Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2023 Apr:183:38-48.
doi: 10.1016/j.ejca.2023.01.014. Epub 2023 Jan 31.

Atezolizumab with or without bevacizumab and platinum-pemetrexed in patients with stage IIIB/IV non-squamous non-small cell lung cancer with EGFR mutation, ALK rearrangement or ROS1 fusion progressing after targeted therapies: A multicentre phase II open-label non-randomised study GFPC 06-2018

Olivier Bylicki  1 , Pascale Tomasini  2 , Gervais Radj  3 , Florian Guisier  4 , Isabelle Monnet  5 , Charles Ricordel  6 , Laurence Bigay-Game  7 , Margaux Geier  8 , Christos Chouaid  4 , Catherine Daniel  9 , Aurelie Swalduz  10 , Anne-Claire Toffart  11 , Helene Doubre  12 , Jean-Michel Peloni  13 , Diane Moreau  14 , Fabien Subtil  15 , Jean-Michel Grellard  16 , Marie Castera  16 , Benedicte Clarisse  16 , Pedro-Henrique Martins-Lavinas  15 , Chantal Decroisette  17 , Laurent Greillier  2 ; GFPC
Affiliations
Free article
Clinical Trial

Atezolizumab with or without bevacizumab and platinum-pemetrexed in patients with stage IIIB/IV non-squamous non-small cell lung cancer with EGFR mutation, ALK rearrangement or ROS1 fusion progressing after targeted therapies: A multicentre phase II open-label non-randomised study GFPC 06-2018

Olivier Bylicki et al. Eur J Cancer. 2023 Apr.
Free article

Abstract

Background: Previous reports showed limited efficacy of immune checkpoint inhibitors as single-agent treatment for non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutation or ALK/ROS1 fusion. We aimed at evaluating the efficacy and safety of immune checkpoint inhibitor combined with chemotherapy and bevacizumab (when eligible) in this patient subgroup.

Methods: We conducted a French national open-label multicentre non-randomised non-comparative phase II study in patients with stage IIIB/IV NSCLC, oncogenic addiction (EGFR mutation or ALK/ROS1 fusion), with disease progression after tyrosine kinase inhibitor and no prior chemotherapy. Patients received platinum, pemetrexed, atezolizumab, bevacizumab (PPAB cohort) or, if not eligible to bevacizumab, platinum-pemetrexed-atezolizumab (PPA cohort). The primary end-point was the objective response rate (RECIST v1.1) after 12 weeks, evaluated by blind independent central review.

Results: 71 patients were included in PPAB cohort and 78 in PPA cohort (mean age, 60.4/66.1 years; women 69.0%/51.3%; EGFR mutation, 87.3%/89.7%; ALK rearrangement, 12.7%/5.1%; ROS1 fusion, 0%/6.4%, respectively). After 12 weeks, objective response rate was 58.2% (90% confidence interval [CI], 47.4-68.4) in PPAB cohort and 46.5% (90% CI, 36.3-56.9) in PPA cohort. Median progression-free survival and overall survival were 7.3 (95% CI 6.9-9.0) months and 17.2 (95% CI 13.7-NA) months in PPAB cohort and 7.2 (95% CI 5.7-9.2) months and 16.8 (95% CI 13.5-NA) months in PPA cohort, respectively. Grade 3-4 adverse events occurred in 69.1% of patients in PPAB cohort and 51.4% in PPA cohort; Grade 3-4 atezolizumab-related adverse events occurred in 27.9% and 15.3%, respectively.

Conclusion: Combination approach with atezolizumab with or without bevacizumab and platinum-pemetrexed achieved promising activity in metastatic EGFR-mutated or ALK/ROS1-rearranged NSCLC after tyrosine kinase inhibitor failure, with acceptable safety profile.

Trial registration: ClinicalTrials.gov NCT04042558.

Keywords: EGFR-mutation; Immunotherapy; Non-small cell lung cancer; Resistance.

PubMed Disclaimer

Conflict of interest statement

Conflict of interest statement The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: O.B reports adviser and consultant for BMS, AstraZeneca, Roche, MSD, Takeda; P.T reports adviser and consultant for Roche, AstraZeneca, BMS, Amgen, Takeda, Janssen-Cillag and Novartis; F.G reports research support from Takeda and Pfizer, adviser and consultant for Amgen, BMS, AstraZeneca, Roche, MSD, Pfizer and Takeda; C.R reports research support from AstraZeneca, reports adviser and consultant for BMS, AstraZeneca and Takeda; L.B-G reports adviser and consultant for AstraZeneca, MSD, BMS, Amgen, Takeda, Viatris, Ipsen and Pfizer; M.G reports research support from BMS and Roche, adviser and consultant for BMS, AstraZeneca, Pfizer and Sanofi; C.C reports adviser and consultant for AstraZeneca, Roche, Sanofi Aventis, BMS, MSD, Lilly, Novartis, Pfizer, Takeda, Bayer and Amgen; C.Da. reports adviser and consultant for AstraZeneca, BMS and Novartis; A.S. reports adviser and consultant for Roche and Lilly; A-C.T reports adviser and consultant for AstraZeneca, Roche, MSD, BMS, Leo Pharma, Amgen, Nutrician, Pfizer; H.D. reports research support from MSD and Pfizer, adviser and consultant BMS, Amgen, Leo Pharma, Novartis, Roche; C.De. reports adviser and consultant for AstraZeneca, Roche, Sanofi, Janssen-Cilag, Takeda, BMS, Sandoz, Novartis, Lilly and Pfizer; L.G. reports research support from Abbvie, AstraZeneca, BMS, MSD, Novartis, Pfizer, PharmaMar, Roche, Sanofi and Takeda, adviser and consultant for Abbvie, AstraZeneca, BMS, Lilly, MSD, Novartis, Pfizer, Roche, Sanofi and Takeda. All other authors have declared no conflicts of interest.

Publication types

MeSH terms

Associated data