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

AbbVie is abandoning plans to seek out an FDA quick OK for its troubled oncology drug Rova-T in third-line relapsed/refractory (R/R) small cell lung cancer (SCLC).

This comes after the biopharma posted midstage data for the experimental drug it believes can be a blockbuster in third-line SCLC patients with high DLL3 expression; the data disappointed, or, as AbbVie put it, it won’t be going to the FDA for an accelerated review “based on magnitude of effect across multiple parameters in this single-arm study.”

According to the data, of the 177 patients in the open-label test, the best overall response rate was 29%, with objective response rate at just 16%, with most seeing double this as the standard needed. It also came with a median overall survival of 5.6 months.

“We continue to believe Rova-T has potential for patients with small cell lung cancer and other DLL3-expressing cancers,” said Mike Severino, M.D., EVP of research and development and chief scientific officer at AbbVie, in a release. “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.”

Rovalpituzumab tesirine (aka Rova-T) works as an antibody-drug conjugate targeting the cancer-stem cell-associated delta-like protein 3 (DLL3), which is expressed in more than 80% of small cell lung cancer patient tumors. The drug combines a targeted antibody that delivers a cytotoxic agent directly to the DLL3-expressing cancer cells, all the while aiming to not hit healthy cells, thereby reducing side effects.

This also comes after the phase 2 TRINITY data were delayed last fall, when the FDA asked AbbVie to include six-month durability data, with critics rounding on the company, suggesting this was a potentially ominous sign. AbbVie said its ongoing phase 3 studies, namely MERU and TAHOE, “will continue to investigate Rova-T in first- and second-line SCLC.”

But investors weren’t happy, with shares in the $178 billion market cap company down more than 8% premarket on the news. That’s because the drug was bought for $5.8 billion upfront, with $4 billion reserved for milestones, from Stemcentrx; with a cost like that, you want better bang for your buck.

A couple of summers ago at ASCO, the drug’s data were also questioned, with some seeing its middling results as not being worthy of a potentially $10 billion price tag.  

There remain few treatments for SCLC outside surgery and chemotherapy, with most targeted meds going after non-small cell lung cancer.

Analysts at Jefferies said: "The headline results from the TRINITY study for Rova-T in 3L r/r SCLC have fallen short of what would be required by the FDA to file for an accelerated approval. The Rova-T program is now pushed back over a year with results from the 1L and 2L PIII MERU and TAHOE studies not expected until H2'19. Results from the TRINITY study will be presented at ASCO. We have previously highlighted that a negative outcome from the TRINITY study could have a 4%-5% negative impact on ABBV's earnings and valuation."