Business Wire

Kite Announces New Data Analyses for CAR T Therapy in Patients with Blood Cancers at the 2018 American Society of Clinical Oncology Meeting

Del

Kite, a Gilead Company (Nasdaq: GILD), today announced new analyses from the ZUMA chimeric antigen receptor T (CAR T) cell therapy development program that are being presented at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. The results include analyses of the ZUMA-1 study of Yescarta® (axicabtagene ciloleucel) in adult patients with refractory large B-cell lymphoma showing that response status may predict rates of progression-free survival (PFS) (Abstract #3003) and that treatment responses were consistent across prior lines of therapy (Abstract #3039). Additionally, an analysis of the ZUMA-3 study evaluating investigational KTE-C19 for the treatment of adult patients with relapsed or refractory acute lymphoblastic leukemia (ALL) showed that patients experienced manageable safety and encouraging efficacy irrespective of prior blinatumomab use (Abstract #7006).

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180604005338/en/

“With the U.S. approval of Yescarta last year, we aim to transform the treatment of patients with refractory large B-cell lymphoma,” said Alessandro Riva, MD, Gilead’s Executive Vice President, Oncology Therapeutics & Head, Cell Therapy. “We are also committed to studying Yescarta and other CD19-directed CAR T therapies for people with other relapsed or refractory blood cancers. Based on the strength of the ZUMA-1 data, we are now evaluating the potential of Yescarta in the second-line treatment setting in a Phase 3 study, ZUMA-7, and we continue to evaluate KTE-C19 in Phase 1/2 studies in ALL and other hematologic cancers.”

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, 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.

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.

A Marketing Authorization Application (MAA) for axicabtagene ciloleucel is currently under review with the European Medicines Agency (EMA).

Ongoing Responses, Response by Prior Lines of Therapy in ZUMA-1 (Abstracts #3003 and #3039)

Long-term ZUMA-1 follow-up data have shown an overall response rate (ORR) of 83 percent (n=84/101), including 58 percent (n=59/101) of patients with a complete response at a median follow-up of 15.1 months. In this long-term follow-up, Grade 3 or higher cytokine release syndrome (CRS) and neurologic events were seen in 12 percent and 29 percent of patients, respectively.

A new analysis of ZUMA-1 suggests that response status three months after infusion of Yescarta may be predictive of longer-term disease control. Of the 42 patients with complete response and nine with partial response at three months, the 12-month PFS rates were 79 percent and 78 percent, respectively. This abstract has also been selected for inclusion in the 2018 Best of ASCO® program.

“We are encouraged by the strong long-term complete response rates in ZUMA-1, which represents a patient population that previously had few if any remaining treatment options,” said Frederick L. Locke, MD, ZUMA-1 Co-Lead Investigator and Vice Chair of the Department of Blood and Marrow Transplant and Cellular Immunotherapy at Moffitt Cancer Center in Tampa, Florida. “Importantly, this new study analysis indicates that response status at three months is potentially predictive of prolonged PFS.”

An additional ZUMA-1 analysis evaluated outcomes based on prior therapy the patients had received. The results indicate long-term clinical benefit for patients with refractory large B cell lymphoma, irrespective of the number of prior lines of therapy.

Rates of Response with Prior Blinatumomab Treatment in ZUMA-3 (Abstract #7006)

Phase 1 data for KTE-C19, an investigational CD19 CAR T cell therapy, presented at the 2017 Annual Meeting of the American Society of Hematology (ASH) demonstrated high rates of complete response in adult patients with relapsed or refractory acute lymphoblastic leukemia (ALL). A new analysis of data from the ZUMA-3 study shows patients responded to KTE-C19 regardless of prior treatment with blinatumomab, an FDA-approved treatment for relapsed or refractory ALL. After eight or more weeks of follow-up, 63 percent (n=5/8) of patients with prior blinatumomab treatment and 80 percent (n=8/10) of patients without prior blinatumomab treatment had achieved a complete response or complete response with incomplete hematological recovery. Overall, 94 percent (n=17/18) of patients had minimal residual disease (MRD)-negative remission. KTE-C19 was also manufactured successfully in both groups, with similar product characteristics in terms of CD4/CD8 ratio and other measures.

“As a CD19/CD3 bispecific T cell antibody, the possible impact of prior blinatumomab use on the efficacy of KTE-C19 – a CD19-directed CAR T therapy – was an important question for exploration,” said Bijal Shah, MD, ZUMA-3 investigator and medical oncologist, Moffitt Cancer Center. “We observed that prior blinatumomab use did not affect the manufacturing of efficacious product, and that high response rates were seen regardless of previous treatment with blinatumomab.”

Grade 3 or higher CRS was seen in 27 percent of patients with prior blinatumomab and in 17 percent of patients without prior blinatumomab. Grade 3 or higher neurologic events were seen in 36 percent of patients with prior blinatumomab and 67 percent of patients without prior blinatumomab. A greater number of subjects in the blinatumomab-naïve group received the higher 1 × 106 cells/kg dose.

KTE-C19 for ALL is investigational and has not been proven safe or efficacious.

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.

Please see accompanying full Prescribing Information, including BOXED WARNING and Medication Guide.

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 Kite’s ability to complete the Phase 3 study of Yescarta for the treatment of relapsed or refractory large B-cell lymphoma (ZUMA-7) and the Phase 1/2 studies of KTE-C19 for the treatment of acute lymphoblastic leukemia and other hematologic cancers in the currently anticipated timelines, or at all. In addition, there is the possibility of unfavorable results from additional clinical trials involving Yescarta and KTE-C19. Further, Kite may be unable to obtain regulatory approval for axicabtagene ciloleucel from the European Commission or other regulatory authorities. 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 March 31, 2018, 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.

US Prescribing Information for Yescarta, including BOXED WARNING and Medication Guide, is available at www.kitepharma.com and www.gilead.com .

For more information on Kite, please visit the company’s website at  www.kitepharma.com . Learn more about Gilead at www.gilead.com , follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

Contact information

Gilead Sciences
Investors
Sung Lee, 650-524-7792
or
Media
Nathan Kaiser, 650-522-1853

Om 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.

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

GHX Exhibiting at MEDICA 2018 – World Forum for Healthcare15.10.2018 08:00Pressemelding

Global Healthcare Exchange (GHX), a leader in cloud-based healthcare supply chain management solutions, will be exhibiting at the leading international trade fair for the medical sector, MEDICA 2018, in Düsseldorf, Germany between the 12th and 15th November, 2018. GHX provides a full range of intelligent eCommerce and supply chain solutions specifically designed for the complex world of healthcare. The organisation’s technology connects thousands of healthcare suppliers, manufacturers and distributors with hospitals and GPOs – as well as to Governments for reporting processes. GHX technology enables the right devices, equipment, services and medicines to flow efficiently through the European healthcare supply chain. MEDICA attendees are invited to visit GHX in Hall 16, Stand F20-2, to discover how the organisation’s deep commitment to the healthcare industry, unrivalled understanding of the sector and proactive approach to collaboration to develop best practice, ensures its technology

Intertops Poker satellite sending another winner to the Malta Poker Festival where €500K is guaranteed!15.10.2018 07:06Pressemelding

Intertops Poker is sending another online satellite tournament winner to play in the €500,000 guaranteed Malta Poker Festival Main Event that runs from November 1st – 6th at the Portamaso Casino. The $2,500 prize package covers the winner’s buy-in to the Malta Poker Festival Main Event, Day 1C. $500 toward travel expenses is included. The online champion will stay at the posh Hilton Hotel November 2 – 7th. The Intertops team will take them to an exclusive MPF VIP party. The Poker Manager at Intertops Poker, said: “The Malta Poker Festival is a brand new event but I am sure it will be a hit, and there is still chance for players to earn their seat at the tables for the main event. “The festival has it all; it is set in a stunning location, it is playing in a prestigious casino and it has a life-changing prize pot. So if you think you have what it takes to lift the trophy, sign-up for the satellite now. Satellites: To register, open the Intertops Poker lobby, click ‘Poker’ > ‘Tournaments

Results from Pradaxa® RE-SPECT ESUS® and RE-SPECT CVT® trials to be presented at the 11th World Stroke Congress15.10.2018 07:00Pressemelding

Boehringer Ingelheim today announced that primary results from two key trials, RE-SPECT ESUS® and RE-SPECT CVT®, will be presented at the upcoming World Stroke Congress in Montreal, Canada 17-20 October 2018. These primary analyses will contribute to the scientific community’s understanding of both disease states and the clinical profile of dabigatran etexilate (Pradaxa®). The results from RE-SPECT ESUS, the first randomised trial comparing dabigatran etexilate with acetylsalicylic acid (ASA) in any indication, will add further insight into the prevention of secondary stroke in patients with an embolic stroke of undetermined source (ESUS).1 As the first comparison to ASA, this trial will also offer further important insights into the clinical profile of dabigatran etexilate. RE-SPECT CVT will provide additional knowledge regarding treatment of patients with cerebral venous thrombosis (CVT).2 It is the first exploratory, prospective, randomised controlled study of any non-vitamin K anta

IFC and Alipay Announce 10x1000 Tech for Inclusion Programme to Inspire Technology Leaders in Emerging Markets15.10.2018 04:15Pressemelding

International Financial Corporation (“IFC”), a member of the World Bank Group, and Ant Financial Services Group (“Ant Financial”), the world’s leading tech company and the operator of Alipay, jointly announced the 10x1000 Tech for Inclusion programme at the 2018 Annual Meetings of the International Monetary Fund and the World Bank Group. The initiative will include a comprehensive programme that embraces interactivity and the exchange of ideas to provide training to 10,000 tech experts in emerging markets from both public and private sectors over the next 10 years. Alibaba Group founder and Executive Chairman Jack Ma said that the programme aims to build an interactive and open platform to increase support for tech leaders and skilled individuals who are working to alleviate poverty and make basic financial services more broadly accessible in Indonesia, which will be the first stop of the programme within emerging markets. “I believe that investing in people is investing for the future

Chugai Presents Results from Phase III Study of Satralizumab in NMOSD at ECTRIMS 201815.10.2018 03:00Pressemelding

Chugai Pharmaceutical Co., Ltd. (TOKYO:4519) announced that results from the phase III study of satralizumab (development code: SA237), SAkuraSky Study (NCT02028884), were presented at the Congress of European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2018 held in Berlin, Germany from October 10 to 12. Satralizumab is a humanized investigational recycling anti-IL-6 receptor monoclonal antibody for the treatment of neuromyelitis optica spectrum disorder (NMOSD), which currently has no approved treatments. “These positive pivotal results for satralizumab, showing a significant reduction in relapses in patients, are a significant positive step in the potential treatment of NMOSD,” said Dr. Takashi Yamamura, Director, Department of Immunology, National Institute of Neuroscience, National Center of Neurology and Psychiatry, Tokyo. “Many people with NMOSD are suffering from frequent relapses and often persistent motor dysfunction and loss of sensation, and end up r

Guidewire InsuranceSuite Positioned as a Leader in Gartner's Magic Quadrant for P&C Core Platforms, North America, for Second Consecutive Year14.10.2018 17:10Pressemelding

GUIDEWIRE CONNECTIONS 2018–- Guidewire Software, Inc. (NYSE: GWRE), provider of the industry platform Property and Casualty (P&C) insurers rely upon, today announced that Guidewire InsuranceSuite™ has been recognized as a Leader in Gartner, Inc.'s “Magic Quadrant for P&C Core Platforms, North America 1 .” InsuranceSuite comprises essential core systems based on a common technology platform covering the P&C insurance lifecycle including underwriting, policy, billing, and claims management. It was positioned highest on the ability to execute axis and furthest on the completeness of vision axis in the report. The report can be viewed here. “While many vendors are playing to specific strengths, market leaders are expanding the scope of their capabilities with a growing emphasis on broader ecosystems with partners accessible through prebuilt integration in an app-store-like venue. As the number of ecosystem partners grows, this promises customers quicker access to a range of new capabilitie