CAR-T, Results

#ASH17: Novartis’ 6-month Kymriah data in DLBCL sets up a head-to-head fight with Gilead

Novartis $NVS has the kind of evidence of durability for its CAR-T drug Kymriah at 6 months it needs to win a quick shot at competing with Gilead on diffuse large B-cell lymphoma (DLBCL) cases.

Just a day after completing their filing with the FDA, Novartis reported Wednesday that among 81 patients at month 3, the complete response rate hit 32% with the partial response rate coming in at 6%. Their abstract on Kymriah (CTL019) for ASH also shows that among 46 patients evaluable at 6 months, the CR rate was 30% — with 95% remaining consistently free of any sign of their cancer — and the PR rate was 7%. Researchers said that response rates were consistent across subgroups (including those with double-hit lymphoma). Median duration of response was not reached and the 6-month probability of being relapse free was 73.5% — maintaining the kind of efficacy for this cancer that has made CAR-T a new factor in combating blood cancers.

That is right in line with Kite’s reported 31% complete response rate at 6 months, which also provided evidence of durability that suggests a blockbuster future for these drugs.

The latest data puts Novartis on a short track to going head-to-head with Gilead, which paid close to $12 billion to land Kite and its newly approved CAR-T drug Yescarta. The FDA has proven to be more than willing to speed up their OKs on cancer drugs, especially when they are working with already approved therapies.

Kymriah was approved last August for acute lymphoblastic leukemia (ALL), the first such OK for any CAR-T after years of rivalry in the clinic.

To be sure, there are dangers for patients to consider — with cytokine storms and neurological toxicity playing a big role — but Novartis’ abstract also spells out how an aggressive response can help manage side effects, with no deaths from side effects to report for an advanced, heavily pretreated group of patients.

States the abstract:

Overall, 86% of patients had grade 3 or 4 adverse events (AEs). Cytokine release syndrome (CRS) occurred in 58% of infused patients, with 15% grade 3 and 8% grade 4 using the Penn grading scale and managed by a protocol-specific algorithm. 15% of patients received anti-IL6 therapy, tocilizumab, for CRS management with good response and 11% of patients received corticosteroids. Other grade 3 or 4 AEs of special interest included neurologic AEs (12%, managed with supportive care), cytopenias lasting >28 days (27%), infections (20%), and febrile neutropenia (13%). Three patients died within 30 days of infusion, all due to disease progression. No deaths were attributed to CTL019. No CRS or neurologic event associated deaths occurred.



The best place to read Endpoints News? In your inbox.

Full-text daily reports for those who discover, develop, and market drugs. Join 21,000+ biopharma pros who read Endpoints News by email every day.

Free Subscription

Biomanufacturing