Authors
Anna Passarelli, Michele Bartoletti, Alberto Farolfi, Maria Lucia Iacovino, Francesco Perrone, Clorinda Schettino, Laura Arenare, Marcella Montico, Gustavo Baldassarre, Daniela Califano, Carmela Pisano, Valeria Andretta, Grazia Artioli, Alice Bergamini, Roberto Bianco, Alessandra Bologna, Domenica Lorusso, Anna Fagotti, Marica Gentile, Stefania Napolitano, Elena Poletto, Antonella Savarese, Giuseppa Scandurra, Giorgio Valabrega, Claudio Zamagni, Yvonne G Lin, Layal Maatouk, Sandro Pignata
Published in
International journal of gynecological cancer : official journal of the International Gynecological Cancer Society. Pages 104957. Aug 09, 2026. Epub Aug 09, 2026.
Abstract
The phosphatase and tensin homolog-phosphoinositide 3-kinase (PI3K)-protein kinase B (AKT) pathway is frequently altered in gynecological tumors, notably in endometrial cancer where PIK3CA mutations are found in nearly half of patients. Despite this, evidence of clinical activity of PI3K inhibitors in endometrial cancer is poor and limited. Alpelisib, an oral PI3K alpha-selective inhibitor, showed encouraging preliminary activity in advanced gynecological tumors harboring PIK3CA alterations. Inavolisib is a highly potent and selective PI3K inhibitor.
The MITO END-4 trial aims to assess the efficacy and safety of inavolisib in patients with endometrial cancer who have received platinum-based chemotherapy and immunotherapy. The primary objective is to determine the anti-tumor activity (assessed by objective response rate) of inavolisib in patients with advanced endometrial cancer with PIK3CA mutated tumors.
The study tests the hypothesis that inavolisib has superior anti-tumor activity compared to historically available standard therapies in previously treated patients with advanced endometrial cancer harboring a PIK3CA mutation.
This is a phase II, single-arm, multicenter trial in which advanced endometrial cancer patients whose tumors harbor a pathogenic PIK3CA mutation will receive inavolisib.
Patients aged 18 years and older with documented evidence of PIK3CA mutated advanced endometrial cancer (endometrioid, serous, clear cell, carcinosarcoma or mixed histology) will be enrolled. Patients have previously received at least 1 platinum-based chemotherapy in any setting (adjuvant or advanced) with or without immune checkpoint inhibitor, alone or in combination. Not more than 4 lines of therapy are allowed. Key exclusion criteria include uterine sarcoma and prior treatment with any PI3K, AKT, or mechanistic target of rapamycin (mTOR) inhibitor.
Objective response rate defined as a complete response or partial response by the Investigator using RECIST v1.1 criteria over the whole treatment period.
48 patients.
May 2028.
MITO END-4; EU-CT NUMBER: 2025-522981-61-00; NCT07522697.
PMID:
42701058
Bibliographic data and abstract were imported from PubMed on 06 Sep 2026.
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