The company said Monday that it will not seek approval for Revlimid as a maintenance therapy for patients with diffuse large B-cell lymphoma (DLBCL) based on the lack of a survival benefit reported in a phase III clinical trial.
Celgene shares fell 3.09% to $104.60 in after-hours trading Monday following the company announcement.
The REMARC study evaluated maintenance therapy with Revlimid compared with placebo in DLBCL patients responding to first-line treatment. Revlimid achieved the study's primary endpoint of prolonging progression-free survival, but an interim analysis of overall survival showed no benefit, Celgene said.
DLBCL is the most common form of non-Hodgkin lymphoma, a cancer that affects white blood cells. A majority of Revlimid's current sales are derived from multiple myeloma.
Celgene is conducting four additional studies of Revlimid in other forms of non-Hodgkin lymphoma. Results from two of these studies are expected in 2017.
Revlimid sales are forecast to reach $6.7 billion this year, according to Celgene guidance. The company's 2020 financial guidance counts on expanded indications for Revlimid to deliver between $1 billion and $1.5 billion in new sales.
"Although an indication in DLBCL is not critical to hitting their 2020 target, it puts pressure on the other Revlimid expansion trials to show clear success," writes Evercore ISI analyst Mark Schoenebaum in an email to clients Monday night. He adds, "The largest remaining indication under investigation is follicular lymphoma (studied in the RELEVANCE trial), which is now likely to be necessary to meet their 2020 guidance."
Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.