Tumori Journal Abstract Book - October 2020 - 13

A - Thoracic Cancers	

13

University of California Los Angeles/TRIO-US Network, Los Angeles; 4The
Cancer Institute Hospital of JFCR, Tokyo; 5National Kyushu Cancer Center,
Fukuoka; 6Wakayama Medical University Hospital, Wakayama; 7Samsung
Medical Center, Seoul; 8Department of Internal Medicine, National Taiwan
University Hospital, Taipei City; 9Eli Lilly and Company, Copenhagen; 10Eli
Lilly and Company, Indianapolis; 11Lilly Oncology, Utrecht; 12LungenClinic,
Airway Research Center North (ARCN), German Center for Lung Research
(DZL), Grosshansdorf; 13Second Medical Oncology Unit, Istituto Oncologico
Veneto, Padua

Background: In EGFR mutated, metastatic (met) NSCLC,
outcomes from EGFR tyrosine kinase inhibitors (TKIs)
have differed historically by mutation (mut) type present,
with lower benefit reported in pts with an exon 21 L858R
(ex21) versus (v) an exon 19 deletion (ex19). In the phase
3 RELAY trial, RAM+ERL provided a superior PFS v
PBO+ERL (Nakagawa K, et al, Lancet Oncol.
2019.20:1655-69). Additional efficacy and safety by mut
type are reported here for the first time.
Patients and methods: Pts with untreated met NSCLC, an
EGFR ex19 or ex21 mut, and no CNS mets were randomized (1:1) to receive erlotinib (150 mg/day) with either
ramucirumab (10 mg/kg) (RAM+ERL) or placebo

(PBO+ERL), Q2W, until RECIST1.1-defined progression
or unacceptable toxicity. Stratification factors included
mut type (ex19/ex21) and region (East Asia/Other). The
primary endpoint was PFS. Secondary and exploratory
endpoints included ORR, DCR, DOR, safety, PFS2, and
biomarker analyses. Statistical analyses included Cox
regression and Kaplan-Meier estimation. Adverse events
were evaluated using NCI-CTCAE 4.0.
Results: More pts with ex21 v ex19 (83% v 72%) were of
Asian race. PFS, ORR, and DCR showed consistent
improvements across mut types for RAM+ERL v
PBO+ERL (Table). The safety profile (Grade ⩾3, serious
AEs, dose adjustments) was similar between the mut types.
Exploratory data are forthcoming.
Conclusions: RAM+ERL-treated pts with ex21 mut had
similar treatment benefit as pts with ex19 mut, which was
consistent with that of the ITT. The safety profiles were as
expected. These results support RAM+ERL as a first-line
therapy for both ex19 and ex21-positive met NSCLC.
Previously submitted at ESMO (2020), Nakagawa et al.
Reused with permission.

Ex19
 
PFS
Median, months
HR* (95% CI)*; Log-rank p-value*
1yr PFS rate, %
ORR, %
DCR, %
DOR n responders
Median, months
HR (95% CI)*

RAM+ERL
(n=123)

Ex21
PBO+ERL (n=120)

19.6
12.5
0.651 (0.469-0.903); p=0.01
74
54
79
83
96
96
97
99
18.2
11.0
0.542 (0.380-0.772)

RAM+ERL (n=99)

PBO+ERL (n=105)

 
19.4
11.2
0.618 (0.437-0.874); p=0.006
70
47
74
66
95
95
73
69
16.2
11.1
0.731 (0.493-1.083)

PFS, progression free survival; ORR, objective response rate; DCR, disease control rate; DOR, duration of response; HR, hazard ratio.
Median follow-up time = 20.7 mo (range, 0.1-35.4).
*unstratified.

A17
Pretreatment Lung Immune
Prognostic Index (LIPI) as
biomarker in patients (pts) with
advanced non-small cell lung
cancer (aNSCLC) treated with first
line pembrolizumab: preliminary
results from a retrospective
multicenter analysis
Veccia A.1, Sforza V.2, Vattemi E.3, Inno A.4, Kinspergher S.1,
Dipasquale M.1, Gori S.4, Morabito A.2, Caffo O.1
1
Medical Oncology, Santa Chiara Hospital, Trento; 2Thoracic Medical
Oncology, Istituto Nazionale Tumori, 'Fondazione G Pascale', IRCCS, Napoli;
3
Medical Oncology, Central Hospital, Bolzano; 4Medical Oncology, IRCCS
Ospedale Sacro Cuore Don Calabria, Negrar di Valpolicella, Verona

Background: Although immunotherapy represents a milestone in the treatment of aNSCLC, the clinicians need predictive biomarkers to better select pts most likely to benefit
from immune checkpoint inhibitors (ICIs). Recently, the
pretreatment LIPI was reported as an inflammatory biomarker associated with survival and response outcomes in
pts treated with ICIs.
Patients and methods: We retrospectively reviewed the
clinical records of aNSCLC pts with PDL1 ⩾ 50% expression who received pembrolizumab as first line treatment
from August 2017 to December 2019 at four Italian oncology departments. Pretreatment derived neutrophils/(leucocytes minus neutrophils) ratio (dNLR) and lactate
dehydrogenase (LDH) values were evaluated in order to
calculate LIPI. The score was based on dNLR (ratio ⩽ 3
and > 3 were scored 0 and 1, respectively), and LDH



Tumori Journal Abstract Book - October 2020

Table of Contents for the Digital Edition of Tumori Journal Abstract Book - October 2020

Contents
Tumori Journal Abstract Book - October 2020 - Cover1
Tumori Journal Abstract Book - October 2020 - Cover2
Tumori Journal Abstract Book - October 2020 - I
Tumori Journal Abstract Book - October 2020 - II
Tumori Journal Abstract Book - October 2020 - Contents
Tumori Journal Abstract Book - October 2020 - IV
Tumori Journal Abstract Book - October 2020 - V
Tumori Journal Abstract Book - October 2020 - 1
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Tumori Journal Abstract Book - October 2020 - Cover3
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