Results

AbbVie grapples with another setback as 2 PhIII trials for its PARP veliparib flop

Up until now, PARP inhibitors have been blazing a broad, long trail of success in the clinic, with Lynparza, Rubraca and now Zejula hitting a busy and growing market for cancer patients.

AbbVie CEO Richard Gonzalez

But AbbVie $ABBV won’t be joining that crowd anytime soon.

Researchers at the company chose to announce late Wednesday that their PARP, veliparib, failed in two Phase III studies in patients with squamous non-small cell lung cancer (NSCLC) and triple negative breast cancer.

Details will have to wait until an upcoming cancer drug conference. But AbbVie prepped a few short words for the late-stage burial detail.

“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,” said Gary Gordon, the VP of oncology clinical development at AbbVie. “Unfortunately, these data do not support the use of veliparib in combination with chemotherapy in these patients.”

There’s plenty of work ahead as the rest of the new wave of PARPs looks to broaden labels and expand market penetration. Still to be heard from? Pfizer, which grabbed talazoparib in their $14 billion acquisition of Medivation. The pharma giant will need to do much better than AbbVie if it wants to justify the price it paid.

AbbVie has been hustling up a big late-stage effort to bring new drugs to the market, before it loses patent protection on the all-important $16 billion Humira flagship franchise. But it’s been struggling on the cancer front, failing so far to impress analysts with Rova-T, which it acquired in a $10 billion buyout.

Geoffrey Porges at Leerink likes some of AbbVie’s late-stage programs, but he’s writing off veliparib as essentially worthless. He noted:

While two disappointing trials would not normally completely doom a program, the lack of effect indeed confirms our view that veliparib has limited activity and is not competitive with other products in this class. For this reason we are taking the probability of success (POS) of the program to zero, and reducing our revenue and earnings expectations accordingly.


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