December 6, 2015 11:32am

NVS’ latest findings from study of two kinds of blood cancer track earlier results bolster its confidence in a 2017 U.S. regulatory submission.


 

NVS is testing CTL019, its investigational chimeric antigen receptor T cell therapy, or CART, on 15 adult patients with the most-common non-Hodgkin’s lymphoma, called diffuse large B-cell lymphoma (DLBCL), and 11 follicular lymphoma patients.

 

The ongoing P2 study is on patients with advanced disease, who have not responded to standard treatment.

 

The Bottom line: Overall response rates or those who saw some reduction in cancer, at three months were 47% in DLBCL patients and 73% in follicular lymphoma, Novartis said on Sunday at the American Society of Hematology conference in Orlando. Earlier findings, from just half the patient count, were similar!

NVS’ findings will keep CTL019 on track for 2017 regulatory submission with the U.S. FDA as it seeks to find new ways of fighting DLBCL, which has an estimated 25,000 new U.S. cases and 10,000 deaths each year.

Four patients developed an inflammatory, often flu-like response common when cancer cells are killed; two developed neurologic toxicity, Novartis said.

 

It is expected that CART therapies will command prices up to $450,000 when they hit the market by 2017. Novartis acknowledged costs will be high, but declined to give dimensions. (Source: John Miller, Reuters)