Compositions comprising a combination of nivolumab and ipilimumab
This provides pharmaceutical compositions that comprise a combination of an anti-cancer agent which is an first antibody and a second antibody. In some embodiments, the first antibody is an anti-Programmed Death-1 (PD-1) antibody. In certain embodiments, the composition is a fixed dose formulation. In certain embodiments, the composition is administered as a flat-dose. The disclosure also provides a kit for treating a subject afflicted with a disease, the kit comprising a dosage of any composition disclosed herein and instructions for using the composition in any of the disclosed methods for treating a disease.
1. A pharmaceutical composition comprising
about 1.54 mg/ml nivolumab, about 4.62 mg/ml ipilimumab, about 18.46 mM Tris hydrochloride (HCl), about 1.54 mM sodium citrate dihydrate, about 1.15% mannitol, about 96.15 mM NaCl, about 93.85 μM pentetic acid, and about 0.012% PS80.
2. The composition of claim 1 , wherein the composition:
(i) is stable at about 5° C. for at least about 1 week;
(ii) is stable at about 40° C. for at least about 1 week; or
(iii) is stable at about 25° C. for at least about 1 week.
3. A kit comprising the composition of claim 1 and instructions to administer the composition to a subject in need thereof.
4. The pharmaceutical composition of claim 1 , wherein the pH of the composition is about 6.0, about 6.2, about 6.5, about 6.6, or about 7.0.
5. The pharmaceutical composition of claim 1 , wherein the pH is about 6.2.
6. The pharmaceutical composition of claim 1 , wherein the pH is about 6.2.
7. The pharmaceutical composition of claim 1 , wherein the pH is 6.1.
8. The pharmaceutical composition of claim 1 , comprising 1.54 mg/mL nivolumab and 4.62 mg/ml ipilimumab.
9. The pharmaceutical composition of claim 1 , comprising about 30 mg nivolumab and about 90 mg ipilimumab.
10. The pharmaceutical composition of claim 1 , comprising about 40 mg nivolumab and about 120 mg ipilimumab.
11. The pharmaceutical composition of claim 1 , comprising 18.46 mM Tris hydrochloride (HCl).
12. The pharmaceutical composition of claim 1 , comprising 1.54 mM sodium citrate dihydrate.
13. The pharmaceutical composition of claim 1 , comprising 1.15% mannitol.
14. The pharmaceutical composition of claim 1 , comprising 96.15 mM NaCl.
15. The pharmaceutical composition of claim 1 , comprising 93.85 μM pentetic acid.
16. The pharmaceutical composition of claim 1 , comprising 0.012% PS80.
17. The pharmaceutical composition of claim 1 , comprising 18.46 mM Tris hydrochloride (HCl) and 1.54 mM sodium citrate dihydrate.
18. The pharmaceutical composition of claim 1 , comprising 1.15% mannitol, 96.15 mM NaCl, and 93.85 μM pentetic acid.
19. The pharmaceutical composition of claim 1 , comprising 18.46 mM Tris hydrochloride (HCl), 1.54 mM sodium citrate dihydrate, 1.15% mannitol, 96.15 mM NaCl, and 93.85 μM pentetic acid.
20. The pharmaceutical composition of claim 1 , comprising 18.46 mM Tris hydrochloride (HCl), 1.54 mM sodium citrate dihydrate, 1.15% mannitol, 96.15 mM NaCl, 93.85 μM pentetic acid, and 0.012% PS80.
21. The pharmaceutical composition of claim 20 , wherein the pH is 6.2 at 25° C.
22. The pharmaceutical composition of claim 1 , wherein the pH is between about 6.0 and about 7.0.
23. The pharmaceutical composition of claim 1 , wherein the composition:
(i) is stable at 5° C. for at least 1 week;
(ii) is stable at 40° C. for at least 1 week; or
(iii) is stable at 25° C. for at least 1 week.
24. A pharmaceutical composition comprising 1.54 mg/ml nivolumab, 4.62 mg/ml ipilimumab, 18.46 mM Tris hydrochloride (HCl), 1.54 mM sodium citrate dihydrate, 1.15% mannitol, 96.15 mM NaCl, 93.85 μM pentetic acid, and 0.012% PS80.
25. The pharmaceutical composition of claim 24 , wherein the pH is between about 6.0 and about 7.0.
26. The pharmaceutical composition of claim 24 , wherein the pH is 6.2 at 25° C.
27. The pharmaceutical composition of claim 24 , wherein the composition:
(i) is stable at 5° C. for at least 1 week;
(ii) is stable at 40° C. for at least 1 week; or
(iii) is stable at 25° C. for at least 1 week.
28. The pharmaceutical composition of claim 24 , comprising about 30 mg nivolumab and about 90 mg ipilimumab.
29. The pharmaceutical composition of claim 24 , comprising about 40 mg nivolumab and about 120 mg ipilimumab.