Long-term follow-up of efficacy and safety of selinexor
maintenance treatment in patients with TP53wt advanced or
recurrent endometrial cancer: A subgroup analysis of the
ENGOT-EN5/GOG-3055/SIENDO study

J 2024

Long-term follow-up of efficacy and safety of selinexor maintenance treatment in patients with TP53wt advanced or recurrent endometrial cancer: A subgroup analysis of the ENGOT-EN5/GOG-3055/SIENDO study

MAKKER, Vicky, Jose Alejandro PEREZ-FIDALGO, Giorgio VALABREGA, Erika HAMILTON, Toon Van GORP et. al.

Basic information

Original name

Long-term follow-up of efficacy and safety of selinexor maintenance treatment in patients with TP53wt advanced or recurrent endometrial cancer: A subgroup analysis of the ENGOT-EN5/GOG-3055/SIENDO study

Authors

Edition

Gynecologic Oncology, SAN DIEGO, ACADEMIC PRESS INC ELSEVIER SCIENCE, 2024, 0090-8258

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30214 Obstetrics and gynaecology

Country of publisher

United States of America

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

URL

Impact factor

Impact factor: 4.700 in 2022

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.1016/j.ygyno.2024.05.016

UT WoS

001257369900001

Keywords in English

Cancer biomarker; Endometrial neoplasm; Exportin 1 proteinp; 53 tumor-suppressor protein

Abstract

V originále

Objective To report long-term efficacy and safety of selinexor maintenance therapy in adults with TP53 wild-type (TP53wt) stage IV or recurrent endometrial cancer (EC) who achieved partial remission (PR) or complete remission (CR) following chemotherapy. Methods Analysis of the prespecified, exploratory subgroup of patients with TP53wt EC from the phase 3 SIENDO study was performed. Progression-free survival (PFS) benefit in patients with TP53wt EC and across other patient subgroups were exploratory endpoints. Safety and tolerability were also assessed. Results Of the 263 patients enrolled in the SIENDO trial, 113 patients had TP53wt EC; 70/113 (61.9%) had TP53wt/proficient mismatch repair (pMMR) EC, and 29/113 (25.7%) had TP53wt/deficient mismatch repair (dMMR) EC. As of April 1, 2024, the median PFS (mPFS) for TP53wt patients who received selinexor compared with placebo was 28.4 versus 5.2 months (36.8-month follow-up, HR 0.44; 95% CI 0.27–0.73). A benefit in mPFS was seen with selinexor versus placebo regardless of MMR status (patients with TP53wt/pMMR EC: 39.5 vs 4.9 months, HR 0.36; 95% CI 0.19–0.71; patients with TP53wt/dMMR EC: 13.1 vs 3.7 months, HR 0.49; 95% CI 0.18–1.34). Selinexor treatment was generally manageable, with no new safety signals identified. Conclusion In the phase 3 SIENDO study, selinexor maintenance therapy showed a promising efficacy signal and a manageable safety profile in the prespecified subgroup of patients with TP53wt EC who achieved a PR or CR following chemotherapy.

Citovat

MAKKER, Vicky, Jose Alejandro PEREZ-FIDALGO, Giorgio VALABREGA, Erika HAMILTON, Toon Van GORP, Jalid SEHOULI, Klaudia REGINÁČOVÁ, Debra L RICHARDSON, Tamar PERRI, Amit M OZA, David S MILLER, Eva Maria Guerra ALÍA, Ugo De GIORGI, Stephanie HENRY, Daniel L SPITZ, Pauline WIMBERGER, Markéta BEDNAŘÍKOVÁ, Hye Sook CHON, Jerónimo MARTÍNEZ-GARCIA, Carmela PISANO, Jonathan S BEREK, Ignacio ROMERO, Giovanni SCAMBIA, Lorena FARIÑAS-MADRID, Joseph BUSCEMA, Fabienne SCHOCHTER, Kai LI, Pratheek KALYANAPU, Christopher J WALKER and Ignace VERGOTE. Long-term follow-up of efficacy and safety of selinexor maintenance treatment in patients with TP53wt advanced or recurrent endometrial cancer: A subgroup analysis of the ENGOT-EN5/GOG-3055/SIENDO study. Gynecologic Oncology. SAN DIEGO: ACADEMIC PRESS INC ELSEVIER SCIENCE, 2024, vol. 185, June 2024, p. 202-211. ISSN 0090-8258. Available from: https://dx.doi.org/10.1016/j.ygyno.2024.05.016.

@article{2416319,
   author = {Makker, Vicky and PerezandFidalgo, Jose Alejandro and Valabrega, Giorgio and Hamilton, Erika and Gorp, Toon Van and Sehouli, Jalid and Regináčová, Klaudia and Richardson, Debra L and Perri, Tamar and Oza, Amit M and Miller, David S and Alía, Eva Maria Guerra and Giorgi, Ugo De and Henry, Stephanie and Spitz, Daniel L and Wimberger, Pauline and Bednaříková, Markéta and Chon, Hye Sook and MartínezandGarcia, Jerónimo and Pisano, Carmela and Berek, Jonathan S and Romero, Ignacio and Scambia, Giovanni and FariñasandMadrid, Lorena and Buscema, Joseph and Schochter, Fabienne and Li, Kai and Kalyanapu, Pratheek and Walker, Christopher J and Vergote, Ignace},
   article_location = {SAN DIEGO},
   article_number = {June 2024},
   doi = {http://dx.doi.org/10.1016/j.ygyno.2024.05.016},
   keywords = {Cancer biomarker; Endometrial neoplasm; Exportin 1 proteinp; 53 tumor-suppressor protein},
   language = {eng},
   issn = {0090-8258},
   journal = {Gynecologic Oncology},
   title = {Long-term follow-up of efficacy and safety of selinexor maintenance treatment in patients with TP53wt advanced or recurrent endometrial cancer: A subgroup analysis of the ENGOT-EN5/GOG-3055/SIENDO study},
   url = {https://www.sciencedirect.com/science/article/pii/S0090825824002348?via%3Dihub},
   volume = {185},
   year = {2024}
}

TY  - JOUR
ID  - 2416319
AU  - Makker, Vicky - Perez-Fidalgo, Jose Alejandro - Valabrega, Giorgio - Hamilton, Erika - Gorp, Toon Van - Sehouli, Jalid - Regináčová, Klaudia - Richardson, Debra L - Perri, Tamar - Oza, Amit M - Miller, David S - Alía, Eva Maria Guerra - Giorgi, Ugo De - Henry, Stephanie - Spitz, Daniel L - Wimberger, Pauline - Bednaříková, Markéta - Chon, Hye Sook - Martínez-Garcia, Jerónimo - Pisano, Carmela - Berek, Jonathan S - Romero, Ignacio - Scambia, Giovanni - Fariñas-Madrid, Lorena - Buscema, Joseph - Schochter, Fabienne - Li, Kai - Kalyanapu, Pratheek - Walker, Christopher J - Vergote, Ignace
PY  - 2024
TI  - Long-term follow-up of efficacy and safety of selinexor maintenance treatment in patients with TP53wt advanced or recurrent endometrial cancer: A subgroup analysis of the ENGOT-EN5/GOG-3055/SIENDO study
JF  - Gynecologic Oncology
VL  - 185
IS  - June 2024
SP  - 202-211
EP  - 202-211
PB  - ACADEMIC PRESS INC ELSEVIER SCIENCE
SN  - 00908258
KW  - Cancer biomarker
KW  - Endometrial neoplasm
KW  - Exportin 1 proteinp
KW  - 53 tumor-suppressor protein
UR  - https://www.sciencedirect.com/science/article/pii/S0090825824002348?via%3Dihub
N2  - Objective To report long-term efficacy and safety of selinexor maintenance therapy in adults with TP53 wild-type (TP53wt) stage IV or recurrent endometrial cancer (EC) who achieved partial remission (PR) or complete remission (CR) following chemotherapy. Methods Analysis of the prespecified, exploratory subgroup of patients with TP53wt EC from the phase 3 SIENDO study was performed. Progression-free survival (PFS) benefit in patients with TP53wt EC and across other patient subgroups were exploratory endpoints. Safety and tolerability were also assessed. Results Of the 263 patients enrolled in the SIENDO trial, 113 patients had TP53wt EC; 70/113 (61.9%) had TP53wt/proficient mismatch repair (pMMR) EC, and 29/113 (25.7%) had TP53wt/deficient mismatch repair (dMMR) EC. As of April 1, 2024, the median PFS (mPFS) for TP53wt patients who received selinexor compared with placebo was 28.4 versus 5.2 months (36.8-month follow-up, HR 0.44; 95% CI 0.27–0.73). A benefit in mPFS was seen with selinexor versus placebo regardless of MMR status (patients with TP53wt/pMMR EC: 39.5 vs 4.9 months, HR 0.36; 95% CI 0.19–0.71; patients with TP53wt/dMMR EC: 13.1 vs 3.7 months, HR 0.49; 95% CI 0.18–1.34). Selinexor treatment was generally manageable, with no new safety signals identified. Conclusion In the phase 3 SIENDO study, selinexor maintenance therapy showed a promising efficacy signal and a manageable safety profile in the prespecified subgroup of patients with TP53wt EC who achieved a PR or CR following chemotherapy.
ER  -

MAKKER, Vicky, Jose Alejandro PEREZ-FIDALGO, Giorgio VALABREGA, Erika HAMILTON, Toon Van GORP, Jalid SEHOULI, Klaudia REGINÁČOVÁ, Debra L RICHARDSON, Tamar PERRI, Amit M OZA, David S MILLER, Eva Maria Guerra ALÍA, Ugo De GIORGI, Stephanie HENRY, Daniel L SPITZ, Pauline WIMBERGER, Markéta BEDNAŘÍKOVÁ, Hye Sook CHON, Jerónimo MARTÍNEZ-GARCIA, Carmela PISANO, Jonathan S BEREK, Ignacio ROMERO, Giovanni SCAMBIA, Lorena FARIÑAS-MADRID, Joseph BUSCEMA, Fabienne SCHOCHTER, Kai LI, Pratheek KALYANAPU, Christopher J WALKER and Ignace VERGOTE. Long-term follow-up of efficacy and safety of selinexor maintenance treatment in patients with TP53wt advanced or recurrent endometrial cancer: A subgroup analysis of the ENGOT-EN5/GOG-3055/SIENDO study. \textit{Gynecologic Oncology}. SAN DIEGO: ACADEMIC PRESS INC ELSEVIER SCIENCE, 2024, vol.~185, June 2024, p.~202-211. ISSN~0090-8258. Available from: https://dx.doi.org/10.1016/j.ygyno.2024.05.016.

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