BeiGene Announces Global Phase 3 Clinical Interim Analysis Results of Baizean® in the Treatment of Second- and Third-Line Non-Small Cell Lung Cancer

On April 13, BeiGene (Nasdaq code: BGNE; Hong Kong Stock Exchange code: 06160) announced its anti-PD-1 antibody Bazeran® at the American Association for Cancer Research (AACR) 2021 annual meeting (Tilelizumab) The interim analysis results of the global phase 3 clinical trial RATIONALE 303 compared with docetaxel for second-line or third-line locally advanced or metastatic non-small cell lung cancer (NSCLC) patients.

Biozeran® is the first humanized lgG4 anti-programmed death receptor 1 (PD-1) monoclonal antibody developed by BeiGene’s immuno-oncology biological platform.
It is designed to minimize interaction with macrophages.
Fcγ receptor binding in the cell.

Preclinical data indicate that the binding of Fcγ receptors in macrophages activates antibody-dependent cell-mediated killer T cells, thereby reducing the anti-tumor activity of PD-1 antibodies.

RATIONALE 303 was carried out in 10 countries in Asia, Europe, America and Oceania, and a total of 805 patients were enrolled.

These patients were randomized to the Bezian® test arm or the docetaxel test arm at a ratio of 2:1.

As of the data cut-off point of August 10, 2020, BeiGene conducted a pre-designated interim analysis of OS for the intention-to-treat (ITT) population and was evaluated by an independent data monitoring committee.

In the interim analysis, RATIONALE 303 reached the primary endpoint of overall survival (OS) for the ITT population.

In the ITT population, the median OS of the Bezian® test arm was 17.
2 months, while the data of the docetaxel test arm was 11.
9 months.

Among patients with high PD-L1 expression, the median OS was 19.
1 months in patients treated with Bazin® and 11.
9 months in the docetaxel trial group.

In terms of secondary results, the median progression-free survival (PFS) of the Baizean® treatment group was 4.
1 months, the objective response rate (ORR) was 21.
9%, and the median duration of response (DoR) was 13.
5 months.
The median PFS of the patients in the docetaxel trial group was 2.
6 months, the ORR was 7.
0%, and the median DoR was 6.
2 months.

At 12 months, the probability of PFS was 23.
3% in the Baizian® treatment group and 5.
7% in the docetaxel test group.

In general, Bezian® is generally tolerated in patients.
Compared with docetaxel, the incidence of adverse events of grade 3 or above is significantly reduced.

It is reported that the new indication listing application (sBLA) based on the results of this trial was accepted in China in March 2021 and is currently under review.

At present, there are 16 registered clinical trials of Baizean® in China and globally, including 13 phase 3 clinical trials and 3 key phase 2 clinical trials.

End reference materials: [1] BeiGene WeChat public account in the past selected onlookers Nature: Subverting a century of cancer metabolism theory! It is not necessarily a good thing that the cancer that consumes glucose crazily is not cancer cells.
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