Public information shows that this is a subcutaneous administration fixed combination of the EGFR/MET bispecific antibody amivantamab developed by Johnson&Johnson and recombinant human hyaluronidase. In June of this year, Johnson&Johnson submitted a biopharmaceutical approval application for subcutaneous injection of bevacizumab to the US FDA, for all indications of approved or submitted intravenous bevacizumab preparations, covering different types of non-small cell lung cancer (NSCLC). According to Johnson&Johnson's previous press release, patients were able to complete the injection of the subcutaneous formulation within 5 minutes.

Evantomab is a humanized EGFR/MET bispecific antibody. It has multiple anti-cancer mechanisms, not only blocking EGFR and MET mediated signaling, but also guiding immune cells to target tumors carrying activating and drug-resistant EGFR/MET mutations and amplifications. The intravenous formulation of this product was first granted accelerated approval by the FDA in May 2021, and has since been approved for multiple indications, including:
 Adult patients with locally advanced or metastatic NSCLC who have EGFR exon 20 insertion mutations, undergo platinum based chemotherapy during or after chemotherapy progression;
 The first-line treatment of locally advanced or metastatic NSCLC adult patients with EGFR exon 19 deletion or L858R substitution mutation in exon 21 confirmed by FDA approved testing using the third-generation EGFR-TKI oral drug lazertinib tablets;
Combination standard chemotherapy (carboplatin and pemetrexed) is used to treat locally advanced or metastatic NSCLC adult patients with EGFR exon 19 deletion or L858R substitution mutation in exon 21.

In China, three marketing applications for the intravenous injection version of bevacizumab have been accepted by the NMPA, including the combination therapy with lanzetinib mesylate tablets, which has also submitted marketing applications to the CDE.

Evantazumab injection (subcutaneous injection) is a subcutaneous administration fixed combination of Evantazumab and recombinant human hyaluronidase. According to a previous press release from Johnson&Johnson, in the PALOMA-3 study, subcutaneous and intravenous preparations of bevacizumab showed similar overall response rates in NSCLC patients with EGFR exon 19 deletion or L858R mutation. Subcutaneous preparations also showed significantly shortened administration time, 5-fold reduction in infusion related reactions, and longer overall survival, progression free survival, and duration of remission. The detailed experimental results of this study were published in the Journal of Clinical Oncology. In addition, the data from Phase 2 trial PALOMA-2 also supports the dosing frequency of bevacizumab injection (subcutaneous injection) every two weeks and every three weeks.

According to the official website of the Chinese Drug Clinical Trials and Information Disclosure Platform, Johnson&Johnson is conducting two international multicenter clinical studies in China on the subcutaneous injection of bevacizumab, including a phase 2 study targeting patients with advanced or metastatic solid tumors (including EGFR mutant non-small cell lung cancer); And a phase 3 study to evaluate the efficacy and safety of the product in combination with Lenvatinib tablets in patients with advanced or metastatic non-small cell lung cancer with EGFR mutations who experience disease progression after receiving osimertinib and chemotherapy.

The application for market launch of this dual antibody product subcutaneous injection in China signifies significant progress in its research and development process in China.

Source: https://pharm.jgvogel.cn/c1445875.shtml