HUTCHMED will take a multi-asset slate to ESMO Asia and ASH in early December, flagging new and updated readouts across fruquintinib, savolitinib, surufatinib, sovleplenib, and the first-in-human anti-CD47 antibody HMPL-A83. No efficacy metrics were disclosed ahead of the meetings, but the company is positioning several programs on a registration or label-expansion track, with a final long-term analysis from the Phase 3 ESLIM-01 study of sovleplenib in chronic ITP set as the hematology anchor.
The core event is a coordinated conference push spanning oncology and hematology. At ESMO Asia, HUTCHMED will show Phase 2 results from the FRUSICA-2 registration program in second-line RCC, data from a first-in-human dose-escalation of HMPL-A83 in advanced solid tumors, and an update from a Phase 2/3 study of surufatinib plus camrelizumab with nab-paclitaxel/gemcitabine in first-line metastatic pancreatic cancer. The thoracic track includes multiple analyses tied to the savolitinib plus osimertinib strategy for EGFR-mutant NSCLC with acquired MET amplification or overexpression, including PROs from the Phase 3 SACHI trial and methodologic work on MET testing by FISH and NGS. At ASH, the final long-term efficacy and safety analysis from ESLIM-01 in ITP rounds out the set.
Strategically, the cadence signals a portfolio designed around four levers: angiogenesis and angio‑immuno blockade (fruquintinib, surufatinib), MET-driven resistance (savolitinib combinations), innate immunity modulation (CD47), and autoimmune hematology (sovleplenib). FRUSICA-2’s positioning as a registration study indicates intent to extend fruquintinib beyond colorectal cancer, potentially aligning with Takeda’s ex‑China rights to drive a broader global label. The savolitinib posters focus on the enabling infrastructure—patient-reported outcomes against chemotherapy and assay concordance for MET amplification—suggesting HUTCHMED and its partner are preparing the evidentiary and operational groundwork as much as the efficacy narrative.
RCC is the most direct lifecycle test for fruquintinib. The program appears to explore both monotherapy and PD-1 combination paths, a sign the team is hedging against increasingly crowded second-line options that include VEGFR TKIs and TKI–mTOR combinations. For sponsors and CROs, the trial design choice will dictate cost and complexity: monotherapy could be faster with lower operational friction at community sites, while combinations will demand tighter immune-related safety monitoring and potentially narrower eligibility. Any clean safety profile will matter as sponsors weigh sequencing against current regimens where tolerability drives persistence as much as tumor control.
In EGFR-mutant NSCLC after osimertinib, the savolitinib combination hinges less on response rate and more on practicalities of patient identification and regulatory acceptance of biomarker definitions. Parallel presentations on PROs, progression patterns, and assay methodology point to an effort to lock down cutoffs and cross-platform reproducibility between FISH and NGS. Sites should expect protocolized reflex testing and re-biopsy logistics to become more prescriptive; screen failure rates and turnaround times will be as pivotal to success as the clinical effect size. Regulators will scrutinize whether diagnostic approaches are harmonized enough to support broad label language.
The HMPL-A83 first-in-human readout will be judged on hematologic safety and mitigation of on-target anemia, long a class bottleneck for CD47 agents. Unless a clear safety window emerges, combination ambitions will be hard to operationalize. In pancreatic cancer, surufatinib layered onto PD‑1 plus gem/nab‑paclitaxel is an aggressive strategy in a setting where IO combinations have struggled. The bar is durability with manageable toxicity; otherwise the regimen risks being operationally heavy without clear differentiation versus current first-line standards.
The sovleplenib long-term Phase 3 analysis could be the most actionable dataset for near-term practice and policy. Sustained platelet responses, steroid-sparing effects, and a clean infection signal would support chronic use and payer adoption, while informing monitoring schedules that sites can implement without excessive clinic load.
What to watch next is less the headline numbers than the scaffolding around them: clarity on FRUSICA-2’s registrational path and geographic scope with Takeda, a consistent and regulator-ready MET testing algorithm that sites can run at scale, evidence that HMPL-A83 can clear class safety hurdles, and whether sovleplenib’s durability translates into guideline traction. The operational winners will be programs that minimize diagnostic friction, keep AE management predictable, and fit within site bandwidth already stretched by biomarker-driven workflows.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
