AbbVie Halts Rova-T Phase III Second-Line Lung Cancer Study

AbbVie, Inc. (NYSE:ABBV) announced that it has stopped enrollments in a pivotal phase III study —TAHOE — evaluating its cancer candidate rovalpituzumab tesirine or Rova-T in second-line small cell lung cancer (SCLC).

AbbVie said that the Independent Data Monitoring Committee (IDMC), responsible for ongoing review of data, recommended stoppage of enrollment. 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.

AbbVie clarified that IDMC’s recommendation is only for the TAHOE study and does not apply to other studies on Rova-T. The company continues to evaluate the candidate as a third-line treatment in SCLC indication. Rova-T is also being evaluated in an early-stage eight-arm "basket study" in neuroendocrine tumors.

AbbVie’s stock has declined 6.4% this year so far against an increase of 9.1% 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 March this year, Rova-T fell short of expectations in a phase II TRINITY study evaluating it in third line or later SCLC. AbbVie said it will not seek accelerated approval of Rova-T in the third-line setting after consulting with the FDA. Back then, investor concerns about the success of the remaining studies — MERU (first line setting) and TAHOE — had increased after the failure of TRINITY.

AbbVie had significant confidence in Rova-T’s potential and believed the candidate had blockbuster potential. AbbVie had in the past guided peak sales for Rova-T of $5 billion. The failure of TRINITY and now the halt on TAHOE has raised skepticism on Rova-T’s potential and has brought into question the viability of the Stemcentrx deal.

Rova-T was a key candidate in AbbVie’s oncology pipeline. AbbVie believes that oncology will be its major growth driver over the next 10 years. Its key cancer drug, what it calls a “pipeline in a molecule”, is Imbruvica. It is currently approved for nine indications across six different cancer types. Imbruvica has multi-billion dollar potential. Several studies on Imbruvica are ongoing to evaluate the drug alone or in combination in different patient segments. AbbVie expects Imbruvica peak sales of more than $7 billion and revenues of about $5 billion in 2020. AbbVie markets Imbruvica in partnership with J&J (NYSE:JNJ) .

AbbVie is also studying another key cancer drug, Venclyxto/Venclexta in label expansion studies to address the broader relapsed/refractory chronic lymphocytic leukemia (“CLL”) patient population, expand into earlier lines of therapy, and broaden into other hematologic malignancies like multiple myeloma and acute myeloid leukemia (“AML”). Regulatory applications seeking approval for Venclexta plus Roche’s (OTC:RHHBY) Rituxan for relapse/refractory CLL (based on MURANO study data) were approved in the United States in June and in the EU in October 2018. Label expansion for this indication has expanded the patient population for Venclexta significantly, which will boost its commercial potential. Also, in July, AbbVie filed U.S. regulatory application for Venclexta in first-line AML while data from the phase III program in multiple myeloma is expected in first half of 2019. AbbVie/Roche also plan to file for approval of Venclexta +Roche’s Gazyva in first-line CLL setting soon.

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 top-ranked large-cap pharma stock is Merck & Co., Inc. (NYSE:MRK) , carrying a Zacks Rank #2 (Buy). Merck’s earnings estimates have increased 1.4% for 2018 and 0.8% for 2019 over the past 60 days. The company’s shares have increased 39% this year so far.

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