Pemigatinib

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

iStock, Iryna Olkhova Partners Summit Therapeutics and Akeso are expected to steal the show at the American Society of Clinical Oncology’s annual conference with data from their potential Keytruda rival, alongside Revolution Medicine’s groundbreaking pancreatic cancer candidate and other assets that could reshape patient care. The upcoming American Society of Clinical Oncology annual conference will showcase data that could move the needle for some hard-to-treat cancers and those for which advances have been dormant for decades. Some 40,000 attendees from around the world will gather from May 29 to June 2 at Chicago’s McCormick Place Convention Center to present and discuss the latest innovations in cancer care. The 2026 ASCO meeting will include more than 7,000 abstracts, with studies exploring cutting-edge therapies that experts say could reshape the industry and patient care. “ASCO 2026 is shaping up to be one of the most exciting meetings in years for gastrointestinal oncology,” Allyson Ocean, a medical oncologist at NewYork-Presbyterian and Weill Cornell Medicine, told BioSpace in an email. “For pancreatic cancer specifically, there is a palpable sense at this year’s ASCO that we may be entering a fundamentally different era.” Elsewhere, experts are awaiting data on bispecific antibodies, as well as potentially practice-changing presentations in prostate, lung and blood cancers. Pancreatic cancer in the spotlight Heading into ASCO 2026, all eyes are on Revolution Medicines and pancreatic cancer . The company scored a plenary session spot at the conference for the Phase III RASolute 302 trial, evaluating its RAS inhibitor daraxonrasib against chemotherapy in previously treated patients with metastatic pancreatic ductal adenocarcinoma (PDAC). Revolution stunned the cancer world last month when topline data revealed that the pill nearly doubled overall survival , an unprecedented win in a disease with just a 13% 5-year relative survival rate. “This is a huge moment in pancreas cancer,” said Meredith Pelster, associate director of Gastrointestinal Cancer Research at Sarah Cannon Research Institute, who is an investigator on the RASolute trial but not an author on the plenary abstract. “You can feel the excitement.” Daraxonrasib is an oral drug that targets RAS mutations, common in PDAC, non-small cell lung cancer (NSCLC) and colorectal cancer. Patients in RASolute taking daraxonrasib had a median overall survival of 13.2 months, compared to 6.7 months for those on chemotherapy, according to Revolution’s press release . The company’s shares rallied 40% the day of the announcement. Additional RASolute data will be presented on Sunday, and experts are eager for information on the depth of the response, results based on patients’ specific mutations, and more. Pelster is looking to learn more about toxicities, after earlier data showed that the vast majority of patients developed a rash and around 30% had serious side effects. “We just want to understand that, so that we can counsel the patients and know how to manage it appropriately,” Pelster told BioSpace in an interview. Pancreatic cancer Can Revolution’s ‘miracle’ pancreatic cancer drug be topped? Immuneering, Actuate say yes Last month, Revolution Medicines’ RAS inhibitor doubled survival in a Phase 3 pancreatic cancer trial. On the biotech’s heels are Immuneering, Actuate Therapeutics, Erasca and more, looking to improve on that result with increased tolerability—and more time for patients. May 18, 2026 · 7 min read · Heather McKenzie Read more Adding to the buzz around the gastrointestinal space is the deployment of blood tests for circulating tumor DNA (ctDNA) to help manage patient care. A notable late-breaker will discuss the CIRCULATE trial, which tested using ctDNA to guide decisions for adjuvant treatment in stage II colon cancer. The strategy could spare some patients unnecessary chemotherapy while flagging others who might need more treatment, Ocean said. This year’s ASCO reflects a broader shift toward biomarker-driven precision oncology for gastrointestinal cancers, Ocean said. Other anticipated presentations in the space include trials looking at Pfizer’s Braftovi plus cetuximab and chemotherapy in colorectal cancer, Shanghai KeChow Pharma ’s Tunlametinib plus vemurafenib in colorectal cancer, and Incyte’s Pemazyre in bile-duct cancer. Bispecifics and HARMONi-6 For Leerink Partners analyst Daina Graybosch, the focus is on bispecific antibodies, particularly the Keytruda rival ivonescimab, in development by Summit Therapeutics and its Chinese partner Akeso. Akeso’s closely watched Phase III trial HARMONi-6 also claimed a spot in ASCO’s plenary session. The trial puts the PD-1/VEGF bispecific ivonescimab plus chemotherapy up against BeOne Medicines’ Tevimbra plus chemotherapy as first-line treatment for patients with advanced squamous NSCLC. The session comes on the heels of positive progression-free survival (PFS) data presented at the European Society for Medical Oncology Congress in October 2025. Median PFS was 11.14 months for patients treated with the ivonescimab combo compared to 6.9 months in the comparator group. “The big debate is, what does this look like in overall survival?” Graybosch, senior managing director of immuno-oncology at Leerink, said in an interview with BioSpace . That answer will help determine where ivonescimab and other bispecifics fit in the treatment landscape, she said. “For me, it’s: How much better than Keytruda is it going to be?” Graybosch added. “Then, what does that mean in terms of who is going to have sustainable revenues from a bispecific?” Ivonescimab has the potential to shake up the therapeutic status quo, in which Merck’s blockbuster PD-1 inhibitor Keytruda currently reigns supreme. The asset grabbed attention when it bested Keytruda i n a China-only trial in 2024 in advanced NSCLC. But more recent global trials have missed their marks on PFS overall survival, tempering expectations and raising questions about ivonescimab’s global potential. Lung Cancer Summit’s Bispecific Misses Survival Endpoint in Global Phase III Trial but Analysts Remain Optimistic Despite mixed results, analysts maintained faith in ivonescimab’s ability to cross over between Eastern and Western patient populations. May 30, 2025 · 3 min read · Nick Paul Taylor Read more This puts even more pressure on the overall survival data for HARMONi-6, a China-only trial, that will be presented this weekend, Graybosch said. “If you believe that the data is going to degrade in effect from China to a global study, you need to see a really impressive result in China.” Other companies are also showcasing data on PD-1/VEGF bispecifics this weekend. Bristol Myers Squibb and BioNTech have Phase 2 data in NSCLC and Phase 2/3 data in colorectal cancer for their bispecific PD-1/VEGF-A inhibitor pumitamig. Pfizer, meanwhile, has updated Phase 2 data for its PD-1/VEGF bispecific antibody in patients with NSCLC. Practice-changing potential In addition to RASolute302 and HARMONi-6, the other plenary session slots at this year’s ASCO have the potential to shift practice for both common and rare cancers, experts said. One such trial could help determine whether oncologists should add Johnson & Johnson’s androgen receptor inhibitor ERLEADA before and after surgery for patients with high-risk localized prostate cancer. The LIBRETTO-432 trial will analyze event-free survival with Eli Lilly’s Retevmo in stage IB-IIIA RET fusion-positive NSCLC in the adjuvant setting, to see whether the drug should move from advanced to earlier-stage disease. And the Phase III SARC041 trial is testing Lilly’s CDK4 inhibitor Verzenio in a rare, difficult-to-treat sarcoma called dedifferentiated liposarcoma (DDLS). Another notable late-breaker with the potential to change practice is a Phase III study of Incyte’s anti-CD19 monoclonal antibody Monjuvi/Minjuvi plus lenalidomide and R-CHOP chemotherapy vs. current R-CHOP standard of care in newly diagnosed patients with diffuse large B cell lymphoma (DLBCL). “The first-line treatment of diffuse large B cell lymphoma has not been changed for a couple of decades,” Andres Sirulnik, head of the Hematology Clinical Development Unit at Regeneron, told BioSpace . “People are waiting to see the results.” Regeneron is presenting its own data in frontline DLBCL, an early readout of its bispecific antibody Ordspono plus chemotherapy in the Phase III OLYMPIA-3 trial. The treatments could offer patients a shorter, less cumbersome regimen, Sirulnik said. “We are hoping that this also will translate to better outcomes.”