AbbVie’s Rova-T hits yet another setback

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Dive Brief:

  • AbbVie will stop enrollment into a Phase 3 study of its experimental cancer drug Rova-T after a data monitoring committee found patients were dying sooner on the treatment arm than those on the control arm.
  • Called TAHOE, the trial compared Rova-T to the chemotherapy topotecan in second-line advanced small cell lung cancer (SCLC).
  • AbbVie said the decision to halt TAHOE does not affect other Rova-T studies. However, opportunities for the antibody-drug conjugate to prove effective are narrowing. Another study read out negatively earlier this year, calling into question the company's decision to buy the drug's original developer Stemcentrx for nearly $6 billion upfront.

AbbVie has invested a lot in Rova-T (rovalpituzumab tesirine). In April 2016, it put down $5.8 billion to buy the drug's maker, Stemcentrx, with up to $4 billion lined up in potential milestone payments. While the deal gave AbbVie other assets, the primary aim was to acquire Rova-T, then seen as a very promising asset with a multi-billion dollar peak revenue opportunity.

Things have gone downhill since then. In March this year, AbbVie announced it wouldn't push Rova-T through for accelerated approval in third-line SCLC following disappointing results in its Phase 2 TRINITY study, a decision that knocked over 10% off the value of AbbVie's stock. This latest announcement on TAHOE appears to have done much the same, with shares in the company sliding by more than 3% Thursday morning.

According to, there are still a number of Rova-T studies ongoing in SCLC: a Phase 1/2 study in combination with Opdivo (nivolumab) and Yervoy (ipilimumab) in patients with extensive-stage SCLC; a Phase 3 trial (MERU) as maintenance therapy in SCLC following first-line platinum-based chemotherapy; and an earlier study in solid tumors.

It's not just AbbVie that has struggled to find an effective drug in SCLC, which is a harder-to-treat form of the lung cancer. Despite being the first drug in almost two decades to pick up approval for SCLC, Bristol-Myers Squibb's Opdivo failed to extend overall survival as maintenance therapy following first-line chemotherapy in extensive-stage SCLC, and fell short in second-line SCLC as well.

Roche, on the other hand, has done better. Tecentriq in combination with chemotherapy was just granted priority review by the Food and Drug Administration for extensive-stage small cell lung cancer, following results that showed the checkpoint inhibitor extended overall survival.

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