Clinical Trials

Date: 2017-12-10

Type of information: Presentation of results at a congress

phase: 1-2

Announcement: presentation of results at the 59th American Society of Hematology (ASH) Annual Meeting9

Company: Kite Pharma (USA - CA)

Product: Yescarta™ (axicabtagene ciloleucel) (KTE-C19) (autologous T cells transduced with retroviral vector encoding an anti-CD19 CD28/CD3 zeta chimeric antigen receptor)

Action mechanism:

• cell therapy/immunotherapy product/gene therapy/CAR-T cell therapy. KTE-C19 is Kite Pharma's lead product candidate in which a patient's T cells are genetically modified using a gammaretroviral vector to express a chimeric antigen receptor (CAR) designed to target the antigen CD19, a protein expressed on the cell surface of B cell lymphomas and leukemias.
• Yescarta™ has been granted Priority Medicines (PRIME) regulatory support for DLBCL in the European Union. A Marketing Authorization Application (MAA) for axicabtagene ciloleucel is currently under review with the European Medicines Agency (EMA) and potential approval is expected in the first half of 2018.

Disease: refractory diffuse large B cell lymphoma, refractory primary mediastinal B cell lymphoma, refractory transformed follicular lymphoma

Therapeutic area: Cancer - Oncology - Rare diseases

Country: Canada, Israel, The Netherlands, USA

Trial details:

• ZUMA-1 is a single arm, open-label, multi-center study, designed to determine the safety and efficacy of KTE-C19 in patients with refractory diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), or transformed follicular lymphoma (TFL). Upon completion of the Phase 1 portion of the study, Kite expects to proceed with the Phase 2 portion that will include a total of approximately 112 patients.
• ZUMA-1 is supported in part by funding from The Leukemia & Lymphoma Society (LLS) Therapy Acceleration Program®.(NCT02348216)

Latest news:

• • On December 10, 2017, Kite, a Gilead company announced long-term follow-up data from the pivotal ZUMA-1 study of Yescarta™ (axicabtagene ciloleucel) in patients with refractory large B-cell lymphoma. With a minimum follow-up of one year after a single infusion of Yescarta™ (median follow-up of 15.4 months), 42 percent of patients continued to respond to therapy, including 40 percent with a complete remission. Detailed results from this updated analysis were simultaneously presented at the Annual Meeting of the American Society of Hematology (ASH) in Atlanta and published in The New England Journal of Medicine.
• To evaluate the durability of Yescarta responses, an updated analysis was conducted when patients in ZUMA-1 had been followed for a minimum of one year (n=108). In this updated analysis, 82 percent of patients had responded to Yescarta™, including 58 percent of patients who had achieved complete remission. At a median of 15.4 months post-infusion, 42 percent of patients remained in response, including 40 percent in complete remission. The median duration of response was 11.1 months (95 percent CI: 3.9 months to not estimable [NE]); in patients who have achieved a complete remission, the median duration of response was not reached (95 percent CI: NE). Median overall survival had not been reached (95 percent CI: 12 months to NE) with an overall survival rate at 18 months of 52 percent (95 percent CI: 41 to 62).
• In the updated analysis, 12 percent of patients experienced Grade 3 or higher cytokine release syndrome (CRS) and 31 percent experienced neurologic toxicities respectively. The most common Grade 3 or higher reactions were neutropenia (79 percent), anemia (45 percent) and thrombocytopenia (40 percent). Ten patients experienced a serious adverse event six months after Yescarta™ infusion, including eight patients with infections. No new onset CRS or neurologic events related to Yescarta were observed in the updated analysis.
• • On August 7, 2017, Kite Pharma announced that patients in the European Union (EU) are now being treated with axicabtagene ciloleucel, in the safety expansion cohort of ZUMA-1. Kite is currently enrolling adult patients with relapsed/refractory diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, and transformed follicular lymphoma at multiple EU medical centers. The first patient treated in the safety expansion cohort was at the Academic Medical Center (AMC) in Amsterdam by Professor Dr. Marie José Kersten. Additional patients are expected to be treated in multiple clinical sites across Europe in 2017.
• Kite filed a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for axicabtagene ciloleucel in July 2017, the first CAR-T application in Europe.Kite has been granted access to Priority Medicines (PRIME) regulatory support in the EU for treatment of refractory DLBCL. Access to the PRIME initiative is granted by the EMA to support the development and accelerate the review of new therapies to treat patients with a high unmet need.
• • On April 2, 2017, Kite Pharma announced two plenary presentations of positive data from the primary analysis of ZUMA-1 for its lead CAR-T candidate, axicabtagene ciloleucel, in patients with refractory aggressive B-cell non-Hodgkin lymphoma (NHL) at the 2017 American Association of Cancer Research Annual Meeting in Washington. Both presentations were given by Frederick L. Locke, M.D., the ZUMA-1 Co-Lead Investigator, and Director of Research for the Immune Cell Therapy Program at Moffitt Cancer Center in Tampa, Florida.
• The study met the primary endpoint of objective response rate (ORR) recorded after a single infusion of axicabtagene ciloleucel, with 82 percent (p < 0.0001). These results demonstrate the treatment effect of axicabtagene ciloleucel in diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL) and transformed follicular lymphoma (TFL), which are types of aggressive NHL.
• ZUMA-1 enrolled 111 patients of whom 101 were successfully treated with axicabtagene ciloleucel. ZUMA-1 patients were heavily pretreated and representative of those in the SCHOLAR-1 pooled analysis of refractory aggressive NHL. The key ZUMA-1 patient characteristics are below:
• - Stage III/IV disease (85 percent)
• - Refractory to chemotherapy, no prior autologous stem cell transplant (ASCT) (79 percent)
• - Relapsed within 12 months of ASCT (21 percent)
• - Received three or more lines of prior therapy (69 percent)
• - Refractory to two consecutive lines of prior therapy (54 percent).The following table shows response data including the month 6 ORR and CR as well as ongoing response rates at the primary analysis data cut-off.

  			DLBCL (n=77)						TFL/PMBCL (n=24)						Combined (n=101)
  			ORR (%)			CR (%)			ORR (%)			CR (%)			ORR (%)			CR (%)
  ORR			82			49			83			71			82			54
  Month 6			36			31			54			50			41			36
  Ongoing			36			31			67			63			44			39

  ORR was generally consistent in key subgroups. ORR in patients who are refractory to second or greater line of therapy was 83 percent and 76 percent in patients who relapsed within 12 month of ASCT.
• With a median follow-up of 8.7 months, the median overall survival (OS) has not yet been reached. The overall duration of response (DOR) was 8.2 months and has not yet been reached for patients with a CR. In the SCHOLAR-1 pooled analysis, the median OS was estimated to be 6.6 months with only 8 percent achieving CR with currently available therapies.
• As previously reported, the most common grade 3 or higher adverse events included anemia (43 percent), neutropenia (39 percent), decreased neutrophil count (32 percent), febrile neutropenia (31 percent), decreased white blood cell count (29 percent), thrombocytopenia (24 percent), encephalopathy (21 percent) and decreased lymphocyte count (20 percent). As compared to the interim analysis, grade 3 or higher cytokine release syndrome (CRS) decreased from 18 percent to 13 percent and neurologic events decreased from 34 percent to 28 percent. There were three deaths throughout the course of the trial not due to disease progression. Two events, one hemophagocytic lymphohistiocytosis (HLH) and one cardiac arrest in the setting of CRS, were deemed related to axicabtagene ciloleucel. The third case, a pulmonary embolism, was deemed unrelated. There were no cases of cerebral edema.
• • On February 28, 2017, Kite Pharma announced positive data from the primary analysis of ZUMA-1 for axicabtagene ciloleucel (previously referred to as KTE-C19), in patients with chemorefractory aggressive B-cell non-Hodgkin lymphoma (NHL). The study met the primary endpoint of objective response rate, or rates of tumor response (complete response + partial response) recorded after a single infusion of axicabtagene ciloleucel, with 82 percent (p < 0.0001).
  • These results demonstrate the treatment effect of axicabtagene ciloleucel in a patient population with multiple types of aggressive NHL, including diffuse large B-cell lymphoma enrolled in Cohort 1, as well as primary mediastinal B-cell lymphoma and transformed follicular lymphoma enrolled in Cohort 2.
  • One hundred one patients were treated in ZUMA-1. The following table shows the ORR and rate of complete response (CR) as well as the month 6 ORR and CR:

• 				DLBCL  (n=77)								TFL/PMBCL  (n=24)								Combined  (n=101)
  				ORR (%)				CR (%)				ORR (%)				CR (%)				ORR (%)				CR (%)
  ORR				82				49				83				71				82				54
  Month 6				36				31				54				50				41				36

  • Four of the 101 patients in ongoing CR did not have a month 6 tumor assessment prior to the data cut-off and are therefore categorized as non-responders for month 6 in the table above. These patients have an opportunity to be counted as a month 6 CR in a follow-up analysis, which may increase the month 6 response and month 6 CR rate.
  • At month 6, 41 percent of treated patients achieved a response, including 36 percent in CR. Five of the 101 patients (5 percent) continue to experience highly significant and durable partial responses (PR) with minimal abnormalities in PET scans. One of these PRs converted to a CR at month 9.
  • With a median follow-up of 8.7 months for this primary analysis, the median overall survival (OS) has not yet been reached. In a similar patient population, the median OS was estimated to be 6.6 months (SCHOLAR-1 study, ASCO 2016).
  • The most common grade 3 or higher adverse events included anemia (43 percent), neutropenia (39 percent), decreased neutrophil count (32 percent), febrile neutropenia (31 percent), decreased white blood cell count (29 percent), thrombocytopenia (24 percent), encephalopathy (21 percent) and decreased lymphocyte count (20 percent). As compared to the interim analysis, grade 3 or higher cytokine release syndrome (CRS) decreased from 18 percent to 13 percent and neurologic events decreased from 34 percent to 28 percent. There were no cases of cerebral edema.
  • As previously reported at the American Society of Hematology Annual Meeting in 2016, there were three deaths not due to disease progression in the study. Two events, one hemophagocytic lymphohistiocytosis and one cardiac arrest in the setting of CRS, were deemed related to axicabtagene ciloleucel. The third case, a pulmonary embolism, was deemed unrelated. Between the interim analysis that included 62 patients, and this primary analysis which now includes all 101 patients, there were no additional deaths due to adverse events.
  • Kite intends to seek regulatory approval of axicabtagene ciloleucel in aggressive NHL based upon the combined data from all 101 patients and plans to complete its rolling submission of the Biologics License Application (BLA) by the end of the first quarter of 2017. In addition, Kite plans to submit a marketing authorization application (MAA) for axicabtagene ciloleucel for the treatment of relapsed or refractory DLBCL, PMBCL and TFL with the European Medicines Agency (EMA) in 2017.
• • On December 6, 2016, Kite Pharma presented results from the ZUMA-1 trial of axicabtagene ciloleucel (KTE-C19) in patients with chemorefractory aggressive non-Hodgkin lymphoma 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.
• 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. 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.
• • On October 7, 2016, Kite Pharma announced updated results from the Phase 1 portion of Kite's ZUMA-1 clinical trial of its lead product candidate, KTE-C19, in patients with chemorefractory, aggressive non-Hodgkin lymphoma (NHL). The results were provided in an oral presentation at the European Society for Medical Oncology (ESMO) annual congress. Ongoing complete remissions in phase 1 of ZUMA-1: a phase 1-2 multi-center study evaluating the safety and efficacy of KTE-C19 (anti-CD19 CAR T cells) in patients with refractory aggressive B cell non-Hodgkin Lymphoma (NHL). Abstract 1048O; Presenter: Frederick Locke , M.D., Moffitt Cancer Center , Tampa, FL ; Friday, October 7, 2016 : 4:00-5:30pm CEST ; Proffered Paper session: Immunotherapy of Cancer; Location: Copenhagen . Phase 1 of ZUMA-1 treated a total of 7 patients with chemorefractory, diffuse large B-cell lymphoma (DLBCL). KTE-C19 related adverse events consisted predominantly of cytokine release syndrome (CRS) and neurotoxicity which were generally reversible. Grade 3 or higher CRS was observed in 14 percent and neurotoxicity in 57 percent; all were reversible except in one patient with dose-limiting toxicity. KTE-C19 achieved rapid and durable responses in patients with chemorefractory disease (objective response rate 71 percent, complete remission rate 57 percent). Ongoing complete remissions were observed in 3 of 7 patients as of 12-month study follow-up. "These data complement our recently reported interim topline results from ZUMA-1 Phase 2 and support the potential for KTE-C19 to be a breakthrough therapy for chemorefractory, aggressive NHL," said David Chang , M.D., Ph.D., Executive Vice President, Research and Development, and Chief Medical Officer of Kite. "We are encouraged that the complete remission rate of 43 percent in the Phase 1 portion of the study continues through month 12 and look forward to reporting additional data on the durability of response to KTE-C19 from the Phase 2 portion of ZUMA-1 in 2017."
• • On September 26, 2016, Kite Pharma announced topline results from a pre-planned interim analysis of ZUMA-1 for its lead product candidate, KTE-C19, in patients with chemorefractory diffuse large B-cell lymphoma (DLBCL). KTE-C19 met the primary endpoint of objective response rate (ORR), p < 0.0001, with ORR of 76 percent, including 47 percent complete remissions (CR). ZUMA-1 enrolled patients with chemorefractory aggressive NHL into two cohorts. Cohort 1 included patients with DLBCL, and Cohort 2 enrolled patients with transformed follicular lymphoma (TFL) and primary mediastinal B-cell lymphoma (PMBCL). Kite's intent is to seek regulatory approval of KTE-C19 in DLBCL, TFL and PMBCL based upon the combined data of both cohorts.
• The interim analysis of ZUMA-1 evaluated the ORR in the first 51 patients in Cohort 1 with at least three months of follow-up. This analysis also included an additional 11 patients in Cohort 2. The table below summarizes the response rates from this interim analysis together with the previously reported results from the Phase 1 portion of ZUMA-1 (Neelapu ASCO 2016).

	ZUMA-1 Phase 1		ZUMA-1 Phase 2
	DLBCL (n=7)		DLBCL (n=51)		TFL/PMBCL (n=11)		Combined (n=62)
	ORR (%)	CR (%)	ORR (%)	CR (%)	ORR (%)	CR (%)	ORR (%)	CR (%)
ORR	71	57	76	47	91	73	79	52
Month 3	43	43	39	33	64	64	44	39
Months 6 and 9	43	43	Data pending

• Across the combined 62 patients, the most common grade 3 or higher adverse events included neutropenia (66 percent), anemia (40 percent), febrile neutropenia (29 percent), thrombocytopenia (29 percent), and encephalopathy (26 percent). Grade 3 or higher cytokine release syndrome (CRS) and neurological toxicity was observed in 18 percent and 34 percent of patients, respectively. Two patients died from KTE-C19 related adverse events (hemophagocytic lymphohistiocytosis and cardiac arrest in the setting of CRS).
• The Phase 2 interim outcomes in ZUMA-1 are largely consistent with results from the Phase 1 portion of the study and the National Cancer Institute (NCI) study based on the same CAR construct, a low-dose cyclophosphamide-fludaribine conditioning regimen, and Kite's proprietary manufacturing process (Kochenderfer ASCO 2016).
• Additional data from this interim analysis will be submitted for presentation at an upcoming scientific meeting. The primary analysis of 101 patients with chemorefractory aggressive NHL (DLBCL, TFL and PMBCL) will include approximately six months of follow-up and is expected in the first quarter of 2017.
• • On July 8, 2016, Kite Pharma announced that it has completed enrollment of 72 patients in DLBCL cohort in the Phase 2 portion of ZUMA-1. The DLBCL cohort of ZUMA-1 enrolled patients whose disease is chemorefractory (no response to last line of therapy or has relapsed within 12 month of autologous stem cell therapy). Patients received a lymphodepletion regimen that consisted of "low-dose" chemotherapy regimen of cyclophosphamide (500 mg/m²) and fludarabine (30 mg/m²) daily for 3 days prior to infusion of the target KTE-C19 dose of 2 x 10⁶ cells/kg.
• • On November 5, 2015, Kite Pharma announced upcoming presentations related to KTE-C19, Kite's lead product candidate, that will take place at the 57th ASH Annual Meeting in Orlando, Florida , December 5-8, 2015:
• "Phase 1 Biomarker Analysis of the ZUMA-1 (KTE-C19-101) Study: A Phase 1-2 Multi-Center Study Evaluating the Safety and Efficacy of Anti-CD19 CAR T Cells (KTE-C19) in Subjects with Refractory Aggressive Non-Hodgkin Lymphoma (NHL)" Six subjects with refractory aggressive NHL have received KTE-C19. CAR T cells expanded substantially and persisted through at least 1 month in 3 subjects evaluated to date. Pro-inflammatory, immune-homeostatic cytokines and chemokines peaked within 2 weeks. Timing of peak KTE-C19 expansion and serum cytokine profiles and clearance in this multicenter study with an optimized, shortened manufacturing process were consistent with results of the NCI study.
• Phase 1 Clinical Results of the ZUMA-1 (KTE-C19-101) Study: Subjects received KTE-C19 at a target dose of 2 x 10⁶ (minimum 1 x 10⁶) anti-CD19 CAR T cells/kg after a fixed dose conditioning chemotherapy regimen of cyclophosphamide and fludarabine. The primary objective of phase 1 is to evaluate the safety of KTE-C19 as determined by the incidence of dose-limiting toxicities (DLT). Cytokine release syndrome (CRS) was graded per revised criteria (Lee et al. Blood 2014). Key secondary objectives include evaluating the overall response rate (ORR=CR+PR) per Cheson 2007, duration of response, levels of CAR T cells in the blood, and levels of serum cytokines. Key inclusion criteria include ? 18 years old, ECOG 0-1, and chemotherapy-refractory disease defined as stable disease or progressive disease as best response to last line of therapy, or disease progression ? 12 months after autologous stem cell transplant (ASCT). Subjects must have received at least prior anti-CD20 therapy and an anthracycline containing regimen.  As of 28 July 2015, 6 subjects were dosed in the phase 1 portion of the study. All subjects are evaluable for safety with a median follow up time of 4.8 weeks post KTE-C19 infusion and 3 subjects have had 1 month tumor assessments. Two subjects experienced only grade (gr) 1-2 KTE-C19 related events. Three subjects had gr 3 KTE-C19 related events as highest gr toxicities; all these events were reversible within 3 days. CRS and neurotoxicity were managed with supportive care, tocilizumab and systemic steroids. One subject experienced a DLT of gr 4 encephalopathy and gr 4 CRS. This subject died within 30 days of KTE-C19 cell infusion; the death was due to an intracranial hemorrhage deemed unrelated to KTE-C19 per the investigator. Of the 3 subjects assessed for response at one month, 2 achieved a complete response and one achieved a partial response. Key safety and efficacy findings are summarized in the table. Preliminary phase I results of the ZUMA-1 study demonstrate that KTE-C19 can be centrally manufactured and administered in a multicenter trial. The predominant toxicities include CRS and neurotoxicity which are generally reversible. Complete and partial responses have been observed in subjects with refractory disease at 1 month after KTE-C19 administration. This potentially pivotal study is the first enrolling multicenter anti?CD19 CAR T cell trial in refractory aggressive NHL. Kite recently announced that the ZUMA-1 trial transitioned to the pivotal Phase 2 trial (see below).
• •  On April 19, 2016, Kite Pharma announced updated clinical results from the phase 1 portion of Kite's ZUMA-1 trial of  KTE-C19, in patients with chemorefractory, aggressive non-Hodgkin lymphoma (NHL). Updated Phase 1 Results from ZUMA-1: A Phase 1-2 Multi-Center Study Evaluating the Safety and Efficacy of KTE-C19 (Anti-CD19 CAR T Cells) in Subjects with Refractory Aggressive Non-Hodgkin Lymphoma (NHL) Session: Early Clinical Trials Evaluating Cell-based, Checkpoint Inhibitors, and Novel Immunotherapeutics; Abstract Number: CT135; Presenter: Armin Ghobadi , M.D., Washington University , St. Louis.
• Phase 1 of ZUMA-1 treated a total of 7 patients with chemorefractory, diffuse large B cell lymphoma (DLBCL) KTE-C19 related adverse events consisted predominantly of cytokine release syndrome (CRS) and neurotoxicity which were generally reversible. Grade 3 or higher CRS was observed in 14% and neurotoxicity in 57%; all were reversible except in one patient with dose-limiting toxicity.
• KTE-C19 achieved rapid and durable responses in patients with chemorefractory disease (objective response rate 71%, complete response rate 57%). Ongoing complete response (CR) observed in 3 of 7 patients. One ongoing CR as of 9-month study follow-up and 2 ongoing CRs as of 6-month study follow-up.
• • On November 2, 2015, Kite Pharma announced that it has opened enrollment for the Phase 2 portion of its ongoing Phase 1/2 clinical trial (ZUMA-1) of KTE-C19 in patients with refractory, aggressive NHL. Kite Pharma expects that the Phase 2 portion of the trial will include a total of approximately 112 patients.
• • On August 17, 2015, Kite Pharma provided an update from the Company's ongoing Phase 1/2 clinical trial of KTE-C19 in patients with refractory aggressive non-Hodgkin's lymphoma (NHL) who have failed prior chemotherapy treatments and have a poor prognosis. In May, Kite announced that the first patient was treated with KTE-C19 in the Phase 1 portion of the trial and multiple patients have since been treated. Complete responses have been observed by investigators. The responses happened shortly after treatment was administered and Kite is monitoring these patients to determine durability of treatment. To date, toxicities associated with treatment have been similar to those observed in the National Cancer Institute's study of anti-CD19 CAR T cell therapy. There was one patient death early in the study, which was determined to be unrelated to KTE-C19 by the study investigator. After appropriate discussions with the FDA, Kite continued to enroll and treat patients in its study and the study was never placed on clinical hold. Kite has submitted an abstract and plans to present top-line data from the Phase 1 portion of the trial at the upcoming 2015 American Society of Hematology (ASH) Annual Meeting, to take place in Orlando, FL , December 5-8, 2015 . Kite Pharma is now on track to transition to the Phase 2 portion of the trial and plan to present Phase 1 data at ASH later this year.
• • On May 21, 2015, Kite Pharma announced that the first patient in its Phase 1/2 clinical trial of KTE-C19 in patients with refractory aggressive NHL has been treated. "We are at a pivotal moment for our Company and for the industry as a whole as we initiate the first company-sponsored clinical trial of CAR T-cell therapy in patients with refractory diffuse large B-cell lymphoma (DLBCL)" said Arie Belldegrun, M.D., FACS, Chairman, President and Chief Executive Officer. Dr. Belldegrun continued, "Kite has met its goal of initiating the first company-sponsored clinical trial of KTE-C19 in the first half of this year and plans to commence an additional three trials of KTE-C19 before year-end. Our first study is expected to provide pivotal results in 2016, leading to the potential launch and commercialization of KTE-C19 in 2017." Kite's Phase 1/2 clinical trial of KTE-C19 is a single arm, open-label, multi-center study, designed to determine the safety and efficacy of KTE-C19 in patients with refractory DLBCL, primary mediastinal B-cell lymphoma (PMBCL), or transformed follicular lymphoma (TFL). Upon completion of the Phase 1 portion of the study, Kite expects to proceed with the Phase 2 portion that will include a total of approximately 112 patients.

Is general: Yes