On February 12, 2024, the Volume. 42 Issue. 2 of Cancer Cell, a highly regarded oncology journal with an impact factor of 50.3, was published online. ASTRUM-004, Henlius’ pivotal phase 3 clinical study of anti-PD-1 mAb HANSIZHUANG (serplulimab) plus chemotherapy as first-line treatment for previously untreated locally advanced or metastatic squamous non-small-cell lung cancer (sqNSCLC), was highlighted on the front cover of the issue. This marks the first time a clinical study of an innovative Chinese drug has been featured on the journal's cover in its 22-year history. The study was led by Professor Caicun Zhou from Shanghai Pulmonary Hospital.

"Zhou et al. report the results of a phase 3 trial that demonstrates the efficacy and safety of serplulimab plus chemotherapy as first-line treatment for patients with advanced squamous non-small-cell lung cancer (sqNSCLC)." The editors highly commended ASTRUM-004 and the cover design. "The cover features a collage of pathology slices and vibrant hues that illustrate the intricacy of the disease and the impact of the ASTRUM-004 study on research and innovation in sqNSCLC."

Cancer Cell also published a preview essay that highlights, "trials dedicated specifically to squamous cell histology, such as ASTRUM-004, are essential. They hold the potential to provide more concrete and definitive evidence, guiding tailored treatment strategies for this distinct histology subgroup." And "the ASTRUM-004 study provides compelling evidence for serplulimab plus chemotherapy as an effective first-line treatment alternative for advanced squamous NSCLC, thereby broadening our therapeutic options against this challenging malignancy."

ASTRUM-004 is a randomized, double-blind, international multicentre phase 3 study to compare the clinical efficacy and safety of serplulimab plus chemotherapy versus chemotherapy in patients with locally advanced or metastatic sqNSCLC who have not previously received systemic treatment. As of January 31, 2023, a total of 537 patients were randomized 2:1 to receive intravenous serplulimab 4.5 mg/kg or placebo (up to 35 cycles) in combination with chemotherapy (carboplatin and nab-paclitaxel, 4-6 cycles) in 3-week cycles. Updated analysis of progression-free survival (PFS) showed that with a median follow-up of 16.9 months, the PFS benefit of serplulimab-chemotherapy vs. placebo-chemotherapy was maintained (IRRC-assessed, median, 8.3 vs. 5.7 months; hazard ratio [HR] 0.53, 95% CI 0.42-0.67). The HR for PFS consistently favoured serplulimab-chemotherapy group across the prespecified subgroups. Final analysis of overall survival (OS) demonstrated that with a median follow-up of 31.1 months, OS was significantly prolonged with the addition of serplulimab (median, 22.7 vs. 18.2 months; HR 0.73, 95% CI 0.58-0.93; p=0.010, crossing the significance boundary of 0.046). By the time of the final analysis, 97 (54.2%) patients in the placebo-chemotherapy group had crossed over to serplulimab monotherapy. The median OS in the placebo-chemotherapy group adjusted by the two-stage model was 11.5 months (95% CI 9.6–13.5), resulting in an adjusted HR of 0.49 (95% CI 0.37–0.64). The safety profile of serplulimab plus chemotherapy was manageable. In conclusion, serplulimab plus chemotherapy could be a promising treatment option for this patient population.

Results of the overall population ASTRUM-004 were initially presented at the IASLC 2023 World Conference on Lung Cancer (WCLC 2023) in the form of oral presentation. Additionally, the data from its Asian subgroup were showcased in a poster session at the European Society of Medical Oncology Asia (ESMO Asia) Congress 2023. ASTRUM-004 was published online in January 2024 in Cancer Cell, a highly regarded oncology journal, and this further cover feature highlights the study's importance in the international clinical arena and its far-reaching impact on the field of sqNSCLC treatment. Previously in 2022, the new drug application (NDA) of serplulimab for the treatment of sqNSCLC has been approved by the National Medical Products Administration (NMPA) based on the results of ASTRUM-004. Furthermore, HANSIZHUANG has been recommended as Grade I by the 2023 CSCO Guidelines for Non-Small Cell Lung Cancer for the first-line treatment of advanced sqNSCLC due to its outstanding clinical effectiveness and survival advantages for sqNSCLC patients.

Looking forward, Henlius will actively improve efficiency through innovations, focusing on patients and unmet medical needs to bring more high-quality and affordable therapies to patients worldwide.

https://mp.weixin.qq.com/s/4AWAn-PMIGhAg3bnhNy-Kg