Roche's CD79b-Targeted ADC Polivy Demonstrates Significant Efficacy in Phase III POLARIX Trial for First-Line DLBCL Treatment

News on November 24, 2021 /BioValleyBIOON/ -- Recently, the positive results of Roche's pivotal Phase 3 POLARIX trial (NCT03274492) were published in an abstract at the American Society of Hematology (ASH) Annual Meeting. This is an international Phase 3, randomized, double-blind, placebo-controlled study.Conducted in previously untreated (first-line) patients with diffuse large B-cell lymphoma (DLBCL), evaluated the CD79b-targeted antibody-drug conjugate (ADC) Polivy (polatuzumab vedotin) in combination with the chemotherapy regimen MabThera/Rituxan (brand name: 美罗华, generic name: rituximab, 利妥昔单抗) + cyclophosphamide + doxorubicin + prednisone (abbreviation:Polivy+R-CHP Regimen), Standard treatment regimen MabThera/Rituxan + Cyclophosphamide + Doxorubicin + Vincristine + Prednisone (Abbreviation:R-CHOP Regimen) for efficacy, safety, and pharmacokinetics in first-line treatment.

As of the data cutoff date of June 28, 2021, the median follow-up was 28.2 months,The study met its primary endpoint: compared with the R-CHOP treatment group, the Polivy+R-CHP treatment group showed a significant and clinically meaningful improvement in progression-free survival (PFS).Specifically, compared with the R-CHOP treatment group, the Polivy+R-CHP treatment groupThe relative risk of disease progression, recurrence, or death was significantly reduced by 27%.(HR=0.73; 95% CI: 0.57-0.95; p<0.02). The 2-year PFS rate was 76.7% in the Polivy+R-CHP group and 70.2% in the R-CHOP group. Compared with the R-CHOP group,Event-free survival (EFS) was superior (HR=0.75; 95% CI: 0.58-0.96; p=0.02), and disease-free survival (DFS) was also superior (HR=0.70; 95% CI: 0.50-0.98)., no difference in overall survival (OS) (HR=0.94; 95%CI:0.65-1.37; p=1.37), and no significant difference in complete response rate by PET-CT (78.0% vs 74.0%; p=0.16). In this study, Polivy+R-CHP showed a safety profile similar to R-CHOP.

DLBCL is an aggressive lymphoma, for newDiagnosisFor patients with DLBCL, extending progression-free survival may be transformative. Currently, 40% of patients relapse after initial treatment. Results from the Phase 3 POLARIX trial indicate that, in previously untreated DLBCL patients, compared to the standard treatment regimen (R-CHOP),The Polivy+R-CHP regimen is the first significant improvement in patient outcomes in 20 years.

Polivy is a first-in-class antibody-drug conjugate (ADC) targeting CD79b and represents the first approved chemoimmunotherapy for the treatment of DLBCL. Currently, Polivy is utilized as a ready-to-use, fixed-duration treatment regimen in relapsed or refractory (R/R) DLBCL and has been approved in over 60 countries worldwide, including the European Union and the United States, for use in combination with bendamustine and MabThera/Rituxan (rituximab) to treat R/R DLBCL.

DLBCL is a histological subtype of non-Hodgkin lymphoma (NHL) and is classified as an aggressive disease. DLBCL is the most common type of NHL, accounting for 30-40% of all NHL cases. DLBCL often occurs in middle-aged and elderly individuals, primarily in people over 60 years old. It has been reported that this disease...DiagnosisThe median age was 64 years. Rituximab combined with chemotherapy is the standard regimen for first-line treatment of DLBCL; however, about 40% of patients relapse due to insufficient treatment response. Although autologousStem CellsASCT is recommended for patients with relapsed or refractory DLBCL, but about half of the patients cannot undergo ASCT due to the failure of salvage chemotherapy before ASCT. In addition, there is currently no standard treatment regimen for patients who are ineligible for ASCT due to reasons such as age or complications. Therefore, there is an urgent need for more effective new treatment options for relapsed or refractory DLBCL.

Polivy was developed by Genentech, a subsidiary of Roche, in collaboration with Seattle.GeneticsDevelopment of ADC Technology at Roche,This is a first-in-class ADC specifically targeting CD79b, composed of a humanized anti-CD79b antibody conjugated with the antimitotic agent MMAE (monomethyl auristatin E).Currently under development for the treatment of several types of non-Hodgkin lymphoma (NHL). CD79b is highly specifically expressed in most types of B-cell NHL, making it a promising target for the development of new therapies. Polatuzumab vedotin targets and binds to CD79b, disrupting these B cells while maximizing the destruction of cancer cells and minimizing the impact on normal cells.

Polivy was approved by the United States in June 2019.FDAAccelerated approval in combination with bendamustine and rituximab (hereinafter referred to as BR therapy) for the treatment of R/R DLBCL patients who have previously received at least two therapies; in the EU, the drug received conditional approval in January 2020, in combination with BR therapy for patients unsuitable for hematopoiesis.Stem CellsTransplanted R/R DLBCL patients. In the United States and the European Union, Polivy has been granted orphan drug designation for the treatment of DLBCL, as well as Breakthrough Therapy Designation (BTD) and Priority Medicines designation (PRIME), respectively.

Notably, Polivy is the first approved chemoimmunotherapy for the treatment of R/R DLBCL. Compared with the commonly used regimen (BR), the combination of this drug with the BR regimen significantly improves clinical outcomes for patients. DLBCL is an aggressive blood cancer that typically becomes more difficult to treat with each recurrence. About 40% of untreated DLBCL patients relapse after standard treatment, and subsequent treatment options are limited. Polivy will provide an important treatment option for such patients.

Currently, Roche is continuing to explore the potential of Polivy to provide clinical benefits in multiple areas of unmet medical need. The company is advancing several studies investigating combination regimens of Polivy with CD20xCD3 T-cell engaging bispecific antibodies mosunetuzumab and glofitamab, with Venclexta/Venclyxto (generic name: venetoclax), with MabThera/Rituxan (rituximab), and with gemcitabine and oxaliplatin. (Bioon.com)

Source of Original Text:Roche's Polivy combo shows 27% PFS benefit in first-line B-cell lymphoma