AbbVie presents Phase 2 results from study of veliparib in patients with NSCLC who are current smokers

3 June 2015  •  Author: Victoria White

AbbVie has 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.


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 haematology 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. Tobacco use accounts for at least 30% of all cancer deaths, causing 87% of lung cancer deaths in men, and 70% 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.

Results support further evaluation of veliparib regimen in patients with advanced NSCLC who smoke

“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.”

The 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 vs. 4.2 months in the C/P arm and median overall survival was 11.7 months in the V+C/P vs. 9.1 months.

In addition, patients were evaluated based on their smoking status. Each experimental arm of the 158 patient study contained current smokers, former smokers and non-smoker (never smoked) subgroups. In the preplanned stratification group, current smokers treated with V+C/P had a median PFS of 5.6 months, compared to 3.3 months for patients treated with C/P alone. Non-smokers treated with V+C/P had a median PFS of 6.4 months, compared to 5.6 months in patients treated with C/P alone. Data for former smokers was not available. Current smokers treated with V+C/P had a median overall survival of 12.5 months, compared to 5.4 months for patients treated with C/P alone. Former smokers treated with V+C/P had a median overall survival of 8.6 months, compared to 14.67 months with those treated with C/P alone.

The data were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting.

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