What are the indications for Serplulimab (generic name)?

Indications of Serplulimab

Serplulimab is indicated for first-line treatment of extensive-stage small-cell lung cancer (ES-SCLC) in combination with carboplatin and etoposide, first-line treatment of advanced squamous non-small-cell lung cancer (NSCLC) in combination with chemotherapy, and first-line treatment of PD-L1-positive esophageal squamous cell carcinoma (ESCC) in combination with chemotherapy. 1, 2, 3

Approved Indications

Small Cell Lung Cancer (SCLC)

• First-line treatment for extensive-stage SCLC in combination with carboplatin and etoposide
  • Based on the ASTRUM-005 phase III trial showing significantly improved overall survival (median 15.8 months vs 11.1 months) compared to chemotherapy alone 1, 4
  • Dosing: 4.5 mg/kg intravenously every 3 weeks with carboplatin and etoposide for 4 cycles, followed by maintenance serplulimab 1

Non-Small Cell Lung Cancer (NSCLC)

• First-line treatment for advanced squamous NSCLC in combination with chemotherapy

  • Based on the ASTRUM-004 trial showing improved progression-free survival and overall survival compared to chemotherapy alone 1, 3
  • Specifically indicated with carboplatin and paclitaxel or nab-paclitaxel 1

• First-line treatment for metastatic, non-squamous NSCLC without EGFR/ALK aberrations in combination with pemetrexed and platinum-based chemotherapy 1

Esophageal Cancer

• First-line treatment for locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) with PD-L1 combined positive score ≥1 in combination with cisplatin and 5-fluorouracil 2
  • Based on a phase III trial showing improved progression-free survival (5.8 vs 5.3 months) and overall survival (15.3 vs 11.8 months) compared to chemotherapy alone 2

Dosing Information

The recommended dosing varies by indication:

• For ES-SCLC: 4.5 mg/kg intravenously every 3 weeks 1, 4
• For NSCLC: 4.5 mg/kg intravenously every 3 weeks 3
• For ESCC: 3 mg/kg intravenously on day 1, every 2 weeks 2

Clinical Considerations

Patient Selection

• For ESCC, PD-L1 testing is required (CPS ≥1) 2
• For non-squamous NSCLC, patients should be tested for EGFR mutations and ALK rearrangements, as serplulimab is indicated for patients without these genetic alterations 1

Safety Profile

• Common adverse events include nausea (24.1%) 5
• Grade ≥3 treatment-related adverse events occurred in 13.8% of patients in the phase I study 5
• In the ASTRUM-004 trial, grade ≥3 adverse events occurred in 35.2% of patients receiving serplulimab plus chemotherapy 3
• Immune-related adverse events may occur, similar to other PD-1 inhibitors

Comparison to Other Immunotherapies

Serplulimab joins other PD-1/PD-L1 inhibitors approved for similar indications:

• For ES-SCLC: Atezolizumab and durvalumab are also approved in combination with platinum-etoposide chemotherapy 1
• For NSCLC: Pembrolizumab, nivolumab, and atezolizumab have established indications 1
• For ESCC: Pembrolizumab is approved for first-line treatment in combination with chemotherapy for patients with PD-L1 CPS ≥10 1

Emerging Research

Recent studies are exploring additional applications of serplulimab:

• Combination therapy with HLX07 (anti-EGFR antibody) plus serplulimab and chemotherapy has shown promising antitumor activity in recurrent or metastatic ESCC 6
• Biomarker analyses from the ASTRUM-005 trial identified a 15-protein signature that may predict response to serplulimab in ES-SCLC patients 4

Serplulimab represents an important addition to the immunotherapy landscape for multiple cancer types, with demonstrated survival benefits in phase III trials across several indications.