Περίληψη:
Bempegaldesleukin (BEMPEG: NKTR-214) is an immunostimulatory IL-2
cytokine prodrug engineered to deliver a controlled, sustained and
preferential IL-2 pathway signal. Nivolumab (NIVO), a PD-L1 inhibitor,
has been shown to prolong survival in patients with advanced melanoma
and recurrence-free survival in the adjuvant setting. PIVOT-02 showed
that BEMPEG plus NIVO was well-tolerated and demonstrated clinical
activity as first-line therapy in metastatic melanoma. PIVOT-12 is a
randomized, Phase Ill, global, multicenter, open-label study comparing
adjuvant therapy with BEMPEG plus NIVO versus NIVO alone in adult and
adolescent patients with completely resected cutaneous stage III/IV
melanoma at high risk of recurrence. The primary objective is to compare
the efficacy, as measured by recurrence-free survival, of BEMPEG plus
NIVO versus NIVO.
Lay abstract: Following surgery, patients with advanced melanoma may
require further treatment to reduce the likelihood of disease
recurrence. Nivolumab (NIVO), a checkpoint inhibitor, reduces the risk
of melanoma recurrence by enhancing the ability of the immune system to
fight disease. Despite the availability of NIVO and other therapies,
many patients with melanoma still experience disease recurrence after
surgery. This article presents information on a clinical trial named
PIVOT-12, which aims to assess the effectiveness of a new
investigational drug called bempegaldesleukin that modifies the immune
system and is given with NIVO to patients with stage III/IV melanoma
following surgery. The main end point being measured is recurrence-free
survival, which measures the time between a patient starting the study
and the date of disease recurrence.
Συγγραφείς:
Eggermont, Alexander M. M.
Ascierto, Paolo A.
Khushalani, I,
Nikhil
Schadendorf, Dirk
Boland, Genevieve
Weber, Jeffrey
and Lewis, Karl D.
Johnson, Daniel
Rivalland, Gareth and
Khattak, Adnan
Majem, Margarita
Gogas, Helen
Long, V,
Georgina
Currie, Sue L.
Chien, David
Tagliaferri, Mary A.
and Carlino, Matteo S.
Diab, Adi
