US 11,377,698 B2Granted

Method of treating a cancer patient without the need for a tissue biopsy

AssigneeInivata Ltd.

InventorsClive Morris, Vincent Plagnol, Tim Forshew

Life of this patent

Estimating the term…

Loading patent…

Abstract

Provided herein, among other things, is a method of treating a cancer patient without the need for a tissue biopsy. In some embodiments, the method may comprise (a) performing or having performed a sequencing assay on cell-free DNA (cfDNA) from a sample of blood from the patient to determine if the cell-free DNA comprises actionable and/or non-actionable sequence variations in one or more target genes, and (b) treating the patient using the following method: i. administering a therapy that is targeted to an actionable sequence variation if the patient is identified as having the actionable sequence variation, and ii. administering a non-targeted therapy in the absence of any follow-up genetic testing on DNA extracted from a tissue biopsy if one or more non-actionable sequence variations and no actionable sequence variations are identified.

Claims10

Dependent claims

A method of treating a cancer patient without the need for a tissue biopsy, comprising:

(a) performing or having performed a sequencing assay on cell-free DNA (cfDNA) from a sample of blood from the patient to determine if the cell-free DNA comprises actionable and non-actionable sequence variations in one or more target genes,
wherein:
(i) an actionable sequence variation is a sequence variation for which there is a therapy that targets the protein encoded by the gene having the sequence variation;
and
(ii) a non-actionable sequence variation is a sequence variation for which there is no therapy that targets the protein having the sequence variation;
(b) determining that the cfDNA has no actionable sequence variations;
(c) confirming that there are no actionable sequence variations in the cfDNA by identifying non-actionable sequence variations in the cfDNA;
and then
(d) administering a therapy that does not target a protein encoded by a gene having an actionable or non-actionable sequence variation to the patient,
wherein the decision to administer the therapy of step (d) is made without considering data obtained from a tumor biopsy.

7 more elements

Dependencies are inferred from the claim text.

Facts

Application: 16/560,504Filed 4 Sep 2019 · us provisional application
Priority: 5 Sep 2018
Published: US 2020/0071772 A15 Mar 2020
Granted: 5 Jul 2022
Term ends: Not estimatedThe source records don’t support an estimate.

Classification8 codes

C12Q 1/6886
For diseases caused by alterations of genetic material: for cancer
A61K 45/00
Medicinal preparations containing active ingredients not provided for in groups a61k31/00 -
C12Q 1/6827
Hybridisation assays: for detection of mutation or polymorphism
C12Q 2600/106
Oligonucleotides characterized by their use: pharmacogenomics, i.e. genetic variability in individual responses to drugs and drug metabolism