Hengrui's "Carrelizumab" new indication has been released!

On March 26, the official website of CDE showed that two listing applications of Hengrui "Carrelizumab" were newly accepted

Previously, Hengrui had announced the news that two phase III clinical endpoints will be reported soon, namely: combined paclitaxel and cisplatin for the first-line treatment of advanced esophageal cancer , combined chemotherapy for the first-line advanced or metastatic squamous non-small cell lung cancer Treatment

First-line treatment for esophageal cancer ( ESCORT-1st study )

At present, there is no first-line indication for PD-1/L1 esophageal cancer in China.

The Phase III ESCORT-1st study, which previously reached its endpoint, is a randomized, double-blind, placebo-controlled, multi-center Phase IIIclinical study to evaluate carrelizumab for injection (Erica®) combined with paclitaxel and The effectiveness and safety of cisplatin compared with placebo combined with paclitaxel and cisplatin in the first-line treatment of advanced esophageal cancer

A total of 596 subjects were enrolled in the study, randomly enrolled according to 1:1, and received carrelizumab for injection (Ireika®) combined with paclitaxel and cisplatin or placebo combined with paclitaxel and cisplatin.

The results of the study show that carrelizumab for injection (Erica®) combined with paclitaxel and cisplatin in the first-line treatment of patients with advanced esophageal cancer can significantly prolong the progression-free survival and total of patients compared with the standard first-line treatment of paclitaxel and cisplatin.

Esophageal cancer refers to a type of malignant tumor that occurs in the epithelium of the esophageal mucosa.

The ESCORT-1st study is the first phase III randomized, double-blind, placebo-controlled multicenter clinical study of PD-1 monoclonal antibody combined with paclitaxel and cisplatin in the first-line treatment of advanced esophageal squamous cell carcinoma.

In addition, this Monday, the FDA also just announced the approval of the K drug pembrolizumab for the first-line treatment indications for esophageal cancer and gastroesophageal junction cancer in the United States

(Recommended reading: Merck’s Keytruda first-line esophageal cancer and gastroesophageal junction cancer were approved by the FDA for marketing )

Squamous non-small cell lung cancer ( SHR-1210-III-307 study )

The SHR-1210-III-307 study, which previously reached the endpoint, is a randomized, double-blind, phase III controlled clinical study to evaluate carrelizumab for injection (erika®) or placebo in combination with paclitaxel and carrelizumab.

A total of 390 subjects were enrolled in the study, and they were randomly enrolled at 1:1.

The results of the study show that carrelizumab combined with chemotherapy for first-line treatment of patients with advanced or metastatic squamous non-small cell lung cancer can significantly prolong the progression-free survival of patients

Lung cancer is currently the number one malignant tumor in China in terms of morbidity and mortality.

About 30-45% of Chinese NSCLC patients are squamous NSCLC
.
Due to the extremely low percentage of positive driver genes in patients with squamous NSCLC, treatment options are very limited
.
At present, the first-line systemic treatment of advanced squamous NSCLC in China is still based on platinum-containing dual-agent chemotherapy.
The effective rate of first-line chemotherapy is about 20-30%, and the survival benefit is limited.
Therefore, there is a huge unmet medical demand
.

Currently in China, PD-1 is highly competitive in the field of NSCLC
.
Although only pembrolizumab has been approved by NMPA to combine carboplatin and paclitaxel in the first-line treatment of squamous non-small cell lung cancer, two other domestic PD-1s have been reported for the market for this indication: BeiGene tislelizumab combined The indications of chemotherapy for the first-line treatment of advanced squamous non-small cell lung cancer were reported in April 2020; Cinda Sindilimab combined with gemcitabine and platinum-based chemotherapy are indicated for the first-line treatment of advanced or metastatic squamous non-small cell lung cancer.
Listed in August 2020
.

After Hengrui's first-line combined treatment of squamous non-small cell lung cancer is reported on the market, four companies in this field will soon compete on the same stage
.

Competition status of 4 domestic PD-1 non-small cell lung cancer indications

(The blue label is an indication that may be reported for listing this time)