Gilead's Kite bags second CAR-T okay with Tecartus nod in mantle cell lymphoma

Yescarta may be falling short of Gilead Sciences' hopes from back when the company shelled out $11.9 billion to buy maker Kite Pharma, at least so far. But in the meantime, it's bringing in CAR-T backup. 

Friday’s FDA approval of Tecartus for previously treated mantle cell lymphoma takes the company from one CAR-T product to a CAR-T franchise. The drug will take its place alongside Yescarta, which bears a go-ahead in diffuse large B-cell lymphoma (DLBCL).

Tecartus will debut with a list price of $373,000, a company spokesman said by email, adding that "When pricing our cell therapies, we consider the clinical attributes of our product in the context of the existing market, and we also rely on third-party market research to select a price that will support patient access."

While Tecartus and Yescarta are both anti-CD19 CAR-T therapies, there are important manufacturing differences between them. Tecartus uses technology that includes T-cell selection and lymphocyte enrichment, which is “necessary in B-cell malignancies such as mantle cell in which there are circulating lymphoblasts in the peripheral blood,” Ken Takeshita, Kite’s global head of clinical development, said ahead of the green light.

“The manufacturing method was tailored to this particular type of lymphoma,” he added, noting that after an MCL patient has failed on chemo and BTK inhibitors, “the prognosis is very poor, about a year or less.”

RELATED: Gilead's Kite files for FDA approval of second CAR-T therapy

Kite is hoping to change that with Tecartus, which showed in a phase 2 study that it could clear cancer completely in 67% of patients, many of whom were heavily pretreated, and provoke a response in 93% of them. More than half of patients were still seeing benefit at a median 12.3 months, and among those with at least two years of post-treatment monitoring, 43% were still in remission without additional therapy.

Importantly for Tecartus, though, patients won’t necessarily have to try a BTK inhibitor—a fast-rising class that includes Johnson & Johnson and AbbVie star Imbruvica—before getting access to the cell therapy.

Compared with its first regulatory go-round in cell therapy, Kite “did a little bit more, I would say, discussion with the FDA on what the clinical data really meant in terms of, ‘What does this data really say to us about the potential for Tecartus in mantle cell lymphoma?' This was a very fruitful discussion for us," Takeshita said.

Of course, that doesn’t mean Tecartus won’t have to face off against Imbruvica and Co. in the marketplace for patients who have failed their initial therapy, which Takeshita said is typically chemo. But the new approval will provide options for patients who might prefer a one-time treatment to a daily pill such as Imbruvica, he pointed out.

“One could be on (Imbruvica) for quite a long time,” he said.

RELATED: ASCO: Gilead CAR-T med Yescarta delivers 93% response rate in slow-growing lymphoma

Gilead will welcome whatever sales Tecartus can capture as it looks to pad Yescarta’s meager $103 million haul from this year’s first quarter. In the meantime, the company is looking to snag an approval for Yescarta in indications including indolent non-Hodgkin lymphoma and move the med earlier into DLBCL use.