I-SPY 2: Veliparib–Carboplatin Improves Complete Response Rate in Triple-Negative Breast Cancer

Excerpt:

“The addition of veliparib–carboplatin to standard chemotherapy appeared likely to improve rate of pathologic complete response among women with triple-negative breast cancer, according to results of I-SPY 2 published inThe New England Journal of Medicine.

“Researchers calculated an 88% predictive probability that the veliparib (ABT-888, AbbVie) and carboplatin combination would remain effective when added to standard chemotherapy in phase 3 confirmatory trials.”

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Innovative Trials Produce Promising Breast Cancer Drugs

Excerpt:

“An innovative set of clinical trials have identified two drugs that could provide a fighting chance for women with advanced breast cancer.

“The drugs, neratinib and veliparib, both appear effective in helping women diagnosed with stage 2 or 3 , researchers report.

“These are the first two drugs to come out of the I-SPY clinical , a research effort intended to streamline  testing by better guiding treatments to those who would most benefit from them, said one of the study authors, Dr. Laura Esserman. She is director of breast cancer care at the University of California, San Francisco’s Comprehensive Cancer Center.”

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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

“AbbVie (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.’ “


AbbVie Initiates Veliparib Phase III Trial in BRCA-mutated Advanced Breast Cancer Patients

“AbbVie has initiated its Phase III trial investigating the safety and efficacy of the investigational PARP inhibitor veliparib in combination with carboplatin and paclitaxel in advanced breast cancer patients.

“In the double-blind study, researchers will randomize nearly 300 patients to receive either veliparib, plus the carboplatin/paclitaxel combination, or just the chemotherapy regimen. Metastatic or locally advanced breast cancer patients enrolled in the trial will have to have tumors that are HER2 negative, but positive for BRCA1/2 mutations. AbbVie is working with Myriad Genetics to use its BRACAnalysis test to gauge BRCA mutations in study subjects.

“Researchers will assess in the study whether adding veliparib significantly increases patients’ progression-free survival compared to treatment with only chemotherapy. Other endpoints in the study are overall survival, clinical benefit rate, objective response rate, and duration of response.”

Editor’s note: Clinical trials are research studies that test new treatments on volunteer patients. In many clinical trials, some patients receive the new drug being tested, and for comparison, some patients receive “standard of care” treatment, meaning a U.S. Food and Drug Administration (FDA)-approved treatment that their oncologists would likely have considered for them. This story discusses a new clinical trial that is testing a drug called veliparib. The trial is enrolling people with advanced breast cancer who are HER2 negative and have BRCA1/2 mutations. Some of the patients will be treated with standard chemotherapy (a combination of the drugs carboplatin and paclitaxel), and some will receive veliparib PLUS standard chemotherapy. The trial is randomized, meaning patients will not get to choose which of the two treatments they receive. The goal of the clinical trial is to figure out whether adding veliparib to the chemo improves outcomes for patients.


AbbVie Announces Initiation of Pivotal Phase III Study of Veliparib (ABT-888) for Patients with Non-Small Cell Lung Cancer

“AbbVie (ABBV) announced the initiation of a global Phase III clinical trial evaluating the safety and efficacy of its investigational compound, veliparib (ABT-888), in patients with previously untreated locally advanced or metastatic squamous non-small cell lung cancer (NSCLC). The trial will compare patients randomized to receive either the standard chemotherapies of carboplatin and paclitaxel with the addition of veliparib, versus patients receiving carboplatin and paclitaxel with the addition of placebo.”

Editor’s note: Clinical trials are used to test new cancer treatments. Enrolling in a clinical trial might give a patient access to a promising treatment he/she would otherwise not be able to receive. Learn more about lung cancer clinical trials here.