A randomized phase 2 study of abemaciclib versus docetaxel in patients with stage IV squamous non-small cell lung cancer (sqNSCLC) previously treated with platinum-based chemotherapy.
2018; Lippincott Williams & Wilkins; Volume: 36; Issue: 15_suppl Linguagem: Inglês
10.1200/jco.2018.36.15_suppl.9059
ISSN1527-7755
AutoresGiorgio V. Scagliotti, Igor Bondarenko, Tudor‐Eliade Ciuleanu, Maciej Bryl, Andrea Fülöp, David Vicente, Helge Bischoff, Karla Hurt, Yi Lu, Shawn T. Estrem, Sameera R. Wijayawardana, Alan Y. Chiang, Ramaswamy Govindan,
Tópico(s)Chronic Lymphocytic Leukemia Research
Resumo9059 Background: Abemaciclib is a potent and selective inhibitor of CDK4 & 6 approved for treatment of HR+, HER2- metastatic breast cancer. In a Phase 1 study, abemaciclib showed activity in pts with advanced and/or metastatic NSCLC. This Phase 2 study evaluated the safety and efficacy of abemaciclib vs docetaxel in pts with Stage IV sqNSCLC previously treated with platinum-based chemotherapy. Methods: This multicenter, randomized, open-label trial, evaluated abemaciclib (200 mg PO every 12 hours daily) vs docetaxel (75 mg/m2 IV on Day 1); both on 21 day cycle until disease progression. Adults with confirmed Stage IV NSCLC with measurable disease, ECOG PS ≤1, and who progressed during/after platinum-based chemotherapy were eligible. Pts were randomized 2:1 to receive abemaciclib or docetaxel. Primary endpoint was investigator-assessed PFS. Key secondary endpoints were ORR, DCR, OS, and safety. Results: 159 pts were randomized to abemaciclib (N = 106) and docetaxel (N = 53). Median age was 64 years. 84.3% pts were men. In ITT pts 125 PFS events were observed with median PFS of 2.5 m (95% CI: 1.7, 2.9) for abemaciclib and 4.2 m for docetaxel (95% CI: 2.8, 5.7; stratified HR: 1.77 [95% CI: 1.17, 2.67]; P = .0068). ORR was 2.8% (95% CI: 0.0, 6.0) for abemaciclib and 20.8% (95% CI: 9.8, 31.7) for docetaxel. The DCR (CR + PR + SD) was 50.9% (95% CI: 41.4, 60.5) for the abemaciclib treatment arm and 64.2% (95% CI: 51.2, 77.1) for the docetaxel treatment arm. Median OS was 7.0 m (95% CI: 5.0, 8.8) for abemaciclib and 12.4 m for docetaxel (95% CI: 7.1, 16.0; stratified HR: 1.33 [95% CI: 0.88, 2.02]; P = .1746). Exploratory biomarker data will be available at the meeting. The most common TEAEs with abemaciclib were anemia and diarrhea. Conclusions: In this Phase 2 study, single agent abemaciclib 200 mg did not improve the progression-free survival time over docetaxel; the instantaneous rate of disease progression/death at any given time point was higher with abemaciclib vs docetaxcel. No specific safety concerns were observed. Clinical trial information: NCT02450539.
Referência(s)