Triple Therapy for Squamous NSCLC Shows Real-World Clinical Benefit


The study covered in this summary was published on researchsquare.com as a preprint and has not yet been peer reviewed.

Key Takeaway

  • Combining the immunotherapy sintilimab with paclitaxel/nab-paclitaxel and platinum-based chemotherapy appears to be as effective as when adding it to a gemcitabine-based regimen in squamous cell non–small cell lung cancer (sqNSCLC), suggests a real-world analysis.

Why This Matters

  • Numerous studies have demonstrated the antitumor efficacy of immune checkpoint inhibitors in combination with paclitaxel/nab-paclitaxel and platinum-based chemotherapy in the first-line treatment of sqNSCLC.

  • While the anti-programmed death (PD)-1 monoclonal antibody sintilimab has been shown to achieve a strong antitumor response, the ORIENT-12 randomized controlled trial combined it only with gemcitabine and platinum-based chemotherapy.

  • The current results suggest that combining sintilimab with paclitaxel/nab-paclitaxel and platinum-based chemotherapy could be a novel option for the treatment of sqNSCLC.

Study Design

  • The researchers reviewed the medical records of patients with stage IIIB-IV sqNSCLC and without EGFR or ALK mutations who started treatment between January 2019 and January 2021.

  • Patients were treated with first-line sintilimab plus paclitaxel/nab-paclitaxel (sintilimab-TP) or sintilimab plus gemcitabine (sintilimab-GP), plus platinum-based chemotherapy.

  • Data on patient demographics, performance status, PD-ligand 1 expression, tumor response, and adverse events was gathered, and progression-free and overall survival were determined using Kaplan-Meier analysis.

Key Results

  • Patients in the sintilimab-TP arm received a median of four doses, while those in the sintilimab-GP arm received six doses.

  • After a median follow-up of 12.1 months, the median progression-free survival was 10.9 months in the sintilimab-TP group and 7.5 months with sintilimab-GP (P = .24). Median overall survival was 20.1 months and 16.3 months, respectively (P = .46).

  • The overall response rate was 59.4% in patients given sintilimab-TP vs 40% in those in the sintilimab-GP arm. The disease control rate was 93.6% and 95.0%, respectively.

  • Grade ≥3 adverse events were reported in 37.5% of sintilimab-TP patients and 55.0% of those treated with sintilimab-GP. The most common events included anemia, decreased white blood cell count, and decreased neutrophil count.

Limitations

  • The study was limited by its retrospective and observational design, as well as its small sample size, the authors note. The follow-up period was also short.

Study Disclosures

  • The study was supported by State Key Laboratory of Respiratory Disease-The Open Project, Fundamental and Applied Fundamental Research Project of City-School (Institute) Joint Funding Project, Guangzhou Science and Technology Bureau, and Zhongnanshan Medical Foundation of Guangdong Province.

  • No relevant financial relationships declared.

This is a summary of a preprint research study, “Sintilimab With Chemotherapy as First-Line Treatment for Locally Advanced or Metastatic Squamous Non-Small-Cell Lung Cancer: Real-World Data Study,” published on researchsquare.com on Oct 25 and provided to you by Medscape. The study was led by Chengzhi Zhou, PhD, professor, First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China. This study has not yet been peer reviewed. The full text can be found at researchsquare.com.

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