Novartis says Kymriah reaches primary endpoint in new PhII, although numbers still to come
The race to develop CAR-T therapies has died down since Novartis’ Kymriah and Gilead’s Yescarta first crossed the finish line, though Tecartus also recently received approval. But the companies continue to expand their drugs’ applications, with Novartis preparing to conclude a new Phase II.
Interim data announced by the Swiss pharma show that Kymriah met its primary endpoint of complete response rate in treating patients with relapsed or refractory follicular lymphoma, the second-most common form of non-Hodgkin lymphoma. Based on preliminary trial findings, Kymriah had received RMAT designation from the FDA in April for r/r follicular lymphoma.
No numbers from the trial, dubbed ELARA, were released, nor was any information regarding secondary endpoints. ELARA was single-arm and open-label, and Novartis is expected to file with the FDA sometime in 2021, with EU regulatory submissions after that.
Kymriah was the first CAR-T therapy to hit the market and has previously been approved to treat two different indications: r/r acute lymphoblastic leukemia in children and young adults up to age 25 and r/r adult diffuse large B-cell lymphoma. It’s already the only CAR-T that has two FDA approvals and a third in this new area would put it even farther ahead of Gilead’s products in this regard.
However, Yescarta maintains the upper hand in sales, at least for the first quarter of 2020. The Gilead drug pulled in $140 million from January to March of this year, whereas Kymriah couldn’t break nine digits with $93 million.
Some of that lag can likely be attributed to the manufacturing woes Novartis faced in its rollout of Kymriah a few years ago. The FDA set a higher standard for commercial specifications that Novartis has struggled to maintain, and the pharma has, at times, been unable to deliver the drug reliably when needed.
Novartis’ chief manufacturing role has also been a revolving door since 2017 when Karen Walker and Spencer Fisk both jumped ship within the span of 18 months.
Billions of dollars have poured into CAR-T therapies over recent years, as the innovation was considered a huge breakthrough in cancer treatments. The high cost of development, manufacturing issues and less efficacy on solid tumors than originally hoped have set the field back, however, as the drugs — while moderately financially successful — have not yet reached the ultimate blockbuster status that pharma companies had originally hyped them up to be.
The therapies have also attracted criticism for their exorbitant prices, though some studies have shown the high costs to be worth it to consumers. In the United States, Kymriah costs $475,000 to treat acute lymphoblastic leukemia, while both Kymriah and Yescarta cost $373,000 to treat diffuse large B-cell lymphomas.