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Related Concept Videos

Treatment Resistant Cancers02:56

Treatment Resistant Cancers

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Cancer is the second leading cause of death in the United States. A cancer cell is genetically unstable and hence can mutate faster. They can also modify their microenvironment and escape immune surveillance. The difficulties in treating cancer are further compounded by the emergence of rapid resistance to anticancer drugs. The most common ways to attain resistance in cancer cells include alteration in drug transport and metabolism, modification of drug target, elevated DNA damage response, or...
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Endobronchial Ultrasound-guided Intratumoral Injection of Cisplatin for the Treatment of Isolated Mediastinal Recurrence of Lung Cancer
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Tislelizumab Versus Docetaxel in Patients With Previously Treated Advanced NSCLC (RATIONALE-303): A Phase 3,

Caicun Zhou1, Dingzhi Huang2, Yun Fan3

  • 1Department of Medical Oncology, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, People's Republic of China.

Journal of Thoracic Oncology : Official Publication of the International Association for the Study of Lung Cancer
|October 2, 2022
PubMed
Summary

Tislelizumab significantly improved overall survival in pretreated advanced non-small cell lung cancer (NSCLC) patients compared to docetaxel. This benefit was observed regardless of programmed death-ligand 1 (PD-L1) expression levels.

Keywords:
DocetaxelNon–small cell lung cancerRandomized clinical trialTislelizumab

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Area of Science:

  • Oncology
  • Immunotherapy
  • Clinical Trials

Background:

  • Advanced non-small cell lung cancer (NSCLC) presents a significant therapeutic challenge, particularly in pretreated populations.
  • Tislelizumab, an immune checkpoint inhibitor, targets programmed death-1 (PD-1) to restore anti-tumor immunity.
  • Docetaxel is a standard chemotherapy agent used in second-line NSCLC treatment.

Purpose of the Study:

  • To evaluate the efficacy and safety of tislelizumab compared to docetaxel in patients with pretreated advanced NSCLC.
  • To assess overall survival (OS) as a co-primary endpoint in the intent-to-treat (ITT) and PD-L1-positive populations.
  • To conduct exploratory biomarker analyses to identify potential predictors of treatment response.

Main Methods:

  • The phase 3 RATIONALE-303 trial randomized 805 patients with advanced NSCLC 2:1 to tislelizumab or docetaxel.
  • Patients received intravenous tislelizumab 200 mg or docetaxel 75 mg/m² every 3 weeks.
  • Co-primary endpoints were OS in the ITT and PD-L1 tumor cell ≥25% populations; biomarker analyses included PD-L1 expression, tumor mutation burden, and gene expression.

Main Results:

  • Tislelizumab demonstrated a statistically significant and clinically meaningful improvement in OS versus docetaxel in the ITT population (median 16.9 vs. 11.9 months; HR=0.66).
  • The co-primary endpoint of OS in the PD-L1 tumor cell ≥25% population also showed significant improvement with tislelizumab (median 19.3 vs. 11.5 months; HR=0.53).
  • Exploratory analyses suggested potential associations between NOTCH1-4 mutations and improved efficacy, while tumor mutation burden correlated with progression-free survival but not OS.

Conclusions:

  • Tislelizumab provides a significant and durable overall survival benefit compared to docetaxel in pretreated advanced NSCLC.
  • The efficacy of tislelizumab was consistent across different levels of PD-L1 expression.
  • No new safety concerns were identified with tislelizumab treatment.