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Proffered paper session - Non-metastatic NSCLC and other thoracic malignancies

2875 - A randomized non-comparative phase II study of anti–PD-L1 ATEZOLIZUMAB or chemotherapy as second-line therapy in patients with small cell lung cancer: Results from the IFCT-1603 Trial

Date

21 Oct 2018

Session

Proffered paper session - Non-metastatic NSCLC and other thoracic malignancies

Topics

Cytotoxic Therapy;  Immunotherapy

Tumour Site

Presenters

Jean-Louis Pujol

Citation

Annals of Oncology (2018) 29 (suppl_8): viii596-viii602. 10.1093/annonc/mdy298

Authors

J. Pujol1, L. Greillier2, C. Audigier Valette3, D. Moro-Sibilot4, L. Uwer5, J. Hureaux6, L. Thiberville7, D. Carmier8, J. Madelaine9, J. Otto10, V. Gounant11, P. Merle12, P. Mourlanette13, O. Molinier14, P.A. Renault15, J. Mazieres16, M. Antoine17, A. Langlais18, F. Morin18, P. Souquet19

Author affiliations

  • 1 Pneumologie, Hopital Arnaud de Villeneuve, 34295 - Montpellier/FR
  • 2 Department Of Multidisciplinary Oncology And Therapeutic Innovations, Assistance Publique Hopitaux de Marseille, 13015 - Marseille/FR
  • 3 Pneumologie, Hospital Sainte Musse, 83100 - Toulon/FR
  • 4 Pneumologie, CHU Grenoble-Alpes, Grenoble/FR
  • 5 N/a, Institut de Cancérologie de Lorraine - Alexis Vautrin, 54519 - Vandoeuvre les Nancy/FR
  • 6 Pneumologie, CHU Angers, 49933 - Angers/FR
  • 7 Pneumologie, CHU Hôpitaux de Rouen-Charles Nicolle, 76031 - Rouen/FR
  • 8 Pneumologie, CHRU Bretonneau, 37044 - Tours/FR
  • 9 Pneumologie, CHU de Caen, 14033 - Caen/FR
  • 10 N/a, Centre Antoine Lacassagne, Nice/FR
  • 11 Pneumologie, Hopital Bichat Claude Bernard, 75018 - Paris/FR
  • 12 Pneumologie, CHU, 63011 - Clermont-Ferrand/FR
  • 13 Pneumologie, Clinique des Cedres, Cornebarrieu/FR
  • 14 Pneumologie, Centre Hospitalier Du Mans, 72037 - Le Mans/FR
  • 15 Pneumologie, Centre Hospitalier, Pau/FR
  • 16 Thoracic Oncology, Hospital Larrey, 31400 - Toulouse/FR
  • 17 Pathology, APHP, CancerEst, Tenon University Hospital, 75020 - Paris/FR
  • 18 Clinical research Unit, French Cooperative Thoracic Intergroup, 75009 - Paris/FR
  • 19 Pneumologie, Centre Hospitalier Lyon Sud, 69495 - Pierre Bénite/FR
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Resources

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Abstract 2875

Background

This randomized Phase II trial sought to evaluate the activity of the engineered PD-L1 antibody ATEZOLIZUMAB (ATZ), as systemic therapy of small cell lung cancer (SCLC) progressing after first line platinum – ETOPOSIDE based chemotherapy (CT).

Methods

Patients (pts) were randomly assigned 2:1 to ATZ, 1200 mg IV, every three weeks until progression or unacceptable toxicity, or conventional CT up to six cycles: i.e. second-line oral or IV TOPOTECAN or re-induction of CARBOPLATIN – ETOPOSIDE doublet (investigator choice based on center policy). Main eligibility criteria were performance status (PS) 0-2 and measurable disease (RECIST 1.1). We performed no selection on PD-L1 tissue expression. Patients receiving corticosteroid therapy, pts with autoimmune disease history and these with brain metastases were excluded. The primary endpoint was objective response rate (ORR) at 6 weeks (confirmation needed at 12 weeks).

Results

A total of 73 patients were randomized (ATZ n = 49; CT n = 24) between 03/2017 and 12/2017. One patient in the ATZ group did not receive any treatment. In the ATZ group, 83.7 % of the pts had PS 0-1, 79.6% had an extensive disease and 67.3 % had a sensitive relapse (progression after 90 days since the last dose of first line CT). At six weeks, in the ATZ group and eligible pts (n = 43), ORR was observed in 1 pt (2.3%, CI [0.0; 6.8]) and 8 other pts (18.6%, CI [7.0; 30.2]) had a stable disease. In the CT group and eligible pts (n = 21), 9.5% of the pts achieved an ORR and 52.4% had a stable disease. Progression-free survival were 1.4 months, CI [1.2; 1.5] in the ATZ group and 4.2 months CI [1.5; 5.9] in the CT group. At the time of reporting, 5 pts still benefit from a stable disease in the ATZ group versus none in the CT group. Two pts (4.2%) in the ATZ group experienced a grade 3 fatigue. Two pts developed grade 1 dysthyroidism.

Conclusions

IFCT-1603 trial did not show any efficacy or safety signals for single drug ATEZOLIZUMAB used as treatment in relapsed SCLC. Follow-up data will be updated and search for PD-L1 tissue expression and mutational tumor burden will be presented.

Clinical trial identification

NCT03059667.

Legal entity responsible for the study

IFCT (French Cooperative Thoracic Intergroup).

Funding

Roche.

Editorial Acknowledgement

N/A

Disclosure

L. Greillier: Grants, personal fees and non-financial support: Roche, outside the submitted work. C. Audigier Valette: Roche. D. Moro-Sibilot: Advisory board: Roche, Pfizer, AstraZeneca, BMS, MSD, Lilly, Boehringer, Abbvie, Takeda; Corporate-sponsored research: Boehringer Ingelheim, Abbvie. V. Gounant: AstraZeneca, Roche, Boehringer Ingelheim, BMS, Pfizer, Abbvie, MSD. P-J. Souquet: Grant, personnal fees, congress, board: Roche. All other authors have declared no conflicts of interest.

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