AbbVie Presents Phase 2 Results from Study of Investigational Medicine Veliparib in Patients with Non-Small Cell Lung Cancer at the American Society of Clinical Oncology Annual Meeting

- A Phase 3 study has been initiated evaluating veliparib in NSCLC patients with smoking history

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Jun 01, 2015, 08:00 ET

NORTH CHICAGO, Ill., June 1, 2015 /PRNewswire/ -- AbbVie (NYSE:ABBV), a global biopharmaceutical company, today 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.¹Tobacco 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.¹These 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."

About the Study – Abstract 8038

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).

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 (n=64), compared to 3.3 months (n=31) 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. Data for non-smokers was not available.²

The most common adverse events (>20%) in patients treated with veliparib, carboplatin and paclitaxel were alopecia, anemia, neutropenia, nausea, fatigue and peripheral neuropathy. Grade 3 and 4 (more serious) adverse events were elevated in current smokers treated with veliparib, carboplatin and paclitaxel (66%) compared to carboplatin and paclitaxel (40%).²

About Veliparib (ABT-888)

Veliparib is an investigational oral poly (adenosine diphosphate [ADP]–ribose) polymerase (PARP) inhibitor being evaluated in multiple tumor types. PARP is a naturally-occurring enzyme in the body involved in the repair of DNA damage to cells. Discovered by AbbVie researchers, veliparib is being investigated in combination with DNA-damaging therapies like chemotherapy or radiation. Veliparib is currently being studied in multiple cancers and tumor types, including Phase 3 studies in advanced non-small cell lung cancer and breast cancer. Veliparib is an investigational compound and its efficacy and safety have not been established by the FDA or any other health authority.

About Non-Small Cell Lung Cancer (NSCLC)

Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for approximately 85-90 percent of diagnosed cases.³There are three common subtypes of NSCLC: adenocarcinoma, squamous cell (epidermoid) carcinoma and large cell (undifferentiated) carcinoma.³Adenocarcinoma accounts for approximately 40 percent of lung cancers and is the most common form of NSCLC.³It occurs mainly in current or former smokers, but it is also the most common type of lung cancer seen in non-smokers.³Adenocarcinoma typically originates in the outer parts of the lung. Squamous cell carcinoma accounts for about 25-30 percent of NSCLC cases, and is usually found in the middle airways of the lungs. Squamous cell is often linked to patients with a history of smoking.³Approximately 10-15 percent of NSCLC cases are considered large cell carcinomas, which tend to grow and spread quickly, making it a more difficult-to-treat form of NSCLC. Other subtypes exist, but are less common.³

Lung cancer (both small cell and non-small cell) is the second most common cancer in both men and women.⁴It accounts for about 13 percent of all new cancers in the U.S. and is the leading cause of cancer-related death among both men and women, causing more deaths than colon, breast, and prostate cancers combined.⁴ Worldwide, it is the most common form of cancer.⁵

About AbbVie Oncology

AbbVie's oncology research is focused on the discovery and development of targeted therapies that work against the processes cancers need to survive. By investing in new technologies and approaches, we are breaking ground in some of the most widespread and difficult-to-treat cancers, including multiple myeloma and chronic lymphocytic leukemia. AbbVie's oncology pipeline includes multiple new molecules in clinical trials being studied in more than 15 different cancers and tumor types. For more information on AbbVie Oncology and AbbVie's oncology portfolio, please visit http://oncology.abbvie.com.

About AbbVie

AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

Forward-Looking Statements

Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, the likelihood that the transaction is consummated, the expected benefits of the transaction, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," in AbbVie's 2014 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.


¹ American Cancer Society website. "Tobacco-Related Cancers Fact Sheet" http://www.cancer.org/cancer/cancercauses/tobaccocancer/tobacco-related-cancer-fact-sheet. Accessed April 6, 2015.
² Ramalingam, S., et al. Abstract 8038. "Smoking Status Predicts Sensitivity to PARP Inhibitor, Veliparib, in Patients with Advanced NSCLC"
³ The American Cancer Society (2014) "Non-Small Cell Lung Cancer." http://www.cancer.org/acs/groups/cid/documents/webcontent/003115-pdf.pdf. Last accessed May 1, 2015.
⁴ The American Cancer Society (2014) "What Are the Key Statistics About Lung Cancer?" http://www.cancer.org/cancer/lungcancer-non-smallcell/detailedguide/non-small-cell-lung-cancer-key-statistics. Last accessed May 1, 2015.
⁵ Cancer Research U.K. (2014) "Lung Cancer Incidence Statistics" http://www.cancerresearchuk.org/cancer-info/cancerstats/types/lung/incidence/uk-lung-cancer-incidence-statistics#geog. Last accessed May 1, 2015.