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AbbVie Ends Rova-T Program as 3rd Lung Cancer Study Fails

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AbbVie, Inc. (ABBV - Free Report) announced that it is discontinuing development of its small-cell lung cancer (SCLC) candidate rovalpituzumab tesirine or Rova-T after failure of the third study, MERU.

The phase III MERU study was evaluating Rova-T as a first-line maintenance therapy for advanced SCLC, a difficult-to treat lung cancer, compared to placebo. Interim data from the study demonstrated no survival benefit for patients treated with Rova-T. The lack of survival benefit led the Independent Data Monitoring Committee (IDMC) to recommend termination of MERU.

AbbVie’s stock has declined 28.2% this year so far compared with a decrease of 1.7% recorded by the industry.



We remind investors that Rova-T was added to AbbVie’s portfolio, following the $5.8 billion acquisition of Stemcentrx in June 2016.

In December 2018, AbbVie stopped enrollment in a pivotal phase III study — TAHOE —evaluating Rova-T in second-line SCLC on recommendation of IDMC. The study compared efficacy, safety and tolerability of Rova-T versus topotecan. The IDMC recommendation to halt the study was based on shorter overall survival in the Rova-T arm compared with the topotecan control arm.

In March 2018, Rova-T fell short of expectations in a phase II TRINITY study evaluating it in third-line or later SCLC. The failure of TRINITY and the halt on TAHOE had already raised skepticism on Rova-T’s potential and the success of MERU.

AbbVie had significant confidence in Rova-T’s potential when it bought Stemcentrx and believed the candidate had blockbuster potential. AbbVie had in the past guided peak sales for Rova-T of $5 billion. The discontinuation of the candidate has now brought into question the viability of the Stemcentrx deal. Rova-T was also being evaluated in an early-stage eight-arm "basket study" in neuroendocrine tumors.

Oncology is a key therapeutic area for AbbVie and the company believes that it will be its major growth driver over the next 10 years. Key drugs in its oncology portfolio include Imbruvica, currently approved for quite a few indications and marketed in partnership with J&J (JNJ - Free Report) , and Venclyxto/Venclexta, approved to treat chronic lymphocytic leukemia (CLL) and acute myeloid leukemia (AML) and marketed in partnership with Roche (RHHBY - Free Report) .

Several studies on Imbruvica are ongoing to evaluate the drug alone or in combination in different patient segments. AbbVie is also studying Venclyxto/Venclexta to expand the label to address a broader relapsed/refractory CLL patient population, expand into earlier lines of therapy, and broaden into other hematologic malignancies like multiple myeloma AML.

Despite the presence of successful medicines in its portfolio, AbbVie has had its shares of failure in cancer studies other than Rova-T.

In May 2019, a phase III study evaluating depatuxizumab mafodotin (Depatux-M) failed to show any survival benefit in patients with newly diagnosed glioblastoma, an aggressive form of brain cancer. As a result, AbbVie stopped enrollment in all ongoing Depatux-M studies.

In March 2019, the FDA placed a partial clinical hold on all studies evaluating Venclexta for the treatment of multiple myeloma. The decision was taken after a higher proportion of deaths were observed in the Venclexta arm compared to the control arm of the ongoing phase III BELLINI study.

In April 2017, AbbVie announced that two phase III studies evaluating its PARP inhibitor, veliparib in combination with chemotherapy for squamous non-small cell lung cancer and triple negative breast cancer failed to meet their primary endpoints. Based on the data, AbbVie discontinued development in these indications.

AbbVie currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

A better-ranked large-cap pharma stock is Merck & Co. (MRK - Free Report) , carrying a Zacks Rank #2 (Buy). Shares of Merck have risen 13.5% this year so far. Earnings estimates for 2019 and 2020 have risen 3.2% and 1.3%, respectively over the past 60 days.

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