Tumori Journal Abstract Book - October 2020 - 4

4	
selpercatinib in RET-fusion+ non-small-cell lung cancer
(NSCLC).
Patients and methods: Patients with RET-fusion+ NSCLC
were enrolled to the Phase 1/2 LIBRETTO-001 trial
(NCT03157128), a global, multicenter trial (16 countries, 89
sites). Following the Phase 1 dose escalation portion of the
trial, patients received the recommended dose of 160 mg
orally twice daily. Each cycle was 28 days. The primary endpoint was objective response rate (ORR) per RECIST 1.1.
Secondary endpoints included duration of response (DoR)
and safety. Per health authority agreement, the primary analysis set was defined as the first 105 consecutively enrolled
patients previously treated with platinum-based chemotherapy. Treatment-naïve patients were analyzed separately. All
analyses were based on a 16-Dec-2019 data cutoff date.
Results: In the primary analysis set of platinum-treated
patients (median of 3 prior systemic regimens; range 1-15),
the ORR by investigator assessment was 70% (95% CI 59.8-
78.1, n = 73/105). Responses did not differ by fusion partner
or number or type of prior therapies, including anti-PD-1/
PD-L1 agents and off-label multikinase inhibitor use. The
median DoR was 20.3 months (95% CI 15.6-24.0) with 45 of
73 (62%) responders censored at a median follow-up of 14.8
months. Among 39 treatment-naïve patients, the ORR by
investigator assessment was 90% (95% CI 75.8-97.1, n =
35/39, including 2 responses pending confirmation). Median
DoR was not reached with 27 of 33 (82%) confirmed
responses ongoing at a median follow-up of 7.4 months. In
the safety analysis set consisting of all selpercatinib dosed
patients (N = 702), the most common treatment-related
adverse events (TRAEs) that occurred in ⩾15% of patients
were dry mouth (33.3%), increased AST (24.5%), increased
ALT (23.8%), hypertension (23.2%), diarrhea (19.7%), and
fatigue (16.8%). Only 2% (14 of 702) of patients discontinued selpercatinib for TRAEs.
Conclusions: Selpercatinib achieved marked and durable
antitumor activity in patients with RET-fusion+ NSCLC.
Selpercatinib was well tolerated. Efficacy data assessed by
independent review committee based on the 16-Dec-2019
data cutoff date will be presented. ©2020 ASCO, Inc.
Reused with permission.

A02*
RAMES Trial: A multicentre,
double-blind, randomized, Phase
II Study on Gemcitabine plus
Ramucirumab versus Gemcitabine
alone as second-line treatment
for advanced Malignant Pleural
Mesothelioma (MPM)
Pagano M.1, Ceresoli G.L.2, Paolo Andrea Z.3, Pasello G.4, Garassino
M.5, Grosso F.6, Tiseo M.7, Soto Parra H.8, Zanelli F.9, Cappuzzo F.10,

Tumori Journal 106(2S)
Grossi F.11, De Marinis F.12, Paolo P.13, Berselli A.14, Bonelli C.14, Boni
L.15, Normanno N.16, Pinto C.17
1

Oncology Unit, Clinical Cancer Centrer, Azienda Unità Sanitaria Locale
(AUSL)-IRCCS, Reggio Emilia, Italy, Reggio Emilia; 2Medical Oncology,
Cliniche Humanitas Gavazzeni Bergamo, Italy, Bergamo, Italy; 3Humanitas
Cancer Center, Humanitas Clinical and Research Center, Rozzano, Italy;
4
Istituto Oncologico Veneto IOV IRCCS, Padova, Italy; 5Department of
Medical Oncology Fondazione IRCCS Istituto Nazionale dei Tumori, Milan,
Italy; 6SS Antonio e Biagio Hospital, Department of Oncology, Alessandria
Italy; 7Medical Oncology Unit, University Hospital of Parma, Italy, Parma,
Italy; 8Medical Oncology, University Hospital Policlinico, Vittorio Emanuele
Catania, Italy, Catania, Italy; 9Oncology Unit, Clinical Cancer Centrer, Azienda
Unità Sanitaria Locale (AUSL)-IRCCS, Reggio Emilia, Italy, Reggio Emilia,
Italy; 10Clinical Cancer Centrer, Ravenna, Italy; 11Istituto Toscano TumoriOspedale Civile Livorno, Italy, Livorno, Italy; 12 European Institute of Oncology,
Milan,Italy; 13UOC Oncologia Medica Fondazione IRCCS Ca' Granda Ospedale
Maggiore Policlinico, Milan,Italy; 14Oncology Unit, Clinical Cancer Centrer,
Azienda Unità Sanitaria Locale (AUSL)-IRCCS,, Reggio Emilia,Italy; 15Clinical
Epidemiology Unit, IRCCS San Martino Hospital, Genoa, Italy; 16Cell Biology
and Biotherapy Unit, Istituto Nazionale Tumori, Fondazione Pascale Naples,
Italy, Naples, Italy; 17Oncology Unit, Clinical Cancer Centrer, Azienda Unità
Sanitaria Locale (AUSL)-IRCCS, Reggio Emilia, Italy

Background: Malignant pleural mesothelioma (MPM) is
a rare, highly aggressive malignancy of the mesothelium
that is usually diagnosed at an advanced stage.
Chemotherapy, which is the only available therapeutic
option in the clinical setting, is modestly effective in
MPM.The RAMES Trial (EudraCT number 2016-00113236) is a multicenter, double-blind, randomized Phase II
trial exploring the efficacy and the safety of the addition
of ramucirumab to gemcitabine as the 2°line treatment in
patients with MPM.
Methods: The pts were assigned (1:1) to receive
Gemcitabine 1000 mg/m2 iv on days 1 and 8 every 21
days with Placebo (Arm A) or Ramucirumab 10 mg/kg
iv on day 1, of a 21-day cycle (Arm B), until tolerability
or progressive disease. Pts randomised was stratified by
ECOG/PS (0-1 vs 2), age (= 70 vs > 70 yrs), histology
(epithelioid vs non-epithelioid) and time to progression
(TTP) after 1°line therapy. The primary endpoint was
overall survival (OS). Assuming a proportion of OS
equal to 40% at 1 years in arm A, a 12% absolute
improvement in OS at 1 years was expected in Arm B
(hazard ratio = 0.70). 114 events (156 subjects) are
required for a one-sided log-rank test with alfa = 0.15
to have 80% power.
Results: From December 2016 to July 2018, 164 pts were
randomized, 81 pts in Arm A and 80 Arm B; 3 pts were
randomized but not treated. Characteristics of pts were:
median age 69 yrs (44-81), males 119 (73.9%), females
42 (26.1%); ECOG/PS0 96 (59.6%); histotype epithelioid
132 (81.9%), non-epithelioid 29 (18.1%); stage III 98
(60.7%), stage IV 60 (37.3%), 3 (2.0%) missing; asbestos
exposure assessed 80 (49.7%). Median of courses was
3.50 in Arm A and 7.50 in Arm B. OS was significantly
longer in Arm B with median 13.8 mths (70% CI



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
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