Methods of treating tumors

Abstract

The disclosure provides pharmaceutical compositions comprising an anti-PD-1 antibody or an anti-PD-L1 antibody. In some aspects, the pharmaceutical compositions are formulated for subcutaneous delivery. In some aspects, the pharmaceutical compositions further comprise an endoglycosidase hydrolase enzyme. Other aspects of the present disclosure are directed to methods of subcutaneously delivering a pharmaceutical composition comprising an anti-PD-1 antibody or an anti-PD-L1 antibody.

1 .- 175 . (canceled) 
     
     
         176 . A method of treating a subject afflicted with a cancer comprising subcutaneously administering to the subject a pharmaceutical composition comprising nivolumab in combination with a hyaluronidase, wherein about 600 mg of nivolumab and about 10,000 units of the hyaluronidase are administered about every two weeks. 
     
     
         177 . The method of  claim 176 , wherein the pharmaceutical composition is administered in a total administered volume of about 5 mL. 
     
     
         178 . The method of  claim 176 , wherein the pharmaceutical composition is administered using an auto-injector. 
     
     
         179 . The method of  claim 176 , wherein the pharmaceutical composition is administered using a wearable pump. 
     
     
         180 . The method of  claim 176 , wherein the cancer is selected from the group consisting of squamous cell carcinoma, small-cell lung cancer (SCLC), non-small cell lung cancer (NSCLC), squamous NSCLC, nonsquamous NSCLC, glioma, gastrointestinal cancer, renal cancer, clear cell carcinoma, ovarian cancer, liver cancer, colorectal cancer, endometrial cancer, kidney cancer, renal cell carcinoma (RCC), prostate cancer, hormone refractory prostate adenocarcinoma, thyroid cancer, neuroblastoma, pancreatic cancer, glioblastoma, glioblastoma multiforme, cervical cancer, stomach cancer, bladder cancer, hepatoma, breast cancer, colon carcinoma, head and neck cancer, gastric cancer, germ cell tumor, pediatric sarcoma, sinonasal natural killer, melanoma, bone cancer, skin cancer, uterine cancer, cancer of the anal region, testicular cancer, carcinoma of the fallopian tubes, carcinoma of the endometrium, carcinoma of the cervix, carcinoma of the vagina, carcinoma of the vulva, cancer of the esophagus, cancer of the small intestine, cancer of the endocrine system, cancer of the parathyroid gland, cancer of the adrenal gland, sarcoma of soft tissue, cancer of the urethra, cancer of the penis, rectal cancer, solid tumors of childhood, cancer of the ureter, carcinoma of the renal pelvis, neoplasm of the central nervous system (CNS), primary CNS lymphoma, tumor angiogenesis, spinal axis tumor, brain cancer, brain stem glioma, pituitary adenoma, Kaposi's sarcoma, epidermoid cancer, squamous cell cancer, environmentally-induced cancers including those induced by asbestos, virus-related cancers or cancers of viral origin (e.g., human papilloma virus (HPV-related or -originating tumors)), and any combination thereof. 
     
     
         181 . The method of  claim 176 , wherein the cancer comprises advanced renal cell carcinoma (RCC). 
     
     
         182 . The method of  claim 176 , wherein the cancer comprises melanoma. 
     
     
         183 . The method of  claim 176 , wherein the cancer comprises non-small cell lung cancer (NSCLC). 
     
     
         184 . The method of  claim 176 , wherein the cancer comprises gastroesophageal junction (GEJ) cancer, gastric cancer (GC), or metastatic urothelial carcinoma (mUC). 
     
     
         185 . The method of  claim 176 , wherein the cancer comprises colorectal cancer. 
     
     
         186 . The method of  claim 176 , wherein the cancer comprises urothelial carcinoma. 
     
     
         187 . The method of  claim 176 , wherein the cancer comprises hepatocellular carcinoma (HCC). 
     
     
         188 . The method of  claim 176 , wherein the cancer comprises head and neck cancer. 
     
     
         189 . The method of  claim 176 , wherein the hyaluronidase comprises rHuPH20. 
     
     
         190 . The method of  claim 180 , wherein the hyaluronidase comprises the amino acid sequence as set forth in SEQ ID NO: 5. 
     
     
         191 . A method of treating a subject afflicted with a cancer comprising subcutaneously administering to the subject a pharmaceutical composition comprising nivolumab in combination with rHuPH20, wherein about 600 mg of nivolumab and about 10,000 units of the rHuPH20 are administered about every two weeks, wherein the rHuPH20 comprises the amino acid sequence as set forth in SEQ ID NO: 5. 
     
     
         192 . The method of  claim 176 , wherein the pharmaceutical composition is administered:
 (i) using an auto-injector or a wearable pump;   (ii) by subcutaneous infusion for less than about 10 minutes; or   (iii) both (i) and (ii).   
     
     
         193 . The method of  claim 191 , wherein the pharmaceutical composition is administered:
 (i) using an auto-injector or a wearable pump;   (ii) by subcutaneous infusion for less than about 10 minutes; or   (iii) both (i) and (ii).