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Association details:
Biomarker:No biomarker
Cancer:Lung Non-Small Cell Squamous Cancer
Drug:Hetronifly (serplulimab) (PD1 inhibitor)
Direction:Sensitive
Evidence:
Evidence Level:
Sensitive: A1 - Approval
Source:
Title:

Henlius' Novel Anti-PD-1 mAb HANSIZHUANG (Serplulimab) Receives NMPA Approval for the Treatment of sqNSCLC

Published date:
11/01/2022
Excerpt:
Shanghai Henlius Biotech, Inc. (2696. HK) announced that its first self-developed innovative anti-PD-1 monoclonal antibody (mAb) HANSIZHUANG (generic name: serplulimab injection), in combination with carboplatin and albumin-bound paclitaxel for the first-line treatment of unresectable locally advanced or metastatic squamous non-small cell lung cancer (sqNSCLC), has been approved by the National Medical Products Administration (NMPA), providing an alternative treatment option for patients.
Secondary therapy:
carboplatin + albumin-bound paclitaxel
Evidence Level:
Sensitive: B - Late Trials
Title:

540P - Phase III study of serplulimab plus chemotherapy as first-line therapy for advanced squamous non-small cell lung cancer: ASTRUM-004 Asian subgroup

Published date:
11/27/2023
Excerpt:
Superior efficacy and a manageable safety profile were observed when serplulimab was added to chemo in Asian patients with untreated advanced sNSCLC.
Secondary therapy:
paclitaxel; carboplatin
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Title:

A Phase 3 Study of Serplulimab Plus Chemotherapy as First-Line Treatment for Squamous Non-small-Cell Lung Cancer (ASTRUM-004)

Published date:
08/08/2023
Excerpt:
The HR for PFS consistently favored serplulimab-chemotherapy group across the prespecified subgroups. 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)...Compared with placebo, serplulimab significantly improved survival with a manageable safety profile in previously untreated locally advanced or metastatic sNSCLC patients. Serplulimab plus chemotherapy could be a promising treatment option for this patient population.
Secondary therapy:
carboplatin + paclitaxel