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Non-metastatic NSCLC and other thoracic malignancies

3008 - Clinical activity, safety and predictive biomarkers results from a phase Ia atezolizumab (atezo) trial in extensive-stage small cell lung cancer (ES-SCLC)

Date

10 Oct 2016

Session

Non-metastatic NSCLC and other thoracic malignancies

Presenters

Lecia Sequist

Citation

Annals of Oncology (2016) 27 (6): 493-496. 10.1093/annonc/mdw389

Authors

L.V. Sequist1, A. Chiang2, J. Gilbert3, M. Gordon4, P.R. Conkling5, D. Thompson6, J..P. Marcoux7, S.J. Antonia8, B. Liu9, D.S. Shames10, A. Lopez-Chavez9, C. O'Hear11, M. Fasso11, S. Gettinger2

Author affiliations

  • 1 Center For Thoracic Cancers, Massachusetts General Hospital, 02114 - Boston/US
  • 2 Yale Cancer Center, Yale School of Medicine, New Haven/US
  • 3 Oncology, Vanderbilt University School of Medicine, Nashville/US
  • 4 Division Of Arizona Center For Cancer Care, Pinnacle Oncology Hematology, Scottsdale/US
  • 5 Virginia Oncology Associates, US Oncology Research, Norfolk/US
  • 6 Oncology, Sarah Cannon Research Institute, Nashville/US
  • 7 Thoracic Oncology, Dana Farber Cancer Institute, Boston/US
  • 8 Department Of Thoracic Oncology, Moffitt Cancer Center, Tampa/US
  • 9 Product Development Oncology, Genentech, Inc., South San Francisco/US
  • 10 Oncology Biomarker Department, Genentech, Inc., South San Francisco/US
  • 11 Product Development Oncology, Genentech Inc, A Member of the Roche Group, 94080 - South San Francisco/US
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Resources

Abstract 3008

Background

Most patients (pts) with ES-SCLC receive platinum-based chemotherapy with etoposide, however median survival is

Methods

ES-SCLC pts received atezo IV q3w at 15 mg/kg or 1200 mg as part of a Ph Ia study (NCT01375842). Due to protocol amendments the first 5 pts were PD-L1 selected and the subsequent 12 were not PD-L1 selected. Initially treatment was to last up to 1 y though retreatment at PD was allowed. Later pts were treated until loss of clinical benefit. RECIST v1.1 and irRC assessments were used. PD-L1 expression was centrally evaluated using the VENTANA SP142 IHC assay. Teffector (Teff) gene signature (CD8A, GZMA, GZMB, EOMES, CXCL9, CXCL10, TBX21) and PD-L1 mRNA was measured (iChip).

Results

As of Dec 15, 2015, 17 pts with a minimum follow-up of 6.7 mo, were safety/efficacy evaluable. 65% were male; 88% were ECOG PS 1. Median age was 63 y (range 44-80), and pts were heavily pretreated (65% ≥ 3 prior therapies). 65% pts had all grade (1-5) treatment-related AEs most often fatigue (24%). There were 8 related G3-5 AEs in 3 pts, including 1 G3 pneumonitis leading to treatment discontinuation and 1 G5 hepatic failure. Confirmed ORR by RECIST was 6% (1 PR with DOR of 7 mo, also irPR by irRC) and 24% by irRC. 4/17 pts received atezo for ≥ 6 mo, 2 of these for ≥ 12 mo. 1 irPR pt stopped atezo per protocol after 1 y and remained in irPR for an additional 1 y until PD. Upon retreatment, the patient again derived benefit and is still on atezo as of data cutoff, 2.6 y from first dose. mPFS by RECIST was 1.5 mo (95% CI: 1.2, 2.7), and mOS was 5.9 mo (95% CI: 4.3, 20.1). PD-L1 expression was low overall, consistent with published data. A trend toward greater clinical benefit was seen for Teff gene signature and PD-L1 mRNA.

Conclusions

These initial results in ES-SCLC demonstrate a tolerable safety profile with no new safety signals for atezo. Atezo also showed encouraging single-agent activity, based on the duration of clinical benefit in a subset of patients. Further studies of atezo in ES-SCLC are planned.

Clinical trial identification

NCT01375842

Legal entity responsible for the study

F. Hoffmann-La Roche Ltd.

Funding

F. Hoffmann-La Roche Ltd.

Disclosure

L.V. Sequist: Consulting: uncompensated consulting with BI, Clovis, Merrimack, Novartis, Genentech, Taiho, and consulting with AZ, Ariad Research: BI, AZ, Clovis, Merrimack, Merck, Novartis, Genentech. A. Chiang: Genentech/Roche Advisory Board Research funding for trials: Boehringer Ingelheim, OncoMed, Millenium, Onyx. J. Gilbert: Research funding (for clinical trials, not salary) from AZ, Merck, Pfizer, Threshold. M. Gordon: Research funding from Genentech and Roche for research activities which is provided to the institution. P.R. Conkling: Research funding: USOncology Research. S.J. Antonia: Honoraria: BMS, AstraZeneca, Advisory boards: Genetech, Merck Consulting: BMS, AstraZeneca Research: Medimmune Travel: BMS, AstraZeneca. B. Liu, D.S. Shames, A. Lopez-Chavez: Genentech employee. C. O'Hear: Genentech Employee. Stocker/other ownership: Genentech/Roche. Research funding from Genentech. M. Fasso: Genentech Employee and Aduro Bio Tech, Inc. All other authors have declared no conflicts of interest.

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