Meeting
2017 ASCO Annual Meeting
Association of liver metastases (LM) with survival in NSCLC patients treated with durvalumab (D) in two independent clinical trials.
Authors
Luis G. Paz-Ares
Medical Oncology Department, Hospital 12 de Octubre, Madrid, Spain
Luis G. Paz-Ares , Kui Shen , Brandon W. Higgs , Chris Morehouse , Naiyer A. Rizvi , Neil Howard Segal , Xiaoping Jin , Yanan Zheng , Rajesh Narwal , Ashok Kumar Gupta , Phillip A. Dennis , Pralay Mukhopadhyay , Koustubh Ranade
Organizations
Medical Oncology Department, Hospital 12 de Octubre, Madrid, Spain, MedImmune, Gaithersburg, MD, Columbia University Medical Center, New York, NY, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, MedImmune, Mountain View, CA, AstraZeneca, Gaithersburg, MD
Research Funding
Pharmaceutical/Biotech Company
Background: Immunotherapies have improved survival in NSCLC but not all pts benefit. Besides baseline PDL1 expression, routinely measured clinical factors may predict clinical outcomes in immunotherapy trials. LM are associated with poor prognosis in melanoma and bladder cancer pts treated with anti-PD1/L1, respectively. We examined correlation between pretreatment LM and survival in D-treated NSCLC pts. Methods: CP1108/NCT01693562 and ATLANTIC/NCT02087423 were nonrandomized phase 1/2 and 2 trials, respectively, of D 10 mg/kg Q2W in advanced NSCLC. As of Oct 24/Jun 3 2016, 304/265 primarily pretreated pts were enrolled in CP1108/ATLANTIC Cohort 2. Cox proportional hazards analysis was conducted, first among LM+/− pts, then LM+/− and PDL1 high/low pts. Both models accounted for tumor stage, ECOG/WHO PS, histology, sex, age, smoking and PDL1 status. PDL1 high was defined as ≥25% tumor cells immunostained for PDL1 at any intensity. Results: LM absence was a positive independent predictor of OS and PFS in both trials. LM− and PDL1 high or low pts had improved OS and PFS vs PDL1 low/LM+; PDL1 high/LM+ pts had improved PFS vs PDL1 low/LM+. An independent tumor kinetic model indicated LM as a predictive covariate of rapid tumor growth in D-treated pts. Conclusions: LM are associated with shorter survival in D-treated NSCLC pts in 2 trials irrespective of PDL1 status. Clinical trial information: NCT02087423 and NCT01693562
| CP1108 | N | OS adjusted HR; p | Median OS, mo (95% CI) | PFS adjusted HR; p | Median PFS, mo (95% CI) |
|---|---|---|---|---|---|
| LM+ | 86 | 1.91; 0.0002 | 5.6 (3.3, 9.5) | 1.63; 0.0009 | 1.4 (1.4, 1.9) |
| LM− | 218 | 15.7 (13.6, 24.1) | 3.4 (2.7, 5.3) | ||
| PDL1 high/LM− | 119 | 0.33; <0.0001 | 19.4 (15.6, 28) | 0.35; <0.0001 | 4.8 (2.8, 5.7) |
| PDL1 low/LM− | 85 | 0.55; 0.014 | 9.1 (7.5, 15.7) | 0.51; 0.002 | 2.4 (1.4, 3.9) |
| PDL1 high/LM+ | 46 | 0.66; 0.14 | 6.1 (3.4, 19.2) | 0.50; 0.007 | 1.7 (1.4, 2.9) |
| PDL1 low/LM+ | 35 | 4.3 (1.9, 6.5) | 1.4 (1.2, 1.5) | ||
| ATLANTIC | |||||
| LM+ | 47 | 2.2; <0.0001 | 5.1 (3.5, 8.3) | 1.92; 0.0005 | 1.8 (1.7, 1.9) |
| LM− | 216 | 10.4 (9.3, 13.0) | 3.1 (1.9, 3.6) | ||
| PDL1 high/LM− | 120 | 0.27; <0.0001 | 13.2 (9.3, 17.4) | 0.23; <0.0001 | 3.6 (2.5, 3.9) |
| PDL1 low/LM− | 77 | 0.46; 0.011 | 10.2 (7.2, 12.1) | 0.36; 0.0008 | 1.9 (1.9, 3.5) |
| PDL1 high/LM+ | 29 | 0.61; 0.17 | 5.3 (3.5, 11.3) | 0.37; 0.004 | 1.9 (1.7, 2.4) |
| PDL1 low/LM+ | 16 | 4.3 (2.0, 8.3) | 1.8 (1.5, 1.9) |
All HRs vs PDL1 low/LM+ subgroup
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Abstract Details
Session Type
Poster Session
Session Title
Developmental Therapeutics—Immunotherapy
Track
Developmental Therapeutics and Translational Research,Immunotherapy
Sub Track
Biomarkers and Correlative Studies from Immunotherapy Trials
Clinical Trial Registration Number
NCT02087423 and NCT01693562
Citation
J Clin Oncol 35, 2017 (suppl; abstr 3038)
DOI
10.1200/JCO.2017.35.15_suppl.3038
Abstract #
3038
Poster Bd #
133
Abstract Disclosures
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