On December 2, the official website of China CDE showed that the listing application of Roche vedotin for injection (Polatuzumab vedotin) has been accepted by the China National Medical Products Administration. This is the first anti-CD79b antibody conjugate drug that has been declared and marketed in China ( ADC).

Vibotuzumab is a first-in-class anti-CD79b ADC. CD79b protein is specifically expressed in most B cells. Polivy can specifically bind to CD79b protein and release chemotherapeutic drugs to destroy B cells and minimize its impact on normal cells.

Vibotuzumab mechanism of action

Vibotuzumab was first approved for marketing by the FDA (trade name: Polivy) as early as June 2019, combined with bendamustine + Rituxan (rituximab) for the treatment of patients who have received at least two previous treatments Adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL).

A phase Ib/II clinical trial evaluated Polivy's efficacy in 80 patients with relapsed or refractory DLBCL. The subjects were randomly divided into groups and received standard therapy bendamustine combined with rituximab or Polivy combined with bendamustine and rituximab. The results showed that the complete remission rate was 18% in the standard therapy group and 40% in the Polivy group. In addition, 64% of patients who achieved partial or complete remission in the Polivy treatment group had a remission that lasted more than half a year, and the proportion of patients who had more than one year was 48%.

It is worth noting that in August this year, the pivotal Phase III POLARIX trial of Polivy combined with R-CHP in the first-line treatment of DLBCL reached its primary endpoint. The results of the study showed that Polivy+R-CHP significantly improved PFS in patients compared with R-CHOP. Polivy+R-CHP is the first treatment plan to significantly improve the outcome of such patients compared with standard treatment in 20 years.