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AbbVie (ABBV)'s PARP Inhibitor Fails to Deliver in Two Late-Stage Studies

4/20/2017 5:43:03 AM

AbbVie's PARP Inhibitor Fails to Deliver in Two Late-Stage Studies April 20, 2017
By Alex Keown, Breaking News Staff

CHICAGO – Two Phase III studies of AbbVie (ABBV)’s PARP inhibitor veliparib failed to meet endpoints, AbbVie announced late Wednesday, causing a slight drop in company shares.

AbbVie said veliparib in combination with chemotherapy drugs failed in indications for squamous non-small cell lung cancer (NSCLC) and triple negative breast cancer (TNBC). Veliparib failed to improve overall survival of NSCLC patients who has smoked within the past year and had more than 100 smoking events in their lifetime. It also failed to achieve the complete pathologic response in breast cancer patients.

AbbVie’s announcement puts it behind other companies that have robust PARP inhibitors, such as AstraZeneca (AZN)’s Lynparza, Clovis Oncology (CLVS)’s Rubraca and Tesaro (TSRO)’s recently approved ovarian cancer treatment, Zejula, which was formerly known as Niraparib. The failure at AbbVie also puts it behind Pfizer (PFE), which gained an experimental PARP inhibitor in its acquisition of Medivation last year.

PARP stands for poly ADP ribose polymerase, which is an enzyme many cancer cells are more dependent upon than regular, healthy cells are.

"Research shows there is a role for PARP inhibitors in cancers associated with DNA repair deficits, such as those with BRCA mutations. In these clinical trials, we wanted to explore whether a PARP inhibitor could augment chemotherapy in patients with squamous non-small cell lung cancer and triple negative breast cancer by disrupting the repair of cancer cells," Gary Gordon, vice president of oncology clinical development at AbbVie, said in a statement. "Unfortunately, these data do not support the use of veliparib in combination with chemotherapy in these patients."
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AbbVie said it intends to provide greater detail on the two Phase III trials at either an upcoming medical conference or in an article published in a peer-reviewed journal. Veliparib is also being evaluated in Phase III studies for non-squamous non-small cell lung cancer, BRCA1/2 breast cancer and ovarian cancer.

While AbbVie is now behind in the development of PARP inhibitors, the company has a large oncological pipeline in hematologic oncology and in solid tumors with more than 200 clinical trials in over 20 different tumor types. AbbVie said its oncology portfolio includes three medicines currently approved for use in multiple markets, three investigational treatments in late-stage clinical development and more than 20 programs in Phase 1 and pre-clinical development. AbbVie’s Chief Scientific Officer Michael Severino said the company has a “comprehensive and innovative oncology pipeline” that will provide meaningful therapies to patients.

In a note published earlier, Geoffrey Porges, an analyst with Leerink, touted AbbVie’s oncology pipeline, but said veliparib was essentially worthless, Endpoints reported this morning. Porges said the failure of veliparib in the two trials “confirms our view that veliparib has limited activity and is not competitive with other products in this class.”

Shares of AbbVie are trading at $63.48 as of 10:42 a.m.

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