Sales of Carvykti, a cell therapy used to treat multiple myeloma, were flat between the third and fourth quarters, according to fresh earnings numbers reported by its developers, Johnson & Johnson and Legend Biotech.
In a regulatory filing, Legend said that, based on information provided by J&J’s Janssen subsidiary, Carvykti generated $55 million in net sales from October through December. The therapy brought in the same amount during the three month period between July and September.
A J&J spokesperson said in an email that Carvykti’s sales are “in line” with the company’s expectations, adding that it continues to expand the network of centers offering the therapy in a “targeted, phased approach.”
Carvykti is one of a growing class of drugs known as CAR T-cell therapies, which clinical trials have shown to be powerful weapons against certain blood cancers. The study which led to Carvykti’s approval, for example, tested the therapy in nearly 100 patients with multiple myeloma and found that after a median of about two years of treatment, 83% no longer had cancerous cells in their blood or bone marrow.
Despite being a valuable option for hard-to-treat cancers, CAR-T treatments have run into commercial obstacles.
One of the biggest has been producing enough of them to meet the demands of patients and physicians. Manufacturing CAR-T medicines is inherently difficult, requiring T cells to be collected from the patient, engineered to better fight cancer and then reinfused in a timely manner. But the process has become more challenging due to an industry-wide shortage of viral vectors, a key component for making CAR-T therapies.
On an earnings call this week, J&J CEO Joaquin Duato said demand for Carvykti has been “very strong,” and that the company is working to build up production capacity and expand its provider network.
In a Tuesday evening note to clients, Jefferies analyst Kelly Shi wrote that Carvykti’s sales trajectory is “largely in line” with her team’s expectations of conservative sales growth in the short term until the impact of that manufacturing expansion is realized later this year.
“As we scale our capabilities, we’re well positioned to ensure Carvykti is available to more patients who need it,” the company spokesperson said in response to a BioPharma Dive inquiry.
In the near future, J&J and Legend hope to get Carvykti cleared for use in earlier lines of multiple myeloma treatment.
The medicine is currently approved for patients whose cancer progressed or came back after at least four other kinds of therapies. But initial data should soon be available from a closely watched study named CARTITUDE-4, which is pitting Carvykti against two other multiple myeloma treatment regimens, in patients who’ve previously received one to three drugs. Duato said that study will be “very important” for J&J to achieve its goals in multiple myeloma.
The company already has three products for the cancer type — Carvykti, Darzalex and the recently approved Tecvayli — as well as an experimental medicine, talquetamab, that was submitted to the Food and Drug Administration for approval last month. This portfolio is “the most important growth driver for our pharmaceutical [division] moving forward,” Duato said.
“All in all, this portfolio enables us to do something very significant, which is changing the treatment paradigm,” he added.
Fellow CAR-T developers have seen sales grow after moving their therapies into earlier lines of treatment. Gilead, notably, reported in the third quarter that sales of its drug Yescarta had risen about 80% year over year, to $317 million, due in large part to an approval in the “second-line” setting for large B-cell lymphoma.
Editor’s note: This story has been updated to reflect comment J&J provided after publication.