Tumori Journal Abstract Book - October 2020 - 6

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Given its complexity, both staging and optimal treatment
of stage III NSCLC require an experienced multidisciplinary team. The locally advanced setting is rapidly evolving the treatment paradigm for unresectable disease
changed with the results from PACIFIC trial. In this scenario, the BE-PACIFIC observational study has been
designed to describe the management of patients with
stage III NSCLC in the Italian real-life setting.
Patients and methods: BE-PACIFIC is an observational
multicenter retrospective-prospective cohort study on
stage III NSCLC patients. It includes patients with confirmed diagnosis of Stage III NSCLC at enrollment or
within the prior 6 months. The study is conducted in 48
Italian oncology centers. A total number of 300 patients
will be enrolled in a 12-month period. Results of a preplanned interim analysis, aimed at describing the diagnostic pattern in clinical practice for Stage III NSCLC, are
here reported descriptively.
Results: 138 patients were eligible. The mean duration of
the diagnostic work-up was 47.4 days. Diagnostic process
was entirely performed in the center where the patient was
initially admitted in 44.9% of cases and largely involved
(89.1%) a multidisciplinary team. The diagnostic procedures mainly comprised clinical evaluation, radiological/
imaging examinations for clinical staging, and cyto/histopathologic analyses for pathological confirmation. A 18FFDG PET scan has been carried out in 77.5% of patients. A
bronchoscopy was performed in 53.6% of cases. 83.3% of
patients were tested for PD-L1 expression. Particularly,
PD-L1 expression was assessed on cytological samples in
16.5% of cases and on histological specimens in 80.9%
(2.6% unknown). In 66.1% of cases, =1% of tumor cells
expressed PD-L1, with median level of PD-L1 expression
of 50% (12.5-60%).
Conclusions: The BE-PACIFIC study will draw a detailed
portrait of the current standard practices in locally
advanced NSCLC and this interim analysis offers interesting insights on the diagnostic patterns across Italy.

A05*
Registrational dataset from
the phase 1/2 ARROW trial of
pralsetinib (BLU-667) in patients
(pts) with advanced RET fusion+
non-small-cell lung cancer
(NSCLC)
Curigliano G.1, Cappuzzo F.2, Siena S.3, Marchetti P.4, Gainor J.F.5,
Kim D.6, Lee D.H.7, Besse B.8, Baik C.S.9, Doebele R.C.10, Cassier
P.11, Lopes G.12, Shao-Weng Tan D.13, Garralda E.14, Paz-Ares L.15,
Cho B.C.16, Gadgeel S.M.17, Thomas M.18, Liu S.V.19, Turner C.D.20,
Subbiah V.21
1

European Institute of Oncology, IRCCS, and University of Milan, Milan;
Azienda Unità Sanitaria Locale della Romagna, Ravenna; 3Niguarda Cancer

2

Tumori Journal 106(2S)
Center and Università degli Studi di Milano, Milan; 4Sant' Andrea Hospital
and Sapienza University, Rome; 5Massachusetts General Hospital, Boston;
6
Seoul National University Hospital, Seoul; 7Asan Medical Center, University
of Ulsaarn College of Medicine, Seoul; 8Gustave Roussy Cancer Centre, ParisSaclay University, Orsay; 9University of Washington, Seattle; 10University of
Colorado School of Medicine, Aurora; 11Centre Léon Bérard, Lyon; 12Miller
School of Medicine and Sylvester Comprehensive Cancer Center, Miami;
13
National Cancer Centre Singapore, Singapore; 14Vall d'Hebron Institute
of Oncology and Vall d'Hebron University Hospital, Barcelona; 15University
Hospital 12 de Octubre and Spanish National Cancer Research Center,
Madrid; 16Yonsei Cancer Center, Yonsei University College of Medicine,
Seoul; 17University of Michigan, Ann Arbor; 18Thoracic Oncology and
Translational Lung Research Center Heidelberg and Heidelberg University
Hospital, Heidelberg; 19Lombardi Comprehensive Cancer Center, Georgetown
University, Washington; 20Blueprint Medicines Corporation, Cambridge;
21
University of Texas MD Anderson Cancer Center, Houston

Background: Pralsetinib is an investigational, highly
potent, selective RET kinase inhibitor targeting oncogenic
RET alterations. We present the registrational dataset for
pts with RET fusion+ NSCLC with and without prior
treatment from the global ARROW study.
Material and methods: ARROW (75 sites in 11 countries; NCT03037385) consists of a phase 1 dose escalation
to establish recommended phase 2 dose (400 mg once
daily [QD] orally) and phase 2 expansion cohorts defined
by tumor type and/or RET alteration. Primary objectives
were overall response rate (ORR; blinded independent
central review per RECIST v1.1) and safety. Efficacy analyses are shown for response-evaluable pts (REP) with
RET fusion+ NSCLC who initiated pralsetinib 400 mg
QD by 11 July 2019 and safety for all pts (regardless of
diagnosis) treated with 400 mg QD.
Results: As of 18 November 2019, 354 pts with advanced
solid tumors had received pralsetinib at 400 mg QD;
median follow-up 8.8 months. ORR, disease control rate
(DCR), and% of pts with tumor size reduction are shown
in the table for pts with metastatic RET fusion+ NSCLC
(n=116; 72% KIF5B; 16% CCDC6; 12% other/fusion
type unknown) and with prior platinum treatment (n=80)
or no prior systemic treatment (n=26). ORR was similar
regardless of RET fusion partner, prior therapies, or central nervous system involvement. Overall there were 7
(6%) complete responses, 4 (5%) in prior platinum pts and
3 (12%) in treatment naïve pts; median time to response
overall was 1.8 months and median duration of response
was not reached (95% CI, 11.3-NR). In the safety population (n=354), most treatment-related adverse events
(TRAEs) were grade 1-2, and included increased aspartate aminotransferase (31%), anemia (22%), increased
alanine aminotransferase (21%), constipation (21%) and
hypertension (20%); 4% of pts discontinued treatment
due to TRAEs.
Conclusions: Updated, registrational, centrally reviewed
data demonstrate that pralsetinib has rapid, potent, and
durable clinical activity in pts with advanced RET fusion+
NSCLC regardless of RET fusion genotype or prior therapies, and QD oral dosing is well-tolerated.
Tumori Journal Abstract Book - October 2020

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