Tumori Journal Abstract Book - October 2020 - 141

H - Genitourinary Tumours	
Incorvaia L.1, Fanale D.2, Badalamenti G.2, Iovanna J.3, Porta C.4,
Olive D.5, Corsini L.6, Brando C.6, Bono M.6, Fiorino A.6, La Mantia
M.6, Barraco N.6, Rizzo M.7, Gri N.4, Gristina V.6, Di Miceli S.6,
Bazan V.1, Russo A.6
1

University of Palermo, Department of Biomedicine, Neuroscience and
Advanced Diagnostics (Bi.N.D.), Section of Medical Oncology, Palermo;
2
Department of Surgical, Oncological and Oral Sciences, Section of Medical
Oncology, University of Palermo,, Palermo; 3Centre de Recherche en
Cancérologie de Marseille (CRCM), Team Pancreatic Cancer,, Mareselle;
4
University of Pavia and Division of Translational Oncology, IRCCS Istituti
Clinici Scientifici Maugeri,, Pavia; 5Centre de Recherche en Cancerologie de
Marseille (CRCM), INSERM U1068, Aix-Marseille Universite' and Institut
Paoli-Calmettes, Mareselle; 6University of Palermo, Department of Surgical,
Oncological and Oral Sciences, Section of Medical Oncology, Palermo;
7
IRCCS Istituti Clinici Maugeri, Pavia

Background: Despite immunotherapy has revolutionized
the treatment of metastatic RCC (mRCC), predicting
which patient will benefit from the treatment still remain
an issue. Many elements represent a barrier to the assessment of PD-L1 expressions using immunohistochemistry
(IHC) as biomarker of immunotherapy activity and more
dynamic biomarkers are required for patient selection.
Patients and methods: We performed a prospective study
including a cohort of 56 patients with clear cell RCC
(ccRCC): 21 metastatic patients (mccRCC), 15 with localized disease and a validation cohort of 20 mccRCC. In the
group of mccRCC patients candidate to nivolumab as second line treatment, peripheral blood samples were collected
at baseline, before starting nivolumab (T0), and after a
4-weeks period (T1). The plasma sPD-1, sPD-L1 and pansBTN3A, sBTN3A1 and sBTN2A1 levels were measured
by specific ELISA assays not yet commercially available.
Results: In the sub-population of long-responders patients
(PFS>18 months), the mean pre-treatment (T0) levels of
sPD1 and sPD-L1 were higher respect to the patients with
shorter PFS (<6 months); conversely, the T0 levels of
sBTN2A1 were lower than short-responders. Particularly, the
median PFS of patients with sPD1<8.05 ng/ml measured
before starting nivolumab (T0) was 5.8 months, whereas in
patients with sPD1 >8.05 the median PFS was 17.5 months
(p=0.0274). We investigate the dynamic change of plasmatic
immune-checkpoints after nivolumab treatment (T1). In the
patients with PFS>18 months, the Wilcoxon test for paired
samples showed a statistically significant difference between
T0 and T1 for both sPD1 and sBTN2A1 (sPD1: T0 vs T1
p=0.0078; sBTN2A1 T0 vs T1 p=0.0007). For sPD-L1 probably the small number of samples did not allow us to reach
statistical significance (p=0.097). An exploratory analysis in
metastatic versus localized ccRCC patients, showed that the
concentrations of sPD-1 and sPD-L1 were elevated in the
plasma of metastatic in comparison with localized RCC
patients (sPD-1 p=0.003; sPD-L1 p=0.164).
Conclusions: Soluble PD-1, PD-L1 and BTN2A1 could
help to identify patient's subgroups for immune-checkpoint treatment, driving the therapeutic choice and monitoring the patient's response.

141

H09
CABOZANTINIB (CABO) PLUS
DURVALUMAB (DURVA) IN PATIENTS
(PTS) WITH ADVANCED UROTHELIAL
CARCINOMA (UC) AFTER PLATINUM
CHEMOTHERAPY: SAFETY AND
PRELIMINARY ACTIVITY OF THE
OPEN-LABEL, SINGLE-ARM, PHASE 2
ARCADIA TRIAL
Marandino L.1, Raggi D.1, Giannatempo P.1, Calareso G.1, Alessi A.1,
Colecchia M.1, Madison R.2, Ross J.S.3, Necchi A.1
1
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano; 2Foundation
Medicine, Cambridge, MA, USA; 3Foundation Medicine Inc., Cambridge, MA,
USA; Upstate Medical University, Syracuse, NY, USA

Background: Both DURVA and CABO, an inhibitor of
MET, AXL, and VEGFR, have shown single-agent activity in pts with UC. ARCADIA is a phase 2 study evaluating the combination of CABO with DURVA in pts with
advanced UC or non-UC histology (NCT03824691).
Herein we report the results of the interim safety analysis
and the preliminary activity.
Methods: Pts receive CABO 40 mg daily, orally, and are
administered DURVA 1500 mg, intravenously, q28 days,
until disease progression (PD, by RECIST 1.1) or onset of
unacceptable toxicity. Key inclusion criteria are ECOG-PS
0-1, UC and non-UC histology, failure of 1 or 2 platinumbased regimens for metastatic disease. The response is evaluated by RECIST criteria v.1.1 q2 cycles by CT and PET/
CT scans. The primary endpoint of the study is OS. Other
endpoints include safety (CTCAE v.5.0), objective response
rate (ORR), duration of response, progression-free survival.
PD-L1 expression is assessed using the Ventana SP142
assay. Next-generation sequencing tests (FoundationOne)
on pre-therapy tumor samples are also performed.
Results: As of May 20, 2020, 14 pts were enrolled with a
median follow-up of 5 mo (range 1-8). The median age
was 66 yrs (range 44, 74), 21% were female, and 60% had
an ECOG PS 1. 2 pts had pure neuroendocrine (NE) histology. Four pts (28%) had received 2 prior systemic anticancer therapies. The median tumor mutational burden (TMB)
was 6 mut/Mb. Treatment-related AEs (TRAEs) occurred
in 9 pts (64.3%), all of Grade 1-2, within the first 2 cycles.
One pt (7%) discontinued CABO due to toxicity, none
DURVA. The most common TRAEs were asthenia
(28.6%), diarrhea, creatinine increase and hypertension
(all 21.4%). In 10 response-evaluable pts, partial response
(PR) was obtained in 2 (20%), ongoing at 6+ mo in one
case harboring a driver RET (F116L) mutation. Clinical
benefit (PR + stable disease) was obtained in 28.6%. 0/2
NE tumors responded.
Conclusions: CABO in combination with DURVA demonstrated encouraging clinical activity in pts with advanced
UC with an acceptable safety profile. More mature results,



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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