更长随访持续获益！复宏汉霖抗EGFR单抗HLX07联合H药一线治疗EGFR高表达鳞状NSCLC更新数据公布

Henlius Announces Updated Follow-up Results of Anti-EGFR MAb HLX07 Combined with Serplulimab in First-Line Treatment of EGFR-High Squamous NSCLC

Shanghai, November 2, 2025 — Henlius (2696.HK) announced the latest follow-up results of its independently developed recombinant anti-EGFR mAb HLX07 in combination with the anti-PD-1 mAb serplulimab (trade name in Europe: Hetronifly^®) for the first-line treatment of EGFR-high advanced or metastatic squamous non-small cell lung cancer (sqNSCLC) at the 2025 International Summit on Frontiers and Innovations in Lung Cancer. In September 2025, the company presented 18.6-month median follow-up data from this Phase 2 dose-exploration study at the World Conference on Lung Cancer (WCLC). The newly updated analysis, at a median follow-up of 23.5 months, showed that the combination maintained consistent efficacy and safety outcomes, further confirming its durable clinical-benefit potential in EGFR-high sqNSCLC.

EGFR-High Population: A Large Yet Underserved Clinical Gap

Globally, EGFR-high is observed in approximately 40% to 89% of NSCLC patients, depending on histology and ethnicity, representing millions of new cases each year.^1-3 The prevalence is even higher in sqNSCLC—approaching 90%.^1,2 Importantly, EGFR-high does not equate to EGFR-sensitizing mutations, as the correlation between the two is low. ⁴ Classic sensitizing EGFR mutations are rare in sqNSCLC overall. ⁵ Consequently, most EGFR-high sqNSCLC patients lack sensitizing EGFR mutations and thus derive little benefit from EGFR-TKI (tyrosine kinase inhibitor) therapies. ⁵

Currently, the standard first-line regimen for advanced or metastatic sqNSCLC is PD-(L)1 inhibitor combined with chemotherapy. However, none of these pivotal studies stratified patients by EGFR expression, leaving treatment responses in the EGFR-high population largely unexplored. This subgroup still lacks biomarker-driven precision treatment options; clinical practice continues to rely on non-stratified empirical regimens, and therapeutic responses may vary widely.

Mechanistic Synergy: Dual-Target Coordination for Complementary Benefit

Cetuximab, one of the first EGFR-targeted mAbs approved for colorectal and head-and-neck squamous cell carcinomas, has not been approved for first-line lung cancer treatment. ^6-9 By contrast, Henlius’ HLX07 features lower immunogenicity and higher target affinity. Fc region engineering significantly prolongs its half-life, enabling once-every-three-weeks administration that aligns well with immunotherapy dosing intervals—improving treatment convenience and supporting sustained synergistic antitumor activity. Preclinical studies have shown that HLX07 demonstrates superior bioactivity, inhibiting tumour cell growth across multiple models and displaying strong synergy with serplulimab. ¹⁰ As the first anti-PD-1 mAb approved globally for first-line extensive-stage small cell lung cancer (ES-SCLC), serplulimab now reaches nearly half the world’s population. The combination of HLX07 and serplulimab blocks EGFR signalling while activating immune responses simultaneously, showcasing substantial potential for dual-mechanism synergy.

Encouraging Clinical Signals with Manageable Safety

The HLX10HLX07-sqNSCLC-201 trial is a randomized, multicentre Phase 2 dose-exploration study consisting of four parts evaluating multiple combinations of HLX07 (different doses), serplulimab, and chemotherapy. Part III assessed the preliminary efficacy of the triple combination in treatment-naïve patients with EGFR high expression (H-score ≥ 150). Participants were randomized 1:1 to receive either 800 mg or 1000 mg of HLX07 plus serplulimab and chemotherapy every three weeks.

At the latest 23.5-month median follow-up, both dose groups achieved approximately 70% objective response rates (ORR) and > 90% disease control rates (DCR), consistent with the 18.6-month data. The median progression-free survival (PFS) was 17.4 months in the high-dose group, while the median PFS for the low-dose group was not reached; median overall survival (mOS) and median duration of response (mDOR) were not yet reached in either group. These findings indicate that the combination’s benefits are not only pronounced early but also sustained over time, further supporting its potential clinical value for EGFR-high sqNSCLC.

Most treatment-emergent adverse events (TEAEs), such as rash, were manageable and consistent with previous observations, with no new safety signals identified.

Detailed Data

As of July 31, 2025, 27 patients had been enrolled and randomized to Part III of the study: 13 in Arm A and 14 in Arm B. Patients received HLX07 at 800 mg (Arm A) or 1000 mg (Arm B) plus 300 mg serplulimab and chemotherapy every three weeks. Fifteen patients (55.6%) had metastatic sqNSCLC. The median follow-up was 23.5 months.

By blinded independent central review (BICR) assessment per RECIST v1.1, confirmed ORR was 69.2% (95% CI 38.6–90.9) in Arm A and 71.4% (95% CI 41.9–91.6) in Arm B. Disease control rates were 92.3% (95% CI 64.0–99.8) and 100% (95% CI 76.8–100.0), respectively. Median PFS was not reached in Arm A and 17.4 months (95% CI 8.1–NE) in Arm B. Median OS and mDOR were not reached in either arm as of data cutoff. All patients experienced TEAEs, with grade ≥ 3 events mainly including skin reactions and electrolyte imbalances; no new safety signals were observed compared with similar agents.

Henlius continues to advance its lung-cancer portfolio—from serplulimab, which pioneered immunotherapy in small cell lung cancer (SCLC), to a diverse pipeline including HLX43 and HLX07 targeting multiple molecular subtypes of NSCLC. The company is building a differentiated and comprehensive immuno-oncology product matrix that addresses the needs of broad patient populations. The extended follow-up results from this study further validate the feasibility of combining EGFR targeted therapy with immunotherapy and offer new insights and hope for personalized treatment in EGFR-high sqNSCLC.

媒体：PR@Henlius.com

投资者：IR@Henlius.com