P1.13A.13 ALISertib in Patients with Extensive-Stage Small-Cell Lung Cancer: The Phase 2 ALISCA-Lung1 Study
Recommended Citation
Owonikoko TK, Burns TF, Chiappori AA, Drapkin B, Gentzler RD, Goldschmidt J, Hakimian D, Jotte R, Liu SV, Onitilo AA, Pennell NA, Potugari B, Rios J, Sands J, Spira A, Wang B, Waterhouse DM, Lowenthal BH, Bebchuk JD, DeFazio Eli L, Wong EK, Dowlati A. P1.13A.13 ALISertib in Patients with Extensive-Stage Small-Cell Lung Cancer: The Phase 2 ALISCA-Lung1 Study. J Thorac Oncol 2024; 19(10):S212-S213.
Document Type
Conference Proceeding
Publication Date
10-1-2024
Publication Title
J Thorac Oncol
Abstract
Treatment options are limited for patients with small-cell lung cancer (SCLC) whose disease has progressed on or after platinum-based chemotherapy. Therefore, there is an urgent need for evaluation of novel agents in this setting. Aurora kinase A (AURKA) is a key regulator of mitosis and AURKA expression is associated with worse prognosis in multiple solid tumor types. Alisertib is a highly selective, reversible, ATP-competitive, orally administered, small-molecule AURKA inhibitor under investigation for SCLC. Phase 1/2 clinical trials of alisertib as either monotherapy or in combination with paclitaxel for relapsed/refractory solid tumors (including SCLC) reported response rates of 21-22%. The most common treatment-related grade ≥3 AEs were neutropenia, febrile neutropenia, and leukopenia. Preclinically, greater alisertib sensitivity has been reported in models with high c-Myc expression and/or loss of RB1 function. In a clinical study of alisertib + paclitaxel vs placebo + paclitaxel in SCLC, c-Myc expression or mutations in RB1, RBL1, RBL2, or CDK6 showed strong correlation with an improvement in both PFS and OS in the alisertib arm.
Volume
19
Issue
10
First Page
S212
Last Page
S213