On May 26, 2017 Kite Pharma, Inc., (Nasdaq:KITE), a leading cell therapy company, reported that the U.S. Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) for axicabtagene ciloleucel (Press release, Kite Pharma, MAY 26, 2017, View Source [SID1234519299]). The submission follows positive data demonstrated with a single infusion of axicabtagene ciloleucel in the ZUMA-1 Phase 2 trial in patients with refractory aggressive non-Hodgkin lymphoma (NHL). The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of November 29, 2017. Schedule your 30 min Free 1stOncology Demo! "Patients with refractory aggressive NHL face a dire prognosis with only a 50 percent chance of surviving six months. This underscores the urgent medical need for these patients and why every day matters, from development to manufacturing to clinical experience," said David Chang, M.D., Ph.D., Executive Vice President of Research and Development and Chief Medical Officer of Kite. "We firmly believe in the potential for axicabtagene ciloleucel to address this need and forge a new path for the future of cell therapy."
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The filing acceptance is supported by data from the ZUMA-1 Phase 2 trial which met the primary endpoint of objective response rate (ORR) recorded after a single infusion of axicabtagene ciloleucel with 82 percent (p < 0.0001). At a median follow-up of 8.7 months, 44 percent of patients were in ongoing response, which included 39 percent of patients in complete response (CR).
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). There were three deaths throughout the course of the registrational trial not due to disease progression, of which two events, were deemed related to axicabtagene ciloleucel.
In December 2015, axicabtagene ciloleucel received Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for DLBCL, TFL, and PMBCL. The company expects to submit its Market Authorization Application (MAA) of axicabtagene ciloleucel with the European Medicines Agency (EMA) in the third quarter of 2017.
ZUMA-1 is supported in part by funding from The Leukemia & Lymphoma Society (LLS) Therapy Acceleration Program.
About axicabtagene ciloleucel
Kite’s lead product candidate, axicabtagene ciloleucel, is an investigational therapy in which a patient’s T cells are engineered to express a chimeric antigen receptor (CAR) to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias, and redirect the T cells to kill cancer cells. Axicabtagene ciloleucel has been granted Breakthrough Therapy Designation status for diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL), and primary mediastinal B-cell lymphoma (PMBCL) by the U.S. Food and Drug Administration (FDA) and Priority Medicines (PRIME) regulatory support for DLBCL in the EU.
Author: [email protected]
Aduro Biotech to Host and Webcast an Investor Event in Conjunction with the 2017 ASCO Annual Meeting
On May 26, 2017 Aduro Biotech, Inc. (NASDAQ:ADRO) reported that the Aduro management team will host an investor event with special guest speaker Jason J. Luke, M.D., FACP, Assistant Professor of Medicine at the University of Chicago and a principal investigator for the Phase 1 dose-escalation trial of ADU-S100 in patients with advanced/metastatic solid tumors or lymphomas (Press release, Aduro Biotech, MAY 26, 2017, View Source [SID1234519298]). This event will take place in conjunction with the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, IL on Saturday June 3, 2017, at 6:00 a.m. Central Time. Schedule your 30 min Free 1stOncology Demo! Dr. Luke is a clinical investigator and a medical oncologist whose research focuses on translational therapeutic advances for melanoma and early phase drug development, particularly immunotherapy.
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To access the live webcast and subsequent archived recording of this and other company presentations, please visit the investor section of Aduro’s website at www.aduro.com.
Adaptimmune Announces an Oral Presentation and Four Trials in Progress Posters at the American Society of Clinical Oncology (ASCO) Annual Meeting
On May 26, 2017 Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, reported an oral presentation, as well as four trials in progress posters, at the 2017 ASCO (Free ASCO Whitepaper) annual meeting in Chicago, Illinois on June 2 through June 6, 2017 (Press release, Adaptimmune, MAY 26, 2017, View Source [SID1234519297]). Schedule your 30 min Free 1stOncology Demo! During an oral presentation scheduled for 1:15-1:27 PM CDT on June 5th, Dr. Sandra P. D’Angelo of the Memorial Sloan Kettering Cancer Center will present a full update on Cohorts 1, 2, 3, and 4 from Adaptimmune’s ongoing study of NY-ESO SPEAR T-cells in patients with synovial sarcoma.
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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
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The Company will host a webinar / teleconference on June 6th from 8:00–9:00 AM EDT (1:00 -2:00 PM BST) to discuss the updated synovial sarcoma clinical data. Call in details and the webinar link will be made available in the Investors section of Adaptimmune’s website (View Source).
The four trials in progress posters will summarize the study designs for Adaptimmune’s ongoing NY‑ESO trials in myxoid/round cell liposarcoma (MRCLS), ovarian cancer, and non-small cell lung cancer (NSCLC); the Company’s ongoing MAGE-A10 trial in NSCLC, and its MAGE-A10 triple tumor study in patients with head and neck, melanoma, or urothelial "bladder" tumors.
Adaptimmune will also host a corporate exhibition booth in the Oncology Professionals Hall (Booth #5031).
Details regarding the oral presentation and the four trials in progress posters are as follows:
Oral Presentation:
Monday, June 5, 2017
Session: Developmental Therapeutics—Immunotherapy
• Abstract ID: 3000
— Title: "Open label, non-randomized, multi-cohort pilot study of genetically engineered NY-ESO-1 specific NY-ESO-1c259t in HLA-A2+ patients with synovial sarcoma (NCT01343043)"
— Presentation Time: 1:15-1:27 PM CDT
— Location: Hall D1
Trials in Progress Posters:
Monday, June 5, 2017
Session: Developmental Therapeutics—Immunotherapy
Presentation Time: 8:00-11:30 AM CDT
Location: Hall A
• Abstract ID: TPS3094
— Poster Board #: 187b
— Title: "A phase I/IIa, open-label, clinical trial evaluating the safety and efficacy of autologous T-cells expressing enhanced T-cell receptors (TCRs) specific for NY-ESO-1 in patients with recurrent or treatment refractory ovarian cancer (NCT01567891)"
• Abstract ID: TPS3097
— Poster Board #: 189a
— Title: "A pilot study of NY-ESO-1c259 T-cells in subjects with advanced myxoid/round cell liposarcoma (NCT02992743)"
• Abstract ID: TPS3096
— Poster Board #: 188b
— Title: "Two phase I/II open-label clinical trials evaluating the safety and efficacy of autologous T‑cells expressing enhanced TCRs specific for NY-ESO-1 or MAGE-A10 in subjects with stage IIIb or stage IV non-small cell lung cancer (NCT02588612/NCT02592577)"
• Abstract ID: TPS3098
— Poster Board #: 189b
— Title: "A phase I single-arm, open-label clinical trial evaluating safety of MAGE-A10c796T in subjects with advanced or metastatic head and neck, melanoma, or urothelial tumors (NCT02989064)"
AstraZeneca delivers new data on expanding portfolio of cancer medicines at 2017 American Society of Clinical Oncology (ASCO) Annual Meeting
On May 26, 2017 AstraZeneca, along with its global biologics research and development arm, MedImmune, reported that will demonstrate how it is rapidly delivering on the Company’s science-led strategy for transformational cancer medicine development at the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, US, 2-6 June 2017 (Press release, AstraZeneca, MAY 26, 2017, View Source(asco)-annual-meeting-26052017.html [SID1234519289]). Schedule your 30 min Free 1stOncology Demo! With three new oncology medicines addressing the unmet needs of patients with ovarian, lung, and bladder cancers approved in under three years, AstraZeneca is now halfway to delivering on its promise to launch six new medicines for cancer by 2020.
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This progress is reflected in the 100 company-sponsored and supported abstracts, including five Best-of-ASCO presentations, 11 oral presentations and eight poster discussions, accepted for the meeting. These include new data on approved and potential new medicines from the Company’s pipeline across multiple scientific platforms and tumour types.
Jamie Freedman, Executive Vice President, Oncology at AstraZeneca, said: "2017 is a pivotal year for our oncology portfolio as global launch and development programmes for Lynparza, Tagrisso and Imfinzi gain momentum, with further pivotal data anticipated in the coming months, in particular in 1st-line non-small cell lung cancer. We are excited to demonstrate the strength of our rapidly-expanding portfolio at ASCO (Free ASCO Whitepaper), including the positive OlympiAD results for Lynparza in BRCA-mutated metastatic breast cancer."
Growing confidence in DNA Damage Response (DDR) approach emphasised by OlympiAD results
‘Late-breaker’ data from the OlympiAD trial of Lynparza (olaparib) versus chemotherapy in BRCA-mutated metastatic breast cancer (Abstract #LBA4) are the first positive Phase III results for a poly ADP-ribose polymerase (PARP) inhibitor beyond ovarian cancer. They are an important next step in the development of AstraZeneca’s DDR approach to selectively targeting of tumours through deficiencies in cancer cell DNA repair mechanisms.
Additional Lynparza data will include:
SOLO-2: Oral presentation of Phase III data on the relationship between health-related quality of life (HRQOL) and patient-centred and clinical outcomes with Lynparza maintenance following chemotherapy in patients with BRCA-mutated platinum-sensitive relapsed serous ovarian cancer (Abstract #5507)
Study 19: Randomised Phase II overall survival and updated progression-free survival data for the combination of Lynparza and cediranib versus Lynparza alone in recurrent platinum-sensitive ovarian cancer (Abstract #5535)
AstraZeneca’s unique DDR pipeline will also be illustrated through an oral presentation of Phase I data on the WEE1 inhibitor, AZD1775, in combination with radiation therapy and temozolomide in patients with newly-diagnosed glioblastoma multiforme (GBM) and evaluation of intratumoural drug distribution in patients with recurrent GBM (Abstract #2005). Additional information will also be presented from a Phase I trial of AZD1775 in combination with neoadjuvant weekly cisplatin and docetaxel in borderline-resectable head and neck squamous cell carcinoma (HNSCC) (Abstract #6034).
Extended evidence of the effect of Tagrisso (osimertinib) on CNS metastases
Latest Tagrisso data from the AURA3 trial to be released during an oral presentation will provide further evidence of the response to treatment in patients with epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC) and CNS metastases (Abstract #9005).
Further insights into the ability of Tagrisso to cross the blood-brain barrier will be provided through updated results from the BLOOM trial of Tagrisso in patients with EGFR mutation-positive NSCLC and leptomeningeal disease (Abstract #2020).
New data on Imfinzi (durvalumab) as monotherapy and in combination
Building on exciting recent milestones for its Immuno-Oncology programme, AstraZeneca will be presenting updated data from the NSCLC and bladder cancer cohorts of the Phase I/II Study 1108 of durvalumab in patients with advanced solid tumours. New data in locally-advanced or metastatic urothelial carcinoma (mUC) (Abstract #4525) reinforce the May 2017 US FDA approval of Imfinzi for the treatment of patients with locally advanced or mUC who have disease progression during or following platinum-containing chemotherapy, or whose disease has progressed within 12 months of receiving platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery.
Updated durvalumab monotherapy Study 1108 results in Stage IIIB/IV NSCLC (Abstract #9085) will also be presented. These data underline AstraZeneca’s forward momentum in lung cancer following the positive top-line results of the Phase III PACIFIC trial of durvalumab as sequential treatment in patients with locally-advanced, unresectable (Stage III) NSCLC. In an oral presentation, MedImmune will present data on a novel relationship in NSCLC between EGFR pathway activation and the immunosuppressive molecule CD73 (Abstract #11505).
Medicare Coverage of Prolaris® Test Expands with the Addition of Men Diagnosed with Favorable Intermediate Risk Prostate Cancer
On May 25, 2017 Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, reported that Palmetto GBA, a Medicare Administrative Contractor (MAC) that assesses molecular diagnostic technologies, has issued a positive final Local Coverage Determination (LCD) to expand Medicare coverage of the Prolaris test (Press release, Myriad Genetics, MAY 25, 2017, View Source [SID1234519305]).
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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
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Today’s decision extends coverage to Medicare beneficiaries with favorable intermediate risk prostate cancer and builds on a prior decision that provided coverage for men with low- and very low-risk prostate cancer. The new LCD is posted to the Medicare Coverage Database on the Centers for Medicare & Medicaid Services (CMS) website with an effective date of July 10, 2017. Prolaris is the first and only genetic test to receive Medicare coverage for favorable intermediate and low- or very low-risk prostate cancer in the United States.
"We are excited that the MolDX program has expanded Prolaris coverage to the thousands of Medicare beneficiaries with favorable intermediate risk prostate cancer," said Mark C. Capone, president and CEO, Myriad Genetics. "The coverage decision is another important step to make sure the Prolaris test is broadly accessible to the patients who need it."
Of the newly diagnosed patients with prostate cancer, approximately 20 percent will be favorable intermediate risk prostate cancer, which is defined by National Comprehensive Cancer Network (NCCN) as a Gleason score of 3+4 or less, a percentage of positive biopsy cores less than 50 percent and, at most, one NCCN determinant of intermediate-risk prostate cancer. When combined with the previous Medicare coverage decision, more than 70 percent of Medicare patients with prostate cancer will have access to the Prolaris test.
"It is clinically challenging to determine how best to treat men with favorable intermediate risk prostate cancer. Our goal is to provide physicians with genetic information and help them tailor treatments based on patients’ individual risk profiles." said Michael Brawer, M.D., senior vice president of Urology, Myriad Genetic Laboratories. "The Prolaris test accurately measures the aggressiveness of prostate cancer and give’s both the patient and physician the confidence to make appropriate medical management decisions."
About Prolaris
Prolaris is a novel 46-gene RNA-expression test that directly measures tumor cell growth characteristics to quantify the aggressiveness of prostate cancer and help guide patient care. Prolaris is the only prognostic signature for prostate cancer which has been validated to predict 10-year prostate cancer specific mortality in an untreated patient cohort allowing men to make treatment decisions prior to surgical intervention. Additionally, Prolaris has been extensively validated on its ability to also predict patients that are at higher risk for biochemical recurrence and metastases. Studies have shown that following the Prolaris test almost two-thirds of men are good candidates for more conservative patient management, leading to lower treatment associated side effects and lower overall healthcare costs. For more information on how the Prolaris test can provide information to help decision-making in managing an individual’s localized prostate cancer visit www.Prolaris.com.