AbbVie Presents Results from Multiple Studies of Investigational Compound Veliparib in Patients with Non-Small Cell Lung Cancer at the European Society for Medical Oncology Annual Congress

NORTH CHICAGO, Ill., Sept. 27, 2014 /PRNewswire/ -- AbbVie (NYSE: ABBV) released interim results from an ongoing Phase 2 study of its investigational compound veliparib in combination with chemotherapy, which showed a 35 percent improvement (P-value=0.14) in progression-free survival (PFS) and a 30 percent improvement (P-value=0.21) in overall survival (OS) in patients with previously untreated metastatic or advanced non-small cell lung cancer (NSCLC). These results, which evaluated veliparib as a potential treatment for metastatic or advanced NSCLC, were presented for the first time at the 2014 Annual Congress of the European Society for Medical Oncology (ESMO), September 26-30 in Madrid, Spain.

"There is an urgent need to develop novel treatment options for patients with squamous cell carcinoma," said Suresh S. Ramalingam, M.D., director, Division of Medical Oncology, Emory University. "These data demonstrate activity for veliparib in non-small cell lung cancer patients with squamous histology. The combination of veliparib with chemotherapy merits further evaluation in squamous cell lung cancer."

"Veliparib has shown promise in preliminary trials to possibly limit the replicative potential of cancer cells, induce programmed cell death and work in collaboration with chemotherapy," said Gary Gordon, M.D., Ph.D., divisional vice president, oncology clinical development, AbbVie. "Preliminary data from this randomized study suggest that veliparib may help to improve the progression free survival of patients treated with platinum-based chemotherapy, exemplifying AbbVie's commitment to discovering and developing targeted therapies for hard-to-treat cancers, including squamous non-small cell lung cancer."

Phase 2 Combination Trial in Patients with Non-Small Cell Lung Cancer (Abstract 1234)
The Phase 2, randomized, double-blind trial was designed to evaluate the efficacy and safety of veliparib in combination with carboplatin and paclitaxel, two chemotherapeutic medicines. Patients in the squamous histology subgroup randomized to the veliparib arm demonstrated a PFS rate of 6.1 months compared to 4.1 months (HR=0.50; P-value=0.06) and an OS rate of 10.3 months compared to 8.4 months (HR= 0.71; P-value=0.22). Median PFS was improved from 4.2 to 5.8 months, and median OS was improved from 9.1 to 11.7 months. Common adverse events (≥20% of patients) for the veliparib-containing arm included alopecia (39%), anemia (31%), neutropenia (36%), nausea (28%) and peripheral neuropathy (24%). Grade 3 and 4 adverse events (≥10% of patients) included neutropenia (23%) and anemia (10%).

AbbVie initiated a Phase 3 clinical trial evaluating veliparib in patients with squamous NSCLC earlier in 2014 to confirm the results of this Phase 2 study.

Phase 1 Study in Japanese Patients with Non-Small Cell Lung Cancer (Abstract 1213)
Also during ESMO, AbbVie presented data from a Phase 1 study evaluating veliparib in combination with carboplatin and paclitaxel in Japanese patients with NSCLC, which was designed to evaluate the preliminary efficacy of the treatment, as well as the recommended Phase 2 dose. The study demonstrated an overall response rate of 54.5 percent, with six patients achieving a partial response and four demonstrating stable disease ranging from 40 to 143 days. The study also demonstrated co-administration of carboplatin and paclitaxel had no significant effect on veliparib pharmacokinetics.

Common treatment emergent adverse events (≥20% of patients) were leukopenia (100%), neutropenia (100%), anemia (83.3%), thrombocytopenia (75%), increased aspartate aminotransferase (66.7%) and increased alanine aminotransferase (66.7%). Grade 3 or 4 adverse events occurring in more than two patients were neutropenia (12 patients), leukopenia (4 patients), anemia (3 patients) and hyponatremia (2 patients).

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 that repairs damage to DNA, and in certain types of cancers, repairs cancer cells. Discovered by AbbVie researchers, veliparib is being developed to help prevent DNA repair in cancer cells and increase the effectiveness of common DNA-damaging therapies like chemotherapy or radiation.
Veliparib is currently being studied in more than a dozen cancers and tumor types, including Phase 3 studies in non-small cell lung cancer and breast cancer. Veliparib is an investigational compound and its safety and efficacy have not been evaluated 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.¹ There are three common subtypes of NSCLC: adenocarcinoma, squamous cell (epidermoid) carcinoma and large cell (undifferentiated) carcinoma. Adenocarcinoma accounts for approximately 40 percent of lung cancers and is the most common form of NSCLC in patients who smoke, have smoked or have never smoked. Adenocarcinoma 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. Approximately 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.²

Lung cancer (both small cell and non-small cell) is the second most common cancer in both men and women. It 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.³ Worldwide, it is the most common form of cancer.⁴

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. Our 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 our 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. AbbVie employs approximately 25,000 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.

Responsibility
The directors of AbbVie accept responsibility for the information contained in this document and, to the best of their knowledge and belief (having taken all reasonable care to ensure that such is the case), the information contained in this document is in accordance with the facts and it does not omit anything likely to affect the import of such information.

¹  "Non-Small Cell Lung Cancer." The American Cancer Society, Accessed March 12, 2014:http://www.cancer.org/cancer/lungcancer-non-smallcell/index?sitearea

² "Non-Small Cell Lung Cancer: Detailed Guide." The American Cancer Society, Accessed March 12, 2014:http://www.cancer.org/cancer/lungcancer-non-smallcell/detailedguide/index

³ "What Are the Key Statistics About Lung Cancer?" The American Cancer Society, Accessed March 12, 2014:http://www.cancer.org/cancer/lungcancer-non-smallcell/detailedguide/non-small-cell-lung-cancer-key-statistics

⁴ "Lung Cancer Incidence Statistics." Cancer Research U.K., Accessed March 12, 2014:http://www.cancerresearchuk.org/cancer-info/cancerstats/types/lung/incidence/uk-lung-cancer-incidence-statistics#geog

SOURCE AbbVie