Henlius says Hetronifly improved survival in advanced non-squamous lung cancer after four years

Shanghai Henlius Biotech says final Phase 3 data from the ASTRUM-002 trial show Hetronifly extended survival in driver gene-negative advanced non-squamous non-small cell lung cancer, with results published in Cancer Communications. The analysis also comes as the drug expands globally, including new European approvals and broader commercial access.

Why it matters: - The final ASTRUM-002 analysis suggests Hetronifly can deliver durable survival benefit in a hard-to-treat lung cancer population. - The data strengthen Henlius’ case for using serplulimab earlier in driver gene-negative advanced non-squamous non-small cell lung cancer. - The results add to the drug’s growing global regulatory footprint and may support future expansion in additional cancer settings.

What happened: - Shanghai Henlius Biotech announced final survival findings for Hetronifly, also known as serplulimab and investigational code HLX10, in first-line treatment of driver gene-negative advanced non-squamous non-small cell lung cancer. - The analysis has been published in Cancer Communications. - The Phase 3 ASTRUM-002 trial enrolled 636 treatment-naïve adults with locally advanced or metastatic non-squamous non-small cell lung cancer without EGFR, ALK or ROS1 alterations. - Patients were randomized into three arms: Hetronifly plus HLX04, Hetronifly plus chemotherapy with bevacizumab placebo, or chemotherapy alone with dual placebo. - The data cutoff was Aug. 7, 2025, with median follow-up approaching four years across study arms.

The details: - Median overall survival was 26.8 months with Hetronifly plus chemotherapy, versus 20.3 months with chemotherapy alone. - The risk of death fell by 34% versus chemotherapy monotherapy, with a hazard ratio of 0.66, 95% CI 0.52-0.83, and P<0.001. - Crossover occurred in 37.6% of control-arm patients, which could dilute the observed survival gap. - After statistical adjustment for crossover, two validated models showed adjusted hazard ratios of 0.53 and 0.62. - At 48 months, 34.0% of patients treated with Hetronifly plus chemotherapy were alive, compared with 16.2% in the chemotherapy-only arm. - Median progression-free survival was 11.0 months with Hetronifly combination therapy and 5.7 months with chemotherapy alone. - The treatment cut the risk of disease progression by 46%. - Confirmed objective response rate reached 52.8% with Hetronifly combination treatment, versus 27.6% with chemotherapy alone. - Median duration of response was 15.4 months with Hetronifly combination treatment and 8.3 months with chemotherapy alone. - Subgroup analyses showed a generally consistent trend toward improved survival, including in patients with PD-L1 TPS at least 50% and patients with brain metastases. - Henlius describes serplulimab as a fully humanized anti-PD-1 monoclonal antibody with a differentiated molecular profile. - Preclinical studies suggest the drug promotes PD-1 internalization on T cells and helps preserve CD28 co-stimulatory signaling.

Between the lines: - The crossover in the control arm matters because it can reduce the apparent size of a survival advantage in randomized trials. - The adjusted hazard ratios point to a potentially stronger treatment effect than the unadjusted comparison alone suggests. - The publication in a high-impact oncology journal gives the findings more visibility among clinicians and researchers. - The trial adds to a broader pattern in which PD-1 therapies continue to move into more frontline solid-tumor settings when paired with chemotherapy.

What's next: - Henlius is continuing a global Phase 3 program for Hetronifly across multiple tumor types and treatment settings. - An international Phase 3 trial of Hetronifly with concurrent chemoradiotherapy for limited-stage small cell lung cancer has completed full enrollment. - Bridging studies for extensive-stage small cell lung cancer in the U.S. and Japan have finished recruitment. - Global Phase 3 ASTRUM-015, testing Hetronifly with bevacizumab and chemotherapy for metastatic colorectal cancer, has completed international enrollment. - Investigator-initiated trials are exploring Hetronifly in perioperative and early-stage non-small cell lung cancer. - In China, Hetronifly has received NMPA approval for five indications since its first approval in March 2022. - In the European Union, Hetronifly is approved for extensive-stage small cell lung cancer, oesophageal squamous cell carcinoma and driver gene-negative advanced non-squamous NSCLC, with the nsqNSCLC approval granted in May 2026 and the sqNSCLC approval secured in June 2026. - Outside China and Europe, the drug has approvals in Switzerland, India and several Southeast Asian markets, including Indonesia, Singapore, Malaysia, Cambodia and Thailand. - Henlius says Hetronifly has been launched in 16 European countries and has secured reimbursement in more than 10 major European markets.

The bottom line: - Final ASTRUM-002 data show Hetronifly can extend survival and delay progression in advanced non-squamous lung cancer, while Henlius keeps pushing the drug into more global markets and more cancer types.