Abstract GS4-01: Results from CONTESSA: A phase 3 study of tesetaxel plus a reduced dose of capecitabine versus capecitabine alone in patients with HER2-, hormone receptor + (HR+) metastatic breast cancer (MBC) who have previously received a taxane

摘要: Objectives: The key objectives of CONTESSA are to evaluate the efficacy and safety tesetaxel plus a reduced dose capecitabine as an all-oral regimen versus alone in patients with HER2-, HR+ MBC previously treated taxane. Rationale: Tesetaxel is novel, oral taxane several properties that make it unique, including: administration low pill burden; long (8-day) terminal plasma half-life humans, enabling infrequent, once-every-3 weeks (Q3W) dosing; no observed hypersensitivity reactions; significant activity against chemotherapy-resistant breast cancer cell lines. More than 1,000 have been clinical studies. had encouraging monotherapy Phase 2 study 38 MBC, confirmed objective response rate (ORR) per RECIST 1.1 45% median progression-free survival (PFS) 5.4 months (Seidman et al, 2018 ASCO Annual Meeting). Methodology: multinational, multicenter, randomized (1:1), 3 registration comparing (27 mg/m2 on Day 1 21-day cycle) (1,650 mg/m2/day Days 1-14 approved (2,500 who received more one chemotherapy for advanced disease (neo)adjuvant setting. There was restriction disease-free interval following therapy. primary endpoint PFS assessed by Independent Radiologic Review Committee (IRC). designed 90% power detect 2.5-month improvement (HR=0.71). Secondary endpoints overall (OS), ORR control rate. Results: CONTESSA, which enrolled 685 patients, met improved IRC. Median 9.8 6.9 alone, 2.9 [HR=0.716 (95% CI: 0.573-0.895); p=0.003]. 57% 41% (p=0.0002). OS data immature. associated manageable side effect profile consistent previous Grade ≥3 treatment-emergent adverse events (TEAEs) occurred ≥5% (tesetaxel vs. alone) were: neutropenia (71.2% 8.3%); diarrhea (13.4% 8.9%); hand-foot syndrome (6.8% 12.2%); febrile (12.8% 1.2%); fatigue (8.6% 4.5%); hypokalemia 2.7%); leukopenia (10.1% 0.9%); anemia (8.0% 2.1%). TEAEs resulting treatment discontinuation ≥1% or (4.2% 1.5%); neuropathy (3.6% 0.3%); (0.9% (0.6% Treatment due any event 23.1% 11.9% alone. alopecia 8.0% 0.3% 5.9% 0.9% Conclusion: An significantly Neutropenia most frequent TEAE. Rates clinically were low. Citation Format: Joyce O9Shaughnessy, Lee Schwartzberg, Martine Piccart, Hope S. Rugo, Denise A Yardley, Javier Cortes, Michael Untch, Nadia Harbeck, Gail Wright, Igor Bondarenko, John Glaspy, Zbigniew Nowecki, Fadi Kayali, Arlene Chan, Christelle Levy, Mei-Ching Liu, Sung-Bae Kim, Julie Lemieux, Alexey Manikhas, Sara Tolaney, Elaine Lim, Andrea Gombos, Agostina Stradella, Mark Pegram, Peter Fasching, Laszlo Mangel, Vladimir Semiglazov, Veronique Dieras, Luca Gianni, Danso, Jeff Vacirca, Stew Kroll, Joseph O9Connell, Kevin Tang, Thomas Wei, Andrew Seidman. Results from CONTESSA: phase hormone receptor + (HR+) metastatic (MBC) [abstract]. In: Proceedings 2020 San Antonio Breast Cancer Virtual Symposium; Dec 8-11; Antonio, TX. Philadelphia (PA): AACR; Res 2021;81(4 Suppl):Abstract nr GS4-01.