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Novartis touts new T-cell therapy data in race for FDA approval

| ZURICH, June 7

ZURICH, June 7 Novartis on Wednesday touted new data from its T-cell therapy CTL019, saying it is on a par with results of experimental molecules from Kite Pharma and Juno Therapeutics that also target aggressive blood cancers.

Three months after infusion, the overall response rate (ORR)among 51 adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) was 45 percent, Novartis said, with 37 percent complete responses (CR), or no sign of disease.

Novartis aims for $1 billion in annual sales for CTL019, a drug made by taking T cells from a patient, reprogramming them in the lab to fight cancer, and re-infusing them. The field is crowded, with Kite and Juno also hunting for approval for drugs whose per-patient costs could top $500,000.

"When you look across the three competitors' data sets, they're all in a similar range of responses," Novartis drug development chief Vas Narasimhan said in an interview. "What's critical is to see the data sets fully mature... and look at the overall safety profile."

Narasimhan said no deaths were linked to CTL019, though three patients died from disease progression within 30 days of infusion. Seven suffered severe neurological events.

While so-called "CAR-T therapies" from Novartis, Kite and Juno are now last resorts for patients who have failed other treatments, more doctors are growing convinced they have promise. Globally, there are some 183 CAR-T trials underway.

In March, Novartis filed CTL019 with the U.S. Food and Drug Administration for fast-track approval in B-cell acute lymphoblastic leukemia (ALL) in young patients. The FDA has scheduled a July 12 public meeting for that.

Novartis could file for FDA approval in DLBCL, the most common form of non-Hodgkin lymphoma (NHL) in adults, around October, with European filings planned about the same time.

Rival Kite Pharma's experimental drug axi-cel is also under expedited U.S. review against advanced NHL, with additional trials underway in leukaemia patients.

Kite has said 41 percent of NHL patients responded to axi-cel treatment at the six-month cutoff, with 36 percent in complete response.

Though Juno Therapeutics has suffered significant setbacks -- patient deaths forced it to abandon its lead CAR-T molecule this year -- the company released fresh data last week on another drug, JCAR017, against NHL.

Novartis is studying why some patients respond to CTL019 while others' cancers avoid detection.

Additional trials are planned, including with newer CAR-Ts combined with other drugs.

"There's just a lot of science that's yet to be understood," Narasimhan said. "I hope we have better answers next year ... for what's going on in the non-responders." (Reporting by John Miller, editing by Louise Heavens)

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