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Alberto Abaterusso
Alberto Abaterusso
Articles (358) 

AbbVie's Veliparib Missed Primary Endpoints of 2 Clinical Trials

Investors should know that experiments were evaluated through an ITT analysis

April 21, 2017 | About:

AbbVie Inc. (NYSE:ABBV) informed the markets through PR Newswire April 19 that its PARP inhibitor, Veliparib, assessed with chemotherapy, failed to achieve two Phase 3 clinical trials' primary endpoints.

The combined therapy based on AbbVie's PARP inhibitor and chemo was assessed in squamous non-small cell lung cancer patients and triple negative breast cancer patients.

The PARP inhibitors block a particular molecule that is involved in the repair process of the tumor cells.

Non-small-cell lung carcinoma (NSCLC) is a type of lung cancer that is generally treated either with surgery (pulmonary lobectomy or pneumonectomy) or radiotherapy and chemotherapy.

“Non-small cell lung cancer (NSCLC) accounts for approximately 85% of all lung cancers," according to Medscape. "Squamous cell carcinoma accounts for about 25% to 30% of NSCLC cases. It is usually found in the middle airways of the lungs and is often linked to a history of smoking," according to the American Cancer Society.

Triple-negative breast cancers are among the least common forms of malignant tumors that originate in the breast cells and are a subtype of an invasive tumor that tends to appear more often in younger women.

With the two clinical trials, phase 3, AbbVie aimed to assess the safety and efficacy of its PARP inhibitor, Veliparib, on the aforementioned patients through the two investigational studies as explained hereafter:

  1. In the first of the two studies researchers assessed AbbVie's Veliparib plus chemotherapy (carboplatin and paclitaxel) versus placebo in addition to the chemotherapy (carboplatin and paclitaxel) over a group of 970 advanced-metastatic squamous non-small cell lung cancer patients with a different history of smoking and who didn't undergo any previous treatment. The company says that “the primary endpoint was improvement in overall survival in the group of patients who had smoked within the past 12 months and had more than 100 smoking events in their lifetimes.”​
  2. In the second of the two studies researchers assessed AbbVie's Veliparib plus chemotherapy (carboplatin and paclitaxel) versus placebo in addition to a chemotherapy that was based either on a combination of carboplatin and paclitaxel or on the administration of the only paclitaxel. Veliparib's safety and efficacy was assessed over a group of 312 early-stage triple-negative breast cancer patients. The company says that “the primary endpoint was complete pathologic response.”

It is true that as Dr. Gary Gordon, AbbVie's vice president of oncology clinical development, said, "Data do not support the use of veliparib in combination with chemotherapy in these patients" (PR Newswire), but investors should notice that in the evaluation of the experiment, a statistical analysis called intended to treat (ITT) was used.

The ITT is a statistical analysis in which all the patients who start treatment are considered part of the experiment, regardless of whether they complete it. If a certain number of people with specific systematic characteristics abandon the experiment, even a totally ineffective treatment could appear to be effective if one compares only the pre- and post-treatment conditions of only those who complete the experiment.

If I were an investor in AbbVie, I would also be interested in the full results of the experiments that cover both sub groups: those results that refer to all the patients who started the experiment as well as those results that refer only to those patients who started the treatment and completed the experiment.

The company says that “full results will be presented at upcoming medical meetings or published in a peer-reviewed journal.”

AbbVie is trading at $63.78 per share with a trailing price-earnings (P/E) ratio of 17.57, a price-sales (P/S) ratio of 3.96 and a price-book (P/B) ratio of 21.91. The forward P/E ratio is 9.90 and for 2017 analysts forecast an EPS of $5.5, which represents a 14.1% upside from EPS of 2016.

The company distributes an annual dividend of $2.56 per share through quarterly payments of 64 cents to its shareholders for a dividend yield of 3.98%.

AbbVie has a recommendation rating of 2.4 which ranges between 1.0 (Strong Buy) and 5.0 (Sell) and an average target price per share of $71.28.

Disclosure: I have no positions in AbbVie.

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About the author:

Alberto Abaterusso
I am a freelance writer based in The Netherlands. I have an MBA from Università degli Studi di Bari (Italy), Aldo Moro, even though I come from a family with medical background. My articles mainly cover gold mining stocks. My articles have also been widely linked by popular sites, including MarketWatch, Financial Times, 24hGold, Investopedia, Financial.org, CNBS, MSN Money, Zachs, Reuters and others.

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