D. Tripathy (Houston, TX, United States of America)

The University of Texas M. D. Anderson Cancer Center

Author Of 1 Presentation

 Conference Calendar
Mini Oral session 1 Mini oral

93MO - Overall survival (OS) results by age subgroup from the phase III MONALEESA-7 (ML-7) trial of premenopausal patients (pts) with HR+/HER2? advanced breast cancer (ABC) treated with endocrine therapy (ET) ± ribociclib (RIB) (ID 257)

Presentation Number
93MO
Lecture Time
12:50 - 12:55
Speakers
Session Name
Mini Oral session 1
Room
Channel 2
Date
Fri, 07.05.2021
Time
12:45 - 13:45

Abstract

Background

RIB, a cyclin-dependent kinase 4/6 inhibitor (CDK4/6i), significantly prolonged OS in pre- or perimenopausal pts with HR+/HER2− ABC in ML-7 with updated results (median, 58.7 vs 48.0 mo for RIB + ET vs placebo [PBO] + ET; HR, 0.76 [95% CI, 0.61-0.96]; NCT02278120). Younger pts with HR+/HER2− ABC tend to have a poorer prognosis. We conducted an exploratory analysis to characterize outcomes in pts <40 vs ≥40 y of age.

Methods

Pre- or perimenopausal pts with HR+/HER2− ABC with no prior CDK4/6i or ET for ABC were randomized 1:1 to receive RIB or PBO plus goserelin and a nonsteroidal aromatase inhibitor (NSAI) or tamoxifen. OS and other efficacy endpoints were evaluated by Cox proportional hazards model and summarized using Kaplan-Meier methods.

Results

The median follow-up time was 53.5 mo (data cutoff, 29 June 2020). In the RIB vs PBO arm, 98 vs 88 pts were <40 y and 237 vs 249 pts were ≥40 y. Median age (range) in RIB vs PBO was 35 y (25-39 y) vs 36 y (29-39 y) in pts <40 y, and 45 y (40-58 y) vs 46 y (40-58 y) in pts ≥40 y. In pts <40 y, RIB + ET demonstrated an OS benefit vs PBO + ET (median, 51.3 vs 40.5 mo; HR, 0.65; 95% CI, 0.43-0.98). RIB had a longer median OS vs PBO in pts ≥40 y (median, 58.8 vs 51.7 mo; HR, 0.81; 95% CI, 0.62-1.07). Similar trends were observed for OS in NSAI-treated pts and in all pts for PFS2, time to chemotherapy (CT), and CT-free survival (Table). In pts who discontinued, subsequent antineoplastic therapies were received by 77.3% vs 75.0% of pts age <40 y in RIB vs PBO arms, respectively, and 77.2% vs 79.2% of pts ≥40 y. Subsequent CDK4/6i were received in 16.0% vs 27.5% of pts age <40 y and 11.6% vs 25.7% of pts ≥40 y in RIB vs PBO arms. Adverse events were consistent with the known safety profile of ML-7.

Age <40 y Age ≥40 y
RIB + ET PBO + ET RIB + ET PBO + ET
OS in NSAI cohort n=78 n=66 n=170 n=181
Events, n (%) 36 (46.2) 39 (59.1) 71 (41.8) 81 (44.8)
Median, mo 50.2 40.7 58.7 54.1
HR (95% CI) 0.66 (0.42-1.05) 0.85 (0.61-1.16)
PFS2a n=98 n=88 n=237 n=249
Events, n (%) 54 (55.1) 60 (68.2) 123 (51.9) 161 (64.7)
Median, mo 46.0 25.5 43.6 32.7
HR (95% CI) 0.59 (0.40-0.86) 0.71 (0.56-0.89)
Time to first CTa n=98 n=88 n=237 n=249
Events, n (%) 40 (40.8) 43 (48.9) 104 (43.9) 130 (52.2)
Median, mo NR 36.6 50.2 36.8
HR (95% CI) 0.65 (0.42-1.01) 0.69 (0.53-0.90)
CT-free survivala n=98 n=88 n=237 n=249
Events, n (%) 53 (54.1) 63 (71.6) 137 (57.8) 173 (69.5)
Median, mo 46.5 22.7 41.5 27.6
HR (95% CI) 0.58 (0.40-0.85) 0.68 (0.54-0.85)

ITT, intent to treat; NR, not reached. aIn ITT.

Conclusions

In ML-7, RIB prolonged OS and improved post-progression outcomes in HR+/HER2− ABC, particularly in younger pts, who have a substantial unmet need.

Clinical trial identification

NCT02278120.

Editorial acknowledgement

This abstract was developed with editorial assistance provided by Chris Carter, PhD of MediTech Media, LLC. Editorial support was funded by Novartis Pharmaceuticals Corporation.

Legal entity responsible for the study

Novartis Pharmaceuticals Corporation.

Funding

Novartis Pharmaceuticals Corporation.

Disclosure

Y-S. Lu: Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): Novartis; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Pfizer; Honoraria (self), Speaker Bureau/Expert testimony: Roche; Honoraria (self), Speaker Bureau/Expert testimony, Research grant/Funding (institution): Merck Sharp & Dohme; Honoraria (self), Speaker Bureau/Expert testimony: Eisai. N.S. El Saghir: Honoraria (self), Advisory/Consultancy: Novartis; Honoraria (self), Advisory/Consultancy: Pfizer; Honoraria (self), Advisory/Consultancy: Eli Lilly; Honoraria (self), Advisory/Consultancy: Roche; Honoraria (self), Advisory/Consultancy: AstraZeneca. S.A. Hurvitz: Research grant/Funding (institution): Ambryx; Research grant/Funding (institution): Amgen; Research grant/Funding (institution): Bayer; Research grant/Funding (institution), Travel/Accommodation/Expenses: OBI Pharma; Research grant/Funding (institution): Bimarin; Research grant/Funding (institution): Cascadian; Research grant/Funding (institution): Daiichi Sankyo; Research grant/Funding (institution): Dignitana; Research grant/Funding (institution): Genentech; Research grant/Funding (institution): GSK; Research grant/Funding (institution), Travel/Accommodation/Expenses: Lilly; Research grant/Funding (institution): Macrogenics; Research grant/Funding (institution): Medivation; Research grant/Funding (institution): Merrimack; Research grant/Funding (institution), Travel/Accommodation/Expenses: Novartis; Research grant/Funding (institution): Pfizer; Research grant/Funding (institution): Pieris; Research grant/Funding (institution): Puma; Research grant/Funding (institution): Roche; Research grant/Funding (institution): Seattle Genetics. D. Tripathy: Honoraria (self), Advisory/Consultancy: Genomic Health; Honoraria (self), Advisory/Consultancy: GlaxoSmithKline; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Polyphor; Advisory/Consultancy: Puma Biotechnology; Honoraria (self), Speaker Bureau/Expert testimony: AstraZeneca; Leadership role: OncoPep; Advisory/Consultancy: Sellas Life Sciences Group. F. Cardoso: Honoraria (self): Novartis; Honoraria (self): Amgen; Honoraria (self): Astellas/Medivation; Honoraria (self): AstraZeneca; Honoraria (self): Celgene; Honoraria (self): Daiichi Sankyo; Honoraria (self): Eisai; Honoraria (self): GE Oncology; Honoraria (self): Genentech; Honoraria (self): GSK; Honoraria (self): Macrogenics; Honoraria (self): Medscape; Honoraria (self): Merck-Sharp; Honoraria (self): Merus; Honoraria (self): Mylan; Honoraria (self): Mundipharma; Honoraria (self): Pfizer; Honoraria (self): Pierre Fabre; Honoraria (self): Prime; Honoraria (institution): Roche. M.A. Colleoni: Honoraria (self), Advisory/Consultancy: AstraZeneca; Honoraria (self), Advisory/Consultancy: Pierre Fabre; Honoraria (self), Advisory/Consultancy: Pfizer; Honoraria (self): Novartis; Honoraria (self), Advisory/Consultancy: OBI Pharma; Honoraria (self), Advisory/Consultancy: Puma Biotechnology; Honoraria (self), Advisory/Consultancy: Celldex. S. Campos-Gomez: Honoraria (self), Advisory/Consultancy: Roche; Honoraria (self), Advisory/Consultancy: MSD; Honoraria (self), Advisory/Consultancy: Bristol-Myers Squibb. C. Wang, Y. Wang, J.P. Zarate, A. Chakravartty: Shareholder/Stockholder/Stock options, Full/Part-time employment: Novartis. S-A. Im: Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): AstraZeneca; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Novartis; Honoraria (self), Advisory/Consultancy: Hanmi; Honoraria (self), Advisory/Consultancy: Pfizer; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Eisai; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Amgen; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): MediPacto; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Roche; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Lilly; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): MSD; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): GSK; Research grant/Funding (institution): Daewoong. All other authors have declared no conflicts of interest.

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Author Of 1 Presentation

 On-Demand ePoster Display

106P - Palbociclib (PAL) in Male Patients (pts) With Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative (HR+/HER2-) Advanced Breast Cancer (ABC): Pt Characteristics and Treatment (Tx) Patterns From the POLARIS Study

Abstract

Background

The prevalence of male breast cancer is <1% of all breast cancer cases, limiting the ability to conduct randomized clinical studies in this population. PAL plus an aromatase inhibitor or fulvestrant (FUL) is approved for the Tx of HR+/HER2– ABC in men. This analysis describes real-world pt characteristics and PAL use in male pts enrolled in the POLARIS study.

Methods

POLARIS is an ongoing, prospective, real-world, noninterventional study in pts with HR+/HER2‒ ABC receiving PAL with a targeted enrollment of 1500 pts from ∼110 sites in the United States and Canada. Baseline demographics, clinical characteristics, and Tx patterns were descriptively analyzed in men with HR+/HER2– ABC using pt data collected from medical charts and physician surveys.

Results

A total of 15 men were enrolled at the data cutoff of December 17, 2020; median age was 66 years, 60.0% of pts had recurrent disease, 40.0% had de novo metastatic disease, and 46.7% had visceral disease (Table). PAL plus endocrine therapy (ET) was received as first-line (1L) therapy by 9 pts (60.0%), second-line (2L) therapy by 4 pts (26.7%), and 2L+ therapy by 2 pts (13.3%). Among all pts, 4 initiated PAL with letrozole, 3 with anastrozole, and 7 with FUL; 1 pt did not receive ET during cycle 1 but initiated FUL during cycle 2. PAL was initiated at 125 mg in 13 pts (86.7%) and 100 mg in 2 pts (13.3%). One pt had a dose modification (interruption due to pt decision).

Variable n (%) (N=15)
Age, y
Median (range) 66 (43–82)
Race
White 14 (93.3)
Black or African American 1 (6.7)
Ethnicity
Not Hispanic/Latino 15 (100)
Stage of current diagnosis
Locally advanced (stage III) 1 (6.7)
Metastatic (stage IV) 14 (93.3)
Disposition of diagnosis
Recurrent from earlier stage (stages 0–III) 9 (60.0)
De novo (newly diagnosed stage IV at enrollment) 6 (40.0)
Sites of distant metastases at ABC diagnosis
Median (range) 2.5 (1.0–5.0)
Bone metastases at ABC diagnosis among pts with stage IV disease
Bone only 5 (41.7)
Bone + other sites 7 (58.3)
Visceral disease
Yes 7 (46.7)
No 8 (53.3)
PAL starting dose, mg
125 13 (86.7)
100 2 (13.3)

Conclusions

This is one of the first prospective trials to report pt characteristics and Tx patterns among male pts with HR+/HER2– ABC receiving PAL+ET. In this real-world population with a heavy disease burden, PAL was well tolerated with only 1 pt requiring dose modification. Most men received PAL+ET as 1L therapy and initiated PAL at the recommended dose of 125 mg. Further evaluation of Tx patterns in this population is warranted.

Clinical trial identification

Pfizer; NCT03280303.

Editorial acknowledgement

Editorial support was provided by Jill Shults, PhD, of ICON plc, and was funded by Pfizer Inc.

Legal entity responsible for the study

Pfizer Inc.

Funding

Pfizer, Inc.

Disclosure

J.L. Blum: Advisory/Consultancy: Pfizer Inc; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Novartis; Advisory/Consultancy: Puma Biotechnology; Advisory/Consultancy: Immunogenetics Inc; Advisory/Consultancy: Research to Practice. C. Dicristo: Full/Part-time employment: Pfizer Inc. M. Karuturi: Advisory/Consultancy: Pfizer Inc. E. Jepsen: Full/Part-time employment, Oncology Specialist: Novant Health. Z. Zhang, Y. Wang: Shareholder/Stockholder/Stock options, Full/Part-time employment: Pfizer Inc. D. Tripathy: Advisory/Consultancy, Research grant/Funding (self): Novartis; Advisory/Consultancy, Research grant/Funding (self): Pfizer Inc. All other authors have declared no conflicts of interest.

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