Celgene’s Revlimid just can’t catch a break in the chronic lymphocytic leukemia market—and one analyst isn’t sure it ever will.
Just when the Big Biotech rolled out positive maintenance data for the drug at the American Society of Hematology annual meeting, behemoth Imbruvica from AbbVie and Johnson & Johnson—which is already stifling Revlimid’s CLL prospects—posted some positive data of its own. At the five-year follow-up from the original phase 1b/2 Imbruvica monotherapy trial, the median amount of time relapsed and refractory patients stayed on the treatment was 49 months, with 30% of patients still taking the med. For patients new to CLL therapy, the median mark was 62 months, with 65% of that group still taking Imbruvica.
Under "normal circumstances," the Revlimid data—which showed "impressive" progression-free survival—"would be sufficient to establish a real role for the product in this indication, but the data for very long duration of response to Imbruvica, even from the earliest treatment cohorts, suggests that Revlimid will struggle to get access to this indication,” Leerink Partners analyst Geoffrey Porges wrote in a note to clients.
Celgene’s penetration in CLL has so far been “disappointingly slow,” Porges noted, and he and his colleagues have only “modest” sales for the indication in their long-term Revlimid forecast and Celgene model.
Imbruvica, on the other hand? That med has been steamrolling, and the question for AbbVie and J&J is “how complete Imbruvica’s dominance can be” in the CLL field.
In the second-line-plus market, the med holds the lead, with more than four of every 10 patients starting treatment with Imbruvica. Among new patients, that figure is one in five, with that market share position “steadily increasing,” AbbVie CEO Richard Gonzalez told investors on the Illinois drugmaker’s Q3 conference call.
The way Gonzalez sees it, though, there’s still plenty of room for Imbruvica to expand—and he intends to see it do just that. “We’re still in the very early stages of our trajectory in the front-line setting,” he said. And that's an area that boasts a larger number of patients who tend to stay on therapy for longer.
Comparative studies pitting solo Imbruvica and Imbruvica combos against gold-standard regimens—Teva’s Treanda and Roche’s Rituxan, and a fludarabine-cyclophosphamide-Rituxan cocktail—“will add significantly to the breadth of data supporting Imbruvica," Gonzalez said. And that "will provide physicians with more evidence of the compelling clinical benefit in the front-line setting.”
Luckily for Celgene, it's not relying on a standout CLL performance from its star. As of early last year, the company hadn't included any CLL revenue in its model, COO Jackie Fouse told investors, in part because "it's a very competitive space."
And on the whole, Revlimid is doing just fine. For Q3, the blockbuster was the key driver behind a $150 million revenue beat; it topped estimates by about $147 million all on its own, thanks to "new patient market share gains and increased duration," Celgene said. EvaluatePharma, in its 2016 World Preview report, predicted Revlimid would rake in $13.02 billion in 2022 and rank second worldwide among oncology products, with Imbruvica in the No. 3 spot with $7.29 billion in sales.