Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-10744110-B2
Publication Date
2020-08-18
Expiration Date
Abstract
The present invention provides methods and compositions for treating non-small-cell lung cancer (NSCLC) by administering a) a composition comprising nanoparticles that comprise paclitaxel and an albumin and b) a platinum-based agent (e.g., carboplatin), wherein the individual has diabetes, has four or more metastatic sites, and/or is at least about 70 years old.
Core Innovation
The invention relates to methods of treating non-small cell lung cancer (NSCLC) in an individual in need thereof by administering a composition comprising nanoparticles comprising paclitaxel and an albumin, together with a platinum-based agent. The individual is diagnosed with diabetes prior to the administration step and is selected for treatment based on having diabetes, while excluding individuals with pre-existing peripheral neuropathy of Grade 2, 3, or 4.
The disclosure emphasizes paclitaxel albumin-coated nanoparticles, including nab-paclitaxel/ABRAXANE®, and characterizes the nanoparticle composition by an average diameter of not more than about 200 nm. It also links albumin-stabilized nanoparticle characteristics to the composition, including albumin in an HSA 9:1 ratio and a mean nanoparticle diameter of about 130 nm.
The document further describes combination contexts that may include thoracic radiation and anti-angiogenic agents, and incorporates stage specification including Stage IIIB and Stage IV NSCLC. It also describes selection and dosing regimen guidance via kit/label information for selecting patients and dosing regimens, with explicit attention to patient selection based on diabetes and restrictions excluding pre-existing peripheral neuropathy of Grade 2-4.
Claims Coverage
The partial content identifies one independent claim framework. The claim coverage centers on treating NSCLC in a diabetes-selected individual using paclitaxel-and-albumin nanoparticles together with a platinum-based agent, while excluding individuals with pre-existing Grade 2-4 peripheral neuropathy; dependent refinements specify paclitaxel dose range, weekly administration, platinum-agent interval, nanoparticle average diameter limits, and stage restriction to Stage IIIB or Stage IV NSCLC.
Diabetes-selected NSCLC treatment with nanoparticle paclitaxel plus platinum
Treating non-small cell lung cancer in an individual in need thereof by administering an effective amount of a composition comprising nanoparticles comprising paclitaxel and an albumin and an effective amount of a platinum-based agent, wherein the individual was diagnosed with diabetes prior to the administration step and is selected for treatment based on having diabetes.
Exclusion of pre-existing Grade 2-4 peripheral neuropathy
Treating the diabetes-selected individual while the individual does not have pre-existing peripheral neuropathy of Grade 2, 3, or 4.
Paclitaxel dose range in paclitaxel-and-albumin nanoparticles
The paclitaxel-and-albumin nanoparticle composition provides a paclitaxel dose between about 50 mg/m2 and about 125 mg/m2.
Weekly administration of the paclitaxel-and-albumin nanoparticle composition
Administering the paclitaxel-and-albumin nanoparticle composition weekly.
Platinum-based agent administered once every three weeks
Administering the platinum-based agent once every three weeks.
Nanoparticle average diameter not more than about 200 nm
The nanoparticles in the paclitaxel-and-albumin nanoparticle composition have an average diameter of not more than about 200 nm.
NSCLC stage restriction to Stage IIIB or Stage IV
The method is performed for a non-small cell lung cancer patient having Stage IIIB NSCLC or Stage IV NSCLC.
Overall, the claim coverage is a combined-treatment regimen for NSCLC that is restricted to diabetes-selected individuals and excludes those with pre-existing Grade 2-4 peripheral neuropathy, with dependent refinements specifying paclitaxel dose range, weekly nanoparticle administration, platinum-agent dosing interval, nanoparticle average diameter limits, and eligibility limited to Stage IIIB or Stage IV NSCLC.
Stated Advantages
Documented Applications
Treating non-small cell lung cancer (NSCLC) in an individual diagnosed with diabetes, with selection based on diabetes and exclusion of individuals with pre-existing peripheral neuropathy of Grade 2-4.
Applying treatment to NSCLC patients having Stage IIIB NSCLC or Stage IV NSCLC.
Optional combination with concurrent thoracic radiation and optional administration together with an anti-angiogenic agent.
Interested in licensing this patent?