Kite Announces Long-Term Data From Pivotal ZUMA-1 Study of Yescarta™ (Axicabtagene Ciloleucel) in Patients With Refractory Large B-cell Lymphoma
Kite, a Gilead Company (Nasdaq: GILD), 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.
This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171210005072/en/
Yescarta is the first chimeric antigen receptor T (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, high grade B-cell lymphoma and DLBCL arising from follicular lymphoma. Yescarta is not indicated for patients with primary central nervous system lymphoma.
DLBCL is the most common aggressive non-Hodgkin lymphoma, accounting for three out of every five cases. In the United States each year, there are approximately 7,500 patients with refractory DLBCL who are eligible for CAR T therapy.
“As observed in the SCHOLAR-1 study, treatment options for patients with refractory large B-cell lymphoma have yielded a median overall survival of just six months, with fewer than ten percent of patients achieving complete remission,” said Sattva S. Neelapu, MD, ZUMA-1 Co-Lead Investigator and Professor, Department of Lymphoma/Myeloma, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center. “The durability of response seen with Yescarta in this long-term follow-up reinforces the major advance that CAR T therapy represents for these patients.”
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.
Yescarta has a Boxed Warning in its product label and an associated Risk Evaluation and Mitigation Strategy (REMS) regarding the risks of CRS and neurologic toxicities. Please see below for Important Safety Information.
“Historically, people with refractory large B-cell lymphoma have not been adequately served by available treatment options,” said David Chang, MD, PhD, Worldwide Head of Research and Development and Chief Medical Officer at Kite. “We are encouraged by the durability and depth of response seen in ZUMA-1 more than a year after treatment with Yescarta, which represents an important advance in the treatment of patients with refractory disease.”
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.
U.S. Indication for Yescarta
Yescarta is a CD19-directed genetically modified autologous T cell immunotherapy indicated 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, 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.
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, including fatal or life-threatening reactions, occurred following treatment with Yescarta. In Study 1, CRS occurred in 94% (101/108) of patients receiving Yescarta, including ≥ Grade 3 (Lee grading system) CRS in 13% (14/108) of patients. Among patients who died after receiving Yescarta, four had ongoing CRS events at the time of death. The median time to onset was 2 days (range: 1 to 12 days) and the median duration of CRS was 7 days (range: 2 to 58 days). Key manifestations of CRS 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 (HLH/MAS).
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, that were fatal or life-threatening, occurred following treatment with Yescarta. Neurologic toxicities occurred in 87% of patients. Ninety-eight percent of all neurologic toxicities occurred within the first 8 weeks of Yescarta infusion, with a median time to onset of 4 days (range: 1 to 43 days). The median duration of neurologic toxicities was 17 days. Grade 3 or higher neurologic toxicities 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.
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 two 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).
Allergic reactions may occur with the infusion of Yescarta. Serious hypersensitivity reactions including anaphylaxis, may be due to dimethyl sulfoxide (DMSO) or residual gentamicin in Yescarta.
Severe or life-threatening infections occurred in patients after Yescarta infusion. In Study 1, infections (all grades) occurred in 38% of patients. Grade 3 or higher infections occurred in 23% of patients. 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 after Yescarta infusion 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.
Patients may exhibit cytopenias for several weeks following lymphodepleting chemotherapy and Yescarta infusion. In Study 1, 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.
B-cell aplasia and hypogammaglobulinemia can occur in patients receiving treatment with Yescarta. In Study 1, hypogammaglobulinemia occurred in 15% of patients. Monitor immunoglobulin levels after treatment with Yescarta 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 with Yescarta.
Patients treated with Yescarta 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 receiving Yescarta 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.
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. Serious adverse reactions occurred in 52% of patients. The most common serious adverse reactions (> 2%) include encephalopathy, fever, lung infection, febrile neutropenia, cardiac arrhythmia, cardiac failure, urinary tract infection, renal insufficiency, aphasia, cardiac arrest, Clostridium difficile infection, delirium, hypotension, and hypoxia.
The most common (≥ 10%) Grade 3 or higher reactions include febrile neutropenia, fever, CRS, encephalopathy, infections-pathogen unspecified, hypotension, hypoxia and lung infections.
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 is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases. Gilead has operations in more than 30 countries worldwide, with headquarters in Foster City, California.
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 further clinical trials involving Yescarta. In addition, regulatory agencies, including the EMA, may not approve Yescarta in the currently anticipated timelines or at all, and any marketing approvals may have significant limitations on its use. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and are cautioned not to place undue reliance on these forward-looking statements. Actual results may differ materially from those currently anticipated due to a number of risks and uncertainties. Risks and uncertainties that could cause the actual results to differ from expectations contemplated by forward-looking statements include risks and uncertainties detailed from time to time in Gilead Sciences, Inc.’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2017 as filed with the 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 and disclaim any intent to update any such forward-looking statements.
US Prescribing Information for Yescarta, including BOXED WARNING and Medication Guide, is available at www.yescarta.com .
For more information on Gilead Sciences, please visit the company’s website at www.gilead.com , follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
Sung Lee, 650-524-7792
Nathan Kaiser, 650-522-1853
Om Business Wire
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Følg saker fra Business Wire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Business Wire
Integral Expands Cryptocurrency Market Data Services to Include 14 Cryptocurrencies and 16 Exchanges23.1.2018 22:00 | Pressemelding
Integral (www.integral.com), the financial technology partner trusted by leading banks, brokers, and investment managers to design, deliver and grow their FX businesses, announced today that it has expanded its market data offering for cryptocurrencies to include 14 major cryptocurrencies connecting to all major exchange sources across the U.S., Europe and Asia including Japan and Hong Kong. “An accurate, stable, and reliable reference price is a requirement for any market maker,” said Harpal Sandhu, CEO of Integral. “The Cryptocurrency Market Data Service connects to the most price sources and applies the most advanced price discovery algorithm available.” Integral has years of experience as a technology leader and innovator in foreign exchange and is now applying this ingenuity to the cryptocurrency market. The Market Data Service uses algorithms developed with Stanford University for Integral FX Benchmark to provide the most precise reference prices for cryptocurrencies. “Integral’s
Kimbal Riley to Become Vista Group CEO23.1.2018 21:57 | Pressemelding
Vista Group International (NZX & ASX: VGL) has today announced that Kimbal Riley will take over as Group CEO from Murray Holdaway. Mr Holdaway will take up the position of Chief Product Officer (CPO) for Vista Group, and will continue in his role as an Executive Director on the Vista Group board. This has taken place as part of a succession planning process and will deliver a seamless transition within the business. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180123006545/en/ Kimbal Riley becomes CEO of Vista Group International (Photo: Business Wire) Mr Riley has had an extensive career in senior executive roles in the IT and Services industries in New Zealand and overseas. He joined Vista Group four years ago, with the past two years as CEO of Vista Entertainment Solutions (VES), which is responsible for the largest proportion of the Group’s revenue. He has been focused on building scale in the business and under his lea
IFF Breaks Ground on Flavors/Fragrances Site in Sri City, India23.1.2018 17:00 | Pressemelding
Regulatory News: International Flavors & Fragrances Inc. (NYSE: IFF) (Euronext Paris: IFF), a leading innovator of sensory experiences that move the world, has broken ground on a new flavors and fragrances plant located in Sri City, in the State of Andhra Pradesh in India. Part of a larger investment into the Greater Asia region, the plant is expected to be commercialized in December 2019. The new facility, which will be the largest flavor and fragrance manufacturing facility in India and the largest IFF site in Greater Asia, occupies a 32-acre/130,000m2 plot and will serve IFF flavors and fragrances customers across India and the region. “In this economically vibrant country, it is critical that we invest to provide our customers with winning tastes and scents,” said IFF Chairman and CEO Andreas Fibig. “This new facility is fitted with capabilities tailored for our customers’ needs. Coupled with our excellent consumer insights teams and their deep understanding of the local markets, w
Global Eagle to Elevate Airline Passenger Experience Over North America with More SES HTS Satellite Capacity23.1.2018 14:33 | Pressemelding
Global Eagle Entertainment Inc. (NASDAQ: ENT) is aiming to provide airline passengers travelling across North America with a connected inflight experience far more like the one passengers enjoy on the ground, tripling the amount of high throughput satellite (HTS) capacity secured with SES Networks aboard the SES-15 satellite. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180123005989/en/ Global Eagle to Elevate Airline Passenger Experience Over North America with More SES HTS Satellite Capacity (Photo: Business Wire) SES announced today that Global Eagle has secured a major increase of Ku-band capacity on its new hybrid SES-15 HTS satellite to enable the delivery of high-speed broadband and a wide range of inflight communications and operational applications aboard commercial airline flights throughout the US, including the increasingly important US mainland to Hawaii routes. The multi-year agreement is the latest contract t
Optiv Security Names Simon Church as General Manager and Executive Vice President, Europe; Accelerates International Growth Strategy with Expansion in Europe23.1.2018 14:05 | Pressemelding
Optiv Security, a market-leading provider of end-to-end cyber security solutions, today announced it is continuing to accelerate its international growth strategy by naming Simon Church as general manager and executive vice president, Europe. In his newly created role, Church will establish and grow Optiv’s presence in Europe, enabling the company to serve locally-based organizations and global clients with expanded skills, knowledge and presence. Optiv serves more than 60% of the Fortune 1000, and this appointment will increase its ability to provide US and international clients with worldwide expertise and experience, assisting them in reducing the complexity of their cyber security programs while maximizing the efficacy and value of their security investments. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180123005315/en/ Optiv Security Names Simon Church as General Manager and Executive Vice President, Europe; Accelerate
LEGO® Education Launches New Maker Activities for Schools23.1.2018 14:00 | Pressemelding
LEGO® Education Maker, a continuum of activities for early learning through middle school, is available today to schools around the world. The activities are centered around the iconic LEGO brick and inspired by the open-ended, playful creativity of making. The new, free LEGO Education Maker activities include stimulating challenges for every student at every education level and incorporate LEGO Education solutions including LEGO Education STEAM Park, LEGO Education Simple Machines, LEGO Education WeDo 2.0, LEGO® MINDSTORMS® Education EV3 and LEGO Education Simple and Powered Machines. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180123005927/en/ LEGO® Education Launches New Maker Activities for Schools (Photo: Business Wire) New LEGO Education Maker activities provide unlimited learning for all ages The new LEGO Education Maker activities place educators in the role of facilitators, as they guide their students through a s
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom