HonCode

Go Back   HER2 Support Group Forums > Articles of Interest
Register Gallery FAQ Members List Calendar Search Today's Posts Mark Forums Read

Reply
 
Thread Tools Display Modes
Old 09-23-2022, 09:30 AM   #1
Nguyen
Senior Member
 
Join Date: Nov 2005
Posts: 425
Final overall survival (OS) for abemaciclib plus trastuzumab +/- fulvestrant versus t

Final overall survival (OS) for abemaciclib plus trastuzumab +/- fulvestrant versus trastuzumab plus chemotherapy in patients with HR+, HER2+ advanced breast cancer (monarcHER): A randomized, open-label, phase II trial


Abstract LBA18

Background

Abemaciclib, an oral, selective CDK4 & 6 inhibitor, significantly improved PFS in HR+, HER2+ advanced breast cancer (ABC; locoregionally recurrent or metastatic) when combined with fulvestrant and trastuzumab, compared to trastuzumab plus chemotherapy in monarcHER (Tolaney 2020, Lancet Oncol.) Here, we report the OS results at the prespecified final analysis.

Methods

monarcHER (NCT02675231) is a randomized, multicenter, open-label phase 2 trial. Randomization was 1:1:1 to arm A (abemaciclib 150mg PO BID, trastuzumab IV, fulvestrant 500mg IM), arm B (abemaciclib, trastuzumab), and arm C (trastuzumab, SOC chemotherapy). Stratification factors were number of prior systemic regimens for ABC and measurable disease. Exploratory biomarker analyses were also conducted, including evaluation of intrinsic subtypes by RNAseq.

Results

At the time of data cutoff (31 Mar 2022), of the 237 patients enrolled, 157 deaths had occurred across the treatment arms, 50 deaths (63%) arm A, 54 deaths (68%) arm B, and 53 deaths (67%) arm C. Median follow-up was 52.9 months. mOS was 30.3 months in arm A, 31.43 months in arm B and 22.7 months in arm C (A v C: HR 0.75 [95% CI 0.47, 1.21]; nominal 2-sided p-value 0.243; B v C: HR 0.73 [95% CI 0.46, 1.15]; nominal 2-sided p-value 0.177). In exploratory RNAseq analyses, luminal subtypes were associated with longer PFS (8.6 v 5.4 months [HR 0.54, 95% CI 0.38, 0.79]) and OS (31.7 v. 19.7 months [HR 0.68, 95% CI 0.46, 1]) compared to non-luminal. Updated PFS and safety findings were consistent with the primary analysis (data cutoff 8 Apr 2019).

Conclusions

Abemaciclib plus trastuzumab fulvestrant numerically improved OS in women with HR+, HER2+ ABC compared to chemotherapy plus trastuzumab with a manageable safety profile.
Nguyen is offline   Reply With Quote
Reply

Thread Tools
Display Modes

Posting Rules
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Smilies are On
[IMG] code is On
HTML code is On

Forum Jump


All times are GMT -7. The time now is 03:22 AM.


Powered by vBulletin® Version 3.8.7
Copyright ©2000 - 2022, vBulletin Solutions, Inc.
Copyright HER2 Support Group 2007 - 2021
free webpage hit counter