The chimeric antigen receptor (CAR)-T therapy market currently consists of two approved treatments: Novartis’ Kymriah (tisagenlecleucel) and Gilead’s Yescarta (axicabtagene ciloleucel).
Kymriah was the first such treatment to be approved, gaining US Food and Drug Administration (FDA) approval just over a month ahead of Gilead’s treatment.
Such a fine margin did not allow Kymriah to break ahead, in terms of sales, especially with later approvals for the treatments arriving at similar times.
In fact, second quarter financials revealed that Kymriah has ground to make up on its competitor, after it only secured sales of $58m (€52m) compared to Yescarta earning Gilead $120m (€107m).
Despite this, Novartis called attention to the product as a ‘key growth driver’ in Q2 results, with CEO, Vas Narasimhan, calling attention to a ‘very solid performance’ by the drug in a call with investors.
On Gilead’s investor call, CEO, Daniel O’Day, had a few sobering comments to be made on the ‘near-term’ prospect for the treatment, suggesting that reimbursements and ‘patient flow dynamics’ could create ‘variability’ on quarter-to-quarter sales of Yescarta.
Regarding the future trajectory of the treatment, O’Day said, “When I take a step back and think about the mid- to long-term trajectory of Yescarta and the duration of response in patients, I continue to be very encouraged.”
Gilead’s CEO called attention to the ‘very consistent’ response seen in patients treated for diffuse large B-cell lymphoma (DLBCL).
Broader than Yescarta, O’Day continued to explain that Kite is conducting trials of cell therapies in earlier lines of therapy, other hematologic diseases, solid tumors, and allogeneic production.
The ability to treat solid tumors and to produce the allogeneic treatments would be a significant point of differentiation from competitors – and is an area being explored by more companies than just Gilead.
Allogeneic product would allow companies to sidestep the manufacturing hurdles currently faced by CAR-T treatments, which take more than 20 days to produce through the autologous route.
The manufacturing issues that Novartis has experienced is one of the reasons why sales are lagging behind Gilead; by comparison, Kite’s head of medical affairs for Europe told BioPharma-Reporter that it had managed 97% on-spec treatment manufacture.
