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Abbvie reports results from Phase II trial of veliparib in patients with NSCLC

AbbVie, a global biopharmaceutical company, announced findings from a Phase 2 study of the investigational medicine veliparib combined with the chemotherapy regimen carboplatin and paclitaxel that showed an improvement in median progression-free survival (PFS) in patients with previously untreated metastatic or advanced non-small cell lung cancer (NSCLC) who are current smokers.

These data will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting on June 1 in Chicago. Veliparib is an investigational oral poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor being evaluated for the treatment of various cancer types, including NSCLC.

"The results from this study support further evaluation of this investigational regimen in advanced stage NSCLC patients with smoking history," said Suresh S. Ramalingam, M.D., professor of hematology and medical oncology, Emory University.

"Veliparib showed interesting results when combined with chemotherapy in a subset of patients with smoking history."

Lung cancer patients who are current smokers are at a higher risk of death than non-smokers.1 Tobacco use accounts for at least 30 percent of all cancer deaths, causing 87 percent of lung cancer deaths in men, and 70 percent of lung cancer deaths in women.

These data suggest smoking status may influence efficacy for veliparib-chemotherapy combination in advanced NSCLC. A Phase 3 study has been initiated in NSCLC patients with smoking history based on the results seen in the Phase 2 study.2

"As we continue to evaluate our investigational medicines, we hope to bring treatments to market that address the unmet need and provide meaningful benefit for patients," said Gary Gordon, M.D., vice president, oncology clinical development, AbbVie.

"The results from this study reinforce AbbVie’s continued investigation of veliparib in treating advanced non-small cell lung cancer, including patients with a history of smoking."

This Phase 2 study evaluated survival outcomes in previously untreated metastatic or advanced NSCLC patients treated with either a regimen consisting of a carboplatin, paclitaxel and placebo (C/P) or carboplatin, paclitaxel combined with veliparib (V+C/P).

Median overall PFS in the V+C/P was 5.8 months (n=105) vs. 4.2 months (n=53) in the C/P arm (CI 0.46 -1.17) and median overall survival was 11.7 months in the V+C/P vs. 9.1 months (CI 0.54-1.18).