It's official—AbbVie dumps Rova-T after another lung cancer fail

abbvie
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. But multiple failures have led to the program's demise. (AbbVie)

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.

Featured Webinar

From Concept to Market: Overcoming the Challenges of Manufacturing and Clinical Trials

In this webinar we will reveal the inner workings of the manufacturing and pharmacy department of a CRO/CDMO, so you understand the different regulatory and operational considerations faced by a clinical research pharmacy.

Learn how CRO/CDMOs successfully address operational and regulatory challenges for pharmaceutical and biotechnology clients; and how this can make the difference between study success or failure.

RELATED: Billions spent, but AbbVie can't catch a break with Rova-T as it cans SCLC trial

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.

RELATED: AbbVie ditches plans for accelerated Rova-T review after weak phase 2 data 

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."

Suggested Articles

Xevinapant in combination with standard cisplatin-based chemoradiation therapy (CRT) reduces the risk of death in high-risk patients with locally adva

The agency also gave the company’s diagnostic, run on the high-throughput Panther Fusion laboratory platform, a green light for pooled testing.

Smith & Nephew has signed up to acquire Integra LifeSciences’ orthopedics business focused on the growing upper and lower extremity markets.