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AbbVie takes PARP inhibitor into third phase III trial

Veliparib under investigation for use in advanced breast cancer

AbbVie has started a phase III trial of its PARP inhibitor veliparib as a first-line therapy for advanced breast cancer in combination with chemotherapy.

The study will compare the combination of veliparib (ABT-888) alongside chemotherapy to paclitaxel and carboplatin with chemotherapy in patients with HER2-negative, BRCA1/2-positive breast cancer.

This is the third phase III trial AbbVie has started for veliparib, which works by interfering with the DNA repair process in cells and should make tumours more sensitive to DNA-damaging chemotherapy.

AbbVie now has now closed the gap in the race to bring the first PARP inhibitor to market, particularly with the demise of Sanofi's former leader iniparib last year. Merck & Co and Tesaro are arguably in pole position at the moment with lead candidate niraparib in a phase III trial for ovarian cancer due to generate data next year. If positive niraparib could reach the market in early 2016.

Meanwhile, rival candidate olaparib from AstraZeneca (AZ) has just been turned down for accelerated approval by an FDA advisory committee, reducing its chances of winning the race. AZ will likely now have to complete an ongoing phase III trial in ovarian cancer which is due to complete at the end of 2015 to secure approval.

AbbVie has taken a slightly different tack with veliparib, going for indications that are not limited to "genetically-deficient" tumours such as BRCA-positive breast cancer, according to Scott Brun, the firm's vice president of clinical development.

The PARP inhibitor is also being tested as a neo-adjuvant therapy in triple-negative breast cancer - where veliparib and chemotherapy is used to de-bulk tumours prior to surgery - and in non-small cell lung cancer (NSCLC), which are also very hard-to-treat treatment settings.

"NSCLC is an area that no other PARP inhibitor has explored [and] we are able to go there because we found a way to successfully combine with carboplatin-based chemotherapy," he said in a recent investor presentation. That "broadens our opportunity for veliparib as a consequence," added Brun.

AbbVie also has an ongoing phase II trial looking at the drug in combination with whole brain radiation in patients who have brain metastases from lung cancer.

Other PARP inhibitors in clinical development include BioMarin's BMN 673 (phase III in breast cancer), Clovis Oncology's rupacarib (phase II in ovarian cancer) and Eisai's E7016 (phase II in melanoma).

27th June 2014

From: Research



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