US 12,252,549 B2
Pertuzumab plus trastuzumab fixed dose combination
Tanja Badovinac-Crnjevic, Basel (CH); Yu Chien Fredriksson, Basel (CH); Sarah Heeson, Welwyn Garden (GB); Ihsan Hamdi Nijem, Brisbane, CA (US); Whitney Paige Kirschbrown, San Mateo, CA (US); and Eleonora Restuccia, Basel (CH)
Assigned to Genentech, Inc., South San Francisco, CA (US); and Hoffmann-La Roche Inc., Little Falls, NJ (US)
Filed by Genentech, Inc., South San Francisco, CA (US); and Hoffmann-La Roche Inc., Little Falls, NJ (US)
Filed on Jun. 28, 2021, as Appl. No. 17/304,909.
Claims priority of provisional application 63/065,795, filed on Aug. 14, 2020.
Claims priority of provisional application 63/045,712, filed on Jun. 29, 2020.
Prior Publication US 2021/0403599 A1, Dec. 30, 2021
Int. Cl. A61P 35/00 (2006.01); C07K 16/32 (2006.01); C12N 9/26 (2006.01); A61K 38/00 (2006.01); A61K 39/00 (2006.01)
CPC C07K 16/32 (2013.01) [A61P 35/00 (2018.01); C12N 9/2474 (2013.01); A61K 38/00 (2013.01); A61K 2039/505 (2013.01); C12Y 302/01035 (2013.01)] 10 Claims
 
1. A method of treating HER2-positive early breast cancer patients comprising subcutaneously administering a therapeutically effective amount of a fixed dose combination (FDC) co-formulation of pertuzumab, trastuzumab, and hyaluronidase to said HER2-positive patients, said method comprising administering to said HER2-positive patients 8 cycles of neoadjuvant chemotherapy with concurrent administration of 4 cycles of said FDC during cycles 5 to 8, wherein:
(a) said neoadjuvant chemotherapy comprises:
(i) 4 cycles of 60 mg/m2 doxorubicin and 600 mg/m2 cyclophosphamide every 2 weeks followed by 80 mg/m2 paclitaxel weekly for 12 weeks; or
(ii) 4 cycles of 60 mg/m2 doxorubicin and 600 mg/m2 cyclophosphamide every 3 weeks followed by 4 cycles of docetaxel at 75 mg/m2 for the first cycle and then 100 mg/m2 for subsequent cycles if tolerated every 3 weeks;
(b) said FDC is administered to said HER2-positive patients every 3 weeks for 4 cycles as a loading dose FDC comprising 1200 mg pertuzumab, 600 mg trastuzumab and 30,000 units of hyaluronidase, followed by maintenance dose FDC comprising 600 mg pertuzumab, 600 mg trastuzumab and 20,000 units of hyaluronidase; and
(c) said therapeutically effective amount causes a pathological complete response rate of about 60% or more in said HER2-positive patients; and
(d) said therapeutically effective amount results in ≤0.4% treatment-emergent neutralizing anti-pertuzumab antibodies in said HER2-positive patients.