ELACESTRANT IN COMBINATION WITH ABEMACICLIB IN WOMEN WITH BREAST CANCER
The present disclosure relates to methods of treating breast cancer in a patient, comprising administering to the patient a therapeutic combination comprising elacestrant, or a pharmaceutically acceptable salt thereof, and abemaciclib, or a pharmaceutically acceptable salt thereof. The present disclosure also relates to methods of treating breast cancer in a patient that produce a longer Progression Free Survival time as compared to other treatments.
1 . A method of treating breast cancer in a patient, comprising administering to the patient a therapeutic combination comprising elacestrant, or a pharmaceutically acceptable salt thereof, and abemaciclib, or a pharmaceutically acceptable salt thereof.
2 . The method of claim 1 , wherein the patient is a postmenopausal women.
3 . The method of claim 1 , wherein the patient has not received prior therapy with a CDK4/6 inhibitor or a SERD.
4 . The method of claim 1 , wherein the breast cancer in the patient has progressed on prior endocrine therapy.
5 . The method of claim 1 , wherein the breast cancer in the patient is ER+ breast cancer.
6 . The method of claim 5 , wherein the breast cancer in the patient is HER2− breast cancer.
7 . The method of claim 1 , wherein the breast cancer in the patient is advanced or metastatic breast cancer.
8 . The method of claim 1 , wherein the elacestrant is administered to the patient at a dose of from 200-500 mg/day.
9 . The method of claim 8 , wherein the elacestrant is administered to the patient at a dose of from 250-450 mg/day.
10 . The method of claim 9 , wherein the elacestrant is administered to the patient at a dose of about 300 mg/day.
11 . The method of claim 10 , wherein the elacestrant is administered to the patient at a dose of about 300 mg/day, in one administration per day.
12 . The method of claim 9 , wherein the elacestrant is administered to the patient at a dose of about 400 mg/day.
13 . The method of claim 12 , wherein the elacestrant is administered to the patient at a dose of about 400 mg/day, in one administration per day.
14 . The method of claim 1 , wherein the abemaciclib is administered to the patient at a dose of from 150-400 mg/day.
15 . The method of claim 14 , wherein the abemaciclib is administered to the patient at a dose of about 200 mg/day.
16 . The method of claim 15 , wherein the abemaciclib is administered to the patient at a dose of about 200 mg/day, in two administrations per day.
17 . The method of claim 16 , wherein the abemaciclib is administered to the patient at a dose of about 100 mg twice per day.
18 . The method of claim 14 , wherein the abemaciclib is administered to the patient at a dose of about 300 mg/day.
19 . The method of claim 18 , wherein the abemaciclib is administered to the patient at a dose of about 300 mg/day, in two administrations per day.
20 . The method of claim 19 , wherein the abemaciclib is administered to the patient at a dose of about 150 mg twice per day.
21 . The method of claim 1 , wherein the elacestrant is administered to the patient at a dose of about 400 mg/day, and the abemaciclib is administered to the patient at a dose of about 300 mg/day.
22 . The method of claim 21 , wherein the abemaciclib is administered to the patient at a dose of 150 mg twice per day.
23 . The method of claim 1 , wherein the elacestrant is administered to the patient at a dose of about 300 mg/day, and the abemaciclib is administered to the patient at a dose of about 300 mg/day.
24 . The method of claim 23 , wherein the abemaciclib is administered to the patient at a dose of 150 mg twice per day.
25 . The method of claim 1 , wherein the elacestrant is administered to the patient at a dose of about 300 mg/day, and the abemaciclib is administered to the patient at a dose of about 200 mg/day.
26 . The method of claim 25 , wherein the abemaciclib is administered to the patient at a dose of 100 mg twice per day.
27 . The method of claim 1 , wherein the elacestrant is administered to the patient at a dose that is the maximum tolerated dose for the patient.
28 . The method of claim 1 , wherein the abemaciclib is administered to the patient at a dose that is the maximum tolerated dose for the patient.
29 . The method of claim 1 , wherein the patient experiences a greater Progression Free Survival time as compared to a patient who was administered a combination of letrozole and abemaciclib, a combination of anastrozole and abemaciclib, or a combination of fulvestrant and abemaciclib.
30 . The method of claim 29 , wherein the breast cancer is ER+/HER2− advanced or metastatic breast cancer, and the patient has progressed on or after prior adjuvant or metastatic endocrine therapy, and has not received prior treatment with a CDK4/6 inhibitor or a SERD.
31 . The method of claim 29 , wherein the patient who was administered a combination of letrozole and abemaciclib was administered 2.5 mg once per day of letrozole and 125 mg twice daily of abemaciclib.
32 . The method of claim 29 , wherein the patient who was administered a combination of anastrozole and abemaciclib was administered 1 mg once per day of anastrozole and 125 mg twice daily of abemaciclib.
33 . The method of claim 29 , wherein the patient who was administered a combination of fulvestrant and abemaciclib was administered 500 mg fulvestrant injection as two 5 mL injections intramuscularly into the buttocks (gluteal area), at a rate of 1-2 minutes per injection, one in each buttock, on days 1, 15, and 29 and once monthly thereafter, and 125 mg twice daily of abemaciclib.
34 . The method of claim 29 , wherein the patient experiences a greater Progression Free Survival time as compared to a patient who was administered a combination of letrozole and abemaciclib and wherein the breast cancer is ER+/HER2− advanced or metastatic breast cancer, and the patient has not received prior systemic anti-cancer therapies for their advanced/metastatic disease, and has not received prior treatment with a CDK4/6 inhibitor or a SERD.
35 . The method of claim 34 , wherein the patient who was administered a combination of letrozole and abemaciclib was administered 2.5 mg once per day of letrozole and 125 mg twice daily of abemaciclib.
36 . The method of claim 1 , wherein the patient experiences a greater Progression Free Survival time as compared to a patient who was administered abemaciclib as a monotherapy.
37 . The method of claim 36 , wherein the breast cancer is ER+/HER2− advanced or metastatic breast cancer, and the patient has received prior systemic anti-cancer therapy including ≤2 prior chemotherapy for metastatic breast cancer permitted for their advanced or metastatic disease, and wherein the prior systemic anti-cancer therapy did not include a CDK4/6 inhibitor or a SERD.
38 . The method of claim 36 , wherein the patient who was administered abemaciclib as a monotherapy was administered 200 mg of abemaciclib twice daily.