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Phase 1/2 study of the safety and clinical activity of durvalumab in patients with non-small cell lung cancer (NSCLC)

Date

09 Oct 2016

Session

NSCLC, metastatic

Presenters

Scott Antonia

Citation

Annals of Oncology (2016) 27 (6): 416-454. 10.1093/annonc/mdw383

Authors

S.J. Antonia1, J.R. Brahmer2, S. Khleif3, A.S. Balmanoukian4, S.I. Ou5, M. Gutierrez6, D. Kim7, S. Kim8, M. Ahn9, J. Leach10, R. Jamal11, D. Jaeger12, G. Jerusalem13, X. Jin14, A. Gupta15, J. Antal15, N.H. Segal16

Author affiliations

  • 1 Department Of Thoracic Oncology, Moffitt Cancer Center, FL 33612 - Tampa/US
  • 2 Department Of Oncology, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore/US
  • 3 Immune Therapy Program And Experimental Therapeutics, GRU Cancer Center, Georgia Regents University, Augusta/US
  • 4 Medical, Oncology, The Angeles Clinic and Research Institute, Los Angeles/US
  • 5 Department Of Medicine, Division Of Hematology Oncology, University of California Irvine School of Medicine, Irvine/US
  • 6 Hematology & Oncology, Hackensack University Medical Center, Hackensack/US
  • 7 Department Of Internal Medicine, Seoul National University Hospital, Seoul/KR
  • 8 Department Of Biochemistry And Molecular Biology, Asan Medical Center, Seoul/KR
  • 9 Department Of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul/KR
  • 10 Oncology Research, Virginia Piper Cancer Institute, Minneapolis/US
  • 11 Department Of Hematology And Oncology, Hôpital Notre Dame, CHUM, University of Montreal, Montreal/CA
  • 12 Medical Oncology, National Center for Tumor Diseases, University Hospitals Heidelberg, Heidelberg/DE
  • 13 Medical Oncology, Centre Hospitalier Universitaire de Liège, Sart-Tilman, Liège/BE
  • 14 Biostatistics, MedImmune, Gaithersburg/US
  • 15 Clinical Development, MedImmune, Gaithersburg/US
  • 16 Department Of Medicine, Memorial Sloan Kettering Cancer Center, New York/US
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Background

High PD-L1 expression in lung tumors is associated with response to PD-L1-targeted treatment. Durvalumab, an anti-PD-L1 monoclonal antibody, was evaluated in patients with advanced solid tumors, including NSCLC, in a Phase 1/2 multicenter, open-label study (NCT01693562).

Methods

Patients received durvalumab 10 mg/kg IV Q2W for up to 12 months or until unacceptable toxicity or disease progression. Safety was evaluated (CTCAE v4.03) through 90 days after last dose; confirmed response (RECIST v1.1) was based on investigator assessment. Retreatment was permitted only upon progression after 12 months of therapy in patients with disease control. Tumor PD-L1 expression was assessed using the Ventana PD-L1 IHC (SP263) assay.

Results

As of 29 April 2016, 304 NSCLC patients received durvalumab; 144 (47%) had non-squamous and 160 (53%) had squamous histology; median age was 65 years (range 26–87 years); ECOG performance status was 0 in 24% and 1 in 76%; and 85% were current/prior smokers. Median number of doses was 6 (range 1–27). Any-grade drug-related AEs were reported in 57% of patients, most frequently fatigue (17%), decreased appetite (9%), and diarrhea (9%). Drug-related AEs were Grade ≥3 in 10% of patients; most common were fatigue, hyponatremia, and colitis (each 1%). Any-grade drug-related AEs led to study drug discontinuation in 5% of patients. Pneumonitis Grade 1–2 occurred in 5 (2%) patients and Grade 4 in 1 (

Conclusions

The safety profile of durvalumab in NSCLC is manageable and consistent with previous reports. Patients with tumors defined as PD-L1 positive had improved ORR and OS.

Clinical trial identification

NCT01693562

Legal entity responsible for the study

MedImmune

Funding

MedImmune

Disclosure

S.J. Antonia: Consulting/Advisory: BMS, AZ, Merck. J.R. Brahmer: Consulting/Advisory: AZ/Medimmune Research funding: AZ/Medimmune. S. Khleif: Leader/stock: Advaxis Honor: MEDI, AZ, NewLink, Advaxis, Lucena, PDS Consult/AB: Gilead, Janssen, Nektan, Merus, GHI, BI Res fund: MEDI, AZ, NewLink, Advaxis, PDS, Serono, IOBiotech, Caretech, Medivation Travel: MEDI, AZ, NewLink, Advaxis, Lucena. A.S. Balmanoukian: Speaker Bureau: BMS, Merck Research funding: Medimmune, Genentech, BMS, Merck Serono. S-H.I. Ou: Consulting/advisory: ARIAD, Pfizer, Roche, AZ Speaker Bureau: Roche, AZ, BI Research funding: ARIAD, AZ, BI< Pfizer, Igyta, Daiichi Sankyo, Clovis. M. Gutierrez: Employment: Hackensack University Medical Center Other relationship: Speaker Bureau Merck/BMS. M-J. Ahn: Honoraria: MSD, BMS, AZ, BI, Novartis Consulting/Advisory: BI, BMS, AZ, MSD, Novartis Research funding: AZ. R. Jamal: Honoraria: BMS, Merck Consulting advisory: BMS, Merck Research funding: BMS, Merck. D. Jaeger: Consulting/Advisory: Roche, BMS, Bayer, Definiens. G. Jerusalem: Honoraria: Novartis, Roche, Celgene Consulting or advisory: Novartis, Roche, Celgene, Amgen, Pfizer Research funding: Novartis, Roche, MSD Travel, accommodations, expenses: Novartis, Roche, GSK. X. Jin: Employment: Unitech Heal Care, Medimmune Stock/other ownership: AZ, United Health group. A. Gupta: Employment: Medimmune Stock/ownership: BMS, AZ Patents, royalties, IP: BMS. J. Antal: Employment: Medimmune Stock/ownership: AZ, GSK. N.H. Segal: Consultancy: Medimmune/AZ, BMS, Roche, Pfizer Research funding: Medimmune/AZ, BMS. All other authors have declared no conflicts of interest.

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