Kite Pharma’s lead cancer drug shows encouraging results

The company reported positive topline results from a pre-planned interim analysis of ZUMA-1 for its product candidate, KTE-C19, in patients with chemorefractory diffuse large B-cell lymphoma (DLBCL).

The trial included 51 patients with DLBCL, and 11 patients with transformed follicular lymphoma (TFL) and primary mediastinal B-cell lymphoma (PMBCL).

The analysis showed that 76% of patients with Non-Hodgkin Lymphoma responded to the treatment, while 47% showed a complete remission.

After three months of follow-up, some patients relapsed, reducing the overall response rate to 39% and the complete remission rate to 33%.

The company said the phase 2 interim outcomes in ZUMA-1 are largely consistent with results from the study’s phase 1 portion and the National Cancer Institute (NCI) study based on the same CAR construct, a low-dose cyclophosphamide-fludaribine conditioning regimen, and its manufacturing process (Kochenderfer ASCO 2016).

Kite Pharma senior vice president of clinical development Jeff Wiezorek said: "ZUMA-1 enrolled patients with chemorefractory aggressive NHL, a disease that is very difficult to treat. 

“The combined CR rate of 39 percent at three months is very exciting as it represents nearly a five-fold increase from the CR rate of 8 percent seen in the SCHOLAR-1 study in a similar patient population.”

Kite intends to release the primary analysis of 101 patients with about six months of follow-up in the first quarter of next year.

The company plans to seek regulatory approval of KTE-C19 to treat patients with DLBCL; TFL; and PMBCL.