Novartis has new data that it hopes can kickstart the take-up of its CAR-T Kymriah in its new B-cell lymphoma indication approved last month in the US.
Updated results from the JULIET trial of the therapy in adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) – reported at the European Haematology Association (EHA) congress over the weekend – reveal an overall response rate (ORR) of 52% out of 93 patients, including 40% complete responses and 12% partial responses, after a median follow-up of 14 months.
The duration of response had not been reached at that point, says Novartis, indicating the effects of Kymriah (pictured above) were durable, and two-thirds of patients were relapse-free one year after the one-shot treatment. There was also evidence that patients with a partial response converted to complete later, in two cases between nine and 12 months after treatment.
Novartis will be hoping the new results will help accelerate the take-up of Kymriah. The CAR-T made sales of $12m in the first quarter of the year after its commercial launch in the US in the fourth quarter of 2017 and – while that initial take-up disappointed analysts which have been predicting 2018 sales of almost $160m – it only included the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukaemia (ALL).
In May, Novartis picked up approval for the drug in the much larger adult B-cell lymphoma population, kicking off direct competition for the first time with Gilead Sciences/Kite’s Yescarta (axicabtagene ciloleucel or axi-cel) which was approved for that indication the previous October and made $40m in the first quarter, ahead of the $16m predicted by analysts.
Celgene and Juno are hoping to crash the party soon with their CAR-T JCAR017 (lisocabtagene maraleucel or liso-cel), and also had data on show at the EHA which they said backed up their claim the CAR-T is potentially ‘best-in-class’.
Updated results from the TRANSCEND study in DLBCL patients involving 114 liso-cel-treated patients – 51 of whom at the dose used in pivotal trials – revealed a 49% ORR, with 46% of patients having a complete response and almost all of them (93%) still in remission after six months’ follow-up.
Given that less than half of the patients in the study were on what Gilead and Kite consider the best dose, the results seem to compare well to the ORRs seen with Kymriah and Yescarta at this point, although for all the therapies the data still has to mature to see how well they can keep patients in remission.
There are plenty of other factors to consider when determining which of the three tops the pile in CAR-T therapy for B-cell lymphomas. Gilead has first-mover advantage but has been unable to deliver its therapy as quickly as hoped because payers have taken time to put processes in place to handle this new type of therapy.
As experience grows, newer entrants should find things go more smoothly, but will still have to hit the ground running when it comes to securing insurance coverage. Ultimately, the winning player could be the company that gets the pricing and access model just right and keeps the not-insignificant production costs of CAR-T under close control.