Lirafugratinib

First patient was dosed at Samsung Medical Center in Seoul, South Korea; a second at Moffitt Cancer Center in Tampa, Florida Global multi-site study includes locations in U.S., Korea, the UK, Spain, and France Study aims to confirm lirafugratinib’s potential efficacy among patients with FGFR2 fusion/rearrangement independent of tumor type FORT LEE, N.J., June 22, 2026 (GLOBE NEWSWIRE) -- Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, today announced that the first patients were dosed in its global Phase 2 study of lirafugratinib in non-cholangiocarcinoma (CCA) solid tumors with FGFR2 fusion or rearrangement. “Elevar believes lirafugratinib has much potential as a strong anti-tumor therapy across a wider range of FGFR2 fusion or rearrangement driven tumors. We are committed to do our best to obtain meaningful study results to present to the FDA,” said Dong-Gun Kim, chief executive officer of Elevar. “We are pleased that the first patients have been dosed and we look forward to completing enrollment.” The trial, known as ReFocus202 (Protocol ID ELE-4008-202; NCT07359820 ), is an open-label, single-arm study evaluating the efficacy and safety among a broad scope of tumors containing an FGFR2 fusion or rearrangement. The primary endpoint is objective response rate. The first patient was dosed at Samsung Medical Center in Seoul, South Korea, and a second patient at Moffitt Cancer Center in Tampa, Florida. The multi-site study is set to take place in the U.S., Korea, the UK, Spain, and France. “Patients with advanced solid tumors harboring FGFR2 fusions or rearrangements often have limited treatment options, particularly beyond cholangiocarcinoma,” said Dr. Richard Kim, ReFocus202 principal investigator and service chief of medical gastrointestinal oncology at Moffitt Cancer Center. “This study gives us an important opportunity to better understand whether selective FGFR2 inhibition with lirafugratinib can benefit a broader group of patients whose tumors are driven by FGFR2 alterations. I am pleased that our team was able to enroll the first patient in the U.S. and contribute to this important effort.” Lirafugratinib received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration (FDA) for CCA. Priority review of its new drug application for the treatment of patients with CCA with FGFR2 fusion/rearrangement who have received prior therapy is ongoing by the FDA, which set a Prescription Drug User Fee Act date of Sep 27, 2026. ReFocus202 aims to confirm the tumor-agnostic potential of lirafugratinib in patients with FGFR2 fusion/rearrangement. In the Phase 1/2 ReFocus study, data from 42 non-CCA solid tumor patients with FGFR2 fusion/rearrangement (13 tumor types) showed meaningful antitumor activity of lirafugratinib. Elevar plans to leverage that dataset, along with data generated under ReFocus202, to conduct an interim analysis across at least seven tumor types with at least five patients per tumor type. For more information about lirafugratinib, visit ElevarTX.com . About Lirafugratinib Lirafugratinib (RLY-4008) is a potent, selective, and oral small molecule inhibitor of FGFR2, a receptor tyrosine kinase that is frequently altered in certain cancers. FGFR2 is one of four members of the FGFR family, a set of closely related proteins with highly similar protein sequences and properties. Preclinically, lirafugratinib demonstrated FGFR2-dependent killing in cancer cell lines and induced regression in in vivo models with minimal inhibition of other targets, including other members of the FGFR family. In addition, lirafugratinib demonstrated strong activity against known clinical on-target resistance mutations in vitro and in vivo preclinical models. Lirafugratinib is currently being evaluated in a clinical trial to enroll additional patients with previously treated, advanced or metastatic solid tumors other than CCA harboring FGFR2 fusion or rearrangement, who have not been treated with prior FGFR inhibitors. About Elevar Therapeutics Elevar Therapeutics, Inc. is a fully integrated biopharmaceutical company built on the promise of elevating treatment outcomes for patients who have limited or inadequate therapeutic options. A subsidiary of HLB Group based in Fort Lee, New Jersey, Elevar’s expertise is rooted in oncology and grounded in compassion. Our team of experienced scientists and industry leaders is highly focused on identifying and developing medicines for complex yet under-treated health conditions, with a shared goal of making a meaningful difference in the lives of patients. For more information, follow us on LinkedIn and Twitter or visit ElevarTX.com. Media Contact: Rosemary Ostmann RoseComm Cell: (201) 615-7751

CHICAGO, June 2, 2026 /PRNewswire/ -- At the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, 3H Pharmaceuticals released new clinical data for its wholly owned candidate, 3HP-2827. The ongoing study focuses on patients with advanced cholangiocarcinoma (CCA) and other solid tumors carrying FGFR2 alterations—an area of persistent and significant unmet need. The data showed that 3HP-2827, a highly selective FGFR2 inhibitor, demonstrated encouraging anti-tumor activity in patients with advanced CCA driven by FGFR2 fusions or rearrangements, as well as notable tumor shrinkage in FGFR2-mutated solid tumors. On May 31 in Chicago, on the sidelines of the ASCO meeting, eChinaHealth spoke with Academician Zhou Jian, President of Zhongshan Hospital, Fudan University. He shared his views on the current treatment landscape for FGFR2-altered CCA, the clinical profile and future potential of 3HP-2827, and the prospects for further advances in the field. Continue Reading 3HP-2827 Brings New Hope to Patients with Advanced CCA Harboring FGFR2 Alterations Speed Speed Academician Zhou noted that CCA is a highly aggressive cancer, with incidence rising in both China and worldwide. For patients with advanced disease, the prognosis is extremely poor—even worse than for hepatocellular carcinoma. Currently, the standard first-line treatment for advanced CCA remains chemotherapy plus immunotherapy. In recent years, however, a growing number of new approaches have emerged. Drugs targeting IDH1 and FGFR, for instance, have already received approval. At this year's ASCO Annual Meeting alone, more than 80 abstracts on CCA were presented, with FGFR2-targeted therapy emerging as a particularly active area of research. Earlier studies have validated the efficacy of FGFR2 inhibition in CCA, and as these targeted agents are refined, the efficacy data continue to improve. Looking ahead, FGFR2-directed therapy is expected to play a larger role in the treatment of advanced CCA, offering patients more precise and effective options. 3HP-2827, a novel and highly selective FGFR2 inhibitor, is being evaluated in a multicenter clinical study in China led by Academician Fan Jia and Professor Shen Lin, with RLY-4008 as the active comparator. To date, the efficacy of 3HP-2827 appears comparable to the early-stage clinical results reported for RLY-4008, and both agents have shown superior efficacy compared with pan-FGFR inhibitors. In addition, 3HP-2827 has demonstrated a favorable safety profile. Of note, the patient population in the current study was more heavily pretreated: 80% of patients had previously received an immune checkpoint inhibitor (ICI) in combination with chemotherapy, and 60% had undergone prior anti-angiogenic therapy. Additional clinical data will be important to further evaluate the potential of this approach. Based on available data, both RLY-4008 and Pemigatinib have shown greater efficacy in the first-line treatment of advanced CCA than in the second-line setting. The latest data for single-agent RLY-4008 show an objective response rate (ORR) of 46.5% among 144 second-line patients, while the ORR reached 63.6% in a small cohort of 11 first-line patients—though the limited sample size in the first-line group requires cautious interpretation and further validation. For Pemigatinib, prior phase II and the most recent phase III data report an ORR of 35.5% in 146 second-line patients and 47.0% in 83 first-line patients. To date, 3HP-2827 has generated preliminary efficacy evidence in the second-line setting. Evaluating its single-agent activity in the first-line setting to pursue a first-line indication represents an important next step. Academician Zhou said he expects the future first-line treatment paradigm for CCA to shift toward a multi-drug, multi-modality combination approach integrating chemotherapy, immunotherapy and targeted therapy. Such a strategy, he noted, is scientifically sound and could improve both treatment efficacy and patient outcomes. From a safety perspective, the main adverse reactions linked to 3HP-2827 are FGFR2-related toxicities affecting the skin and mucosa — a profile distinct from that of chemotherapy or immunotherapy. That difference suggests a low risk of overlapping toxicity when used in combination, supporting the potential for 3HP-2827 to be added to existing regimens. In addition, among patients with FGFR2 fusion- or rearrangement-driven CCA treated with 3HP-2827, two achieved complete disappearance of target lesions, and the majority experienced substantial tumor shrinkage. Because most CCA patients are no longer candidates for surgery at initial diagnosis, the pronounced tumor-shrinking effect of 3HP-2827 opens the door to exploring conversion therapy in the future — using preoperative single-agent treatment to downstage tumors and expand the pool of patients eligible for curative resection. Currently, most FGFR2-targeted agents in clinical development are aimed at CCA patients with FGFR2 fusions or rearrangements. In contrast, patients with FGFR2-mutated solid tumors have few options, with no approved therapies to date. FGFR2 mutations occur across a wide range of solid tumors — including biliary tract cancers, gynecologic malignancies, melanoma, colorectal cancer, lung cancer, gastric cancer and urothelial carcinoma — representing a patient population larger than that of FGFR2 fusions or rearrangements. The longstanding lack of a targeted treatment for this group highlights a significant unmet medical need. The activity observed with 3HP-2827 suggests a potential new treatment approach for these patients. The clinical data released by 3H Pharmaceuticals at the meeting showed that among patients with FGFR2-mutated solid tumors, 3HP-2827 achieved a best objective response rate (ORR) of 57.1% and a disease control rate (DCR) of 100%. Although the number of enrolled patients remains small at this stage, the cohort already includes multiple clinically relevant FGFR2 mutation sites, including N549K, Y375C, C382R and F276C. Looking ahead, the clinical development program for 3HP-2827 should continue to gather additional data in FGFR2-mutated solid tumors and initiate a multi-histology basket trial, with the goal of further evaluating its potential in this patient population. In the interview, Academician Zhou Jian of Zhongshan Hospital, Fudan University, discussed the latest clinical data on 3HP-2827, a highly selective FGFR2 inhibitor, in patients with FGFR2-altered advanced CCA and other solid tumors. He noted that while chemotherapy plus immunotherapy remains the current standard first-line treatment for advanced CCA, FGFR2-targeted therapy is emerging as an important precision medicine approach. Looking ahead, Zhou recommended pursuing first-line treatment studies, combination therapy regimens and basket trials targeting FGFR2 mutations — strategies that could further expand the reach of precision oncology. Note: 3HP-2827 is a highly selective FGFR2 inhibitor independently developed by 3H Pharmaceuticals. It works by specifically inhibiting FGFR2 phosphorylation, blocking the FGFR2 signaling pathway and producing anti-tumor activity. The drug is designed to offer a more effective and better-tolerated treatment option for patients with FGFR2 alterations, especially those who have developed resistance to prior therapies. About Academician Zhou Jian Academician Zhou Jian is a member of the Chinese Academy of Sciences and a leading authority in hepatobiliary oncology and liver transplantation. He currently serves as President of Zhongshan Hospital, Fudan University, and Executive Deputy Director of the Liver Cancer Institute at Fudan University. He holds numerous prestigious academic appointments, including Executive Chair of the National Health Commission's Expert Committee for the Guidelines on the Diagnosis and Treatment of Primary Liver Cancer, President of the Chinese Society of Oncology for the Chinese Medical Association, Chairman of the Asia-Pacific Primary Liver Cancer Expert (APPLE) Association, and Chairman of the Chinese Society of Clinical Oncology (CSCO) Expert Committee on Hepatocellular Carcinoma. He also serves on the Executive Council of the Asian Pacific Association for the Study of the Liver (APASL) and is Vice President and Secretary-General of the Chinese College of Surgeons, Chinese Medical Doctor Association. Recognized as one of China's leading physician-scientists, he has been honored with a National Science Fund for Distinguished Young Scholars award, a Chang Jiang Distinguished Professorship from the Ministry of Education, and a National "Ten Thousand Talents Program" designation as a Leading Talent in Scientific and Technological Innovation. He is a five-time recipient of the National Science and Technology Progress Award, having served as the principal investigator for one award and as a co-principal investigator for two others. Academician Zhou has authored or co-authored over 154 peer-reviewed articles as first or corresponding author in journals such as The Lancet, The New England Journal of Medicine, Cell, Journal of Clinical Oncology, The Lancet Gastroenterology & Hepatology, The Lancet Oncology, Signal Transduction and Targeted Therapy, and Cell Research, earning an H-index of 100. Contact: Li Hao [email protected] SOURCE 3H Pharmaceuticals 21% more press release views with Request a Demo