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Proffered Paper session - NSCLC, metastatic 1

1207O - Bevacizumab + erlotinib vs erlotinib alone as first-line treatment of pts with EGFR mutated advanced non squamous NSCLC: Final analysis of the multicenter, randomized, phase III BEVERLY trial

Date

18 Sep 2021

Session

Proffered Paper session - NSCLC, metastatic 1

Topics

Cytotoxic Therapy;  Clinical Research

Tumour Site

Non-Small Cell Lung Cancer

Presenters

Maria Carmela Piccirillo

Citation

Annals of Oncology (2021) 32 (suppl_5): S949-S1039. 10.1016/annonc/annonc729

Authors

M.C. Piccirillo1, L. Bonanno2, M.C.C. Garassino3, C. Dazzi4, L. Cavanna5, G. Esposito6, M.A. Burgio7, F. Rosetti8, S. Rizzato9, L. Arenare10, P. Gargiulo10, R. Di Liello10, F. De Marinis11, L. Crinò7, F. Morgillo12, F. Ciardiello12, N. Normanno13, C. Gallo14, C. Gridelli15, A. Morabito6

Author affiliations

  • 1 Clinical Trial Unit, Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale, 80131 - Naples/IT
  • 2 Medical Oncology 2, Istituto Oncologico Veneto, IRCCS, 35128 - Padova/IT
  • 3 Department Of Medical Oncology, Istituto Nazionale dei Tumori di Milano - Fondazione IRCCS, 20133 - Milano/IT
  • 4 Medical Oncology Unit, AUSL of Romagna, Hospital of Ravenna, 48100 - Ravenna/IT
  • 5 Oncology An Hematology Department, Oncology Unit,, Piacenza General Hospital, 29121 - Piacenza/IT
  • 6 Thoracic Medical Oncology, Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale, 80131 - Napoli/IT
  • 7 Department Of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, 47014 - Meldola/IT
  • 8 Medical Oncology And Hematology, Mirano ULSS 3, Serenissima Regione Veneto, 30174 - Mirano/IT
  • 9 Oncology Department, Azienda Sanitaria Universitaria Friuli Centrale, 33100 - Udine/IT
  • 10 Clinical Trial Unit, Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale, 80131 - Napoli/IT
  • 11 Division Of Thoracic Oncology, IEO, European Institute of Oncology IRCCS, 20141 - Milano/IT
  • 12 Medical Oncology, Department Of Precision Medicine, Università degli Studi della Campania ''Luigi Vanvitelli'', 80131 - Napoli/IT
  • 13 Cellular Biology And Biotherapy, Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale, 80131 - Napoli/IT
  • 14 Medical Statistics, Università degli Studi della Campania ''Luigi Vanvitelli'', 80128 - Napoli/IT
  • 15 Division Of Medical Oncology, Azienda Ospedaliera “S.G. Moscati”, 83100 - Avellino/IT

Resources

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Abstract 1207O

Background

Adding bevacizumab to erlotinib prolonged PFS in NEJ026 and CTONG 1509 trials, but limited data are available in non-Asian patients (pts). BEVERLY is an Italian no-profit, randomized, open-label, multicenter phase III trial of bevacizumab (BEV) plus erlotinib (E) vs E alone as first-line treatment for EGFR-mutated advanced NSCLC.

Methods

Eligible pts were randomized 1:1 to E (150mg daily) alone or combined with BEV (15mg/kg iv q3w) until disease progression or unacceptable toxicity. Center, ECOG PS and type of mutation (ex19 deletion vs ex21 L858R vs others) were stratification variables. Co-primary endpoints were investigator-assessed PFS (IA-PFS) and blinded-independent centrally-reviewed PFS (BICR-PFS). Secondary endpoints were OS, QoL, IA- and BICR- objective response rate (ORR) and safety; biomarker analyses are also planned. 126 events out of 160 randomized pts were required to detect a PFS prolongation with BEV from 10 to 16.7 mos (HR 0.60), with 2-sided α=0.05, 80% power.

Results

From Apr 11, 2016 to Feb 27, 2019, 160 pts were randomized to BEV+E (80) or E alone (80). Pts were mainly female (63.8%), never smokers (51.9%), ECOG PS 0-1 (98.1%), median age 66 (IQR 59-73); 55% of pts had ex19Del and 41% L858R mutation. At a median follow-up of 31 mos, 130/160 (81.3%) pts had a PFS event (progression or death) and 84/160 (52.5%) died. BEV+E significantly prolonged IA-PFS over E alone with a median of 15.4 vs 9.7 mos (HR 0.60; 95%CI 0.42-0.85, log-rank P=0.0039). Median OS was 28.4 vs 23.0 mos in BEV+E and E arms, respectively (HR 0.70; 95%CI 0.46-1.10, log-rank P=0.12). One toxic death was reported, due to intracranial hemorrhage with BEV+E. Hypertension (any grade: 49% vs 18%; grade≥3: 24% vs 5%), skin rash (grade≥3: 31% vs 14%), thromboembolic events (any grade: 11% vs 4%), and proteinuria (any grade: 23% vs 6%) were more frequent with the experimental combination treatment.

Conclusions

The addition of BEV to E significantly prolonged IA-PFS compared with E alone as first-line treatment in Italian EGFR-mutated NSCLC patients, with no unexpected safety issues. Blinded radiologic revision of PFS and ORR is ongoing and will be presented at the meeting.

Clinical trial identification

NCT02633189; EudraCT 2015-002235-17.

Editorial acknowledgement

Legal entity responsible for the study

Clinical Trial Unit, Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale.

Funding

Roche provided partial funding and experimental drugs.

Disclosure

M.C. Piccirillo: Financial Interests, Personal, Invited Speaker: Astellas; Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Invited Speaker: Daiichi Sankyo; Financial Interests, Institutional, Research Grant: Roche; Financial Interests, Institutional, Research Grant: AstraZeneca; Financial Interests, Institutional, Research Grant: Bayer. L. Bonanno: Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Invited Speaker: MSD; Financial Interests, Personal, Invited Speaker: BMS; Financial Interests, Personal, Invited Speaker: Boehringer Ingelheim. L. Cavanna: Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: Merck; Financial Interests, Personal, Sponsor/Funding: Pfizer; Financial Interests, Personal, Sponsor/Funding: Celgene; Financial Interests, Personal, Sponsor/Funding: Ipsen. F. Rosetti: Financial Interests, Personal, Sponsor/Funding: Roche. S. Rizzato: Financial Interests, Personal, Sponsor/Funding: Roche; Financial Interests, Personal, Sponsor/Funding: Amgen. R. Di Liello: Financial Interests, Personal, Invited Speaker: Astellas. F. Morgillo: Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Advisory Board: Lilly; Financial Interests, Institutional, Research Grant: AstraZeneca. F. Ciardiello: Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: Merck; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Advisory Board: Servier; Financial Interests, Institutional, Research Grant: Merck; Financial Interests, Institutional, Research Grant: Roche; Financial Interests, Institutional, Research Grant: Amgen. All other authors have declared no conflicts of interest.

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