Novartis keeps its CAR-T lead with positive Phase II data

Novartis ($NVS), leading a pack of companies developing genetically engineered T cells to fight cancer, unveiled more promising data on its Phase II treatment as it wends toward an FDA filing.

In results presented at the American Society of Hematology meeting, Novartis' CTL019 shrank or eradicated tumors in more than half of patients with non-Hodgkin lymphoma (NHL) that persisted after prior treatment. The data fall in line with earlier results from smaller trials of CTL019, and Novartis told Reuters it remains on track to file the treatment for FDA approval in 2017.

In 15 patients with large B-cell lymphoma, the most common type of NHL, Novartis' T cell therapy posted a three-month overall response rate of 47%, and, after 6 months, the treatment completely removed the cancer of 20% of patients. In 11 patients with follicular lymphoma, CTL019's overall response rate was 73% at three months, and three patients recorded complete responses after 6.

But there were a pair of relapses in the study, as one partial responder in the large B-cell lymphoma arm experienced disease progression after 6 months, and one follicular lymphoma patient ran into the same issue after one year.

And, in keeping with most CAR-T treatments, CTL019 led to a few cases of dangerous immune response. Four patients in the study developed cytokine release syndrome, an inflammatory response that leads to flu-like symptoms, and two experienced neurologic toxicities, Novartis said.

Novartis remains in pole position ahead of Juno Therapeutics ($JUNO), Kite Pharma ($KITE) and others developing CAR-T therapies for blood cancers. Each has come through with promising clinical results in cancers with particularly bleak prognoses, but it remains to be seen how readily the companies can produce cell therapies at commercial scale. Creating therapeutic CAR-Ts requires extracting cells from patients, genetically modifying them and then re-infusing the new material, a roughly two-week process that will likely present hurdles if and when Novartis and its rivals win FDA approvals.

- read the results
- here's the Reuters story