Subcutaneous injection of "Herceptin" is available in China, providing opportunities for early-stage and metastatic HER2-positive breast cancer

Can be taken orally without injection, can be intramuscular injection without intravenously
.
The improvement of popular drug dosage forms has always been the focus of drug research and development, and anti-tumor drugs are no exception
.
On October 9, according to the NMPA official website, Roche trastuzumab injection (subcutaneous injection) (trade name: Herceptin) was approved for marketing in China for the treatment of patients with early-stage and metastatic HER2-positive breast cancer
.

Subcutaneous Herceptin administration takes only 5 minutes

On June 29, 2020, the FDA approved the hypodermal injection Phesgo:registered: for marketing
.

Phesgo is a subcutaneous injection developed by Roche that combines Pertuzumab, Trastuzumab and hyaluronidase in a fixed-dose combination to deliver in minutes, greatly shortening the patient's treatment time, compared with the standard intravenous infusion of pertuzumab + trastuzumab + chemotherapy regimen, not only from 5 hours to 5 minutes, but also simple to operate, During the pandemic, patients can do it at home or in a treatment center without going to the hospital, which is a major innovation in oncology medicine!

In the Phase 3 randomized FeDeriCa trial (NCT03493854), 500 patients enrolled in locally advanced or inflammatory stage II-IIIC HER2-positive operable breast cancer were randomized 1:1 to intravenous pertuzumab (840 mg loading dose, 420 mg maintenance dose) + trastuzumab (8 mg/kg loading dose, 6 mg/ kg maintenance dose) or subcutaneous Phesgo (1200 mg pertuzumab plus 600 mg trastuzumab loading dose of 15 mL, followed by 600 mg pertuzumab plus 600 mg trastuzumab maintenance dose 10 mL), both given every 3 weeks in conjunction
with neoadjuvant chemotherapy.

The results showed that the pathological complete response rates of patients in the subcutaneous injection group and the intravenous infusion group were almost the same, 59.
7% and 59.
5%,
respectively.
The lower CI limit of 90% for GMR is 1.
14, which is greater than the pre-specified limit of non-inferiority, i.
e.
comparable concentrations of drugs in the blood while demonstrating similar efficacy
.
In addition, Phesgo combination chemotherapy was comparable to intravenous trastuzumab, pertuzumab and chemotherapy, no new safety signals were found, and there was no significant difference in
cardiotoxicity.

All in all, Phesgo has comparable efficacy and similar
safety profile to intravenous trastuzumab and pertuzumab.
However, compared with intravenous infusion of pertuzuzub + trastuzumab, a single subcutaneous injection of Phesgo is administered more than 90% faster, greatly shortening the administration time
.

Can double antibodies also be injected subcutaneously?

amivantamab is the first FDA-approved EGFR/c-Met bispecific antibody drug, and in July 2020, Johnson & Johnson/Janssen applied to CDE for an intravenous dosage form of amivantamab, and in September of the same year, it received breakthrough therapy designation
from CDE.
This EGFR/c-Met bispecific antibody drug can not only treat EGFR-refractory mutation 20ins, but also produce good efficacy
in patients with MET mutation after osimertinib resistance.
On June 21, the official website of CDE showed that the subcutaneous injection form of amivantamab was declared for clinical trial
in China.
Subcutaneous administration is more convenient than intravenous administration and improves patient compliance
.

A Phase I clinical study of amivantamab subcutaneous injection dosage form in the treatment of advanced solid malignancies (NCT04606381, PANOMA study)
was disclosed in October 2020.
The results of the Phase I PANOMA study presented at this year's AACR conference showed that the use of amivantamab in the subcutaneous injection form has good efficacy and safety
.