Kite Pharma Inc (NASDAQ: KITE) presented results from the ZUMA-1 trial of axicabtagene ciloleucel (KTE-C19) in patients with chemorefractory aggressive non-Hodgkin lymphoma (NHL) in two oral presentations at the American Society of Hematology (ASH) 58th Annual Meeting in San Diego, California.
ZUMA-1 enrolled 111 patients with diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), or transformed follicular lymphoma (TFL). Patients were required to have chemorefractory disease, defined as progressive or stable disease as best response to last line of therapy, or disease progression ≤12 months after autologous stem cell transplant. Manufacturing was successful for 110 patients, and 101 patients were treated. The pre-specified interim analysis was triggered when 51 patients with DLBCL had a minimum of three months of follow-up. At the time of interim analysis, 11 patients with PMBCL/TFL had been followed for three months. An additional 31 patients with one month of follow-up were included in the late breaker presentation.
“The vast majority of patients enrolled in ZUMA-1 are unable to undergo autologous stem cell transplant due to chemorefractory disease. This group has a dire need for more effective therapies,” said Jeff Wiezorek, M.D., Senior Vice President of Clinical Development. “We are encouraged by the high rate of complete remissions in this group and look forward to presenting longer follow-up at the primary analysis in the first quarter 2017. We are grateful to the patients and investigators who have made this important study possible.”
ZUMA-1 met the primary endpoint of objective response rate (ORR), p < 0.0001. Response rates by disease subtype are shown in the table below. Responses were observed across key subgroups, including 75 percent CR in patients who relapsed in ≤12 months after autologous stem cell transplant and 47 percent CR in patients refractory to second line or later chemotherapy. At the month three assessment, 39 percent of patients were in CR.
|Best Overall Response in Patients with ≥3 Month Follow-up|
|TFL / PMBCL||11||91%||73%|
In 93 patients with a minimum one month follow-up, the most common grade 3 or higher adverse events included neutropenia (63 percent), anemia (42 percent), leukopenia (40 percent), febrile neutropenia (29 percent), thrombocytopenia (26 percent), encephalopathy (19 percent), hypophosphatemia (17 percent), and decreased lymphocyte count (17 percent). Grade 3 or higher CRS and NE were observed in 13 percent and 29 percent of patients, respectively. Three patients died from treatment-emergent adverse events (hemophagocytic lymphohistiocytosis, cardiac arrest in the setting of CRS and pulmonary embolism). There were no cases of cerebral edema.
The primary analysis of ZUMA-1 will include a minimum of 6 months of follow-up. Kite intends to seek regulatory approval of axicabtagene ciloleucel in refractory aggressive NHL and plans to complete its rolling submission of the Biologics License Application (BLA) in the first quarter of 2017.
The late-breaker abstract (LBA-6), “KTE-C19 (anti-CD19 CAR T Cells) Induces Complete Remissions in Patients with Refractory Diffuse Large B-Cell Lymphoma (DLBCL): Results from the Pivotal Phase 2 ZUMA-1,” was presented by Sattva S. Neelapu, M.D., Associate Professor, Deputy Department Chair ad interim, Department of Lymphoma/Myeloma, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX. (Original Source)
Shares of Kite Pharma Inc are currently trading at $52.63, down $0.99 or -1.84%. KITE has a 1-year high of $75.90 and a 1-year low of $38.41. The stock’s 50-day moving average is $48.36 and its 200-day moving average is $54.14.
On the ratings front, Kite Pharma Inc has been the subject of a number of recent research reports. In a report released yesterday, Stifel Nicolaus analyst Thomas Shrader reiterated a Buy rating on KITE. Separately, on the same day, Canaccord Genuity’s John Newman reiterated a Buy rating on the stock and has a price target of $75.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Thomas Shrader and John Newman have a yearly average return of 0.9% and a loss of 12.0% respectively. Shrader has a success rate of 43% and is ranked #2041 out of 4256 analysts, while Newman has a success rate of 35% and is ranked #4158.
Sentiment on the street is mostly bullish on KITE stock. Out of 11 analysts who cover the stock, 9 suggest a Buy rating and 2 recommend to Hold the stock. The 12-month average price target assigned to the stock is $72.00, which implies an upside of 35% from current levels.
Kite Pharma, Inc. is a clinical stage biotechnology company, which engages in the development and commercialization of novel cancer immunotherapy products designed to target and kill cancer cells. It uses engineered autologous cell therapy, which involves the genetic engineering of T cells. Its lead product candidate, KTE-C19, a CAR-based therapy, which seeks treat patients with refractory diffuse large B-cell lymphoma, primary mediastinal large B-Cell lymphoma, and transformed follicular lymphoma.