2024 World Conference on Lung Cancer (WCLC) - Posters-P1.13A.13 ALISertib in Patients with Extensive-Stage Small-Cell Lung Cancer: The Phase 2 ALISCA-Lung1 Study

Pdf Summary

The ALISCA-Lung1 study is a phase 2 clinical trial investigating ALISertib in patients with extensive-stage small-cell lung cancer (SCLC) who have progressed following treatment with platinum-based chemotherapy. SCLC treatment options are limited once initial therapies fail, hence the need for exploration of novel treatments.<br /><br />Aurora kinase A (AURKA), a key player in cell division, is associated with a poor prognosis when overexpressed in various cancers. Alisertib, a selective AURKA inhibitor, has shown promise in preclinical studies, particularly in cells exhibiting high c-Myc expression and RB1 loss. Previous clinical trials indicated a percentage of objective response rates and reported common adverse effects like neutropenia and leukopenia.<br /><br />The ALISCA-Lung1 study aims to enroll up to 60 patients across 25 U.S. sites. It has an extensive biomarker analysis plan to correlate specific biomarkers (e.g., c-Myc expression, RB1 loss) with response to Alisertib. This includes next-generation sequencing and immunohistochemistry-based assessments. <br /><br />Primary objectives involve assessing the efficacy of Alisertib in terms of objective response rate (ORR), duration of response (DOR), disease-control rate (DCR), progression-free survival (PFS), and overall survival (OS). Secondary objectives focus on comprehensive safety profiling and pharmacokinetic evaluation.<br /><br />Enrollment criteria include adults with confirmed SCLC and measurable lesions, prior platinum-based therapy, and anti-PD-L1 treatment. Exclusion factors incorporate previous AURKA-specific treatment, major recent surgeries, active infections, or unstable CNS metastases.<br /><br />The trial is sponsored by Puma Biotechnology Inc. and aims to refine companion diagnostics for future clinical applications. The study design is iterative, with interim data guiding further recruitment and development, making it a significant resource in enhancing late-stage SCLC treatment options.

Asset Subtitle

Taofeek Owonikoko

Meta Tag

Speaker Taofeek Owonikoko

Topic SCLC & Neuroendocrine Tumors

Keywords

ALISCA-Lung1

Alisertib

small-cell lung cancer

SCLC

Aurora kinase A

biomarker analysis

clinical trial

platinum-based chemotherapy

c-Myc expression

Puma Biotechnology