Entinostat, nivolumab and ipilimumab for women with advanced HER2-negative breast cancer : a phase Ib trial
© 2024. The Author(s), under exclusive licence to Springer Nature America, Inc..
We report the results of 24 women, 50% (N = 12) with hormone receptor-positive breast cancer and 50% (N = 12) with advanced triple-negative breast cancer, treated with entinostat + nivolumab + ipilimumab from the dose escalation (N = 6) and expansion cohort (N = 18) of ETCTN-9844 ( NCT02453620 ). The primary endpoint was safety. Secondary endpoints were overall response rate, clinical benefit rate, progression-free survival and change in tumor CD8:FoxP3 ratio. There were no dose-limiting toxicities. Among evaluable participants (N = 20), the overall response rate was 25% (N = 5), with 40% (N = 4) in triple-negative breast cancer and 10% (N = 1) in hormone receptor-positive breast cancer. The clinical benefit rate was 40% (N = 8), and progression-free survival at 6 months was 50%. Exploratory analyses revealed that changes in myeloid cells may contribute to responses; however, no correlation was noted between changes in CD8:FoxP3 ratio, PD-L1 status and tumor mutational burden and response. These findings support further investigation of this treatment in a phase II trial.
Medienart: |
E-Artikel |
---|
Erscheinungsjahr: |
2024 |
---|---|
Erschienen: |
2024 |
Enthalten in: |
Zur Gesamtaufnahme - year:2024 |
---|---|
Enthalten in: |
Nature cancer - (2024) vom: 14. Feb. |
Sprache: |
Englisch |
---|
Beteiligte Personen: |
Roussos Torres, Evanthia T [VerfasserIn] |
---|
Links: |
---|
Themen: |
---|
Anmerkungen: |
Date Revised 14.02.2024 published: Print-Electronic Citation Status Publisher |
---|
doi: |
10.1038/s43018-024-00729-w |
---|
funding: |
|
---|---|
Förderinstitution / Projekttitel: |
|
PPN (Katalog-ID): |
NLM368458792 |
---|
LEADER | 01000naa a22002652 4500 | ||
---|---|---|---|
001 | NLM368458792 | ||
003 | DE-627 | ||
005 | 20240215232157.0 | ||
007 | cr uuu---uuuuu | ||
008 | 240215s2024 xx |||||o 00| ||eng c | ||
024 | 7 | |a 10.1038/s43018-024-00729-w |2 doi | |
028 | 5 | 2 | |a pubmed24n1294.xml |
035 | |a (DE-627)NLM368458792 | ||
035 | |a (NLM)38355777 | ||
040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
041 | |a eng | ||
100 | 1 | |a Roussos Torres, Evanthia T |e verfasserin |4 aut | |
245 | 1 | 0 | |a Entinostat, nivolumab and ipilimumab for women with advanced HER2-negative breast cancer |b a phase Ib trial |
264 | 1 | |c 2024 | |
336 | |a Text |b txt |2 rdacontent | ||
337 | |a ƒaComputermedien |b c |2 rdamedia | ||
338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
500 | |a Date Revised 14.02.2024 | ||
500 | |a published: Print-Electronic | ||
500 | |a Citation Status Publisher | ||
520 | |a © 2024. The Author(s), under exclusive licence to Springer Nature America, Inc. | ||
520 | |a We report the results of 24 women, 50% (N = 12) with hormone receptor-positive breast cancer and 50% (N = 12) with advanced triple-negative breast cancer, treated with entinostat + nivolumab + ipilimumab from the dose escalation (N = 6) and expansion cohort (N = 18) of ETCTN-9844 ( NCT02453620 ). The primary endpoint was safety. Secondary endpoints were overall response rate, clinical benefit rate, progression-free survival and change in tumor CD8:FoxP3 ratio. There were no dose-limiting toxicities. Among evaluable participants (N = 20), the overall response rate was 25% (N = 5), with 40% (N = 4) in triple-negative breast cancer and 10% (N = 1) in hormone receptor-positive breast cancer. The clinical benefit rate was 40% (N = 8), and progression-free survival at 6 months was 50%. Exploratory analyses revealed that changes in myeloid cells may contribute to responses; however, no correlation was noted between changes in CD8:FoxP3 ratio, PD-L1 status and tumor mutational burden and response. These findings support further investigation of this treatment in a phase II trial | ||
650 | 4 | |a Journal Article | |
700 | 1 | |a Ho, Won J |e verfasserin |4 aut | |
700 | 1 | |a Danilova, Ludmila |e verfasserin |4 aut | |
700 | 1 | |a Tandurella, Joseph A |e verfasserin |4 aut | |
700 | 1 | |a Leatherman, James |e verfasserin |4 aut | |
700 | 1 | |a Rafie, Christine |e verfasserin |4 aut | |
700 | 1 | |a Wang, Chenguang |e verfasserin |4 aut | |
700 | 1 | |a Brufsky, Adam |e verfasserin |4 aut | |
700 | 1 | |a LoRusso, Patricia |e verfasserin |4 aut | |
700 | 1 | |a Chung, Vincent |e verfasserin |4 aut | |
700 | 1 | |a Yuan, Yuan |e verfasserin |4 aut | |
700 | 1 | |a Downs, Melinda |e verfasserin |4 aut | |
700 | 1 | |a O'Connor, Ashley |e verfasserin |4 aut | |
700 | 1 | |a Shin, Sarah M |e verfasserin |4 aut | |
700 | 1 | |a Hernandez, Alexei |e verfasserin |4 aut | |
700 | 1 | |a Engle, Elizabeth L |e verfasserin |4 aut | |
700 | 1 | |a Piekarz, Richard |e verfasserin |4 aut | |
700 | 1 | |a Streicher, Howard |e verfasserin |4 aut | |
700 | 1 | |a Talebi, Zahra |e verfasserin |4 aut | |
700 | 1 | |a Rudek, Michelle A |e verfasserin |4 aut | |
700 | 1 | |a Zhu, Qingfeng |e verfasserin |4 aut | |
700 | 1 | |a Anders, Robert A |e verfasserin |4 aut | |
700 | 1 | |a Cimino-Mathews, Ashley |e verfasserin |4 aut | |
700 | 1 | |a Fertig, Elana J |e verfasserin |4 aut | |
700 | 1 | |a Jaffee, Elizabeth M |e verfasserin |4 aut | |
700 | 1 | |a Stearns, Vered |e verfasserin |4 aut | |
700 | 1 | |a Connolly, Roisin M |e verfasserin |4 aut | |
773 | 0 | 8 | |i Enthalten in |t Nature cancer |d 2020 |g (2024) vom: 14. Feb. |w (DE-627)NLM307030067 |x 2662-1347 |7 nnns |
773 | 1 | 8 | |g year:2024 |g day:14 |g month:02 |
856 | 4 | 0 | |u http://dx.doi.org/10.1038/s43018-024-00729-w |3 Volltext |
912 | |a GBV_USEFLAG_A | ||
912 | |a GBV_NLM | ||
951 | |a AR | ||
952 | |j 2024 |b 14 |c 02 |