AbbVie, Inc. (ABBV - Free Report) announced disappointing results from a pivotal phase II study, evaluating its promising cancer candidate rovalpituzumab tesirine or Rova-T in third-line or later small cell lung cancer (SCLC).
AbbVie said it will not seek accelerated approval of Rova-T in the third-line SCLC setting after consulting with the FDA.
AbbVie’s stock crashed more than 12% on Thursday in response to the news. The stock has returned 2.1% this year so far, comparing favorably with a decrease of 0.2% recorded by the industry.
The TRINITY study is a single-arm study without a comparator. It is evaluating the efficacy of Rova-T for the treatment of patients with relapsed/refractory SCLC with high expression of the protein DLL3 and who have received at least two previous treatment regimens, including at least one platinum-based regimen. SCLC is characterized by poor outcomes with very few treatment choices available.
In the study, the best overall response rate was 29% while the objective response rate was only 16%. The median duration of response was 4.1 months. The median overall survival rate was 5.6 months while the probability of survival at 12 months was 17.5%. The results were much lower than what the company had hoped for and not significant enough to be prioritized for accelerated approval.
However, phase III studies of Rova-T in the first- and second-line settings, MERU and TAHOE, respectively, are ongoing. However, investor concerns about the success of these remaining studies increases after the failure of TRINITY.
Rova-T was added to AbbVie’s portfolio following the $5.8 billion acquisition of Stemcentrx in June 2016. 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 at $5 billion. The failure of TRINITY has raised scepticism on Rova-T’s potential and has brought into question the viability of the Stemcentrx deal. Rova-T is also being evaluated in an early-stage eight-arm "basket study" in neuroendocrine tumors.
Rova-T was a key candidate in AbbVie’s oncology pipeline. AbbVie’s key cancer drug at present is Imbruvica, marketed in partnership with J&J (JNJ - Free Report) . Imbruvica, currently approved for quite a few indications, has multi-billion dollar potential and AbbVie is exploring the potential to expand Imbruvica’s label into solid tumors and autoimmune diseases.
AbbVie is also conducting studies on another cancer drug, Venclyxto/Venclexta to expand the label 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 AML. Data from the phase III MURANO study of Venclexta plus Roche’s (RHHBY - Free Report) Rituxan in relapse/refractory CLL presented in September last year showed that the combination led to a profound improvement in progression free survival compared to Teva Pharma’s (TEVA - Free Report) Treanda plus Rituxan. Regulatory applications seeking approval for this combination use are under review in the United States.
AbbVie carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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