Betta Pharmaceuticals unveils the second-line Phase II clinical study data of the third-generation EGFR-TKI befortinib

April 10-15, 2021, the 112th American Association for Cancer Research (AACR) Annual Meeting will be held
.

The second-line clinical study of befortinib mesylate is a multi-center, open, single-arm phase II clinical study.
The goal is to evaluate the drug resistance and EGFR-T790M mutation-positive after receiving first-generation or second-generation EGFR-TKI treatment.
Efficacy and safety in patients with locally advanced or metastatic NSCLC
.

As of October 18, 2020, data show that 75-100 mg of befortinib mesylate capsules have been used to treat locally advanced or metastatic non-small cell lung cancer patients who have developed T790M mutations after EGFR-TKI resistance.
188 patients have been independent The review committee (IRC) assessed and confirmed PR, the objective response rate (ORR) was 64.
8% (95% CI: 59.
0-70.
3), and the disease control rate (DCR) was 95.
2% (95% CI: 92.
0-97.
3)
.

Of the 34 patients with brain metastases at baseline, 18 were confirmed as PR by IRC assessment, the objective intracranial response rate (iORR) was 52.
9% (95% CI: 35.
1-70.
2), and the intracranial disease control rate (iDCR) was 97.
1 %
.

Befortinib mesylate of Betta Pharmaceuticals is a third-generation EGFR inhibitor.
It has submitted a marketing application to the National Food and Drug Administration in March 2021, and is intended to be used in the locally advanced stage of T790M mutation after the previous use of EGFR-TKI resistance.
Or the treatment of metastatic non-small cell lung cancer
.

Indeed, methanesulfonic Beifu Phar derived from alternative compounds of Nigeria YiFang Biotech (Shanghai) Co.
, Ltd
.

As early as December 2018, in the announcement of the resolutions of the 30th meeting of the second board of directors of Betta Pharmaceuticals, Betta Pharmaceuticals stated that it will pay a total of 230 million yuan to Yifang Biologics for the first payment and subsequent R&D milestones, and the product will be launched.
Sales commission will be added afterwards
.

Yifang Bio's D-0316 is the current befortinib mesylate

       Up to now, three third-generation EGFR inhibitors have been approved in China, namely AstraZeneca’s Osimertinib, Hausen Pharmaceutical’s Ametinib, and Iris' Vometinib

       The author believes that the existing three generations of EGFR inhibitors are not much different from the results of clinical trials.

       In terms of the domestic treatment costs of the current three generations of EGFR inhibitors, osimertinib and ametinib have obvious cost advantages because they entered medical insurance.

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