AbbVie $ABBV has managed to convince at least one prominent analyst that Rova-T is absolutely worthless, as the company’s vision of a $5 billion earner gradually dissolves.
Geoffrey Porges at Leerink took a look at AbbVie’s formal presentation of its Trinity trial data at ASCO and came away shaking his head. His conclusion:
The results shown in the presentation were even worse than we had feared, and although AbbVie’s stock sold off much more than the value of Rova- T after the announcement, we can’t help but regard the ongoing trials as largely fruitless exercises. Furthermore, the toxicity signal from the trial, along with the relatively marginal efficacy signal, justifies the complete elimination of all revenue associated with Rova-T from our company forecast and valuation for AbbVie.
There was a lot to dislike about the data, he says, including the high 34% discontinuation rate in the study; “49 or these 116 premature discontinuations were due to progressive disease, with the others being due to adverse events or other undisclosed reasons.”
For the primary endpoint over response rate, measured by change in the target lesion, of the 301 evaluable patients (presumably the other 38 patients were deceased or lost to follow up), the investigator-measured response rate was 18%, increasing modestly to 19.7% in the DLL3 high group.
As measured by the independent review board, the response rate fell to 12.4% for the combined population, and 14.3% in the DLL3-high patients. And serious adverse events in the drug group ran high.
AbbVie paid $5.8 billion in cash for this drug, promising up to $4 billion more in milestones to acquire the little-known biotech unicorn Stemcentrx. And with money like that on the table, expectations were running high, fueling forecasts that the pharma company could get past the eventual loss of patent protection on Humira in style. AbbVie itself projected peak sales at $5 billion a year.
Porges’ conclusion: The drug and the class look dead on arrival at ASCO.
Ultimately it seems unlikely in our view that Rova-T, or perhaps any variant of DLL3 antibody-drug conjugate medicine, will come to market, at least while the profile looks the way it did in TRINITY.
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