COMBINATION TREATMENTS WITH SERIBANTUMAB
Compositions and methods for treating a cancer in a selected human patient are provided, comprising administering to the patient a combination of an anti-ErbB3 antibody (e.g., Seribantumab) and a second anti-cancer therapeutic. A cancer to be treated by the methods and compositions disclosed herein includes cancers that are heregulin (HRG) positive cancers.
1 . A method of treating a patient having heregulin (HRG) positive non-small cell lung cancer (NSCLC), the method comprising administering to the patient once on day 1 of a 21-day treatment cycle an anti-neoplastic therapy consisting of:
i. a dose of 3000 mg seribantumab; and
ii. a dose of 75 mg/m 2 docetaxel,
to treat the NSCLC in the patient.
2 . The method of claim 1 , wherein the cancer is positive for HRG mRNA as measured by RNA in-situ hybridization (RNA-ISH), wherein the HRG RNA-ISH results in a score of ≧1+.
3 . The method of claim 1 , wherein the cancer is positive for HRG as measured by quantitative RT-PCR.
4 . The method of claim 1 , wherein the patient has failed at least one systemic therapy for locally advanced and/or metastatic NSCLC.
5 . The method of claim 1 , wherein the patient has progressed following treatment with no more than three systemic therapies for locally advanced or metastatic disease, one of which systemic therapies comprised a platinum-based regimen.
6 . The method of claim 1 , wherein docetaxel is co-administered at least 30 minutes before administration of seribantumab.
7 . The method of claim 1 , wherein the anti-neoplastic therapy is administered intravenously.
8 . The method of claim 1 , wherein the treatment produces at least one therapeutic effect selected from the group consisting of: reduction in size of a tumor, reduction in metastasis, complete remission, partial remission, stable disease, increase in overall response rate, or a pathologic complete response.
9 . The method of claim 1 , wherein the NSCLC is EGFR wild-type.
10 . The method of claim 1 , wherein the NSCLC is a squamous cell carcinoma.
11 . A method of treating a patient having HRG positive non-small cell lung cancer (NSCLC, the method comprising administering to the patient once on day 1 of a 21-day treatment cycle an anti-neoplastic therapy consisting of:
i. a dose of 3000 mg seribantumab; and
ii. a dose of 500 mg/m 2 pemetrexed,
to treat the NSCLC in the patient.
12 . The method of claim 10 , wherein the tumor is positive for HRG mRNA as measured by RNA in-situ hybridization (RNA-ISH), wherein the HRG RNA-ISH results in a score of ≧1+.
13 . The method of claim 11 , wherein the cancer is positive for HRG as measured by quantitative RT-PCR.
14 . The method of claim 11 , wherein the patient has failed at least one systemic therapy for locally advanced and/or metastatic NSCLC.
15 . The method claim 11 , wherein the patient has progressed following treatment with no more than two systemic therapies for locally advanced or metastatic disease, one of which systemic therapies comprised a platinum-based regimen.
16 . The method of claim 11 , wherein the pemetrexed is co-administered at least 30 minutes before the administration of seribantumab.
17 . The method of claim 11 , wherein the treatment produces at least one therapeutic effect selected from the group consisting of: reduction in size of a tumor, reduction in metastasis, complete remission, partial remission, stable disease, increase in overall response rate, or a pathologic complete response.
18 . The method of claim 11 , wherein the NSCLC is EGFR wild-type.
19 . The method of a claim 11 , wherein the NSCLC is a squamous cell carcinoma.
20 . The method of claim 11 , wherein the antineoplastic therapy is administered intravenously.