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39O - Ribociclib (RIB) + non-steroidal aromatase inhibitor (NSAI) + goserelin in premenopausal Asian women with hormone-receptor-positive (HR+), HER2-negative (HER2–) advanced breast cancer (ABC): Results from the randomized Phase III MONALEESA-7 study
- Seock-Ah Im
- Seock-Ah Im
- Joohyuk Sohn
- Debu Tripathy
- Louis Chow
- Keun Seok Lee
- Kyung Hae Jung
- Govind Babu
- Young-Hyuck Im
- Nagi El Saghir
- Mei-Ching Liu
- Ivan Diaz-Padilla
- Jahangir Alam
- Oliver Kong
- Michelle Miller
- Yen-Shen Lu
Abstract
Background
In the Phase III MONALEESA-7 trial (NCT02278120), RIB + NSAI/tamoxifen (TAM) + goserelin (GOS) prolonged progression-free survival (PFS) vs placebo (PBO) + NSAI/TAM + GOS in premenopausal patients (pts) with HR+, HER2– ABC. RIB benefit was observed irrespective of endocrine therapy (ET) partner (NSAI or TAM). Here we report a preplanned analysis from a subset of Asian pts, with a focus on pts who received RIB + NSAI + GOS.
Methods
Premenopausal pts (≤1 line of prior chemotherapy; no prior ET for ABC) received RIB or PBO + NSAI (letrozole or anastrozole)/TAM + GOS. Primary endpoint: PFS, with a prespecified subset analysis in pts of Asian race. Secondary endpoints included overall response rate (ORR), clinical benefit rate (CBR), and safety.
Results
198 pts were of Asian race (RIB 99 vs PBO 99); of which, 166 received NSAI (82 vs 84). 474 pts were of non-Asian race; of which, 329 pts received NSAI (166 vs 163). As of Aug 20, 2017, among pts of Asian race, 48 pts in the RIB + NSAI arm vs 26 pts in the PBO + NSAI arm and 83 vs 67 pts of non-Asian race were still receiving treatment; the most common reason for discontinuation was disease progression (Asian: 27 vs 49; non-Asian 61 vs 76). Consistent PFS benefit for RIB + NSAI vs PBO + NSAI was observed in Asian and non-Asian pts (Table). ORR and CBR were higher for RIB + NSAI vs PBO + NSAI in Asian and non-Asian pts with measurable disease. The most common (≥5% in either arm) Grade 3 and 4 adverse events are shown in the table. New Fridericia’s corrected QT interval >500 ms occurred in (RIB + NSAI vs PBO + NSAI) 3.8% vs 0% of Asian pts and 0.6% vs 0% of non-Asian pts. AE, adverse event; CI, confidence interval; NR, not reached; SD, standard deviation. ORR = confirmed complete response + partial response. CBR = confirmed complete response + partial response + (stable disease or non-complete response/non-progressive disease ≥24 weeks).Asian race Non-Asian race RIB + NSAI n = 82 PBO + NSAI n = 84 RIB + NSAI n = 166 PBO + NSAI n = 163 Median age, years (range) 43.0 (27.0–58.0) 45.0 (29.0–58.0) 42.5 (25.0–55.0) 45.0 (29.0–55.0) Mean weight, kg (SD) 59.9 (12.1) 55.8 (9.1) 69.2 (16.4) 74.1 (18.4) Median PFS, months (95% CI) NR (16.4–NR) 11.0 (7.4–15.6) 23.8 (17.8–NR) 16.5 (12.8–22.2) Hazard ratio (95% CI) 0.414 (0.259–0.663) 0.664 (0.479–0.920) Patients with measurable disease at baseline, n 65 76 127 123 ORR,* n (%) [95% CI] 38 (58.5) [46.5–70.4] 26 (34.2) [23.5–44.9] 59 (46.5) [37.8–55.1] 46 (37.4) [28.8–45.9] CBR,† n (%) [95% CI] 56 (86.2) [77.8–94.6] 48 (63.2) [52.3–74.0] 101 (79.5) [72.5–86.5] 79 (64.2) [55.8–72.7] Most common (≥5% in either arm) Grade 3 AEs, % Neutropenia 58.5 4.8 53.0 2.5 Leukopenia 12.2 0 16.3 1.8 Most common (≥5% in either arm) Grade 4 AE, % Neutropenia 15.9 1.2 7.2 0
Conclusions
Consistent treatment benefit with RIB + NSAI + GOS was observed in pts of Asian and non-Asian race. The safety profile was manageable, irrespective of race, and was consistent with that observed in the full population.
Editorial acknowledgement
Editorial assistance was provided by Kate Gaffey, PhD of ArticulateScience Ltd.
Clinical trial identification
NCT02278120.
Legal entity responsible for the study
Novartis Pharmaceuticals Corporation.
Funding
Novartis Pharmaceuticals Corporation.
Disclosure
S-A. Im: Advisory role: Novartis; Grants: AstraZeneca; Advisory role: Hanmi, Roche, Pfizer. D. Tripathy: Grants, personal fees: Novartis; Personal fees: Pfizer. L. Chow: Travel expenses: Novartis, Roche, Pfizer. N. El Saghir: Honorarium for lectures and advisory boards: Novartis, Pfizer, Lilly. M-C. Liu: Advisory board: Pfizer, Roche, Novartis; Travel fee: International Congress on Clinical Trials in Hemto-Oncology. I. Diaz-Padilla, O. Kong, M. Miller: Employee, stock holder: Novartis. J. Alam: Employee: Novartis. All other authors have declared no conflicts of interest.