Treatment with tumor infiltrating lymphocyte therapies in combination with CTLA-4 and PD-1 inhibitors
AssigneeIovance Biotherapeutics, Inc.
InventorsMaria Fardis, Friedrich-Reinhard Graf Finck von Finckenstein, Zelanna Goldberg
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Abstract
The present invention provides improved and/or shortened processes and methods for preparing TILs in order to prepare therapeutic populations of TILs with increased therapeutic efficacy for the treatment of cancer with TILs in combination with CTLA-4 and PD-1 inhibitors and/or PD-L1 inhibitors as described herein.
Claims18
A method of treating melanoma in a patient or subject who has received no prior PD-1 therapy and no prior PD-L1 therapy, comprising administering to the patient or subject a therapeutically effective amount of a therapeutic population of tumor infiltrating lymphocytes (TILs) and a therapeutically effective amount of pembrolizumab, wherein a first amount of a non-myeloablative lymphodepletion regimen is administered to the patient or subject in advance of the administration of the therapeutically effective amount of the therapeutic population of TILs to the patient or subject, and subjecting the patient or subject to administration of an amount of pembrolizumab every six weeks after the administration of the therapeutically effective amount of the therapeutic population of TILs to the patient or subject.
A method of treating metastatic melanoma in a patient or subject who has received no prior PD-1 therapy and no prior PD-L1 therapy, the method comprising the steps of:
- (a) obtaining and/or receiving a first population of tumor infiltrating lymphocytes (TILs) from a tumor resected from the subject or patient;
- (b) performing a first expansion by culturing the first population of TILs in a cell culture medium comprising IL-2 to produce a second population of TILs, wherein the first expansion is performed for about 3-14 days to obtain the second population of TILs;
- (c) performing a second expansion by supplementing the cell culture medium of the second population of TILs with additional IL-2, OKT-3, and antigen presenting cells (APCs), to produce a third population of TILs, wherein the second expansion is performed for about 7-14 days to obtain the third population of TILs, wherein the third population of TILs is a therapeutic population of TILs;
- (d) harvesting the therapeutic population of TILs obtained from step (c);
- (e) administering a therapeutically effective amount of the therapeutic population of TILs from step (d) to the patient or subject;
- and
- (f) administering a therapeutically effective amount of pembrolizumab every six weeks after the administration of the therapeutically effective amount of the therapeutic population of TILs to the patient or subject;
- wherein the patient or subject is treated with a non-myeloablative lymphodepletion regimen prior to step (e).
Dependencies are inferred from the claim text.