KEY TAKEAWAYS
- The IPSOS phase III trial aimed to assess if the efficacy and tolerability of atezolizumab monotherapy in Asian NSCLC patients with no PDC eligibility mirrored the wider IPSOS trial results.
- The primary endpoint was OS.
- The study exhibited consistent safety and efficacy with ITT results, validating its performance in PDC-ineligible patients.
S.M. Lee and his research group aimed to assess the efficacy and tolerability differences in systemic therapy for nonsmall cell lung cancer (NSCLC) between Asian and non-Asian populations through a subgroup analysis of Asian patients within the IPSOS study.
Patients with locally advanced/metastatic NSCLC lacking driver mutations and ineligible for first-line platinum-doublet chemotherapy (1L PDC) were randomized 2:1 to receive either atezolizumab (1200 mg intravenously every 3 weeks) or single-agent chemotherapy (vinorelbine or gemcitabine) in 3- or 4-week cycles. Analyses focused on participants from China and Vietnam, evaluating the primary endpoint of overall survival (OS) and key secondary endpoints, including OS rates, objective response rate (ORR), progression-free survival (PFS), and safety.
Among 453 patients randomized in the intention-to-treat (ITT) population, 70 from China and Vietnam (43 atezolizumab; 27 chemotherapy) were analyzed. Median age was 74 years (range, 47-84), 16% were ≥80 years old, 93% were male, and 83% had ECOG PS ≥2. As of the data cutoff (30 Apr 2022), the atezolizumab arm demonstrated a numerically longer median OS than chemotherapy (unstratified HR, 0.74; 95% CI: 0.41, 1.35). Atezolizumab also exhibited numerically longer median PFS, higher 1- and 2-year OS rates, and ORR compared to chemotherapy.
Adverse events (AEs) of Grade 3/4 occurred in 57% (n=24) for atezolizumab and 52% (n=12) for chemotherapy. Grade 5 AEs occurred in 2 atezolizumab patients and none in the chemotherapy group. AEs in the atezolizumab arm for the Asian subpopulation were comparable to the overall IPSOS safety population. The observed safety data for atezolizumab were generally consistent with the expected profile for the underlying disease and atezolizumab monotherapy in this patient population.
The results demonstrated that 1L atezolizumab monotherapy was safe and efficacious, consistent with ITT results in patients ineligible for platinum-doublet chemotherapy. The research was sponsored by Hoffmann-La Roche.
Source: https://cattendee.abstractsonline.com/meeting/10925/presentation/1636
Clinical Trial: https://clinicaltrials.gov/study/NCT03191786
Lee SM, Han B, Peters S, et al. ”Atezolizumab vs Single-Agent Chemo in NSCLC Patients Ineligible for a 1L Platinum Regimen: Asian Subgroup Analysis of IPSOS.” Presented at: IASLC 23 World Conference on Lung Cancer. ( September 9-12 2023), Singapore. DOI:https://doi.org/10.1016/j.jtho.2023.09.1168
