FDA Decision For Dupixent As Novartis Drives Its CAR-T

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Includes: AMGN, JUNO, KITE, NVS, REGN, SNY
by: EP Vantage

Welcome to your weekly digest of approaching regulatory and clinical readouts. Sanofi (NYSE:SNY) and Regeneron’s (NASDAQ:REGN) dermatitis MAb Dupixent, due a US decision by March 29, is forecast to be Sanofi’s biggest growth driver, but its launch could be delayed by an expected patent challenge from Amgen (NASDAQ:AMGN).

Also, as the first quarter comes to a close, a number of catalysts are expected for Novartis' lead CAR-T project CTL019, with a filing in pediatric acute lymphoblastic leukemia due, along with lymphoma data from the Juliet study. How the asset stacks up against Kite's (KITE) competing project, KTE-C19, will be closely watched.

The return of Sanofi’s foe

Worldwide sales of Dupixent are expected to hit a huge $4.3bn by 2022, according to sellside consensus from EvaluatePharma, and over half of this is assigned to US sales. The project has an NPV of $15.7bn, or 14% of Sanofi’s market cap; Regeneron collects worldwide royalties.

The MAb is forecast to be Sanofi’s biggest growth driver, looking to plug the gap left by declining Lantus sales, and is also one of the biggest expected launches of the year (Autoimmune disease vies with cancer to dominate the class of 2017, January 30, 2017).

However, patent challenges could delay launch. Expecting to lock horns with Amgen again, Sanofi and Regeneron took a pre-emptive strike this week by seeking a court order declaration that Dupixent does not infringe some of Amgen’s IP, namely the ‘487 patent, which cites antibodies against IL-4 and IL-13, the mechanism Dupixent also uses.

Amgen’s patent was originally issued for a now abandoned asthma treatment. Although not disclosed this looks to have been AMG 317, which lacked efficacy in a phase II trial.

Dupixent is also being tested in asthma and data from a phase III trial are expected later this year, with a US filing in this indication due in the fourth quarter. Its expansion into persistent asthma makes up just over $1bn of the consensus.

Novartis’ driving test

Novartis has long been one of the leading players fighting to bring the first CAR-T therapy to market, but its broader cell therapy plans have often been opaque. Now a key moment approaches as the Swiss group aims to submit CTL019 to the US FDA by the end of the first quarter – meaning within the next week.

The initial filing will be in paediatric acute lymphoblastic leukaemia, based on the global, multicentre Eliana study, which at the Ash meeting yielded an 82% complete remission rate at three months' follow-up, falling to 60% at month six (Ash – Novartis makes its case for driving a CAR into the real world, December 5, 2016).

However, a much bigger indication for the first CAR-T therapies is aggressive lymphoma, a use in which a rolling BLA for Kite’s competing KTE-C19 is due to be completed also in the first quarter. And yet another event also promised by March 31 is Novartis’s own lymphoma data for CTL019, from the Juliet study.

With Kite last month reporting six-month results from the Zuma-1 trial the benchmark has been set: across the combined lymphoma cohort the overall remission rate with KTE-C19 at six months was 41%, with 36% of patients in complete remission.

Novartis’ plan is to reveal interim data on 50 patients in Juliet in the first quarter and present a primary analysis of 80 by the half-year; at its last financial update it said it was gunning for US and EU filings in lymphoma by the end of the year.

The Swiss company has held its cards close to its chest, and has so far revealed barely any lymphoma data for CTL019. Since Juno’s (NASDAQ:JUNO) troubles made this a two-horse race, the first look at Juliet results will be keenly awaited by Kite and Novartis investors alike.

Trial

Indication

Timeline

Trial ID

Eliana

Paediatric ALL

Filing Q1 2017

NCT02435849

Juliet

Diffuse large B-cell lymphoma

3mth data Q1 & Q2, filing Q4 2017

NCT02445248