Novartis may still be grappling with Kymriah sales, but historic CAR-T promise still shines through 5-year data – Endpoints News

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.

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