Johnson & Johnson and Legend Biotech’s Carvykti continues to grow in multiple myeloma despite the introduction of a more convenient option.
Carvykti generated $117 million in the second-quarter sales, up from $72 million in the first three months of the year. The increase suggests the two companies’ efforts to ramp up supply are working.
Manufacturing capacity has been a limiting factor for Carvykti’s performance since its launch last Spring, and expansion is key as the partners angle for earlier lines of treatment. Under a regular review timeline, the FDA has set April 5, 2024, as the target decision date for Carvykti’s application as a second- to fourth-line myeloma treatment, Legend said Tuesday.
The standard review is somewhat disappointing given that industry watchers were expecting a priority review, which might’ve enabled a launch in December. But the longer timeline shouldn’t be much of a problem because J&J and Legend don’t have enough supply to meet existing demand, RBC Capital Markets analysts said in a Tuesday note.
Although production yield has increased, Legend hasn’t seen any meaningful changes in its order processing backlog, CEO Ying Huang, Ph.D., told investors on a call Tuesday.
The demand pressure on Carvykti should have theoretically eased a little after the FDA in October approved J&J’s off-the-shelf bispecific drug Tecvayli, also for late-line treatment of myeloma. But doctors are essentially using bispecifics “as a bridge” therapy while patients wait to get their CAR-T treatment, Steve Gavel, Legend’s SVP of commercial development in the U.S. and Europe, said on the call.
Importantly, commercial insurers are still reimbursing for Carvykti following Tecvayli treatment, he added.
In addition, although the FDA hasn’t approved Carvykti for earlier uses, doctors are increasingly using the CAR-T therapy off label in those settings, especially in patients who’re at high risk of relapse, Gavel said. By Legend’s estimate, about 15% to 20% of second-line patients are deemed high risk.
With production picking up and demand still strong, Carvykti is catching up with Bristol Myers Squibb’s first-to-market Abecma. In the second quarter, Abecma generated $132 million in sales, which marked a decline from $147 million in the first quarter. What’s more, BMS expects its drug slide further in the third quarter because of a planned manufacturing maintenance period in June, BMS’ CFO David Elkins said on the company’s second-quarter earnings call.
The FDA requires maintenance for any aseptic cGMP manufacturing facility every year, Legend’s Huang explained. For Carvykti’s facility in New Jersey, J&J and Legend have adopted a rotation strategy to avoid shutting down the facility entirely during maintenance.
“Every six months, we will have to do the so-called aseptic simulation run,” Huang said. “But it really wouldn’t affect the revenues so much that you’re going to see quarter-over-quarter decrease here.”
Carvykti also appears to have an advantage of “operational flexibility” over Abecma because it can be more easily managed in the outpatient setting, according to Gavel. In the second quarter, outpatient use of Carvykti jumped to 30%, versus 18% in the first quarter. Abecma’s outpatient rate has stayed below 10%, Gavel said.
On the flip side, Carvykti has had more manufacturing out-of-specification cases than its rival. Along with their second-to-fourth-line application, J&J and Legend are asking the FDA to widen Carvykti’s manufacturing standards. If approved, that should further lower the out-of-spec rate for the cell therapy. Eventually, the pair’s goal is to cut the out-of-spec rate to low- to mid-single-digit percentages, Huang said.
To further help with supply, Legend aims to bring a factory in Ghent, Belgium, online by the end of 2023. Once operational, the facility will first help make clinical supply for the CARTITUDE-6 trial, for which Legend plans to start enrollment in the fourth quarter. The trial will test Carvykti in patients with newly diagnosed myeloma following treatment with standard combination therapy.

https://www.biopharmadive.com/news/carvykti-multiple-myeloma-abstract-leaked-johnson-johnson-legend/648030/