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Novartis to release long-awaited CAR-T data in June

April 25, 2017

After Jefferies analyst Biren Amin said last night that he thought Novartis would be presenting its midstage CAR-T blood cancer data from Juliet at a Swiss conference in mid-June, the Big Pharma has confirmed to FierceBiotech that it will indeed be posting the long-awaited data.

In a note to clients posted last night, Amin said that “Titles released for the International Conference on Malignant Lymphoma (ICML) indicate that Novartis intends to present the interim look from the phase 2 Juliet trial in DLBCL [diffuse large B-cell lymphoma].”

The Juliet data have already been seen by Novartis and the FDA, with the midstage test assessing its cutting-edge CAR-T med tisagenlecleucel (CTL019) in DLBCL patients, a key battle ground with rival biotech Kite Pharma and its axicabtagene ciloleucel (KTE-C19), as both race to be first to market.

But it had not been revealed to the wider world, and no exact timeline had been given as to when and where these data were to be posted.

Amin believed however that he saw a strong hint: “The program for ICML indicates that Novartis will present phase 2 interim data from the Juliet study in DLBCL on Wednesday, June 14, 2017, at the conference in Lugano, Switzerland,” he wrote.

This morning, Novartis told FierceBiotech that his hunch was correct: “We’re planning to present Juliet at the ICML,” a company spokesperson told me.

Amin added in his note: “Recall that the company recently guided to presenting this data in 2Q17 and that an abstract was not included in the ASCO titles released last week. At their R&D day in January, Novartis guided to having an interim analysis of 50 patients available by 1Q17 and 80 patients in 2Q17, both with 3-month follow-up.”

He says that interim analysis from Novartis “will be important to gauge the competitive dynamics between CTL019 and Kite’s Axi-cel.”

Just last week, the Swiss major was handed its second FDA “breakthrough” tag for the Juliet trial, with the first being for B-cell acute lymphoblastic leukemia in pediatric and young adult patients.

Kite recently finished off its rolling submission with the FDA for a BLA of its med in B-cell non-Hodgkin lymphoma patients who are ineligible for autologous stem cell transplant.

The biotech also has FDA breakthrough labels for DLBCL, transformed follicular lymphoma and primary mediastinal B-cell lymphoma.

RELATED: Novartis drug development chief outlines CAR-T research commitment

In an interview with FierceBiotech last week, Chief Medical Officer Vas Narasimhan, M.D., said the breakthrough designation it got this week from the FDA “hopefully gives some indication” of how the data have panned out.

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