KEY TAKEAWAYS
- The phase 3 IPSOS trial compared 1L atezolizumab monotherapy to single-agent chemotherapy in platinum-ineligible patients for efficacy and safety.
- The trial spanned 91 sites in 23 countries, comparing atezolizumab monotherapy to single-agent chemotherapy.
- Eligible patients had stage IIIB or IV NSCLC and could not undergo platinum-doublet chemotherapy for various reasons.
- Atezolizumab demonstrated improved overall survival, better quality of life, and fewer severe adverse events compared to chemotherapy in NSCLC patients.
The Phase 3 open-label trial enrolled eligible patients with stage IIIB or IV NSCLC from 91 sites across multiple continents. Investigators deemed platinum-doublet chemotherapy unsuitable for patients with an ECOG performance status of 2 or 3 or those aged 70 years or older with an ECOG performance status of 0-1 but having substantial comorbidities or contraindications. Participants were randomly assigned in a 2:1 ratio to receive intravenous atezolizumab (1200 mg every 3 weeks) or single-agent chemotherapy (vinorelbine or gemcitabine per local label). The primary endpoint was overall survival (OS) analyzed in the intention-to-treat population, while safety analyses were performed in the safety-evaluable population.
A total of 453 patients were enrolled in the study from September 11, 2017, to September 23, 2019. Of these, 302 patients received atezolizumab, and 151 received chemotherapy. Atezolizumab demonstrated improved OS compared to chemotherapy, with a median OS of 10.3 months (95% CI 9.4-11.9) vs 9.2 months (95% CI 5.9-11.2) and a stratified HR of 0.78 (95% CI 0.63-0.97, p=0.028). The 2-year survival rate was 24% (95% CI 19.3-29.4) for atezolizumab and 12% (95% CI 6.7-18.0) for chemotherapy. Atezolizumab also showed positive effects on patient-reported health-related quality-of-life functioning scales and symptoms, with fewer grade 3-4 treatment-related adverse events (16% of 300 vs 33% of 147) and treatment-related deaths (1% vs 3%) compared to chemotherapy. First-line atezolizumab monotherapy showed improved overall survival, doubled 2-year survival rate, maintained quality of life, and favorable safety in advanced NSCLC patients ineligible for platinum-based chemotherapy.
Source:https://pubmed.ncbi.nlm.nih.gov/37423228/
Clinical Trial:https://classic.clinicaltrials.gov/ct2/show/NCT03191786
Lee SM, Schulz C, Prabhash K, Kowalski D, Szczesna A, Han B, Rittmeyer A, Talbot T, Vicente D, Califano R, Cortinovis D, Le AT, Huang D, Liu G, Cappuzzo F, Reyes Contreras J, Reck M, Palmero R, Mak MP, Hu Y, Morris S, Höglander E, Connors M, Biggane AM, Vollan HK, Peters S. First-line atezolizumab monotherapy versus single-agent chemotherapy in patients with non-small-cell lung cancer ineligible for treatment with a platinum-containing regimen (IPSOS): a phase 3, global, multicentre, open-label, randomised controlled study. Lancet. 2023 Jul 6:S0140-6736(23)00774-2. doi: 10.1016/S0140-6736(23)00774-2. Epub ahead of print. PMID: 37423228.
