Two new indications for Hetronifly (serplulimab) in esophageal and lung cancer expand the European footprint of Shanghai Henlius Biotech’s anti-PD-1 antibody, which the European Commission has now approved for use across two distinct first-line solid tumor settings.
The EC granted marketing authorization for Hetronifly (serplulimab) in combination with fluoropyrimidine- and platinum-based chemotherapy for adult patients with unresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 at a combined positive score (CPS) of 5 or greater. A second indication covers serplulimab combined with carboplatin and pemetrexed for the first-line treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (nsNSCLC) in adults without EGFR or ALK/ROS1 mutations who are ineligible for local therapy with curative intent. Both indications extend across all EU member states and the broader European Economic Area.
The EC decisions were supported by two randomized, double-blind, multicenter Phase III trials. In ESCC, serplulimab combined with cisplatin and 5-fluorouracil met its pre-specified primary endpoint versus chemotherapy alone in previously untreated locally advanced or metastatic disease. In nsNSCLC, serplulimab added to carboplatin and pemetrexed similarly met its primary endpoint compared with chemotherapy in treatment-naive advanced disease. The company reported that both combinations demonstrated acceptable safety and tolerability profiles, though trial identifiers were not disclosed in the regulatory announcement.
The two approvals place serplulimab in direct competition with pembrolizumab (Keytruda, MSD), which holds EC authorization in both settings using overlapping regimens. In ESCC, pembrolizumab is approved at a higher PD-L1 threshold of CPS 10 or greater, meaning serplulimab’s CPS 5 cutoff could broaden the eligible patient population. In nsNSCLC, pembrolizumab combined with pemetrexed and platinum chemotherapy represents the established standard of care for the same biomarker-unselected, mutation-negative population that serplulimab now targets.
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