On June 2, 2026 3H Pharmaceuticals reported new clinical data for its wholly owned candidate, 3HP-2827 at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. 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 (Free ASCO Whitepaper) 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.
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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 (Free ASCO Whitepaper) 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.
(Press release, 3H Pharmaceuticals, JUN 2, 2026, View Source [SID1234666385])