AbbVie (ABBV) aims to position its investigational therapy Rova-T (rovalpituzumab tesirine) as a standard of care treatment for patients suffering with SCLC (small cell lung cancer) as well as other neuroendocrine cancers. The acquired drug discovery platform is also expected to add multiple targeted solid tumor therapies to AbbVie’s portfolio in the future.
The above diagram shows the total deaths attributable to various neuroendocrine cancers in the United States in 2017. The diagram also shows a breakdown of mortalities attributable to various types of lung cancers in 2017.
AbbVie expects data in 2Q18 from TRINITY, its open-label, single-arm study evaluating Rova-T, a DLL3 (delta-like protein 3)-targeted antibody-drug conjugate (or ADC), in patients suffering with relapsed/refractory (or R/R) SCLC and expressing a high level of DLL3. Based on data from this registrational trial, AbbVie plans to file an NDA (New Drug Application) with the FDA (U.S. Food & Drug Administration) for Rova-T in the third line plus SCLC indication.
AbbVie aims to rapidly advance Rova-T in the R/R SCLC indication from 2018 to 2020. Besides TRINITY, the company is also recruiting patients in the TAHOE study to compare Rova-T with topotecan, the only FDA-approved therapy for relapsed SCLC, as a second-line therapy for advanced or metastatic SCLC patients. These patients also express a high level of DLL3 protein. AbbVie thus aims to advance the solid tumor treatment paradigm by creating an awareness about targeting tumor-initiating cells and positioning the DLL3 protein as a major solid tumor biomarker. Rova-T is thus expected to enable AbbVie to compete aggressively with other biomarker-based solid tumor players such as Pfizer (PFE), Bristol-Myers Squibb (BMY), and Merck & Co. (MRK).
AbbVie accounts for 1.4% of the Vanguard Growth ETF (VUG).
In the next part, let’s take a look at the market opportunity for Rova-T in the SCLC segment.