The meeting, which is being held virtually on
'The evidence supporting our innovation in hematologic malignancies continues to grow, providing assurance of the lasting and positive impact our diverse oncology pipeline could achieve over time,' said
New Long-Term Efficacy Data and the Potential of CAR T Therapy for More Patients
Building on three-year data presented at ASH 2019, overall survival results at four years from the pivotal ZUMA-1 trial of Yescarta in patients with refractory large B-cell lymphoma will be presented (Abstract #1187). Additionally, new data include one-year follow-up results from the ZUMA-2 study evaluating KTE-X19 in relapsed or refractory mantle cell lymphoma (Abstract #1120), as well as several studies evaluating the potential of Yescarta in new indications include an interim analysis of ZUMA-12 in first-line large B-cell lymphoma among patients with high-risk features (Abstract #405) and the ZUMA-5 primary analysis in relapsed or refractory indolent non-Hodgkin lymphoma (NHL), including follicular lymphoma (FL) and marginal zone lymphoma (MZL; Abstract #700).
Data from the ZUMA-5 primary analysis form the basis for the supplemental Biologics License Application (sBLA) for Yescarta currently under review by the
'Our data at ASH build on the established strengths of our CAR T franchise, including practice-changing potential in new cancers,' said
Harnessing Potential First-in-Class Anti-CD47 Antibody in Difficult-to-Treat Malignancies
Researchers will give an oral presentation of updated results from the Phase 1b study of magrolimab in patients with previously-untreated acute myeloid leukemia (AML) who cannot undergo treatment with intensive chemotherapy, including patients with TP53-mutant AML (Abstract #330). The FDA recently assigned Breakthrough Designation to magrolimab, in combination with azacitidine for the treatment of adult patients with newly-diagnosed MDS including intermediate-, high-, or very high-risk tumor types to expedite the development and regulatory review of this investigational treatment. Magrolimab also received PRIME Designation for treatment of MDS from the
ABOUT MAGROLIMAB
Magrolimab is a first-in-class, investigational monoclonal antibody against CD47 and macrophage checkpoint inhibitor that is designed to interfere with recognition of CD47 by the SIRP receptor on macrophages, thus blocking the 'don't eat me' signal used by cancer cells to avoid being ingested by macrophages. Magrolimab is being developed in several hematologic and solid tumor malignancies, including MDS. Magrolimab has been granted Fast Track Designation for the treatment of MDS, AML, DLBCL and FL. Magrolimab has also been granted Orphan Drug Designation by the FDA and EMA for treatment of MDS and AML.
About 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 DLBCL not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.
About
About Kite
Kite, a
Gilead and Kite Forward-Looking Statements
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 ongoing and additional clinical studies involving Yescarta, Tecartus and magrolimab and the possibility that Gilead and Kite may be unable to initiate or complete one or more of such studies in the currently anticipated timelines or at all. There is also the risk that the FDA may not approve Yescarta for the treatment of relapsed or refractory FL or MZL after at least two prior therapies in the anticipated timelines or at all, and any marketing approvals if granted, may have significant limitations on its use. Further, it is possible that Gilead may make a strategic decision to discontinue development of magrolimab or that the FDA and other regulatory agencies may not approve magrolimab for the treatment of MDS and other indications, and any marketing approvals, if granted, may have significant limitations on its use. 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
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