The invention relates to a method of enhancing the solubility and/or the rate of dissolution of a Class II or Class IV low solubility molecule, a method of producing a spray-dried composition, and a spray-dried composition comprising a Class II or Class IV low solubility molecule, albumin and an agent that prevents self-aggregation of albumin.

Provided are methods of treating cancer with non-competitive, anti-OX40 antibodies and antigen-binding fragments thereof that bind to human OX40 (ACT35, CD134, or TNFRSF4), in combination with a chemotherapeutic agent.

Provided are methods of treating cancer with non-competitive, anti-OX40 antibodies and antigen-binding fragments thereof that bind to human OX40 (ACT35, CD134, or TNFRSF4), in combination with a chemotherapeutic agent.

Provided are methods of treating cancer with non-competitive, anti-OX40 antibodies and antigen-binding fragments thereof that bind to human OX40 (ACT35, CD134, or TNFRSF4), in combination with a chemotherapeutic agent.

The present invention relates to a method for treating a tumor with a KRAS mutation. In the method, a compound 2-fluoro-5-methoxy-4-[(4-(2-methyl-3-oxo-2,3-dihydro-1H-isoindole-4-oxy)-5-trifluoromethyl-pyrimidine-2-yl)amino]-N-(1-methyl-piperidine-4-yl)benzamide or a pharmaceutically acceptable salt thereof is used, which can be administered alone or in combination with a KRAS inhibitor and/or an MEK inhibitor.

The present invention relates to a method for treating a tumor with a KRAS mutation. In the method, a compound 2-fluoro-5-methoxy-4-[(4-(2-methyl-3-oxo-2,3-dihydro-1H-isoindole-4-oxy)-5-trifluoromethyl-pyrimidine-2-yl)amino]-N-(1-methyl-piperidine-4-yl)benzamide or a pharmaceutically acceptable salt thereof is used, which can be administered alone or in combination with a KRAS inhibitor and/or an MEK inhibitor.

The present disclosure relates to a method of predicting therapeutic response or prognosis of an anticancer drug for metastatic breast cancer, and treating HR+/HER2− metastatic breast cancer. When the biomarker of an embodiment of the present disclosure is used as a marker for predicting therapeutic response or prognosis of an anticancer drug for metastatic breast cancer of a specific type, it is possible to predict therapeutic response or prognosis of an anticancer drug, and accordingly, a therapeutic method suitable for a patient may be applied to maximize the treatment effect.

The present disclosure relates to a method of predicting therapeutic response or prognosis of an anticancer drug for metastatic breast cancer, and treating HR+/HER2− metastatic breast cancer. When the biomarker of an embodiment of the present disclosure is used as a marker for predicting therapeutic response or prognosis of an anticancer drug for metastatic breast cancer of a specific type, it is possible to predict therapeutic response or prognosis of an anticancer drug, and accordingly, a therapeutic method suitable for a patient may be applied to maximize the treatment effect.

The present invention concerns improved methods and compositions for preparing SN-38 conjugates of proteins or peptides, preferably immunoconjugates of antibodies or antigen-binding antibody fragments. More preferably, the SN-38 is attached to the antibody or antibody fragment using a CL2A linker, with 1-12, more preferably 6-8, alternatively 1-5 SN-38 moieties per antibody or antibody fragment. Most preferably, the immunoconjugate is prepared in large scale batches, with various modifications to the reaction scheme disclosed herein to optimize yield and recovery in large scale. Other embodiments concern optimized dosages and/or schedules of administration of immunoconjugate to maximize efficacy for disease treatment and minimize side effects of administration.

The present invention concerns improved methods and compositions for preparing SN-38 conjugates of proteins or peptides, preferably immunoconjugates of antibodies or antigen-binding antibody fragments. More preferably, the SN-38 is attached to the antibody or antibody fragment using a CL2A linker, with 1-12, more preferably 6-8, alternatively 1-5 SN-38 moieties per antibody or antibody fragment. Most preferably, the immunoconjugate is prepared in large scale batches, with various modifications to the reaction scheme disclosed herein to optimize yield and recovery in large scale. Other embodiments concern optimized dosages and/or schedules of administration of immunoconjugate to maximize efficacy for disease treatment and minimize side effects of administration.