181P - Anti-PD-1 antibodies in non-small cell lung cancer (NSCLC): The real-life setting experience

Date 15 April 2016
Event European Lung Cancer Conference 2016 (ELCC) 2016
Session Poster lunch
Topics Immunotherapy
Non-small-cell lung cancer
Therapy
Presenter Elizabeth Dudnik
Citation Journal of Thoracic Oncology (2016) 11 (supplement 4): S57-S166. S1556-0864(16)X0004-4
Authors E. Dudnik1, M. Moskovitz2, M. Wollner3, A. Zer1, J. Bar4, A. Agbarya5, T. Idan6, Y. Shechtman2, M. Abu Amna3, N. Peled1
  • 1Thoracic Cancer Unit, Rabin Medical Center Davidoff Cancer Centre, Beilinson Campus, 49100 - Petach Tikva/IL
  • 2Oncology, Rambam Health Care Center, 31000 - Haifa/IL
  • 3Department Of Oncology, Rambam Health Care Center, 31096 - Haifa/IL
  • 4Medical Oncology, Chaim Sheba Medical Center, 52621 - Ramat Gan/IL
  • 5Oncology Department, Assuta Medical Center, Haifa/IL
  • 6Sackler Medical School, Tel Aviv University, Tel Aviv/IL

Abstract

Background

Nivolumab and pembrolizumab have been recently approved by the FDA as a 2nd-line treatment of NSCLC. The data regarding their efficacy and toxicity in the real-life setting is lacking.

Methods

87 patients (pts) with advanced NSCLC received intravenous nivolumab 3 mg/kg q2 weeks (n-85) or pembrolizumab 2 mg/kg q3 weeks (n-2) between Feb 2015 and Jan 2016, and were observed for safety, ORR, PFS and OS. PFS and OS were analyzed be the COX proportional hazards model. 181PT1

ParameterPFSOS
 Pr > ChiSqHR (95% CI)Pr > ChiSqHR (95% CI)
Age0.8051.006 (0.960–1.054)0.6051.015 (0.958–1.076)
Gender0.6941.190 (0.500–2.833)0.8040.869 (0.288–2.626)
Smoking0.9790.982 (0.244–3.950)0.5040.537 (0.086–3.337)
Histology (Sq vs Adeno)0.6701.228 (0.477–3.162)0.2571.902 (0.625–5.785)
Liver mets0.9260.960 (0.402–2.292)0.6690.807 (0.301–2.165)
Brain mets0.5110.724 (0.276–1.899)0.0550.222 (0.048–1.037)
ECOG PS (2/3 vs 0/1)0.0043.190 (1.436–7.088)0.0026.526 (1.972–21.601)
Previous Tx (2 vs 1)0.8791.076 (0.418–2.771)0.6591.306 (0.399–4.274)
Previous Tx (3+ vs 1)0.7480.841 (0.293–2.418)0.4690.563 (0.119–2.668)

Results

Pt baseline characteristics: median age 67 y (range, 43–92); males 68%; smokers 85%; ECOG PS≥2 48%; adenoca/ sq.cell ca/other histology 61%/22%/17%; brain metastases 21%; liver metastases 23%; treatment (Tx) line: 2nd/3rd/4th +-line 59%/25%/16%. PD-L1 status was assessed in 2 pts. 56 pts were evaluable for response; ORR (RECIST 1.1) was 28%, all the responses are ongoing. Median duration of follow-up was 10 weeks (range, 0.1–24); median number of Tx cycles delivered was 5 (range, 1–13). 45% of pts progressed, and 30% of pts died. Median OS has not been reached, median PFS currently projects to 13 weeks. In univariate and multivariate analysis, the only variable which significantly correlated with PFS and OS was ECOG PS (table). 1 pt with Crohn's disease developed G5 neutropenia; no other new safety signals were observed. An updated data will be presented during the conference.

Conclusions

Efficacy and toxicity profile of anti-PD-1 agents in the real-life setting correlates well with the published data. ECOG PS≥2 is associated with poor prognosis; presence of brain/liver metastases and number of previous Tx lines do not affect outcomes.

Clinical trial identification

Not applicable

Legal entity responsible for the study

Davidoff Cancer Center, Rabin Medical Center

Funding

BMS and MSD provided nivolumab and pembrolizumab for patients, no research funding or other form of support was received from the pharmaceutical company.

Disclosure

E. Dudnik: Honoraria for lectures – MSD. J. Bar: Advisory board fees – MSD, BMS. A. Agbarya: Advisory board fees, honoraria for lectures – BMS. N. Peled: Honoraria for lectures, consultant and advisor for BMS and MSD. All other authors have declared no conflicts of interest.