Investigational Drug
Alisertib
TrialFetch AI Analysis
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Overview
Alisertib (MLN8237) is an investigational oral cancer drug studied in several solid tumors and blood cancers. Human trials have shown tumor responses, but results vary by cancer type. A phase 3 trial in peripheral T-cell lymphoma did not establish a benefit over the treatments used for comparison. (ascopubs.org)
Mechanism of action
Alisertib inhibits Aurora A kinase (AURKA), a protein involved in organizing the mitotic spindle and controlling cell division. Inhibiting it can disrupt chromosome segregation and lead to cancer-cell death or senescence. (haematologica.org)
Efficacy
- Relapsed or refractory peripheral T-cell lymphoma: In the randomized phase 3 Lumiere trial, the centrally assessed objective response rate was 33% with alisertib versus 45% with the investigator’s choice of pralatrexate, gemcitabine, or romidepsin. Median progression-free survival was 115 versus 104 days; the trial did not demonstrate superiority for alisertib. (ascopubs.org)
- Small-cell lung cancer: In a phase 2 study of alisertib alone, 10 of 48 response-assessable patients (21%) had a partial response. In a separate randomized phase 2 trial, adding alisertib to paclitaxel yielded median progression-free survival of 3.32 months versus 2.17 months with paclitaxel plus placebo; the prespecified intent-to-treat analysis did not show a statistically significant difference. (sciencedirect.com)
- Endocrine-resistant metastatic breast cancer: In a randomized phase 2 trial, response rates were 19.6% with alisertib alone and 20.0% with alisertib plus fulvestrant. Adding fulvestrant did not improve response rate or progression-free survival. (jamanetwork.com)
Safety
Low blood-cell counts are a prominent risk. In Lumiere, anemia occurred in 53% of alisertib recipients versus 34% of comparator recipients, and neutropenia in 47% versus 31%. In the small-cell lung cancer combination trial, grade 3 or higher drug-related adverse events occurred in 67% with alisertib plus paclitaxel versus 22% with paclitaxel plus placebo; investigators reported four treatment-related deaths in the alisertib arm and none in the control arm. Risks may differ across doses and combinations. (ascopubs.org)
Further reading
- Phase 3 Lumiere trial in peripheral T-cell lymphoma
- Phase 2 small-cell lung cancer monotherapy study
- Randomized phase 2 small-cell lung cancer combination study
- Randomized phase 2 breast cancer study
Last updated: Sep 2026
Active trials using Alisertib
Found 2 active trials using this drug:
TrialFetch AI summary: For adults with HR-positive, HER2-negative recurrent or metastatic breast cancer that has progressed after at least two endocrine therapy lines and prior CDK4/6 inhibitor therapy; prior chemotherapy for metastatic disease is not allowed. Patients receive one of three doses of alisertib, an investigational oral Aurora A kinase inhibitor, with endocrine therapy.
ClinicalTrials.gov ID: NCT06369285
TrialFetch AI summary: Adults with extensive-stage SCLC that progressed during or after platinum-based chemotherapy and anti-PD-L1 therapy, with no more than two prior systemic treatment lines, receive oral alisertib monotherapy. Alisertib inhibits Aurora A kinase, disrupting cell division; the study evaluates outcomes in biomarker-defined subgroups.
ClinicalTrials.gov ID: NCT06095505
