Compositions and methods of use of interleukin-10 in combination with immune check-point pathway inhibitors
AssigneeEli Lilly and Company
InventorMartin Oft
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Abstract
The present disclosure provides a method for the treatment of neoplastic disease in a mammalian subject the method comprising the administration of an IL-10 agent in combination with the administration of at least one modulator of at least one immune checkpoint pathway. The present disclosure further provides a method for the treatment of neoplastic disease wherein the neoplasm has a low or intermediate tumor mutation burden, low or intermediate level of expression of the immune checkpoint molecule, or metastatic neoplastic disease.
Claims26
A method of treating a neoplastic disease in a mammalian subject, wherein the neoplastic disease is non-small cell lung cancer that has (i) an intermediate tumor mutation burden of greater than 15 but less than 100 mutations per megabase sequenced, or a low tumor mutation burden of less than or equal to 15 mutations per megabase sequenced, and (ii) a low PD-L1 expression or an intermediate PD-L1 expression, the method comprising administering to the subject:
- a) a therapeutically effective amount of an immune checkpoint pathway modulator;
- and
- b) a therapeutically effective amount of an IL-10 agent,
- wherein the immune checkpoint pathway modulator is a PD1 pathway inhibitor selected from monoclonal antibodies that interfere with the binding of PD1 and PDL1;
- and
- wherein the IL-10 agent is a dimeric molecule having IL-10 activity and comprising two IL-10 polypeptides that bind to the IL-10 receptor and modulate the same signaling pathway as IL-10 and are capable of eliciting a biological response characteristic of IL-10.
Dependencies are inferred from the claim text.