Veliparib Plus Temozolomide for Melanoma Improves Progression-Free Survival

Share this content:
Median progression-free survival with veliparib at two different doses in combination with temozolomide nearly doubled compared with placebo.
Median progression-free survival with veliparib at two different doses in combination with temozolomide nearly doubled compared with placebo.

Median progression-free survival with veliparib at two different doses in combination with temozolomide nearly doubled compared with placebo; however, the results did not reach statistical significance, a new study published online ahead of print in the journal Annals of Oncology has shown.

For the multicenter, double-blind, phase II trial, researchers enrolled 346 patients with unresectable stage III or IV metastatic melanoma and randomly assigned them 1:1:1 to receive temozolomide plus veliparib 20 mg or 40 mg, or placebo twice daily.

Results showed that median progression-free survival was 3.7 months (95% CI: 3.0, 5.5) with veliparib 20 mg, 3.6 months (95% CI: 1.9, 4.1) with veliparib 40 mg, and 2 (95% CI: 1.9, 3.7) with placebo.

Researchers found that median overall survival was 10.8 (95% CI: 9.0, 13.1), 13.6 (95% CI: 11.4, 15.9), and 12.9 (95% CI: 9.8, 14.3) months, respectively, indicating no statistically significant difference in overall survival between treatment arms.

The study also demonstrated an objective response rate of 10.3% with veliparib 20 mg, 8.7% with veliparib 40 mg, and 7.0% with placebo.

RELATED: In Melanoma, Tumor Cell Adhesion Increases Risk for Sentinel Lymph Node Metastasis

Exploratory analyses demonstrated an improved progression-free survival among patients with low ERCC1 expression when they received veliparib.

In regard to safety, the frequencies of leukopenia, neutropenia, and thrombocytopenia were significantly higher in the veliparib treatment arms.

Veliparib is a potent, poly ADP-ribose polymerase-1 and -2 inhibitor that has been shown to increase the efficacy of temozolomide in preclinical models.

Reference

  1. Middleton MR, Friedlander P, Hamid O, et al. Randomized phase 2 study evaluating veliparib (ABT-888) with temozolomide in patients with metastatic melanoma. Ann Oncol. 2015. [epub ahead of print]. doi: 10.1093/annonc/mdv308.

Related Resources

You must be a registered member of Cancer Therapy Advisor to post a comment.

Sign Up for Free e-newsletters



Regimen and Drug Listings

GET FULL LISTINGS OF TREATMENT Regimens and Drug INFORMATION

Bone Cancer Regimens Drugs
Brain Cancer Regimens Drugs
Breast Cancer Regimens Drugs
Endocrine Cancer Regimens Drugs
Gastrointestinal Cancer Regimens Drugs
Gynecologic Cancer Regimens Drugs
Head and Neck Cancer Regimens Drugs
Hematologic Cancer Regimens Drugs
Lung Cancer Regimens Drugs
Other Cancers Regimens
Prostate Cancer Regimens Drugs
Rare Cancers Regimens
Renal Cell Carcinoma Regimens Drugs
Skin Cancer Regimens Drugs
Urologic Cancers Regimens Drugs