Henlius reports positive results from ASTRIDE U.S. bridging study for serplulimab in combination with chemotherapy for first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC)

Serplulimab shows longer survival than atezolizumab in U.S. ES-SCLC trial data.

What the company is saying

Shanghai Henlius Biotech, Inc is highlighting positive results from the ASTRIDE trial, which compared serplulimab plus chemotherapy to atezolizumab plus chemotherapy for first-line treatment of extensive-stage small cell lung cancer (ES-SCLC) in the United States. The company emphasizes that serplulimab achieved a median overall survival of 12.4 months versus 10.2 months for atezolizumab, despite a higher proportion of patients with liver metastasis (49.5% vs 40.0%). One- and two-year overall survival rates favored serplulimab (52.4% and 32.2%) over atezolizumab (41.4% and 17.6%). The announcement stresses the consistency of these results with the global ASTRUM-005 phase 3 trial, and frames the findings as supporting serplulimab’s clinical benefit and applicability to U.S. patients. Executive remarks from Dr. David R. Gandara and Dr. Jason Zhu reinforce the clinical significance and potential for broader adoption. The company also notes that serplulimab is already approved in over 50 countries and included in reimbursement systems in more than 10, including Germany, Italy, and Spain, and has received FDA orphan-drug designation.

What the data suggests

The ASTRIDE trial enrolled 201 patients at 63 U.S. sites between 2022 and 2025, with a median follow-up of 14.1 months as of February 18, 2026. The serplulimab group had a higher baseline risk, with 49.5% of patients having liver metastasis compared to 40.0% in the atezolizumab group. Median overall survival was 12.4 months for serplulimab and 10.2 months for atezolizumab (hazard ratio 0.82, 95% CI 0.56–1.20). One-year OS rates were 52.4% for serplulimab and 41.4% for atezolizumab; two-year OS rates were 32.2% and 17.6%. Among patients with no prior chemotherapy, median OS was 13.4 months (serplulimab) and 10.8 months (atezolizumab), HR 0.77 (95% CI 0.50–1.17). Median progression-free survival was 5.4 months (serplulimab) and 4.9 months (atezolizumab). Objective response rates were similar (65.7% vs 67.0%), as were median durations of response (4.2 vs 4.0 months). Grade ≥3 treatment-emergent adverse events occurred in 73.7% (serplulimab) and 73.0% (atezolizumab), with drug-related grade ≥3 events in 20.2% and 25.0%, and immune-related adverse events in 21.2% and 23.0%. The trial included 5% Black or African American and 4.5% Hispanic or Latino patients. These results are consistent with the global ASTRUM-005 trial, which enrolled 585 subjects from 114 sites in countries including Poland, Georgia, and China, and met its primary endpoint in December 2021.

Analysis

The announcement is primarily a factual disclosure of realised clinical trial results from the ASTRIDE study, with comprehensive numerical data on efficacy and safety endpoints. Nearly all key claims are supported by hard data, including patient numbers, survival rates, and adverse event rates. The only forward-looking statements are general references to 'potential benefit' and 'commitment to finding better treatment options,' which are standard and not materially exaggerated. There is no evidence of narrative inflation or overstatement: the language is proportionate to the results, and no large capital outlay or speculative commercial projections are discussed. However, as is typical for clinical trial updates, there is no financial or profitability data disclosed, so the true_signal cannot exceed weak_positive. The gap between narrative and evidence is minimal, with the data fully supporting the claims.

Risk flags

• ●No formal hypothesis testing for superiority or noninferiority was planned in the ASTRIDE trial, so statistical significance of the observed survival benefit is not established, which may limit regulatory or payer acceptance.
• ●Grade ≥3 treatment-emergent adverse events were high in both arms (over 73%), indicating substantial toxicity risk typical for this patient population and therapy class.
• ●While serplulimab is approved in over 50 countries and included in reimbursement in more than 10, U.S. regulatory approval is not yet granted, and the pathway or timeline for FDA submission based on ASTRIDE data is not specified.
• ●The trial population, while including underrepresented groups, remains limited in size (201 patients), and the open-label, descriptive design may introduce bias or limit generalizability compared to double-blind studies.

Bottom line

Henlius reports that serplulimab plus chemotherapy achieved longer median overall survival than atezolizumab plus chemotherapy in a 201-patient U.S. trial for first-line ES-SCLC, with two-year survival rates nearly double those of the comparator. Safety profiles were similar, with high rates of serious adverse events in both groups. The trial’s descriptive, open-label design and lack of formal statistical testing mean the results are supportive but not definitive for regulatory purposes. Serplulimab’s global approvals and reimbursement status in Europe are established, but U.S. regulatory submission and approval remain pending. Investors should focus on whether these data will translate into FDA approval and commercial uptake in the U.S. The most important takeaway is that serplulimab demonstrated a clinically meaningful survival advantage in a challenging patient population, but regulatory and commercial outcomes in the U.S. are not yet secured.

Announcement summary

(FSE:2E8) Shanghai Henlius Biotech, Inc announced positive results from the ASTRIDE trial, a randomized, descriptive, open-label U.S. study of serplulimab (Hetronifly®) plus chemotherapy versus atezolizumab plus chemotherapy for first-line treatment of extensive-stage small cell lung cancer (ES-SCLC). The study enrolled 201 patients between 2022 and 2025 across 63 sites in the United States, including over 200 U.S. patients and underrepresented racial and ethnic populations. The trial was led by David R. Gandara, MD, Professor Emeritus at the University of California Davis Comprehensive Cancer Center. As of the February 18, 2026 data cutoff, the median follow-up duration was 14.1 months. The serplulimab group had a higher proportion of patients with liver metastasis (49.5%) compared to the atezolizumab group (40.0%). Median overall survival (OS) was 12.4 months for serplulimab and 10.2 months for atezolizumab, with a hazard ratio (HR) of 0.82 (95% CI, 0.56-1.20). One-year OS rates were 52.4% for serplulimab and 41.4% for atezolizumab, while two-year OS rates were 32.2% and 17.6%, respectively. Among patients with no prior chemotherapy (serplulimab: 82; atezolizumab: 76), median OS was 13.4 and 10.8 months, respectively, with an HR of 0.77 (95% CI, 0.50–1.17). Median progression-free survival (PFS) was 5.4 months for serplulimab and 4.9 months for atezolizumab. Objective response rates (ORR) were 65.7% for serplulimab and 67.0% for atezolizumab. Median duration of response (DOR) was 4.2 months for serplulimab and 4.0 months for atezolizumab. Grade ≥3 treatment-emergent adverse events (TEAEs) occurred in 73.7% of serplulimab patients and 73.0% of atezolizumab patients. Grade ≥3 TEAEs related to the study drugs occurred in 20.2% (serplulimab) and 25.0% (atezolizumab) of patients. Immune-related adverse events occurred in 21.2% (serplulimab) and 23.0% (atezolizumab) of patients. The study included 5% Black or African American patients and 4.5% Hispanic or Latino patients. The ASTRIDE protocol was amended in June 2024 to allow newly diagnosed patients to receive one cycle of chemotherapy before randomization. ASTRIDE complements the global phase 3 ASTRUM-005 trial, which enrolled 585 subjects from 114 sites in countries including Türkiye, Poland, Georgia, and China, with 31.5% of participants being White. ASTRUM-005 met its primary endpoint of overall survival in December 2021. Serplulimab has been approved in more than 50 countries and regions for multiple indications, including ES-SCLC, and is included in reimbursement or public healthcare coverage systems of more than 10 countries, such as the U.K., Germany, Italy, and Spain. The FDA granted serplulimab orphan-drug designation for small cell lung cancer in March 2022. In June 2026, serplulimab received NMPA approval as the world's first anti-PD-1 mAb for perioperative gastric cancer treatment.

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