AbbVie’s Rova-T has failed yet another lung cancer trial, this time as a frontline treatment. But AbbVie didn’t regroup and point to its Rova-T programs in other treatment settings. It axed the drug, once and for all.
The Big Pharma picked up Rova-T, a.k.a. Rovalpituzumab tesirine, in its $5.8 billion buyout of Stemcentrx in 2016. At the time, the drug was in a phase 2 study aimed at a quick FDA nod with the potential to net another $4 billion for Stemcentrx in milestone payments.
Rova-T’s promise lay in targeting delta-like protein 3 (DLL3), which is expressed in more than 80% of tumors in patients with small-cell lung cancer (SCLC). The antibody-drug conjugate is designed to deliver a cytotoxic payload directly to DLL3-expressing cancer cells, while sparing healthy cells and reducing side effects. It carried hope for SCLC patients, who have few treatments outside of surgery and chemotherapy.
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But Rova-T soon ran into trouble.
Early last year, AbbVie scrapped its plans for a speedy approval for Rova-T as a third-line treatment for relapsed or refractory small cell lung cancer. The change came after the company posted phase 2 data showing the drug shrank tumors in just 16% of patients.
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Then, in December, AbbVie called time on a phase 3 study testing Rova-T as a second-line treatment for patients with advanced SCLC. A data monitoring committee recommended the halt because patients taking topotecan, an older chemotherapy drug, were living longer than those on AbbVie’s new drug. At the time, the company made sure to mention that the committee’s recommendation applied only to that study, dubbed TAHOE, and not to its other Rova-T studies.
Now, in its latest and last flop, Rova-T “demonstrated no survival benefit” over placebo in a phase 3 study testing it in the first-line setting. In other words, patients on Rova-T weren’t living longer than those taking placebo. And AbbVie has ended R&D for the drug that it paid billions for just three years ago.
"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 and global head of solid tumor development at AbbVie, in a statement. "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."