There is an unmet need to assess efficacy and safety of therapies for ABC in men. The cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor RIB has been approved for use in combination with LET for the treatment of HR+, HER2– ABC in men and postmenopausal women with no prior therapy for advanced disease. Here we present a subgroup analysis of male pts in CompLEEment-1, an open-label, phase 3b trial evaluating RIB + LET as first-line therapy in a pt population with broad inclusion/exclusion criteria to reflect real-world practice.
Pts with HR+, HER2– ABC and no prior hormonal therapy for ABC received RIB (600 mg daily [QD], 3 weeks on/1 week off) + LET (2.5 mg QD, continuous), and concomitant goserelin or leuprolide. Safety and tolerability (primary outcome), overall response rate (ORR), and clinical benefit rate (CBR) were analyzed for male pts in a subgroup analysis.
There were 39 men in the study. The median follow-up was 10.35 months, and the median duration of exposure to RIB was 8.0 months. Any-grade adverse events (AEs) were reported in 38 pts; 36 AEs were treatment-related. Serious AEs (SAEs) were reported in 4 pts; 1 SAE was related to treatment. No fatal treatment-related SAEs were reported. Most common any-grade AEs (≥ 20%) were neutropenia (n = 14), hot flush (n = 12), diarrhea (n = 10), and fatigue (n = 8). There were 31 pts with at least 1 dose adjustment of RIB; 5 reductions and 27 interruptions were due to AEs. Fourteen pts permanently discontinued treatment: 7 due to progressive disease and 4 due to AEs. ORR in pts with measurable disease was 34.4% (95% confidence interval [CI], 18.6-53.2%), and CBR was 68.8% (95% CI, 50.0-83.9%). Median TTP was not reached.
This subgroup analysis from CompLEEment-1 supports the safety and efficacy of RIB + LET in men with HR+, HER2– ABC, and adds to the clinical understanding of CDK4/6 inhibitors in men with HR+, HER2– ABC.
NCT02941926.
Medical editorial assistance was provided by Rob Camp, PhD, of Healthcare Consultancy Group, LLC, and funded by Novartis Pharmaceuticals Corporation.
Novartis.
Novartis Pharmaceuticals.
M. Campone: Speaker Bureau / Expert testimony: Novartis; Advisory / Consultancy: Lilly. M. De Laurentiis: Honoraria (institution), Advisory / Consultancy: Pfizer; Honoraria (institution), Advisory / Consultancy: Novartis; Honoraria (institution), Advisory / Consultancy: Roche; Honoraria (institution), Advisory / Consultancy: Celgene; Honoraria (institution), Advisory / Consultancy: AstraZeneca. C. Zamagni: Advisory / Consultancy, Research grant / Funding (institution): AstraZeneca; Advisory / Consultancy: Eisai; Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Novartis; Advisory / Consultancy, Research grant / Funding (institution): Pfizer; Advisory / Consultancy: PharmaMar; Advisory / Consultancy, Travel / Accommodation / Expenses: Pierre Fabre; Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Roche; Research grant / Funding (institution): Abbvie; Research grant / Funding (institution): Array BioPharma; Research grant / Funding (institution), Travel / Accommodation / Expenses: Celgene; Research grant / Funding (institution): Medivation; Research grant / Funding (institution): Morphotek; Research grant / Funding (institution): Roche/Genentech. M. Agterof: Advisory / Consultancy: Roche. M. Martin: Advisory / Consultancy, Speaker Bureau / Expert testimony: Pfizer; Advisory / Consultancy, Speaker Bureau / Expert testimony: AstraZeneca; Advisory / Consultancy, Speaker Bureau / Expert testimony: Lilly; Advisory / Consultancy: Puma; Advisory / Consultancy: PharmaMar; Advisory / Consultancy, Speaker Bureau / Expert testimony: Novartis; Advisory / Consultancy: Roche-Genentech; Advisory / Consultancy: Taiho Oncology. All other authors have declared no conflicts of interest.