Roche's First-in-Class Anti-CD79b ADC Polatuzumab Vedotin Nominated for Priority Review in China for Relapsed/Refractory DLBCL

Source: PharmaCube Info

On December 21, the CDE website showed that Roche's Polatuzumab vedotin injection (Polatuzumab vedotin) marketing application was proposed to be included in the priority review for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). This is the first anti-CD79b antibody-drug conjugate (ADC) to be submitted for marketing in China and also the first chemoimmunotherapy approved by the FDA.

Vibotuzumab is a first-in-class anti-CD79b ADC, composed of the CD79-targeting monoclonal antibody Polatuzumab, a cleavable linker, and a small molecule drug. The CD79b protein is specifically expressed in most B cells. Vibotuzumab can specifically bind to the CD79b protein and release chemotherapy drugs to destroy B cells, minimizing the impact on normal cells.

Mechanism of Action of Vibo Tuzumab

Polivy (Pivotal Trial Drug) was first approved by the FDA in June 2019 for marketing (brand name: Polivy). It is used in combination with bendamustine and Rituxan (rituximab) to treat adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have received at least two prior therapies. Subsequently, Polivy was successively approved for marketing in the European Union and Japan.

A previous Phase Ib/II clinical trial of polatuzumab vedotin evaluated its efficacy in 80 patients with relapsed or refractory DLBCL. Participants were randomly assigned to receive either the standard therapy of bendamustine plus rituximab or polatuzumab vedotin in combination with bendamustine and rituximab. The results showed a complete response rate of 18% in the standard therapy group, compared to 40% in the polatuzumab vedotin group. Additionally, among patients in the polatuzumab vedotin treatment group who achieved partial or complete responses, 64% had a duration of response lasting more than six months, with 48% lasting over a year.

In August this year, the key Phase III POLARIX trial of polatuzumab vedotin combined with R-CHP for the first-line treatment of DLBCL reached its primary endpoint. The results showed that Polivy+R-CHP significantly improved PFS in patients compared to the R-CHOP regimen. Polivy+R-CHP is the first treatment regimen in 20 years to significantly improve outcomes for such patients compared to the standard treatment.