Business Wire

Kite Announces Long-term Data From ZUMA-1 Showing Approximately Half of Refractory Large B-cell Lymphoma Patients Were Alive Three Years After Yescarta Treatment

Share

Kite, a Gilead Company (Nasdaq: GILD), today announced new data from the ZUMA-1 trial of Yescarta® (axicabtagene ciloleucel) in adult patients with refractory large B-cell lymphoma. These results included updated overall survival data from the pivotal phase 2 study after three years following a single infusion of Yescarta, as well as an analysis from a separate safety management cohort of patients receiving early steroid intervention for cytokine release syndrome (CRS) and neurologic events. The data were presented today at the 61st American Society of Hematology (ASH) Annual Meeting & Exposition, in Orlando from December 7–10, 2019.

With a minimum follow-up of three years after a single infusion of Yescarta (median follow-up of 39.1 months), approximately half (n=47/101; 47 percent) of patients with refractory large B-cell lymphoma in ZUMA-1 pivotal phase 2 cohorts were alive, and the median overall survival (OS) was 25.8 months. These updated three-year survival data were presented as part of a ZUMA-1 analysis evaluating mechanism of secondary treatment failure following treatment with Yescarta (Abstract #203).

“With approximately half of patients with refractory large B-cell lymphoma in our registrational trial alive three years following treatment with Yescarta, we are delivering towards our goal of potentially life-saving therapy for many patients who previously faced limited treatment options and a poor prognosis prior to the introduction of CAR T therapy,” said Christi Shaw, Chief Executive Officer of Kite. “These results, coupled with an analysis that suggests a reduced risk of severe CRS and neurological events with earlier use of steroids, further support our ongoing leadership in cell therapy and commitment to patient care.”

Yescarta was the first CAR T cell therapy to be approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, and high grade B-cell lymphoma and DLBCL arising from follicular lymphoma. Yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma. The Yescarta U.S. Prescribing Information has a BOXED WARNING for the risks of CRS and neurologic toxicities, and Yescarta is approved with a risk evaluation and mitigation strategy (REMS) due to these risks; see below for Important Safety Information.

Updated results from a separate ZUMA-1 safety management study (Cohort 4) were also presented at the meeting (Abstract #243). In this analysis, patients with relapsed or refractory large B-cell lymphoma treated with Yescarta received earlier steroid intervention, beginning when patients experienced Grade 1 neurologic events or experienced Grade 1 CRS with no improvement after three days of supportive care. Patients could receive optional bridging chemotherapy prior to Yescarta infusion.

In the analysis, 41 patients had received Yescarta, with a median follow-up of 8.7 months; 73 percent of patients received corticosteroids and 76 percent received tocilizumab. Earlier steroid use appeared to decrease the percentage of patients with Grade ≥3 CRS (2 percent) and neurologic events (17 percent), each of which were numerically lower than rates in the registrational cohorts of ZUMA-1 (13 percent CRS, 31 percent neurologic events). There were no Grade 4 or 5 CRS or neurologic events and no Grade 5 AEs related to Yescarta in Cohort 4.

Objective response rate per investigator assessment was 73 percent in Cohort 4, with 51 percent of patients achieving a complete response. The median duration of response was 8.9 months. Fifty-four percent of patients in this cohort remained in an ongoing response with at least six months of follow-up after Yescarta infusion. Median OS in Cohort 4 has not been reached.

“Results from ZUMA-1 Cohort 4 demonstrate that early steroid intervention has the potential to reduce the rate of severe CRS and neurologic events while appearing to maintain comparably impressive efficacy for Yescarta to the pivotal ZUMA-1 study cohorts,” said Max S. Topp, MD, ZUMA-1 Cohort 4 investigator and Professor and Head of Hematology, University Hospital of Wuerzburg, Germany. “Data from this cohort suggest this approach with earlier steroid use may further improve the benefit/risk profile of this CAR T therapy.”

U.S. Important Safety Information for Yescarta

BOXED WARNING: CYTOKINE RELEASE SYNDROME AND NEUROLOGIC TOXICITIES

  • Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving Yescarta®. Do not administer Yescarta® to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids.
  • Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving Yescarta®, including concurrently with CRS or after CRS resolution. Monitor for neurologic toxicities after treatment with Yescarta®. Provide supportive care and/or corticosteroids as needed.
  • Yescarta® is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Yescarta® REMS.

CYTOKINE RELEASE SYNDROME (CRS): CRS occurred in 94% of patients, including 13% with ≥ Grade 3. Among patients who died after receiving Yescarta®, 4 had ongoing CRS at death. The median time to onset was 2 days (range: 1-12 days) and median duration was 7 days (range: 2-58 days). Key manifestations include fever (78%), hypotension (41%), tachycardia (28%), hypoxia (22%), and chills (20%). Serious events that may be associated with CRS include cardiac arrhythmias (including atrial fibrillation and ventricular tachycardia), cardiac arrest, cardiac failure, renal insufficiency, capillary leak syndrome, hypotension, hypoxia, and hemophagocytic lymphohistiocytosis/macrophage activation syndrome. Ensure that 2 doses of tocilizumab are available prior to infusion of Yescarta®. Monitor patients at least daily for 7 days at the certified healthcare facility following infusion for signs and symptoms of CRS. Monitor patients for signs or symptoms of CRS for 4 weeks after infusion. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time. At the first sign of CRS, institute treatment with supportive care, tocilizumab or tocilizumab and corticosteroids as indicated.

NEUROLOGIC TOXICITIES: Neurologic toxicities occurred in 87% of patients. Ninety-eight percent of all neurologic toxicities occurred within the first 8 weeks, with a median time to onset of 4 days (range: 1-43 days) and a median duration of 17 days. Grade 3 or higher occurred in 31% of patients. The most common neurologic toxicities included encephalopathy (57%), headache (44%), tremor (31%), dizziness (21%), aphasia (18%), delirium (17%), insomnia (9%) and anxiety (9%). Prolonged encephalopathy lasting up to 173 days was noted. Serious events including leukoencephalopathy and seizures occurred with Yescarta®. Fatal and serious cases of cerebral edema have occurred in patients treated with Yescarta®. Monitor patients at least daily for 7 days at the certified healthcare facility following infusion for signs and symptoms of neurologic toxicities. Monitor patients for signs or symptoms of neurologic toxicities for 4 weeks after infusion and treat promptly.

YESCARTA® REMS: Because of the risk of CRS and neurologic toxicities, Yescarta® is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Yescarta® REMS. The required components of the Yescarta® REMS are: Healthcare facilities that dispense and administer Yescarta® must be enrolled and comply with the REMS requirements. Certified healthcare facilities must have on-site, immediate access to tocilizumab, and ensure that a minimum of 2 doses of tocilizumab are available for each patient for infusion within 2 hours after Yescarta® infusion, if needed for treatment of CRS. Certified healthcare facilities must ensure that healthcare providers who prescribe, dispense or administer Yescarta® are trained about the management of CRS and neurologic toxicities. Further information is available at www.YESCARTAREMS.com or 1-844-454-KITE (5483).

HYPERSENSITIVITY REACTIONS: Allergic reactions may occur. Serious hypersensitivity reactions including anaphylaxis may be due to dimethyl sulfoxide (DMSO) or residual gentamicin in Yescarta®.

SERIOUS INFECTIONS: Severe or life-threatening infections occurred. Infections (all grades) occurred in 38% of patients, and in 23% with ≥ Grade 3. Grade 3 or higher infections with an unspecified pathogen occurred in 16% of patients, bacterial infections in 9%, and viral infections in 4%. Yescarta® should not be administered to patients with clinically significant active systemic infections. Monitor patients for signs and symptoms of infection before and after Yescarta® infusion and treat appropriately. Administer prophylactic anti-microbials according to local guidelines. Febrile neutropenia was observed in 36% of patients and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad spectrum antibiotics, fluids and other supportive care as medically indicated. Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure and death, can occur in patients treated with drugs directed against B cells. Perform screening for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing.

PROLONGED CYTOPENIAS: Patients may exhibit cytopenias for several weeks following lymphodepleting chemotherapy and Yescarta® infusion. Grade 3 or higher cytopenias not resolved by Day 30 following Yescarta® infusion occurred in 28% of patients and included thrombocytopenia (18%), neutropenia (15%), and anemia (3%). Monitor blood counts after Yescarta® infusion.

HYPOGAMMAGLOBULINEMIA: B-cell aplasia and hypogammaglobulinemia can occur. Hypogammaglobulinemia occurred in 15% of patients. Monitor immunoglobulin levels after treatment and manage using infection precautions, antibiotic prophylaxis and immunoglobulin replacement. The safety of immunization with live viral vaccines during or following Yescarta® treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during Yescarta® treatment, and until immune recovery following treatment.

SECONDARY MALIGNANCIES: Patients may develop secondary malignancies. Monitor life-long for secondary malignancies. In the event that a secondary malignancy occurs, contact Kite at 1-844-454-KITE (5483) to obtain instructions on patient samples to collect for testing.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES: Due to the potential for neurologic events, including altered mental status or seizures, patients are at risk for altered or decreased consciousness or coordination in the 8 weeks following Yescarta® infusion. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, during this initial period.

ADVERSE REACTIONS: The most common adverse reactions (incidence ≥ 20%) include CRS, fever, hypotension, encephalopathy, tachycardia, fatigue, headache, decreased appetite, chills, diarrhea, febrile neutropenia, infections-pathogen unspecified, nausea, hypoxia, tremor, cough, vomiting, dizziness, constipation, and cardiac arrhythmias.

About Kite

Kite, a Gilead Company, is a biopharmaceutical company based in Santa Monica, California. Kite is engaged in the development of innovative cancer immunotherapies. The company is focused on chimeric antigen receptor and T cell receptor engineered cell therapies. For more information on Kite, please visit www.kitepharma.com.

About Gilead Sciences

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California. For more information on Gilead Sciences, please visit the company’s website at www.gilead.com.

Forward-Looking Statement

This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the possibility of unfavorable results from other ongoing and additional clinical trials involving Yescarta. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2019, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead and Kite, and Gilead and Kite assume no obligation to update any such forward-looking statements.

U.S. Prescribing Information for Yescarta, including BOXED WARNING, is available at www.kitepharma.com and www.gilead.com.

Yescarta is a registered trademark of Gilead Sciences, Inc., or its related companies.

For more information on Kite, please visit the company’s website at www.kitepharma.com or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000. Follow Kite on social media on Twitter (@KitePharma) and LinkedIn.

Contact information

Greg Mann, Investors
(424) 322-1795

Nathan Kaiser, Media
(650) 522-1853

About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

PDI Releases International Cloud-Based Logistics Solution for the Fuel Supply Chain28.9.2020 10:00:00 CESTPress release

PDI (www.pdisoftware.com), a global provider of enterprise software solutions to the convenience retail, wholesale petroleum and logistics industries, announced the release of PDI Logistics Cloud international. The company’s holistic logistics software was specifically designed for the fuel supply chain and helps fuel retail, mineral oil, wholesale and hauler companies gain the end-to-end visibility they need to optimize their operations. Logistics Cloud builds on PDI’s heritage of bringing innovative products to the market and enables digital transformation by leveraging the latest technology. Its use of Big Data, IoT, and sophisticated algorithms enable better compartment allocation, automation and forecasting. The software’s robust capabilities—including advanced planning and dispatching, mobile tools, forecasting, telematics, compliance, and analytics—allows businesses to scale, future-proof their operations, and quickly adapt to dynamic market conditions. The solution will allow c

NTT Com Demonstration Test to Link GAIA-X Platform’s “IDS Connector” Technology and SDPF Based on Data Trust ®28.9.2020 08:00:00 CESTPress release

NTT Communications Corporation (NTT Com), the ICT solutions and international communications business within the NTT Group (TOKYO:9432), announced today that beginning October 1 it will collaborate with the International Data Spaces Association (IDSA)1 in a demonstration test as the first phase of contributing to the development of a secure, global data-management platform2 that assures interoperability between data platforms built and managed in countries worldwide. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200927005006/en/ The test environment image (Graphic: Business Wire) The test environment for sharing highly confidential data securely will include IDS Connectors3, the core technology of GAIA-X4, a federated data infrastructure for Europe, and NTT Com’s Things Cloud® IoT platform and Smart Data Platform (SDPF)5, the later incorporating Data Trust®6 policies. The demonstration, in addition to assessing the practica

Shin-Etsu Chemical Has Developed an Epoch-making Type of Molding Silicone Rubber That Does Not Require Post Cure28.9.2020 08:00:00 CESTPress release

In addition to its already being marketed liquid silicone rubber form, Shin-Etsu Chemical Co., Ltd. (Head Office: Tokyo, President, Yasuhiko Saitoh) has now developed a molding silicone rubber that also does not require post cure in its millable form. Shin-Etsu is the first in the industry to have developed a millable (high consistency) type* of silicone rubber that does not require a post cure. Shin-Etsu succeeded in developing this breakthrough product by making use of the unique technology that Shin-Etsu Chemical has cultivated over a long period of years. In the existing molding method for millable-type silicone rubber, after the initial press cure of the silicone molding is performed, a post cure is carried out in order to drive off the residues that are left within the molded product as a result of the vulcanization agent used in rubber molding as well as the low-molecular siloxane. Compared to the existing product, the new silicone rubber molding product that Shin-Etsu has devel

US-Cable Operator Armstrong Turns To Verimatrix To Streamline & Secure VOD Launch28.9.2020 07:15:00 CESTPress release

Regulatory News: Verimatrix, (Paris:VMX) (Euronext Paris: VMX), the leader in powering the modern connected world with people-centered security, today announced that Butler, Pennsylvania-based Armstrong, a leading U.S. cable company offering service in more than 469 zip codes, deployed the Verimatrix Video Content Authority System (VCAS™). Founded 74-years ago, Armstrong is committed to securely offering a wide array of popular streaming options for its large customer base. Armstrong recently incorporated a more sophisticated TiVo platform into its set-top boxes in order to remain at the cutting-edge of technological changes in the television industry. In order to make the transition worthwhile, the company required a high-quality, easy-to-integrate encryption solution that would allow it to offer as many streaming options – and it selected the Verimatrix VCAS solution. “Their high-level anti-piracy software is widely accepted by content owners, something other encryption services simp

Spirit of Wipro Run Brings Together Thousands of Participants Globally27.9.2020 08:52:00 CESTPress release

Wipro Limited (NYSE: WIT, BSE: 507685, NSE: WIPRO), a leading global information technology, consulting and business process services company, today organized the 15th edition of the ‘Spirit of Wipro’ (SOW) Run globally with thousands of participants across 35 countries, running separately, yet together in spirit, at a time of their choosing. The theme for this year’s Run was “United. Unstoppable”, which celebrated camaraderie, resilience and a shared sense of community among several thousands of Wipro employees, their friends and families, alumni, customers, partners and suppliers. The SOW Run is an annual, global tradition at Wipro and has been held every year since its inception. This year too, the Run was organized on schedule despite the pandemic induced constraints. The runners strictly adhered to the local COVID-19 guidelines and safety protocols in various countries while participating in the event. Commenting on the Run, Thierry Delaporte, Chief Executive Officer and Managing

BCG Collaborates with Tencent Marketing Insight to Release 2020 BCG x Tencent Digital Luxury Report25.9.2020 12:21:00 CESTPress release

Since early 2020 when the COVID-19 pandemic broke out worldwide, the luxury market has been hit hard and is expected to decline 25% to 45% compared to the previous year. The Chinese luxury market, however, which has benefitted from successful domestic control of the pandemic and has taken the lead in recovery against a depressed global market environment, is forecast to grow from 20% to 30% in the whole year of 2020. Thanks to its stunning market performance, China has become the main battleground of each major luxury brand. In was in this environment that Boston Consulting Group (BCG) joined hands with Tencent Marketing Insight (TMI) to release the 2020 BCG x Tencent Digital Luxury Report, drawing on deep insights into post COVID-19 trends in the luxury market and consumers based on BCG and TMI’s quantitative consumer research and industry experience, as well as TMI’s marketing and big data capabilities. Crystal Hao, Managing Director & Partner of BCG said, “The luxury market in China