RE: Jackdaw9 Jun 2017 10:53
hey, Trump, Brexit and Corbin were 'minority thoughts'... I like it!
So, the Juliet data came through on wednesday. They were really good - at least as good as Kite's data. There was a lot of chat from Novartis about manufacturing time-lines and how to speed them up, etc. - all OXB relevant, of course. Not sure if it was the election or 'travel-and-arrive' but the OXB stock really didn't react...Yet.
Here's part of the article on it, as reported in FierceBiotech on wednesday.
"It’s been a big week for CAR-T: Novartis, Juno, Kite, Bluebird Bio and Nanjing Legend Biotech all posted positive data for the cutting-edge experimental cancer class at ASCO, and now Novartis has revealed the long-awaited interim Juliet data for its CAR-T candidate at a Swiss conference.
The FDA ‘breakthrough’ tagged Juliet data, which many have been waiting for to see how well it could stack up against rival Kite Pharma, was assessing CTL019 (a.k.a tisagenlecleucel) in 51 relapsing/remitting diffuse large B-cell lymphoma (r/r DLBCL) patients who had already received a series of treatments.
Revealed for the first time today, Novartis says the single-arm, open-label pivotal phase 2 trial hit its primary endpoint, showing a 3-month overall response rate (ORR) of 45% (23 of the 51 patients evaluated), with 37% achieving a complete response (CR) and 8% achieving a partial response (PR), respectively. In all, 141 patients were enrolled, but only 51 were evaluated.
The Swiss Big Pharma said that CR also “remained stable” from 3 months through data cut-off among the patient group. And among the 51 patients with 3 months or more of follow-up or earlier discontinuation, best ORR was 59% (p<0.0001), with 43% achieving CR and 16% achieving PR.
Secondary endpoints from the study include overall survival, duration of response and progression-free survival, although Novartis tells me these are not yet mature enough to assess.
The new data are set to be presented at the International Conference on Malignant Lymphoma (ICML) meeting in Lugano, Switzerland."