AbbVie suffers fresh setback with lung cancer drug Rova-T

The company is looking for new blockbusters to bring in new revenues as its big-selling Humira (adalimumab) has already lost patent protection in Europe, and will face competition from cheaper biosimilars in the US in 2023.

But it doesn’t look like Rova-T fits the bill. AbbVie spent $5.8 billion buying Rova-T’s developer Stemcentrx in 2016, and it seems that the gamble has not paid off.

AbbVie is testing the drug in first, second and third line small cell lung cancer, and results from the phase 3 trial in third line advanced small cell lung cancer (SCLC) already disappointed in March when AbbVie said they did not support a fast-track review by the FDA.

Now AbbVie has said it will halt enrolment to the phase 3 TAHOE study in second line advanced SCLC on the advice of its independent data monitoring committee.

The committee conducted an interim analysis and found that overall survival in patients treated with the drug, full name rovalpituzumab teserine, was shorter compared with the standard care topotecan control arm.

The committee recommended investigators and patients make individual decision whether to stay on Rova-T treatment based on their response.

The decision to halt enrolment only applies to the TAHOE study, and does not affect other Rova-T trials in first and third line disease and neuroendocrine tumours.

But the news added to the speculation that Rova-T will flop in the other trials too – AbbVie’s shares were down 3% on the New York Stock Exchange following the news as investors gave up hope on the drug.

There are concerns that several other drugs from the Stemcentrx deal will also fail too as they are based around the same principle – an antibody delivering a cytotoxic payload to cancer cells expressing a biomarker known as delta-like protein 3 (DLL3).

So far adverse events have been the main problem with Rova-T, suggesting that the cytotoxic payload used in these drugs could be causing off-target side effects.

While clinical development can always spring surprises, both good and bad, the Rova-T episode looks like an example of how a promising-looking drug can turn into a hugely expensive disappointment.

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