KEY TAKEAWAYS
- The IPSOS trial is a phase 3, multicenter, open-label, randomized study comparing atezolizumab (anti-PD-L1) with single-agent chemotherapy in patients with locally advanced or metastatic (NSCLC).
- The primary aim of the IPSOS trial was to assess the efficacy of atezolizumab compared to single-agent chemotherapy in terms of (OS).
- A total of 453 patients were randomized in a 2:1 ratio to receive atezolizumab or single-agent chemotherapy (vinorelbine or gemcitabine) in 3- or 4-week cycles.
- At data cutoff, with a median follow-up of 41.0 months, atezolizumab significantly improved OS compared to single-agent chemotherapy.
- A consistent benefit was observed across key subgroups, including PD-L1 expression levels, ECOG PS, and histology, with improvements in the 2-year OS rate, objective response rate (ORR), and duration of response (DOR).
- Treatment with atezolizumab was generally well-tolerated, with a lower incidence of grade 3/4 treatment-related adverse events than single-agent chemotherapy (16.3% vs 33.3%).
Patients with PD-L1-high NSCLC and an ECOG Performance Status (PS) of 1 or better had longer overall survivals with 1 line of atezo (anti-PD-L1) compared to platinum-doublet chemo (PDC) in IMpower110 (NCT02409342). However, most 1L clinical trials and platinum-based chemo are inaccessible to most NSCLC patients because of their poor ECOG PS (≥2). Patients ineligible for 1L PDC are being compared between atezo and single-agent chemo in a global, multicenter, open-label, randomized Phase 3 study called IPSOS. Patients had locally advanced/metastatic NSCLC without driver mutations and were not candidates for 1L PDC because of a low-Performance Status PS (≥2) or because they were ≥ 70. Patients were assigned to receive either vinorelbine or gemcitabine as a single agent in 3- or 4-week cycles or atezo 1200 mg IV every 3 weeks. OS was the primary metric of success. OS rates, ORR, PFS, DOR, and OS and PFS in PD-L1+ pts were critical secondary endpoints. Both risk and quality of life in terms of health were evaluated.
They shuffled 453 pts (302 atezo; 151 chemos). The average age was 75 (range: 33-94), 31% were ≥80 or older, men made up 72%, and ECOG PS ≥2 was present in 83%. Across critical subgroups, including PD-L1 expression levels, PS, and histology, atezo consistently improved OS compared to chemo at the time of data cutoff (30 Apr 2022) with a median follow-up of 41.0 months (stratified HR, 0.78; 95% CI: 0.63, 0.97; P=0.028). OS rate at 2 years, ORR, and DOR all improved. Patients in the atezo and chemo arms experienced TRAEs of grades 3/4 at 16.3% and 33.3%, respectively, and TRAEs of grades 5 at 1.0% and 2.7%, respectively. Significant improvements from baseline were seen for chest pain TTCD with atezo compared to chemo (HR, 0.51; 95% CI, 0.27, 0.97) and for appetite loss and cough. In platinum-ineligible patients with NSCLC, 1L atezo improved OS compared to chemo, with twice as many patients estimated to be alive at 2 years after treatment with atezo as with chemo. There were no unanticipated safety issues observed among those with a poor prognosis.
Source: https://oncologypro.esmo.org/meeting-resources/esmo-congress/ipsos-results-from-a-phase-iii-study-of-first-line-1l-atezolizumab-atezo-vs-single-agent-chemotherapy-chemo-in-patients-pts-with-nsclc-not
Clinical Trial: https://clinicaltrials.gov/ct2/show/NCT03191786
S.M. Lee, C. Schulz, K. Prabhash, B. Han, A. Szczesna, D.L. Cortinovis, A. Rittmeyer, D. Vicente Baz, R. Califano, L. Tuan Anh, G. Liu, F. Cappuzzo, J.G. Reyes Contreras, M. Reck, Y. Hu, S. Morris, E.K. Hoeglander, M. Connors, H.K.M. Vollan, S. Peters/ IPSOS: Results from a phase III study of first-line (1L) atezolizumab (atezo) vs single-agent chemotherapy (chemo) in patients (pts) with NSCLC not… | OncologyPRO. (n.d.). Oncologypro.esmo.org. Retrieved March 31, 2023, from https://oncologypro.esmo.org/meeting-resources/esmo-congress/ipsos-results-from-a-phase-iii-study-of-first-line-1l-atezolizumab-atezo-vs-single-agent-chemotherapy-chemo-in-patients-pts-with-nsclc-not
