Clinical trials of Phesgo (Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf)

The main study of Phesgo (Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf) compared Phesgo with Pertuzumab + Trastuzumab. The clinical study included 500 patients with HER2+ early-stage breast cancer. Everyone in the study received chemotherapy as part of a complete treatment regimen. The study was designed to find out if there were any differences between PHESGO and Pertuzumab + Trastuzumab. It measured the amount of the drug in the blood, which is typically done to check if an injection works as well as an infusion. It also looked at how safe the drug was and whether it was effective.

The primary endpoint is to compare the non-inferiority of Pertuzumab body serum trough concentration in cycle 7 of Phesgo and intravenous Pertuzumab. Secondary endpoints include trastuzumab serum trough concentration in cycle 7, pathological complete response (pCR) and safety. Compared with intravenous Pertuzumab+Trastuzumab, PHESGO showed that the serum trough concentration of Pertuzumab+Trastuzumab was not inferior. The pCR rate in the Phesgo group was 59.7% (95% confidence interval: 53.3, 65.8), and that in the intravenous Pertuzumab + Trastuzumab group was 59.5% (95% confidence interval: 53.2, 65.6). The safety profile of Phesgo was comparable to intravenous Pertuzumab + Trastuzumab, except for an increase in dosing-related reactions. The most common adverse reactions reported by more than 30% of patients receiving Phesgo were hair loss, nausea, diarrhea, anemia and fatigue.

The original Phesgo drug is not marketed in the country and therefore cannot be included in medical insurance. Since Phesgo's original drug has been on the market overseas for a short time, there is less price and other related information. For specific prices and drug information, please consult Yaode's medical consultant.