- AbbVie's drug veliparib, part of a hot, newer class of oncology treatments called PARP inhibitors, failed two late-stage clinical trials, the company revealed Wednesday.
- One of the Phase 3 studies tested veliparib in patients with advanced or metastatic squamous non-small cell lung cancer (NSCLC) who had a history of smoking, while the other investigated it as a treatment for triple negative breast cancer (TNBC).
- "In these clinical trials, we wanted to explore whether a PARP inhibitor could augment chemotherapy in patients with [NSCLC] and [TNBC] by disrupting the repair of cancer cells," Gary Gordon, AbbVie's VP of oncology clinical development, said in an April 19 statement. "Unfortunately, these data do not support the use of veliparib in combination with chemotherapy in these patients."
The primary endpoint of the NSCLC trial, which AbbVie's candidate failed to meet, was to improve overall survival compared to placebo for one subgroup of patients who had smoked within the last 12 months and at least 100 times in their lives. All patients in the trial received the chemotherapy drugs carboplatin and paclitaxel, and then either veliparib or placebo.
In the other Phase 3 study, the goal was to show veliparib in combo with carboplatin and paclitaxel could achieve better rates of complete pathogenic response for TNBC patients compared to placebo plus carboplatin and paclitaxel or placebo plus just paclitaxel. AbbVie's drug failed there as well.
PARP inhibitors have captured the industry's attention as another mechanism to fight cancer. Efficacy data has been strong for several candidates so far, and the market has begun to flesh out as of late.
AstraZeneca retains a lead with its marketed drug Lynparza (olaparib), but new competition has come onto the market. In December, Clovis Oncology locked down accelerated approval for its PARP inhibitor Rubraca (rucaparib) as a monotherapy for advanced and pretreated ovarian cancer. And a few weeks back, Tesaro received FDA approval for Zejula (niraparib) in recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer — an especially important win because it's the first PARP drug that doesn't require testing for the BRCA mutation.
It's unclear where AbbVie goes from here with veliparib. The drug has fallen short before; showing in a previous Phase 2 trial a slight but not statistically significant improvement in progression-free survival for breast cancer patients.
But these newest failures reinforce the idea that the drug may be a wash, a conclusion that would be a hard pill to swallow for AbbVie, which has made concerted efforts to flesh out its oncology offerings in recent years.
While the North Chicago, Ill.-based drugmaker has three marketed cancer products, one being Imbruvica (ibrutinib), which brought in $1.83 billion through sales and collaborations in 2016, and many pipeline programs, few of its candidates have made it to late-stage testing. AbbVie's $5.8 billion acquisition of Stemcentrx to gain access to the lung cancer drug Rova-T was aimed at addressing that shortfall.
The company is also under immense pressure to expand its portfolio, as the anti-inflammatory Humira (adalimumab) still makes up the lion's share of AbbVie's revenue.