ENDPOINTS NE W S
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`June 13, 2022 11:04 AM EDT
`Updated 06:26 PM
`R&D, Pharma, Cell/Gene T)(
`
`Novartis may still be grappling with
`Kymriah sales, but historic CAR-T
`promise still shines through 5-year data
`
`John Carroll
`Editor& Founder
`
`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 block(cid:173)
`buster revenue, but a new study shows that its positive ef(cid:173)
`fects 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 Novar(cid:173)
`tis, and the median RFS was 43 months. "The median event(cid:173)
`free survival (EFS) for patients in remission within three
`months of infusion (n~65) was 43.8 months."
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`Ca1
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`"These data mark a moment of profound hope for children,
`young adults and their families with relapsed or refractory B(cid:173)
`cell ALL, as relapse after five years is rare," said Stephan
`Grupp, the inaugural director of the Susan Sand Stephen
`Kelly Center for Cancer Immunotherapy at Children's Hospi(cid:173)
`tal of Philadelphia. "Since the approval of Kymriah nearly
`five years ago, we have been able to offer a truly game-chang(cid:173)
`ing option to patients who previously faced a five-year sur(cid:173)
`vival rate of less than 10 percent."
`
`These continuing results alongside the success ofYescarta at
`Kite underscore the original hope that arming patient cells
`for an attack on blood cancers offered a breakthrough ap(cid:173)
`proach that would save scores of lives. It's also a reminder
`that the immediate goal of creating a second-gen, off-the(cid:173)
`shelf approach hasn't been easy, though progress is being
`made.
`
`Kymriah earned $587 million last year, a 24% gain. The rev(cid:173)
`enue 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(cid:173)
`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.
`
`RELATED , 5 years later, CAR-T pioneer Kymriah offers jaw-drop(cid:173)
`ping evidence of durable remissions - even as it still proves a
`tough sell
`
`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 pro(cid:173)
`gression-free survival at the five-year point. And researchers
`determined that durable success here hinges on patients' re(cid:173)
`sponse one year into the treatment.
`
`Correction: Novartis withdrew and corrected its initial release
`outlining survival data, changing a variety of the figures.
`
`AUTHOR
`
`John Carroll
`Editor& Founder
`
`~ john@endpointsnews.com
`ti @JohnCendpts
`in John Carroll on Linked In
`
`UPenn Ex. 2072
`Miltenyi v. UPenn
`IPR2022-00855
`Page 1
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