Paclitaxel plus Eftilagimod Alpha, a soluble LAG-3 protein, in metastatic, HR+ breast cancer: results from AIPAC, a randomized, placebo controlled phase IIb trial
Eftilagimod alpha (efti), a soluble lymphocyte activation gene (LAG-3) protein and MHC class II agonist, enhances innate and adaptive immunity. Active Immunotherapy PAClitaxel (AIPAC) evaluated safety and efficacy of efti plus paclitaxel in patients with predominantly endocrine-resistant, hormone re...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article (Journal) |
| Language: | English |
| Published: |
1 February 2024
|
| In: |
Clinical cancer research
Year: 2024, Volume: 30, Issue: 3, Pages: 532-541 |
| ISSN: | 1557-3265 |
| DOI: | 10.1158/1078-0432.CCR-23-1173 |
| Online Access: | Verlag, kostenfrei, Volltext: https://doi.org/10.1158/1078-0432.CCR-23-1173
|
| Author Notes: | Hans Wildiers, Anne Armstrong, Eveline Cuypere, Florence Dalenc, Luc Dirix, Steve Chan, Frederik Marme, Carolina P. Schröder, Jens Huober, Francois P. Duhoux, Peter Vuylsteke, Agnes Jager, Etienne Brain, Sherko Kuemmel, Zsuzsanna Pápai, Catharina Willemien Menke-van der Houven van Oordt, Luca Perjesi, Christian Mueller, Chrystelle Brignone, Frederic Triebel |
MARC
| LEADER | 00000caa a2200000 c 4500 | ||
|---|---|---|---|
| 001 | 189240964X | ||
| 003 | DE-627 | ||
| 005 | 20241205145035.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 240628s2024 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1158/1078-0432.CCR-23-1173 |2 doi | |
| 035 | |a (DE-627)189240964X | ||
| 035 | |a (DE-599)KXP189240964X | ||
| 035 | |a (OCoLC)1475300994 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rda | ||
| 041 | |a eng | ||
| 084 | |a 33 |2 sdnb | ||
| 100 | 1 | |a Wildiers, Hans |e VerfasserIn |0 (DE-588)1334304017 |0 (DE-627)1892410346 |4 aut | |
| 245 | 1 | 0 | |a Paclitaxel plus Eftilagimod Alpha, a soluble LAG-3 protein, in metastatic, HR+ breast cancer |b results from AIPAC, a randomized, placebo controlled phase IIb trial |c Hans Wildiers, Anne Armstrong, Eveline Cuypere, Florence Dalenc, Luc Dirix, Steve Chan, Frederik Marme, Carolina P. Schröder, Jens Huober, Francois P. Duhoux, Peter Vuylsteke, Agnes Jager, Etienne Brain, Sherko Kuemmel, Zsuzsanna Pápai, Catharina Willemien Menke-van der Houven van Oordt, Luca Perjesi, Christian Mueller, Chrystelle Brignone, Frederic Triebel |
| 264 | 1 | |c 1 February 2024 | |
| 300 | |b Illustrationen | ||
| 300 | |a 10 | ||
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a Computermedien |b c |2 rdamedia | ||
| 338 | |a Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Gesehen am 28.06.2024 | ||
| 520 | |a Eftilagimod alpha (efti), a soluble lymphocyte activation gene (LAG-3) protein and MHC class II agonist, enhances innate and adaptive immunity. Active Immunotherapy PAClitaxel (AIPAC) evaluated safety and efficacy of efti plus paclitaxel in patients with predominantly endocrine-resistant, hormone receptor-positive, HER2-negative metastatic breast cancer (ET-resistant HR+ HER2− MBC).Women with HR+ HER2- MBC were randomized 1:1 to weekly intravenous paclitaxel (80 mg/m2) and subcutaneous efti (30 mg) or placebo every 2 weeks for six 4-week cycles, then monthly subcutaneous efti (30 mg) or placebo maintenance. Primary endpoint was progression-free survival (PFS) by blinded independent central review. Secondary endpoints included overall survival (OS), safety/tolerability, pharmacokinetics/pharmacodynamics, and quality of life. Exploratory endpoints included cellular biomarkers.114 patients received efti and 112 patients received placebo. Median age was 60 years (91.6% visceral disease, 84.1% ET-resistant, 44.2% with previous CDK4/6 inhibitor treatment). Median PFS at 7.3 months was similar for efti and placebo. Median OS was not significantly improved for efti (20.4 vs. 17.5 months; HR, 0.88; P = 0.197) but became significant for predefined exploratory subgroups. EORTC QLQC30-B23 global health status was sustained for efti but deteriorated for placebo. Efti increased absolute lymphocyte, monocyte and secondary target cell (CD4, CD8) counts, plasma IFNγ and CXCL10 levels.Although the primary endpoint, PFS, was not met, AIPAC confirmed expected pharmacodynamic effects and demonstrated excellent safety profile for efti. OS was not significantly improved globally (2.9-month difference), but was significantly improved in exploratory biomarker subgroups, warranting further studies to clarify efti's role in patients with ET-resistant HER2− MBC. | ||
| 700 | 1 | |a Armstrong, Anne |e VerfasserIn |4 aut | |
| 700 | 1 | |a Cuypere, Eveline |e VerfasserIn |4 aut | |
| 700 | 1 | |a Dalenc, Florence |e VerfasserIn |4 aut | |
| 700 | 1 | |a Dirix, Luc |e VerfasserIn |4 aut | |
| 700 | 1 | |a Chan, Steve |e VerfasserIn |4 aut | |
| 700 | 1 | |a Marmé, Frederik |d 1974- |e VerfasserIn |0 (DE-588)132561972 |0 (DE-627)52394893X |0 (DE-576)299226549 |4 aut | |
| 700 | 1 | |a Schröder, Carolina P. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Huober, Jens |e VerfasserIn |4 aut | |
| 700 | 1 | |a Duhoux, Francois P. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Vuylsteke, Peter |e VerfasserIn |4 aut | |
| 700 | 1 | |a Jager, Agnes |e VerfasserIn |4 aut | |
| 700 | 1 | |a Brain, Etienne |e VerfasserIn |4 aut | |
| 700 | 1 | |a Kuemmel, Sherko |e VerfasserIn |4 aut | |
| 700 | 1 | |a Pápai, Zsuzsanna |e VerfasserIn |4 aut | |
| 700 | 1 | |a Menke-van der Houven van Oordt, Catharina Willemien |e VerfasserIn |4 aut | |
| 700 | 1 | |a Perjesi, Luca |e VerfasserIn |4 aut | |
| 700 | 1 | |a Mueller, Christian |e VerfasserIn |4 aut | |
| 700 | 1 | |a Brignone, Chrystelle |e VerfasserIn |4 aut | |
| 700 | 1 | |a Triebel, Frederic |e VerfasserIn |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Clinical cancer research |d Philadelphia, Pa. [u.a.] : AACR, 1995 |g 30(2024), 3 vom: Feb., Seite 532-541 |h Online-Ressource |w (DE-627)325489971 |w (DE-600)2036787-9 |w (DE-576)094502234 |x 1557-3265 |7 nnas |a Paclitaxel plus Eftilagimod Alpha, a soluble LAG-3 protein, in metastatic, HR+ breast cancer results from AIPAC, a randomized, placebo controlled phase IIb trial |
| 773 | 1 | 8 | |g volume:30 |g year:2024 |g number:3 |g month:02 |g pages:532-541 |g extent:10 |a Paclitaxel plus Eftilagimod Alpha, a soluble LAG-3 protein, in metastatic, HR+ breast cancer results from AIPAC, a randomized, placebo controlled phase IIb trial |
| 856 | 4 | 0 | |u https://doi.org/10.1158/1078-0432.CCR-23-1173 |x Verlag |x Resolving-System |z kostenfrei |3 Volltext |
| 951 | |a AR | ||
| 992 | |a 20240628 | ||
| 993 | |a Article | ||
| 994 | |a 2024 | ||
| 998 | |g 132561972 |a Marmé, Frederik |m 132561972:Marmé, Frederik |d 50000 |d 60000 |d 61300 |e 50000PM132561972 |e 60000PM132561972 |e 61300PM132561972 |k 0/50000/ |k 0/60000/ |k 1/60000/61300/ |p 7 | ||
| 999 | |a KXP-PPN189240964X |e 4543036069 | ||
| BIB | |a Y | ||
| SER | |a journal | ||
| JSO | |a {"id":{"eki":["189240964X"],"doi":["10.1158/1078-0432.CCR-23-1173"]},"type":{"bibl":"article-journal","media":"Online-Ressource"},"physDesc":[{"noteIll":"Illustrationen","extent":"10 S."}],"note":["Gesehen am 28.06.2024"],"relHost":[{"type":{"bibl":"periodical","media":"Online-Ressource"},"pubHistory":["1.1995 -"],"recId":"325489971","disp":"Paclitaxel plus Eftilagimod Alpha, a soluble LAG-3 protein, in metastatic, HR+ breast cancer results from AIPAC, a randomized, placebo controlled phase IIb trialClinical cancer research","language":["eng"],"part":{"text":"30(2024), 3 vom: Feb., Seite 532-541","volume":"30","year":"2024","pages":"532-541","extent":"10","issue":"3"},"id":{"eki":["325489971"],"issn":["1557-3265"],"zdb":["2036787-9"]},"physDesc":[{"extent":"Online-Ressource"}],"note":["Gesehen am 08.06.2023","Fortsetzung der Druck-Ausgabe"],"corporate":[{"role":"isb","display":"American Association for Cancer Research"}],"origin":[{"publisherPlace":"Philadelphia, Pa. [u.a.]","dateIssuedKey":"1995","dateIssuedDisp":"1995-","publisher":"AACR"}],"name":{"displayForm":["American Association for Cancer Research"]},"title":[{"title_sort":"Clinical cancer research","title":"Clinical cancer research"}]}],"origin":[{"dateIssuedDisp":"1 February 2024","dateIssuedKey":"2024"}],"name":{"displayForm":["Hans Wildiers, Anne Armstrong, Eveline Cuypere, Florence Dalenc, Luc Dirix, Steve Chan, Frederik Marme, Carolina P. Schröder, Jens Huober, Francois P. Duhoux, Peter Vuylsteke, Agnes Jager, Etienne Brain, Sherko Kuemmel, Zsuzsanna Pápai, Catharina Willemien Menke-van der Houven van Oordt, Luca Perjesi, Christian Mueller, Chrystelle Brignone, Frederic Triebel"]},"recId":"189240964X","person":[{"family":"Wildiers","display":"Wildiers, Hans","given":"Hans","role":"aut"},{"family":"Armstrong","given":"Anne","display":"Armstrong, Anne","role":"aut"},{"family":"Cuypere","given":"Eveline","display":"Cuypere, Eveline","role":"aut"},{"role":"aut","given":"Florence","display":"Dalenc, Florence","family":"Dalenc"},{"role":"aut","family":"Dirix","given":"Luc","display":"Dirix, Luc"},{"family":"Chan","display":"Chan, Steve","given":"Steve","role":"aut"},{"family":"Marmé","given":"Frederik","display":"Marmé, Frederik","role":"aut"},{"display":"Schröder, Carolina P.","given":"Carolina P.","family":"Schröder","role":"aut"},{"family":"Huober","given":"Jens","display":"Huober, Jens","role":"aut"},{"display":"Duhoux, Francois P.","given":"Francois P.","family":"Duhoux","role":"aut"},{"given":"Peter","display":"Vuylsteke, Peter","family":"Vuylsteke","role":"aut"},{"family":"Jager","given":"Agnes","display":"Jager, Agnes","role":"aut"},{"family":"Brain","given":"Etienne","display":"Brain, Etienne","role":"aut"},{"family":"Kuemmel","given":"Sherko","display":"Kuemmel, Sherko","role":"aut"},{"family":"Pápai","display":"Pápai, Zsuzsanna","given":"Zsuzsanna","role":"aut"},{"role":"aut","display":"Menke-van der Houven van Oordt, Catharina Willemien","given":"Catharina Willemien","family":"Menke-van der Houven van Oordt"},{"role":"aut","family":"Perjesi","given":"Luca","display":"Perjesi, Luca"},{"role":"aut","given":"Christian","display":"Mueller, Christian","family":"Mueller"},{"family":"Brignone","display":"Brignone, Chrystelle","given":"Chrystelle","role":"aut"},{"given":"Frederic","display":"Triebel, Frederic","family":"Triebel","role":"aut"}],"title":[{"title_sort":"Paclitaxel plus Eftilagimod Alpha, a soluble LAG-3 protein, in metastatic, HR+ breast cancer","subtitle":"results from AIPAC, a randomized, placebo controlled phase IIb trial","title":"Paclitaxel plus Eftilagimod Alpha, a soluble LAG-3 protein, in metastatic, HR+ breast cancer"}],"language":["eng"]} | ||
| SRT | |a WILDIERSHAPACLITAXEL1202 | ||