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Proffered Paper - Non-metastatic NSCLC and other thoracic malignancies

1215O - Neoadjuvant atezolizumab (A) for resectable non-small cell lung cancer (NSCLC): results from the phase II PRINCEPS trial.

Date

19 Sep 2020

Session

Proffered Paper - Non-metastatic NSCLC and other thoracic malignancies

Presenters

Benjamin Besse

Citation

Annals of Oncology (2020) 31 (suppl_4): S735-S743. 10.1016/annonc/annonc282

Authors

B. Besse1, J. Adam2, N. Cozic3, N. Chaput-Gras4, D. Planchard5, L. Mezquita6, J. Remon Masip7, P. Lavaud8, C. Naltet9, A. Gazzah10, V. Thomas de Montpreville11, M. Ghigna11, S. Mussot12, E. Fadel12, L. Mabille13, B. Duchemann14, F. Barlesi15, J. Soria16, C. Caramella17, O. Mercier18

Author affiliations

  • 1 Dept Of Cancer Medicine, Institut Gustave Roussy, 94805 - Villejuif/FR
  • 2 Pathology, Institut Gustave Roussy, 94805 - Villejuif/FR
  • 3 Sbe, Gustave Roussy - Cancer Campus, 94805 - Villejuif/FR
  • 4 Hematology, Institut Gustave Roussy, 94805 - Villejuif/FR
  • 5 Medical Oncology, Institut Gustave Roussy, 94800 - Villejuif/FR
  • 6 Medical Oncology, Hospital Clínic de Barcelona, 8036 - Barcelona/ES
  • 7 Dept. Oncology, CIOCC- Centro Integral Oncológico Clara Campal, 8023 - Barcelona/ES
  • 8 Medical Oncology Departement, Institut Gustave Roussy, 94805 - Villejuif/FR
  • 9 Thoracic Oncology Department, Institut Gustave Roussy, 94805 - Villejuif/FR
  • 10 Ditep, Institut Gustave Roussy, 94805 - Villejuif/FR
  • 11 Pathology, Hospital Marie Lannelongue, Le Plessis Robinson/FR
  • 12 Surgery, Hospital Marie Lannelongue, Le Plessis Robinson/FR
  • 13 Nuclear Medicine, Hospital Marie Lannelongue, Le Plessis Robinson/FR
  • 14 93, Hôpital Avicenne, 93009 - Bobigny/FR
  • 15 Dept Of Cancer Medicine, Gustave Roussy - Cancer Campus, 94805 - Villejuif/FR
  • 16 Medical Oncology, Gustave Roussy - Cancer Campus, 94805 - Villejuif/FR
  • 17 Radiology, Institut Gustave Roussy, 94805 - Villejuif/FR
  • 18 Ile De France, Centre Chirurgical Marie Lannelongue, 92350 - Le Plessis-Robinson/FR
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Resources

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Abstract 1215O

Background

Neoadjuvant immune checkpoint inhibitors induce major pathologic response (MPR) rates in 17- 45% of NSCLCs. We report the results of a phase 2 trial of neoadjuvant A for NSCLC.

Methods

Patient (pts) with clinical stage IA (≥ 2 cm)-IIIA non N2 NSCLC eligible for surgery, PS 0-1, received 1 injection of A (1200 mg IV D1) followed by surgery between D21-D28. The primary endpoint was the rate of pts without major toxicities or morbidities from D1 until 1 month after the surgery. Fresh tumour tissue was analysed within 4 hours after surgery. Response by RECIST1.1 and major pathological response (MPR; ≤10% viable tumour) were assessed.

Results

From December 2016 to February 2020, 30 pts were enrolled in two centres. The mean age of pts was 64, 50% were female, 7% never smokers, 83% had adenocarcinomas. Pathological stages were I (n=15, 50%), II (n=6, 20%) III (n=9, 30%). All pts had their planned surgery, none were delayed by >15 days. 29 had R0 resection, 1 had R1. Three pts experienced surgical complications: 1 respiratory distress grade 3 with sepsis grade 4, 1 heart block atrioventricular and 1 paresthesia grade 1. There was no grade 5 toxicity. Treatment-related adverse effects (TRAEs) included only one grade 1 parietal pain related to surgery. No RECIST radiological response and no MPR were observed. After A, 15/29 tumours were PD-L1 TC3 or IC3 based on the SP142 assay. 17/30 (56%) tumours had necrosis (med. 5% of tumour surface, 0-80). 20/29 cases had histopathological features of response according to the immune-related pathologic response criteria (irPRC), with isolated or combined features of immune activation (19/20), tissue repair (15/20) and/or tumour cell death (9/20).NGS (11 genes) was performed in 23 tumours resulting in 14 TP53 mutations (mut), 7 KRAS mutations , 3 EGFR mutations, 1 wild-type, 1 STK11 mutations (in a tumour with 80% necrosis).

Conclusions

Surgery after one infusion of A was safe. The short delay between A and surgery might explain the absence of MPR.

Clinical trial identification

NCT02994576.

Editorial acknowledgement

Legal entity responsible for the study

Gustave Roussy.

Funding

Roche-Genentech.

Disclosure

B. Besse: Research grant/Funding (institution): AbbVie; Research grant/Funding (institution): Blueprint Medicines; Research grant/Funding (institution): BeiGene; Research grant/Funding (institution): AstraZeneca; Research grant/Funding (institution): Amgen; Research grant/Funding (institution): BMS; Research grant/Funding (institution): Boehringer Ingelheim; Research grant/Funding (institution): Celgene; Research grant/Funding (institution): Cristal Therapeutics; Research grant/Funding (institution): Daiichi Sankyo; Research grant/Funding (institution): Eli Lilly; Research grant/Funding (institution): GSK; Research grant/Funding (institution): Ignyta; Research grant/Funding (institution): Ipsen; Research grant/Funding (institution): Inivata; Research grant/Funding (institution): Janssen; Research grant/Funding (institution): Merck KGaA; Research grant/Funding (institution): MSD; Research grant/Funding (institution): Nektar; Research grant/Funding (institution): Onxeo; Research grant/Funding (institution): OSE immunotherapeutics; Research grant/Funding (institution): Pfizer; Research grant/Funding (institution): Pharma Mar; Research grant/Funding (institution): Roche-Genentech; Research grant/Funding (institution): Sanofi; Research grant/Funding (institution): Servier; Research grant/Funding (institution): Spectrum Pharmaceuticals; Research grant/Funding (institution): Takeda; Research grant/Funding (institution): Tiziana Pharma; Research grant/Funding (institution): Tolero Pharmace. J. Adam: Honoraria (self), Research grant/Funding (institution): Roche; Honoraria (self): AstraZeneca; Honoraria (self), Research grant/Funding (institution): msd; Honoraria (self), Research grant/Funding (institution): Bayer; Honoraria (self): BMS. N. Chaput-Gras: Research grant/Funding (institution): Roche. D. Planchard: Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: AstraZeneca; Honoraria (self), Advisory/Consultancy: BMS; Honoraria (self), Advisory/Consultancy: Boehringer Ingelheim; Honoraria (self), Advisory/Consultancy: Celgene; Advisory/Consultancy: Daiichi Sankyo; Honoraria (self), Advisory/Consultancy: Eli Lilly; Honoraria (self), Advisory/Consultancy: Merck KGaA; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Pfizer; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Roche-Genentech; Advisory/Consultancy: Samsung; Honoraria (self), Advisory/Consultancy: Per CME; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Prime oncology; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Novaris. L. Mezquita: Honoraria (self), Research grant/Funding (self), Travel/Accommodation/Expenses: Bristol-Myers Squibb; Honoraria (self): Tecnofarma; Honoraria (self): AstraZeneca; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Research grant/Funding (self): Boehringer Ingelheim. J. Remon Masip: Travel/Accommodation/Expenses: Ose Pharma; Advisory/Consultancy: AstraZeneca; Travel/Accommodation/Expenses: MSD; Advisory/Consultancy: Pfizer; Travel/Accommodation/Expenses: Roche; Advisory/Consultancy: BMS. P. Lavaud: Travel/Accommodation/Expenses: Ipsen; Travel/Accommodation/Expenses: Janssen; Travel/Accommodation/Expenses: Mundi Pharma; Travel/Accommodation/Expenses: Astellas; Travel/Accommodation/Expenses: AstraZeneca. C. Naltet: Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Honoraria (self), Travel/Accommodation/Expenses: BMS; Honoraria (self), Travel/Accommodation/Expenses: AstraZeneca; Travel/Accommodation/Expenses: pfizer. A. Gazzah: Research grant/Funding (institution), Travel/Accommodation/Expenses: Roche; Advisory/Consultancy, Travel/Accommodation/Expenses: Novartis; Research grant/Funding (institution), Travel/Accommodation/Expenses: Pfizer; Research grant/Funding (institution), Travel/Accommodation/Expenses: Boehringer Ingelheim; Research grant/Funding (institution): AstraZeneca; Research grant/Funding (institution): bms; Research grant/Funding (institution): Janssen; Research grant/Funding (institution): Merck; Research grant/Funding (institution): Johnson & Johnson; Research grant/Funding (institution): Eli Lilly; Research grant/Funding (institution): MedImmune; Research grant/Funding (institution): NH TherAGuiX. B. Duchemann: Honoraria (self), Travel/Accommodation/Expenses: Roche; Honoraria (self): MSD; Travel/Accommodation/Expenses: Oxyvie; Travel/Accommodation/Expenses: Pfizer; Travel/Accommodation/Expenses: AstraZeneca. F. Barlesi: Honoraria (self), Research grant/Funding (institution): Bristol-Myers Squibb; Honoraria (self), Research grant/Funding (institution): AstraZeneca; Honoraria (self), Research grant/Funding (institution): Pfizer; Honoraria (self), Research grant/Funding (institution): Novartis; Honoraria (self), Research grant/Funding (institution): Boehringer Ingelheim; Research grant/Funding (institution): AbbVie; Research grant/Funding (institution): ACEA; Research grant/Funding (institution): Eisai; Research grant/Funding (institution): Ipsen; Research grant/Funding (self): Ignyta; Honoraria (self), Research grant/Funding (institution): Eli Lilly; Research grant/Funding (institution): Innate Pharma; Research grant/Funding (institution): Loxo; Research grant/Funding (institution): MedImmune; Honoraria (self), Research grant/Funding (institution): Merck KGaA; Honoraria (self), Research grant/Funding (institution): MSD; Honoraria (self), Research grant/Funding (institution): Roche-Genentech; Research grant/Funding (institution): Sanofi; Honoraria (self), Research grant/Funding (institution): Bayer; Honoraria (self), Research grant/Funding (self): Takeda; Honoraria (self), Research grant/Funding (institution): Pierre Fabre. J-C. Soria: Honoraria (self): Clovis; Honoraria (self), Full/Part-time employment: AstraZeneca; Honoraria (self): Boehringer Ingelheim; Honoraria (self): Grammamabs; Honoraria (self): Mission Therapeutics; Honoraria (self): Merus; Honoraria (self): Eli Lilly; Shareholder/Stockholder/Stock options: Gritstone; Honoraria (self): Symphogen; Honoraria (self): Tarveda; Honoraria (self): Pfizer; Honoraria (self): Pharma Mar; Honoraria (self): Roche-Genentech; Honoraria (self): Sanofi; Honoraria (self): Servier; Honoraria (self): Bayer; Honoraria (self): Blend therapeutics; Honoraria (self): Astex; Honoraria (self): Pierre Fabre. C. Caramella: Honoraria (self): pfizer; Honoraria (self): BMS; Honoraria (self): MSD; Honoraria (self): AstraZeneca; Honoraria (self): Roche. All other authors have declared no conflicts of interest.

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