2020 Oncology New Drug Data Card-Ensatinib

In 2020, the State Drug Administration Bureau (NMPA) approved a total of 16 kinds of cancer drugs.

Ensatinib

Q1 Basic information

Ensatinib (Bemena) is a new generation of potent and highly selective ALK inhibitor, jointly developed by Betta Pharmaceuticals and its holding subsidiary Xcovery.

Q2 Listing background

The incidence and fatality rate of lung cancer ranks first in the world and China's malignant tumors.

The positive rate of ALK fusion gene in NSCLC patients is about 3-8%.

ALK indications research and development layout

Q3 indications

Ensatinib's indications declared this time are: to provide new treatment for ALK-positive locally advanced or metastatic NSCLC patients who have progressed after receiving crizotinib treatment or are intolerant to crizotinib.

Q4 Treatment costs

At present, the latest winning bids for 100mg (14 capsules/bottle) and 25mg (7 capsules/bottle) of Ensatinib capsules are 573.

Ensatinib has not yet entered the national medical insurance catalogue.

It is reported that the global sales of the first generation ALK inhibitor crizotinib in 2019 were US$530 million.

Targeted ALK-related drug sales chart

Q5 Evidence-based data and core clinical

A single-arm, multi-center phase II registered clinical study showed that the ORR of ensatinib in the treatment of crizotinib-resistant ALK-positive NSCLC was 52.

The interim analysis results of the international multicenter head-to-head, first-line phase III eXalt3 trial published at the World Conference on Lung Cancer (WCLC) Forum in August 2020 showed that in the ITT population, compared with crizotinib, enzatinib is the first-line treatment The median PFS of ALK-positive NSCLC was significantly longer (25.

Interim analysis results of eXalt3 trial

In the modified ITT population, the median PFS of Ensatinib has not been reached, while the median PFS of crizotinib is 12.

In January 2021, the updated results showed that the eXalt3 study continued to be followed up for 5 months after the interim analysis.

It is reported that Betta Pharmaceuticals plans to submit a new indication for the first-line treatment of NSCLC with Ensatinib in China in 2021.

Data source: NextClinTrial database, which only retains key clinical trials for drug registration or for the purpose of changing guidelines; excludes low-quality researchers who initiate research or exploratory early clinical trials conducted by pharmaceutical companies

Q6 Guide recommendation

Currently, major guidelines recommend the following first-line treatment options for ALK-positive NSCLC:

In the latest version of the CSCO Guidelines for the Diagnosis and Treatment of Non-Small Cell Lung Cancer in 2020, both aletinib and crizotinib are recommended as level I, and aletinib is a priority recommendation.

In the latest edition of the NCCN guidelines, aletinib, brigatinib, and loratinib are recommended as the first-line treatment for ALK-positive advanced NSCLC, and ceritinib is another recommendation.

In the 2019 ESMO clinical practice guidelines for metastatic NSCLC, aletinib and crizotinib are both recommended as the first-line treatment of ALK-positive NSCLC, and aletinib is also remarked as a priority; ceritinib and brigatinib Nepal is recommended as a B-level.

It is believed that with the approval of Ensatinib for marketing, the CSCO lung cancer diagnosis and treatment guidelines in 2021 may be rewritten with a high probability, providing new options for ALK-positive NSCLC patients.