AbbVie announced Wednesday afternoon that it would stop enrollment in a phase 3 trial of its troubled cancer med, Rova-T, in lung cancer patients. The decision came after a data monitoring committee found that patients taking Rova-T had worse survival rates than patients in the control arm.
This is the latest setback for the drug, which saw AbbVie put nearly $10 billion on the table for its own Stemcentrx a few years back, but since it has brought little but pain to the Pharma, and that continues today.
The TAHOE study was assessing Rova-T as a second-line therapy for patients with advanced small cell lung cancer (SCLC). After looking at the trial, a data monitoring committee said it recommended stopping enrollment in TAHOE “due to shorter overall survival in the Rova-T arm compared with the [chemotherapy agent] topotecan control arm.” Read: Patients were living longer on the older chemo med than AbbVie's new drug; the trial has now been halted.
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"Patients are our first priority and we are deeply grateful to the patients and physicians who participated in this trial," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer at AbbVie, in a statement. "We remain committed to discovering and developing transformative therapies for people living with cancer."
AbbVie made sure to mention that the committee’s recommendation only applied to the TAHOE study, and not to its other Rova-T studies, but the action does not bode well for the antibody-drug conjugate. Rova-T (a.k.a Rovalpituzumab tesirine) targets the cancer stem cell-associated delta-like protein 3 (DLL3), which is expressed in more than 80% of tumors in SCLC patients. The treatment combines a targeted antibody that delivers a cytotoxic agent directly to the DLL3-expressing cancer cells, while aiming not to affect healthy cells, thereby reducing side effects.
But this is latest setback in a round of poor shows from AbbVie, coming after it abandoned its plans to seek an accelerated FDA approval for Rova-T as a third-line treatment for relapsed or refractory SCLC. The company made that call after the med turned up weak phase 2 data. Of the 177 patients in the open-label test, the best overall response rate was 29%, with objective response rate at just 16%. The median overall survival was 5.6 months.
“Although the results from the study were not what we hoped for, we look forward to receiving data from the ongoing phase 3 studies in the first- and second-line settings and remain committed to developing Rova-T for the treatment of patients with small cell lung cancer,” Severino said at the time.
AbbVie picked up the beleaguered Rova-T in its $5.8 billion buyout of Stemcentrx back in 2016. At the time, Rova-T was in a phase 2 study geared toward a quick FDA nod and stood to pick up another $4 billion for Stemcentrx in milestone payments.