following first-line (1L) ribociclib (RIB) + aromatase inhibitor (AI) versus AI alone in African American and low socio-economic status (SES) patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2–) metastatic breast cancer (MBC) in US. Maen Hussein, MD, FCS medical director, value-based care TIGOS-LS, an open-label, randomized study of BMS-986489 (atigotatug + nivolumab fixed-dose combination) vs durvalumab as consolidation therapy following chemoradiotherapy in limited-stage small-cell lung cancer. Bradley Monk, MD TroFuse-036/GOG-3123/ENGOT-cx22: A 2-part, phase 3, randomized study of sacituzumab tirumotecan (sac-TMT) + pembrolizumab (pembro) ± bevacizumab (bev) vs standard of care (SoC) as first-line maintenance therapy for PD-L1–positive cervical cancer. Overall survival for patients with pre-treated platinum-resistant ovarian cancer receiving gotistobart in combination with pembrolizumab. Puxitatug samrotecan (AZD8205) vs chemotherapy in patients with B7‑H4–selected advanced/metastatic endometrial cancer: The phase 3 randomized Bluestar‑Endometrial01 (BE01)/GOG-3110/ENGOT-EN28 trial. Manish R. Patel, MD A phase 1, first-in-human study of OP-3136, a novel oral selective KAT6A/B inhibitor, as monotherapy in advanced solid tumors and in combination with endocrine therapy in ER+, HER2− advanced breast cancer (ABC): Preliminary results. A randomized, open-label, phase 3 study of ZL-1310, a DLL3 antibody-drug conjugate (ADC), compared to investigator's choice therapy in participants with relapsed small cell lung cancer (DLLEVATE). BNT326-01: A Phase 1b/2 trial of BNT326/YL202 (HER3 ADC) as monotherapy and in combination with pumitamig (anti-PD-L1 × VEGF bsAb) in patients with advanced solid tumors. Farnesyl transferase inhibitor (FTI) darlifarnib (KO-2806) in combination with adagrasib in KRAS G12C mutated (mut) advanced solid tumors: Preliminary results from the FIT-001 phase 1 first-in-human trial. A phase 3 randomized, open-label study of pasritamig (JNJ-78278343), a T-cell engager targeting human kallikrein-2, with docetaxel versus docetaxel for metastatic castration-resistant prostate cancer. Intismeran autogene to induce de novo neoantigen-specific T cells as adjuvant therapy in melanoma. Shachar Peles, MD, FCS director of cell therapy Fixed-duration subcutaneous (SC) mosunetuzumab (Mosun) in elderly/unfit patients with previously untreated diffuse large B-cell lymphoma (DLBCL): Interim analysis and patient-reported outcomes (PROs) from the phase 2 MorningSun study Ivor Percent, MD Post-hoc efficacy and biomarker analysis of elraglusib plus gemcitabine/nab-paclitaxel versus chemotherapy alone in metastatic pancreatic ductal adenocarcinoma. Cesar Augusto Perez, MD First-in-human study of BG-C9074 (B7-H4–targeting ADC) in advanced solid tumors: Dose escalation and safety expansion. BMS-986504 in patients (pts) with advanced solid tumors with homozygous MTAP deletion (MTAP-del): Exploratory pharmacodynamic (PD) and biomarker analyses from CA240-0007. A phase 1/2, first-in-human, open-label, dose-escalation and -expansion study of TAK-188, a novel antibody-drug conjugate (ADC) targeting CCR8+ regulatory T cells, in adult patients with locally advanced or metastatic solid tumors. A phase 1/2 study of the next-generation nectin-4–targeting antibody-drug conjugate CRB-701 (SYS6002) in patients with recurrent or metastatic head and neck squamous cell carcinoma. Phase I, multicenter, first-in-human (FIH) global study of SIM0505, an anti-CDH6 (CDH6) antibody-drug conjugate (ADC) in patients with advanced solid tumors. First-in-human phase 1a/1b study of LB-LR1109, an anti-LILRB1 monoclonal antibody, as monotherapy in advanced solid tumors and in combination with atezolizumab in advanced NSCLC. Judy Wang, MD A phase 1, first-in-human study of DS5361, a small-molecule, nonsense-mediated mRNA decay (NMD) inhibitor in patients with advanced/metastatic solid tumors (parts 1 and 2). Syed Zafar, MD Durable clinical benefit with B-cell maturation antigen (BCMA)–directed therapy, belantamab mafodotin plus pomalidomide and dexamethasone (BPd) in relapsed/refractory multiple myeloma (RRMM): DREAMM‑8 long‑term responder (LTR) analysis. FCS Chief Executive Officer Ryan Ciarrocchi said, "The ASCO® Annual Meeting highlights the most significant cancer research from around the world, and FCS is proud to once again be recognized among the leaders helping to shape the future of cancer care." All abstracts and presentations are available to view at ASCO® 2026 Annual Meeting. The American Society of Clinical Oncology (ASCO®) represents nearly 50,000 physicians and oncology professionals representing 150 countries who care for people living with all forms of cancer. ASCO® works to conquer cancer through research, education, policy and promotion of high quality and equitable patient care. About Florida Cancer Specialists & Research Institute, LLC: ( FLCancer.com ) For more than 40 years, Florida Cancer Specialists & Research Institute (FCS) has embraced innovation to deliver world-class care and drive the dramatic transformation of oncology care through its robust clinical research program. FCS provides patients with access to a wide range of clinical trials, positioning it as a leader in research among private oncology practices in Florida and across the country. Through its robust clinical research program with Sarah Cannon Research Institute (SCRI) and a suite of independent site management programs, with advanced clinical trial matching technology, FCS offers patients innovative therapies close to home. Each year, FCS conducts more than 180 active clinical trials that directly elevate patient care and accelerate progress in oncology. Many of the cancer drugs approved by the FDA in the U.S over the past decade were accessible to patients at FCS through clinical trial participation before receiving approval. Our outstanding team of highly trained and dedicated physicians is committed to delivering tailored treatment plans that make the best use of cutting-edge precision oncology advancements to enhance patient outcomes. SOURCE Florida Cancer Specialists & Research Institute 21% more press release views with Request a Demo

Data affirms Corbus strategy of targeting tumor types with elevated Nectin-4 expression and clear unmet medical needs while providing an attractive commercial path forward Confirmed ORR of 42.9% observed in 2L oropharyngeal squamous cell carcinoma (OPSCC) at 3.6 mg/kg with median DOR of 6.3 months and PFS of 5.6 months (ongoing) Confirmed ORR of 34.4% observed in 2L cervical cancer at 3.6 mg/kg with median DOR of 8.0 months and PFS of 4.3 months (ongoing) CRB-701 was generally safe and well tolerated with discontinuation rates below 3% About 50% of 2L head and neck cancer cases in the U.S. are HPV-driven OPSCC and receive minimal to no benefit from EGFR-targeted therapies Registrational study of CRB-701 in 2L OPSCC (“TEMPO-1”) on track to initiate in summer 2026 Company to host a conference call and live webcast today, Tuesday, May 26 at 8:00 a.m. EDT, to review the data and a KOL event on Monday, June 1 at ASCO to discuss CRB-701 development in OPSCC NORWOOD, Mass., May 26, 2026 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”) today reported updated data from its Phase 1/2 clinical study ( NCT06265727) of CRB-701 (SYS6002), a next-generation Nectin-4 targeted antibody drug conjugate (ADC). The new data demonstrate robust activity in the second line (2L) setting of two solid tumor types that express high levels of Nectin-4 and are primarily driven by human papilloma virus (HPV): oropharyngeal squamous cell carcinoma (OPSCC) and cervical cancer. These findings will be presented at the upcoming 2026 American Society for Clinical Oncology (ASCO) Annual Meeting being held May 29 – June 2, 2026, in Chicago. The ongoing multi-center Phase 1/2 study is being conducted in the U.S. and Europe. The data reported today derives from an April 1, 2026 data cut of the Phase 1/2 study with a total safety population of 317 patients encompassing all tumor types and all doses. A total of 75 patients with HNSCC were enrolled at the 2.7 mg/kg and 3.6 mg/kg doses, of whom 71 were efficacy evaluable while 4 did not have post-baseline scans. A total of 72 patients with cervical cancer were enrolled at the 2.7 mg/kg and 3.6 mg/kg doses, of whom 70 were efficacy evaluable while 2 did not have post-baseline scans. Safety (n=317) CRB-701 continued to be safe and well tolerated, consistent with findings reported at the ESMO 2025 data cut. The most common treatment-related adverse events (TRAEs) occurring in more than 20% of participants were keratitis (49.2%), alopecia (25.6%), fatigue (22.4%), and dysgeusia (19.9%). Grade 3 adverse events (AEs) were reported in 19.2% of patients, and Grade 4 AEs were reported in 0.9% of patients. There were no Grade 5 events reported. The incidence of peripheral neuropathy remained low at 7.3%, with all events limited to Grade 1 or 2 severity. Skin-related AEs, excluding alopecia, were at 24%. There was only one Grade 3 event (0.3%) reported. There were no skin Grade 4 or 5 events, and no reported cases of Stevens-Johnson Syndrome (SJS) or toxic epidermal necrolysis (TEN). Overall, treatment discontinuations related to CRB-701 remained low at 2.8%. Ocular toxicities, a well-established side effect in multiple approved ADCs, continued to be manageable through prophylactic eye care interventions and dose reductions/interruptions. Ocular AEs were reported in 66.2% of participants, with the vast majority being transient in nature. Grade 3 events were reported in 12.6% of participants and only one Grade 4 event (0.3%) was reported involving exacerbation of pre-existing punctate keratitis and microcysts that resolved to baseline within six weeks. Discontinuations due to ocular AEs remained markedly low at 1.9%. Efficacy in Patients with HNSCC Dosed with CRB-701 at 2.7 mg/kg or 3.6 mg/kg (total n=71) OPSCC (n=41) Dose 2.7 mg/kg (n=20) 3.6 mg/kg (n=21) cORR* 20.0% (4/20) 42.9% (9/21) DCR** 90.0% (18/20) 85.7% (18/21) DoR (months) ongoing 4.8 6.3 PFS (months) ongoing 4.2 5.6 Non-Oropharyngeal HNSCC (n=30) Dose 2.7 mg/kg (n=14) 3.6 mg/kg (n=16) cORR* 7.1% (1/14) 0.0% (0/16) DCR** 57.1% (8/14) 62.5% (10/16) DoR (months) 4.4 NA PFS (months) 2.3 2.7 HNSCC Biomarkers HPV status was determined for 97.3% of the HNSCC participants in the 2.7 mg/kg and 3.6 mg/kg cohorts. In line with published epidemiology, 57.3% of enrolled HNSCC patients were HPV+, with 85.4% of oropharyngeal patients being HPV+. 8 of the 9 patients who achieved PR in the OPSCC cohort were HPV+. In contrast, no confirmed PRs were observed in non-OPSCC HNSCC at the corresponding dose. In-line with published literature, higher Nectin-4 levels were associated with HPV+ HNSCC. In-depth biomarker analysis will be presented at a future conference. *Confirmed objective response rate (cORR) calculated using patients’ confirmed best overall response (BOR) per RECISTv1.1**Disease control rate (DCR) calculated by summing numbers of response-evaluable patients who achieve a BOR of complete response (CR), partial response (PR) or stable disease (SD). Efficacy in Patients with Cervical Cancer Dosed with CRB-701 at 2.7 mg/kg and 3.6 mg/kg Cervical Cancer (n=70) Dose 2.7 mg/kg (n=38) 3.6 mg/kg (n=32) cORR* 18.4% (7/38) including 1 CR 34.4% (11/32) including 2 CRs DCR** 55.3% (21/38) 75.0% (24/32) DoR (months) ongoing 6.8 8.0 PFS (months) ongoing 2.8 4.3 *Confirmed objective response rate (cORR) calculated using patients’ confirmed best overall response (BOR) per RECISTv1.1**Disease control rate (DCR) calculated by summing numbers of response-evaluable patients who achieve a BOR of complete response (CR), partial response (PR) or stable disease (SD). “These data provide important clarity on the clinical and commercial path for CRB-701 in 2L oropharyngeal and 2L cervical cancers, indications that are associated with HPV infection and high expression of Nectin-4, and for which approved and other investigational drugs have shown limited efficacy,” said Yuval Cohen, Ph.D., Chief Executive Officer of Corbus. “In addition, these findings further validate our clinical development strategy aimed at targeting solid tumors outside of metastatic urothelial cancer. We look forward to advancing these programs into registrational trials starting with TEMPO-1, our upcoming OPSCC study initiating this summer.” “OPSCC, which now represents a growing majority of HNSCC cases treated in the U.S., continues to rise in incidence. Largely driven by HPV, OPSCC primarily affects men in their 50s and 60s with little or no history of smoking or heavy alcohol use. Approximately 40-50% of HNSCC patients that reach 2L have OPSCC with persistent, recurrent, or metastatic disease that remains incurable with current treatment options, representing a growing unmet need,” said Glenn J. Hanna, M.D., Director of the Center for Cancer Therapeutic Innovation at Dana-Farber Cancer Institute. “A targeted therapy for this patient population—particularly one directed against the validated target Nectin-4—could represent a significant advance in care. I look forward to seeing how CRB-701 performs in a late-stage clinical study involving this underserved patient population.” Corbus is on track to initiate a registrational study of CRB-701 in 2L OPSCC (“TEMPO-1”) in the summer of 2026. Broad alignment was reached with the U.S. Food and Drug Administration (FDA) on the trial design for a randomized controlled study (n=250), which will explore the efficacy and safety of CRB-701 compared to investigator’s choice of monotherapy with overall response rate (ORR) as the primary endpoint for potential accelerated approval and potential full approval based on overall survival (OS) benefit. Similarly, broad alignment was reached with the FDA regarding the trial design for a randomized controlled study of CRB-701 in 2L cervical cancer. CRB-701 2026 ASCO Data Presentation Details The oral presentation titled, “A phase 1/2 study of the next-generation Nectin-4-targeting antibody drug conjugate CRB-701 (SYS6002) in patients with recurrent or metastatic cervical cancer,” will be presented by Professor Yohann Loriot, Gustave Roussy (Paris) on Friday, May 29 at 4:57 p.m. CDT (Abstract #5508). The poster presentation titled, “A phase 1/2 study of the next-generation Nectin-4-targeting antibody drug conjugate CRB-701 (SYS6002) in patients with recurrent or metastatic head and neck squamous cell carcinoma,” will be presented by Charlene Mantia, M.D., Dana-Farber Cancer Institute (Boston) on Saturday, May 30 at 4:30 p.m. CDT (Abstract #6062/Poster #519). Pre-2026 ASCO Conference Call and Webcast Registration Details Corbus will host a live conference call and webcast today, Tuesday, May 26, 2026, at 8:00 a.m. EDT to review the data. To register for the webcast: click here . Investors Dial 1-877-704-4453 Int’l Investors Dial 1-201-389-0920 Conference ID 13760531 CallMe™: click here 2026 ASCO HNSCC KOL Event Corbus will host an in-person and virtual KOL event during ASCO 2026 to discuss CRB-701 development in OPSCC. The event will be held at Marriott Marquis Chicago starting at 6:30 a.m. CDT on Monday, June 1, 2026 . Date: Monday, June 1, 2026 Time: 6:30 a.m. CDT Location: Marriott Marquis Chicago Participants: Corbus Management Team, joined by leading HNSCC Experts: Ari Rosenberg, M.D., University of Chicago Glenn Hanna, M.D., Dana-Farber Cancer Institute Cesar Augusto Perez Batista, M.D., Sarah Cannon Research Institute A live question-and-answer session will follow the formal presentation. To register for the KOL event, click here . A replay of the event will also be available on the Corbus website. About CRB-701 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 and highly expressed in other tumor types such as cervical and HNSCC. The FDA has granted two Fast Track designations to CRB-701 in HNSCC and cervical cancer. About Corbus Corbus Pharmaceuticals Holdings, Inc. is a clinical-stage company focused on developing 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’ 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 corbuspharma.com . Connect with us on X , LinkedIn and Facebook . Forward-Looking Statements 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 of 1995, as amended, including those relating to the Company's trial results, product development, clinical and regulatory timelines, including timing for completion of trials and presentation of data, anticipated timing for initiation of clinical trials, anticipated regulatory interactions and outcomes, including alignment with FDA on trial design, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities, sufficiency of cash runway 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's current beliefs and assumptions. These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential,” "predict," "project," "should," "would" 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's filings with the Securities and Exchange Commission including those described in our Annual Report on Form 10-K for the year ended December 31, 2025. 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, except as required by law. All product names, logos, brands and company names are trademarks or registered trademarks of their respective owners. Their use does not imply affiliation or endorsement by these companies. INVESTOR CONTACTS : Sean Moran Chief Financial Officer Corbus Pharmaceuticals smoran@corbuspharma.com Dan Ferry Managing Director LifeSci Advisors, LLC daniel@lifesciadvisors.com MEDIA CONTACT : Liz Melone Founder & Principal Melone Communications, LLC Liz@melonecomm.com