The Light of Sinopharm: The first domestic ADC drug Vidicitumab has been approved for a new indication

On January 5, the official website of the China National Medical Products Administration (NMPA) showed that the second indication of the first domestically produced antibody-conjugated drug (ADC) vedicetumab (RC48) was approved for marketing
.

According to the priority review publicity information, the new indication of Vidicitumab is approved for locally advanced or metastatic urothelial disease who have received systemic chemotherapy and HER2 (2+ or 3+) (immunohistochemical results).
cancer
.

In June 2021, Vidicitumab was conditionally approved by the NMPA for HER2-overexpressing locally advanced or metastatic gastric cancer and gastroesophageal junction adenocarcinoma (G/GEJ) who have received 2 systemic chemotherapy treatments
.

In July 2021, the marketing application for the second indication of Vidicitumab was accepted by the NMPA Center for Drug Evaluation (CDE) and was included in priority review for patients who have received systemic chemotherapy and have HER2 (2+ or 3+) (immunohistochemical results) in patients with locally advanced or metastatic urothelial carcinoma
.

The prognosis of patients with urothelial carcinoma and ADC drug metastatic urothelial carcinoma is poor, the median overall survival (OS) is about 15 months, and the 5-year survival rate is about 18%.
Platinum-based chemotherapy is still metastatic.
First-line standard treatment for urothelial carcinoma
.

About 50% of patients respond to platinum-containing therapy, but the response time is short, and the progression-free survival (PFS) is short (7-8 months), and the effective rate of second-line single-agent chemotherapy is about 10%
.

In recent years, the development of immunotherapy and ADC drugs has brought new breakthroughs for metastatic urothelial carcinoma
.

ADC drugs are a class of biopharmaceuticals consisting of targeted antibodies, linkers and cytotoxic drugs
.

He is a rising star in the field of advanced urothelial cancer treatment in recent years
.

A number of studies at home and abroad have confirmed that ADC drugs show excellent efficacy in metastatic urothelial carcinoma
.

Vidicitumab is the first antibody-conjugated drug targeting HER2 independently developed by a Chinese company
.

RC48-C009 study The approval of this new indication is based on the RC48-C009 study, which is an open-label, multi-center, single-arm, non-randomized Phase II study to evaluate RC48 in the failure of previous multi-line chemotherapy.
Efficacy in metastatic urothelial carcinoma after HER2 overexpression
.

The study included 64 patients with HER2-overexpressing locally advanced or metastatic urothelial carcinoma
.

The enrolled patients had failed previous chemotherapy.
Among them, 14.
1% of the patients had received only 1-line therapy, 65.
6% had received 2-line therapy, and 20.
3% had received ≥3-line therapy
.

The primary endpoint was objective response rate (ORR)
.

RESULTS: Confirmed ORR was 50%, median PFS was 5.
1 months, and median OS was 14.
2 months
.

Reference source [1] China National Medical Products Administration's January 5 drug approval certificate pending information.
Retrieved Jan 5, 2022, from https:// .
html[2] Xinan Sheng, et al.
ASCO-2021.
Abstract 4584