- AbbVie on Thursday disclosed the latest clinical setback for its experimental cancer drug Rova-T will be the last, announcing the end of its development program for a therapy once viewed as a foundation for its solid tumor research.
- Per AbbVie, Rova-T did not improve survival in the Phase 3 MERU study, which tested the antibody drug conjugate as a first-line maintenance therapy in advanced small cell lung cancer.
- Rova-T was the key component in AbbVie's 2016 decision to buy Stemcentrx for $6.4 billion. At the time, company executives set expectations for an initial approval in 2018 and as much as $5 billion in peak annual sales.
Rova-T's final curtain was perhaps expected, but nonetheless highlights AbbVie's misstep in buying Stemcentrx.
AbbVie executives figured buying the biotech would expand its position in oncology, with Rova-T, or rovalpituzumab tesirine, being a core part of that effort.
The drug is designed to treat solid tumors with high levels of the DLL3 protein expression, which includes some of the hardest-to-treat cancer types such as glioblastoma and pancreatic.
Instead, Rova-T failed to show a survival benefit in multiple small-cell lung cancer trials. The company decided not to seek accelerated approval in the third-line setting after a Phase 2 failure last March. And further negative data in the second line, disclosed last December, led to a $5.1 billion impairment charge, according to recent regulatory filings.
Now, a data monitoring committee recommended AbbVie end the MERU study early after an interim analysis showed no survival benefit for the treatment when used as a first-line maintenance therapy.
Ever after reducing the value of Stemcentrx assets at the end of 2018, AbbVie had left $1 billion of in-process R&D tied to the buyout on its books. The company did not respond to BioPharma Dive's questions of whether that remaining value would be written down as well.
Shares in AbbVie's were largely unaffected by the news Thursday, as Wall Street analysts and investors had mostly discounted Rova-T already. Cowen analyst Steve Scala, for instance, estimated Rova-T sales of $50 million in 2022 and $150 million in 2024, in a July research note.
The company said it will focus its R&D efforts on other cancer therapies in its pipeline.
"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," Margaret Foley, AbbVie's global head of solid tumor development, said in an Aug. 29 statement.
While Imbruvica (ibrutinib) and Venclexta (venetoclax) have found success in blood cancers, AbbVie's core business remains in immunology, where it sells Humira (adalimumab) and the newly approved drugs Skyrizi (risankizumab) and Rinvoq (upadicitinib).
And AbbVie's $63 billion deal acquire Allergan will also do little to boost the biotech's oncology presence, as Allergan is focused on medical aesthetics, eye care, neuroscience, gastroenterology and women's health.