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AbbVie Announces Topline Results from Two Phase 3 Studies Investigating Veliparib in Combination with Chemotherapy for the Treatment of Patients with Advanced or Metastatic Squamous Non-Small Cell Lung Cancer and Early-Stage Triple-Negative Breast Cancer

(AbbVie) Apr 19, 2017 - AbbVie, a global biopharmaceutical company, today announced that two Phase 3 studies evaluating veliparib, an investigational, oral poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor did not meet their primary endpoints.

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Howard S. Hochster, MD (Posted: April 27, 2017)

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It is not difficult to imagine that PARP inhibitors, which function through the Homologous Repair pathway, would not add much to standard platinum based therapy in unselected lung cancer and TNBC. What is harder to imagine, is what AbbVie would launch phase 3 trials in unselected patient populations who do not have defined DNA repair defects. We can do better in this era of tumor profiling.

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H. Jack West, MD (Posted: April 20, 2017)

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The failure of the phase 3 trial with veliparib combined with chemotherapy is disappointing and yet another reminder of the gulf between promising phase II data and proven benefit in a larger, multicenter phase III trial. This was a large and likely well-conducted study that asked an important question and provided a valuable but humbling answer. Despite recent successes with checkpoint inhibitors and some targeted therapies, it remains quite challenging to generate clinically significant improvements in outcomes in patients with lung cancer.

In the future, trials will increasingly need to focus on more narrow populations as the treatment algorithms incorporate PD-L1 expression and more driver mutations with different standard treatment approaches.

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