AstraZeneca ( AZN.US ) self-developed ADC new drug starts its first Phase III clinical in China

Zhitong Finance APP learned that on April 3, the drug clinical trial registration and information disclosure platform shows that AstraZeneca (AZN.US) has registered a Phase III clinical trial (registration number: CTR20261196) for AZD5335, a treatment for patients with platinum-resistant advanced-grade ovarian epithelial cancer who are positive for folate receptor alpha (FRα) (high expression and low expression) after 1-3 line therapy.

Source: the drug clinical trial registration and information disclosure platform

The domestic clinical portion of the TREVI-OC-01 study is being initiated this time. TREVI-OC-01 is a randomized, open-label, Phase III study, aimed at evaluating the efficacy and safety of AZD5335 compared with standard of care (SoC) among trial subjects with platinum-resistant recurrent ovarian cancer with FRα high expression and FRα low expression who have previously received 1-3 lines of systemic treatment regimens. Of these, in the FRα high-expression cohort, the comparator for AZD5335 is somituximab; in the FRα low-expression cohort, it is compared with chemotherapy regimens selected by the investigators.

The Insight database shows that, currently, worldwide there is only one FRα ADC approved for上市—AbbVie’s somituximab—used only in adult patients with FRα-positive platinum-resistant epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. In addition, there are four FRα ADCs that have progressed to clinical Phase III, from Eli Lilly, AstraZeneca, BeiGene, and Genmab.