Huadong Medicine: ADC's new drug treatment of ovarian cancer has reached the primary end point in overseas key clinical trials

On December 1, Huadong Medicine issued an announcement stating that the US key single-arm clinical trial (SORAYA trial) of the new ADC drug IMGN853 (Mirvetuximab Soravtansine) developed in cooperation with ImmunoGen, Inc.

IMGN853 is the world’s first ADC drug candidate for folate receptor α (FRα) positive ovarian cancer.

Brief introduction of Mirvetuximab soravtansine (picture source: ImmunoGen official website)

On October 20, 2020, Huadong Medicine and ImmunoGen of the United States reached an agreement to obtain the exclusive clinical development and commercialization rights of IMGN853 in Greater China

The announcement showed that the SORAYA trial evaluated the safety and effectiveness of IMGN853 as a single-agent treatment of platinum-resistant ovarian cancer with high FRα expression.

As of November 16, 2021, the median follow-up time of the trial was 8.

It is worth noting that in June this year, Rongchang Biotechnology obtained the conditional approval of NMPA for the innovative ADC gastric cancer drug injection vedicitumumab.

At present, the first clinical trial application of Huadong Medicine IMGN853 in China has been approved by NMPA in March 2021, including the above-mentioned international multi-center phase III study and an evaluation of safety, tolerability and pharmacokinetics in Chinese adult patients The first phase of the study