Novartis may still be grappling with Kymriah sales, but historic CAR-T promise still shines through 5-year data
Five years after Novartis made history with the approval of the first CAR-T, Kymriah, we’re getting a clearer picture of just how important the advance was for some patients.
The pharma giant may still be having trouble manufacturing the treatment or reaching long-cherished goals of blockbuster revenue, but a new study shows that its positive effects have good odds of extending out for years. And for many, it’s looking curative.
The five-year relapse-free survival rate was 44%, says Novartis, and the median RFS was 43 months. “The median event-free survival (EFS) for patients in remission within three months of infusion (n=65) was 43.8 months.”
“These data mark a moment of profound hope for children, young adults and their families with relapsed or refractory B-cell ALL, as relapse after five years is rare,” said Stephan Grupp, the inaugural director of the Susan S and Stephen Kelly Center for Cancer Immunotherapy at Children’s Hospital of Philadelphia. “Since the approval of Kymriah nearly five years ago, we have been able to offer a truly game-changing option to patients who previously faced a five-year survival rate of less than 10 percent.”
These continuing results alongside the success of Yescarta at Kite underscore the original hope that arming patient cells for an attack on blood cancers offered a breakthrough approach that would save scores of lives. It’s also a reminder that the immediate goal of creating a second-gen, off-the-shelf approach hasn’t been easy, though progress is being made.
Kymriah earned $587 million last year, a 24% gain. The revenue steadily drags behind the rival Yescarta, from which Gilead earned $695 million last year.
The drug has had its ups and downs in the clinic as well, with a fail last year in a Phase III for aggressive B-cell non-Hodgkin lymphoma, costing a considerable amount in the still hoped-for blockbuster sales to come. But it also just won approval as a third-line treatment for follicular lymphoma.
This also isn’t the first time that Novartis has reported stellar five-year data. Last year the pharma giant announced that in a group of advanced, treatment-resistant NHL patients, 46% had achieved a complete remission, with 31% marking progression-free survival at the five-year point. And researchers determined that durable success here hinges on patients’ response one year into the treatment.
Correction: Novartis withdrew and corrected its initial release outlining survival data, changing a variety of the figures.