The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of serplulimab (Hansizhuang) for the first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC). This decision marks a significant step forward in providing a new treatment option for patients with this aggressive form of lung cancer.
The positive opinion is based on data from the phase 3 ASTRUM-005 trial (NCT04063163), a randomized, double-blind study that evaluated serplulimab in combination with chemotherapy versus placebo plus chemotherapy in patients with ES-SCLC who had not received prior systemic therapy. The trial enrolled patients aged 18 years or older with an ECOG performance status of 0 or 1.
ASTRUM-005 Trial Results
Initial findings published in JAMA in 2022 showed a median overall survival (OS) of 15.4 months (95% CI, 13.3-not evaluable) for patients treated with serplulimab plus chemotherapy (n = 389) compared to 10.9 months (95% CI, 10.0-14.3) for those given placebo plus chemotherapy (n = 196; HR, 0.63; 95% CI, 0.49-0.82; P < .001). The median progression-free survival (PFS) was 5.7 months (95% CI, 5.5-6.9) in the serplulimab arm versus 4.3 months (95% CI, 4.2-4.5) in the placebo arm (HR, 0.48; 95% CI, 0.38-0.59).
Updated data presented at the 2024 ASCO Annual Meeting further solidified these findings. Patients in the serplulimab arm achieved a median OS of 15.8 months (95% CI, 13.9-17.4) compared with 11.1 months (95% CI, 10.0-12.4) for those in the placebo arm (HR, 0.61; 95% CI, 0.50-0.74; P < .001).
Additional data from the ASCO meeting revealed a median PFS of 5.8 months (95% CI, 5.6-6.9) in the serplulimab arm versus 4.3 months (95% CI, 4.2-4.4) in the placebo arm (HR, 0.46; 95% CI, 0.38-0.57) per IRRC assessment. The confirmed overall response rate (ORR) by IRRC assessment was 68.9% (95% CI, 64.0%-73.5%) in the experimental arm versus 58.7% (95% CI, 51.4%-65.6%) in the control arm. The median duration of response (DOR) was 6.8 months (95% CI, 5.5-7.9) and 4.2 months (95% CI, 3.1-4.2) in the serplulimab and placebo arms, respectively.
Safety Profile
Safety data from the interim analysis in 2022 indicated that treatment-emergent adverse effects (TEAEs) were reported in 95.6% of patients in the serplulimab group versus 97.4% of patients in the placebo group. The rates of grade 3 or higher TEAEs were 82.5% and 80.1%, respectively. The rates of any-grade treatment-related AEs (TRAEs) were 69.9% for the experimental arm versus 56.1% for the control arm. Common grade 3 or higher TRAEs included decreased neutrophil count, decreased white blood cell count, decreased platelet count, and anemia.
Industry Impact
“The positive opinion from CHMP signifies a major milestone in our efforts to accelerate the global reach of our products, and further validates Henlius’ patient-centered research and development approach and commitment to global strategy,” said Jason Zhu, MD, MBA, executive director and chief executive officer of Henlius Biotech. “We look forward to the formal approval of this treatment in Europe, bringing more treatment options and hope to patients there and worldwide.”
Serplulimab has already been approved in China and other countries in Southeast Asia for the first-line treatment of patients with ES-SCLC, based on prior data from ASTRUM-005. The CHMP's positive opinion paves the way for its potential approval in Europe, offering a new therapeutic option for patients battling this challenging disease.
