CompLEEment-1 is a large phase IIIb trial in an expanded pt population with HR+, HER2– ABC (N = 3,246 pts). Here, we present safety and efficacy data for Asian pts from Hong Kong, India, Malaysia, Philippines, Singapore, Taiwan, and Thailand who participated in the study.
Pts with HR+, HER2– ABC, ≤1 line of prior chemotherapy (CT) and no prior endocrine therapy for ABC received RIB + LET. Study design has been reported previously (Lu J. et al, SABCS 2019, Poster P1-19-21). Primary endpoints were safety and tolerability, and secondary endpoint was efficacy.
Overall, 197 Asian pts were included (6.1% of the total CompLEEment-1 population); 1.5% pts were male, 84.8% pts were <65 years (median age: 52.0 years), and 34.0% pts were premenopausal. 2.5%, 65.5%, and 12.7% pts had CNS, visceral and bone-only metastasis, 3.6% had prior CT, 5.1% were ECOG2, and 18.3% had relapsed within < 2 years of adjuvant therapy. The median duration of exposure to RIB was 16.1 months, while the median relative dose intensity was 96.9%; 2 patients (1.0%) were lost to follow-up. Adverse events (AEs) and treatment-related AEs occurred in 192 (97.5%) and 177 (89.8%) pts, while grade ≥ 3 AEs and serious AEs were reported in 142 (72.1%) and 45 (22.8%) pts, respectively. The most common all-grade and grade ≥ 3 treatment-related AEs were neutropenia (66.5% and 47.7%), leukopenia (26.4% and 12.7%), and anemia (18.8% and 4.1%). Overall, 74 (37.6%) pts had ≥ 1 dose reduction of RIB; 52 (26.4%) due to AEs. 112 (56.9%) pts permanently discontinued treatment; 15 (7.6%) due to AEs. Median time to progression was 20.3 months (95% confidence interval [CI], 15.5-22.8). For the 156 pts with measurable disease, overall response rate was 44.9% (95% CI, 36.9-53.0%), and clinical benefit rate was 68.6% (95% CI, 60.7-75.8).
This subgroup analysis supports the efficacy of RIB + LET in Asian pts for first-line endocrine therapy of HR+, HER2– ABC. The safety profile associated with RIB + LET was manageable with few pts discontinuing treatment due to AEs, consistent with previous phase III trials of RIB + LET.
NCT02941926.
Medical editorial assistance was provided by Sara Henriques, PhD of Healthcare Consultancy Group, LLC, and funded by Novartis Pharmaceuticals Corporation.
Novartis Pharmaceuticals.
Novartis Pharmaceuticals.
S. Chatterjee: Research grant/Funding (institution), Site Specific Principal Investigator: Novartis; Research grant/Funding (institution), Site Specific Principal Investigator: Roche; Research grant/Funding (institution), Site Specific Principal Investigator: Alkem; Research grant/Funding (institution), Site Specific Principal Investigator: Samsung Biopsies. M. Md Yusof: Honoraria (institution), Advisory/Consultancy, Speaker Bureau/Expert testimony, writing: AstraZeneca; Novartis; MSD; Astellas; Advisory/Consultancy, Speaker Bureau/Expert testimony, writing: Boeringher Ingelheim; Eli Lilly; Roche; Eisai; Sanofi; Genzyme; Mundi Pharma; Amgen; Advisory/Consultancy, Speaker Bureau/Expert testimony: Zuellig Pharma; Research grant/Funding (self), Principal investigator: Mundi Pharma; Honoraria (institution): Pfizer; Leadership role, executive council member: Malaysian Oncological Society; Leadership role, council member: Breast Cancer women association. T. Dejthevaporn: Honoraria (institution), Advisory/Consultancy, Speaker Bureau/Expert testimony: Novartis; Advisory/Consultancy, Speaker Bureau/Expert testimony: Eisai; AstraZeneca; Honoraria (institution), Advisory/Consultancy, Speaker Bureau/Expert testimony: Pfizer; Honoraria (institution), Advisory/Consultancy: Roche; Leadership role, Vice president: Thai Society of Clinical Oncology. W-P. Chung: Honoraria (self): Novartis; Roche; AstraZeneca; Pfizer; Amgen; Kyowa Kirin; Foundation Medicine; Chugai Pharma; Takeda; Eli Lilly; Sanofi. C.G. Galvez: Speaker Bureau/Expert testimony: Novartis; Roche; Mylan; Amgen; Leadership role, past president: Philippine Breast Cancer Society. A. Cheng: Research grant/Funding (self): AstraZeneca; Eli Lilly; Merck; Gilead Sciences; Incyte Corp.; Astellas Pharma Global Development Inc.; Ignyta; Roche; MSD; Pfizer; Novartis; Bristol-Myers Squibb; AbbVie Limited; United Therapeutics Corporation; Bayer; ARIAD Pharmaceuticals Inc. subsidiary of Takeda; Takeda; Turning Point Therapeutics Inc.. M.L.T. Abesamis-Tiambeng: Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self): Novartis; AstraZeneca; MSD; Roche; Mylan; Eli Lilly. L. Menon-Singh; J. Wu; K. Zhou: Shareholder/Stockholder/Stock options, Full/Part-time employment: Novartis Pharmaceuticals Corporation. H. Azim: Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self): Novartis; Roche; Pfizer; AstraZeneca; Eli Lilly; Amgen; BMS; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self): MSD; Speaker Bureau/Expert testimony, Research grant/Funding (self): Janssen; Advisory/Consultancy: Hekma; Research grant/Funding (self): Bayer. All other authors have declared no conflicts of interest.