Gilead drops anti-BCMA CAR-T from Kite, takes $820M charge

Buried in among Gilead’s fourth-quarter results statement is a line revealing it has abandoned an anti-BCMA cell therapy for multiple myeloma, part of its $12 billion acquisition of Kite Pharma.

The failed KITE-585 program and other costs associated with the acquisition resulted in a whopping $820 million impairment charge in the quarter and add to analyst speculation that with sales of approved CAR-T Yescarta still disappointing, Gilead may have to write down the value of the Kite deal entirely, according to a Bloomberg report.

Gilead’s decision to drop the KITE-585 CAR-T program reflects the increasing competition in the anti-BCMA category and doesn’t come out of the blue. The company said at the J.P. Morgan conference (JPM) last month that it would only press ahead with development of KITE-585 if its profile was very compelling.

“We realized that our 585 program doesn’t have the depth … or durability of response to really allow us to put forward a best-in-class product, so we probably won’t take that forward,” said Gilead’s chief scientific officer John McHutchison at JPM.

Other anti-BCMA candidates are well out in front, including Bluebird/Celgene’s anti-BCMA CAR-T bb2121, which is currently leading the field with new data presented at the American Society of Hematology (ASH) conference in December. The parts also have a longer-acting follow-up (bb21217) already in the clinic.

Meanwhile, ASH heard clinical trial readouts for more than 10 anti-BCMA regimens based on autologous CAR-T, off-the-shelf or allogeneic CAR-T, bispecific antibodies and antibody-drug conjugates, all of which are further along in development than KITE-585.

The crowded field explains why Gilead took the decision to ax its program but coupled with Yescarta’s sluggish uptake—described as “steady and measured” on the fourth-quarter results call—it is starting to make the Kite deal look increasingly like an expensive gamble. And of course, Gilead has also signed several other deals to shore up its cell therapy technology, adding to its outlay on CAR-T.

The CAR-T troubles will be an immediate challenge for Gilead’s new CEO Daniel O’Day, due to take over on March 1 after an acknowledged "trough year" for the biotech stemming from steep declines in hepatitis C virus drug sales and more competition in the HIV category.

Gilead’s commercial operations head Laura Hamill said on the call that the firm is nevertheless hoping for a near-doubling in Yescarta sales this year as it extends the number of centers offering the therapy in the U.S. and continues its rollout in Europe.

Yescarta brought in $264 million in 2018 as a whole, but its fourth-quarter tally of $81 million was only $6 million ahead of its third-quarter sales. Gilead reckons it can add another $200 million in sales this year, according to Hamill.