Swiss pharmaceutical giant Roche (SWX: ROG, OTCMKTS: RHHBY) has announced that the National Medical Products Administration (NMPA) has approved its antibody-drug conjugate (ADC) Polivy (polatuzumab vedotin for injection). Polivy is the world’s first ADC targeting CD79b and is designed for use as a first-line treatment for diffuse large B-cell lymphoma (DLBCL). The ADC is used in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone in patients who have not previously been treated. For adult patients with recurrent or refractory DLBCL who are not suitable for hematopoietic stem cell transplantation, Polivy is used in combination with bendamustine and rituximab.
Approval Based on POLARIX Study
The approval for first-line DLBCL is based on the global Phase III POLARIX study (GO39942). The study showed that compared to the R-CHOP group, the two-year progression-free survival (PFS) rate in the Pola-R-CHP group had a statistically significant improvement, reaching 76.7%. The relative risk of disease progression, recurrence, or death was reduced by 27%, meeting the primary endpoint. Additionally, the safety profile was similar between the two groups. Notably, the proportion of patients completing the full course of treatment was higher in the Pola-R-CHP group, with fewer adverse events causing dose reductions.
Approval Based on GO29365 Study
The approval for recurrent or refractory DLBCL is based on the global, multi-center, randomized, controlled study GO29365. The study compared polatuzumab vedotin combined with bendamustine/rituximab (Pola-BR) to bendamustine combined with rituximab (BR). Results showed that Pola-BR significantly prolonged the median overall survival (OS) of patients to nearly three times that of the control group (12.4 months vs 4.7 months; P=0.002) and reduced the risk of death by 58%, with no serious adverse events observed.
Future Outlook
The approval of Polivy by the NMPA highlights Roche’s commitment to advancing innovative treatments for patients with DLBCL. With demonstrated efficacy and safety in both first-line and recurrent settings, Polivy has the potential to significantly improve patient outcomes. Roche’s ongoing efforts in oncology underscore its dedication to addressing significant unmet needs in the treatment of lymphoma.-Fineline Info & Tech
