Safety and efficacy of everolimus (EVE) plus exemestane (EXE) in postmenopausal women with locally advanced or metastatic breast cancer: final results from EVEREXES

Young Hyuck Im, Bulent Karabulut, Keun Seok Lee, Byeong Woo Park, Aditya Adhav, Havva Yesil Cinkir, Hikmat Abdel-Razeq, Yuan Ching Chang, Sercan Aksoy, Seock Ah Im, Joon Jeong, Yeesoo Chae, James Bowles, Khemaies Slimane, Hongling Xue, Sung Bae Kim

Research output: Contribution to journalArticlepeer-review


Background: This study was conducted to collect clinical safety, tolerability, and efficacy data with the use of everolimus (EVE) combined with exemestane (EXE) in patients with advanced breast cancer (ABC). Methods: The EVEREXES trial initiated in 2012, provided early access to the first dual blockade treatment with EVE + EXE in patients with HR+, HER2 − ABC in Asia and other emerging growth countries. Postmenopausal women with HR+, HER2 − ABC who had documented recurrence or progression, following a nonsteroidal aromatase inhibitor therapy, were treated with EVE (10 mg/day) + EXE (25 mg/day) orally. Results: A total of 235 patients received ≥ 1 dose of study medication. At the end of the study, all patients ceased the treatment. Disease progression (66.0%) was the primary reason of discontinuation. The most common AEs (≥ 20%) were stomatitis, decreased appetite, hyperglycemia, rash, aspartate aminotransferase increased, anemia, alanine aminotransferase increased, cough, and fatigue. No new safety concerns were identified in the current study. Median progression-free survival (PFS) in the Asian subset was similar to that of the overall population (9.3 months in both groups). Confirmed overall response rate (ORR) was achieved for 19.6% of the patients. Efficacy of EVE + EXE across subgroups (prior CT, line of treatment, and presence of visceral metastases) was maintained. Conclusion: The safety and efficacy results from EVEREXES trial are consistent to data previously reported in BOLERO-2. These results support that EVE + EXE could be a viable treatment option for the postmenopausal women with HR+, HER2 − ABC in Asian region.

Original languageEnglish
JournalBreast Cancer Research and Treatment
Publication statusAccepted/In press - 2021

Bibliographical note

Funding Information:
The EVEREXES trial was funded by Novartis Pharma AG, Base, Switzerland. Funding for medical editorial support was also provided by Novartis.

Funding Information:
SA has received personal fees from Roche, Merck, Eli Lilly, Abdi Ibrahim AS, BMS, Novartis, Pfizer, Mustafa Nevzat İlaç Sanayii. SBK has received grant from Novartis, Sanofi-Aventis, Kyowa-Kirin Inc, Dongkook Pharm Co, others from Novartis, Personal fees from Astra-Zeneca, Eli Lilly, Enzychem, Dae Hwa Pharmaceutical Co Ltd, ISU Abix, and Daiichi-Sankyo. KSL has received personal fees from Roche, Novartis, Lilly and nonfinancial support from Dong-A Pharm. SAI has received grant from AstraZeneca, Roche, Pfizer, personal fees from Novartis, and others from Amgen, Eisai, Hanmi, and Novartis. JB, KS, and HX are Novartis employees. FR owns Novartis stocks. All other authors declare no conflict of interest.

Publisher Copyright:
© 2021, The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

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