AbbVie Discontinues Rovalpituzumab Tesirine (Rova-T) Research and Development Program

- MERU, a Phase 3 placebo-controlled trial evaluating Rova-T as a first-line maintenance therapy for advanced small-cell lung cancer (SCLC), demonstrated no survival benefit for patients receiving Rova-T at the interim analysis

- Independent Data Monitoring Committee recommended terminating the study due to lack of survival benefit

News provided by

AbbVie

Aug 29, 2019, 08:45 ET

NORTH CHICAGO, Ill., Aug. 29, 2019 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research based global biopharmaceutical company, today announced that MERU, a Phase 3 trial evaluating Rova-T as a first-line maintenance therapy for advanced small-cell lung cancer (SCLC), demonstrated no survival benefit at a pre-planned interim analysis for patients receiving Rova-T as compared with placebo. The overall safety profile was generally consistent with that observed in previous studies. The MERU trial is being closed, and the Rova-T research and development program has been terminated. AbbVie will move forward prioritizing other development programs within its oncology pipeline.

An Independent Data Monitoring Committee (IDMC) recommended terminating MERU due to lack of survival benefit for patients receiving Rova-T compared with the placebo control arm based on results at a pre-planned interim analysis. Results from the MERU trial will be presented at a future medical meeting and/or published in a peer-reviewed medical journal.

"Small-cell lung cancer continues to be one of the most difficult-to-treat cancers where there is a significant need for transformative therapies. We are disappointed with this outcome for the patients who suffer from this disease," said Margaret Foley, M.D., vice president, global head of solid tumor development, AbbVie. "We remain committed to researching and developing other therapies with the potential to transform care for patients with small-cell lung cancer and other malignancies."

Moving forward, AbbVie will continue to focus research and development efforts on other therapies in its oncology portfolio of investigational and marketed medicines. AbbVie's oncology portfolio currently consists of marketed medicines and investigational medicines being evaluated worldwide in more than 300 clinical trials and in more than 20 different tumor types.

About the Phase 3 MERU Trial
MERU is a Phase 3, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy of rovalpituzumab tesirine (Rova-T) as maintenance therapy following first-line, platinum-based chemotherapy in small-cell lung cancer (SCLC).

About Rovalpituzumab Tesirine (Rova-T)
Rova-T is an investigational antibody-drug conjugate targeting the cancer-stem cell-associated delta-like protein 3 (DLL3)[1], which is expressed in more than 80 percent of small-cell lung cancer (SCLC) patient tumors, where it is prevalent on tumor cells, including cancer stem cells, but not present in healthy tissue.[2] Rova-T combines a targeted antibody with a cytotoxic agent that is delivered directly to the DLL3-expressing cancer cells.

Rova-T is not approved, and its efficacy and safety have not been evaluated by health authorities.

About AbbVie in Oncology
At AbbVie, we strive to discover and develop medicines that deliver transformational improvements in cancer treatment by uniquely combining our deep knowledge in core areas of biology with cutting-edge technologies, and by working together with our partners – scientists, clinical experts, industry peers, advocates, and patients. We remain focused on delivering these transformative advances in treatment across some of the most debilitating and widespread cancers. We are also committed to exploring solutions to help patients obtain access to our cancer medicines. AbbVie's oncology portfolio now consists of marketed medicines and a pipeline containing multiple new molecules being evaluated worldwide in more than 300 clinical trials and more than 20 different tumor types. For more information, please visit http://www.abbvie.com/oncology.

About AbbVie
AbbVie is a global, research and development-based biopharmaceutical company committed to developing innovative advanced therapies for some of the world's most complex and critical conditions. The company's mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, LinkedIn or Instagram.

Forward-Looking Statements
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2018 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

¹ Saunders L. R. et al. A DLL3-targeted antibody-drug conjugate eradicates high-grade pulmonary neuroendocrine tumor-initiating cells in vivo. Sci. Transl. Med. 2015;7(302): 1-13.
²ClinicalTrials.gov (2016). Study of Rovalpituzumab Tesirine (SC16LD6.5) for Third-line and Later Treatment of Subjects With Relapsed or Refractory Delta-Like Protein 3-Expressing Small-Cell Lung Cancer (TRINITY). Accessed March 21, 2018. https://clinicaltrials.gov/ct2/show/NCT02674568?term=SC16LD6.5&rank=2.

SOURCE AbbVie