Roche has shared results from a pivotal five-year follow-up study on the phase III POLARIX trial, which assesses the efficacy of Polivy (polatuzumab vedotin) alongside MabThera/Rituxan (rituximab), cyclophosphamide, doxorubicin, and prednisone (R-CHP), for treating newly diagnosed diffuse large B-cell lymphoma (DLBCL). These findings were discussed during an oral presentation at the 66th American Society of Hematology (ASH) Annual Meeting, held from December 7-10, 2024, in San Diego, USA. The analysis, conducted with a median follow-up of 60.9 months, reviews both primary and secondary endpoints, as well as safety review.
“POLARIX sets a new standard for first-line diffuse large B-cell lymphoma treatment, a milestone not seen for the past two decades. The five-year follow-up offers promising data,” commented Levi Garraway, MD, PhD, Roche’s chief medical officer and global product development lead. “Polivy combined with R-CHP has treated over 38,000 patients worldwide, demonstrating its potential to enhance survival rates in this challenging lymphoma subtype.”
The extended follow-up analysis reported an encouraging trend in overall survival (OS) favoring Polivy with R-CHP over the traditional MabThera/Rituxan, combined with cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP). A noteworthy reduction in mortality risk (HR 0.85; 95% CI: 0.63 – 1.15) was observed among untreated DLBCL patients utilizing the Polivy combination, marking an improvement from the past three-year follow-up data (HR 0.94; 95% CI: 0.67 – 1.33). Continued assessment will occur over the next two years to determine the full OS differential.
“Addressing diffuse large B-cell lymphoma is complex, but the Polivy and R-CHP combination has proven to be a significant stride forward, minimizing relapse and disease progression,” mentioned Gilles Salles, MD, PhD, at Memorial Sloan Kettering Cancer Center. “The observed survival trend supports the growing recognition of Polivy’s role in frontline therapy with R-CHP.”
Beyond OS improvements, an observational study found a nearly 25% reduction in additional post-therapy treatments, like radiation and systemic chemotherapy, in Polivy and R-CHP recipients versus those treated with R-CHOP (38.3% vs 61.7%). With earlier economic assessments linking increased healthcare costs to additional relapsed therapy lines, minimizing these interventions could lessen the burden associated with repeated cycles.
After five years, the combined Polivy and R-CHP treatment maintained progression-free and disease-free survival benefits, aligning with previous three-year data, reinforcing its potential for long-term remission. The latest insights also indicated a slight numerical decrease in lymphoma-related mortality in those treated with Polivy and R-CHP compared to R-CHOP (9.0% vs 11.4%). The safety profiles remain consistent with known liabilities, indicating a secure benefit-risk balance for this treatment.
Insights from a broader cohort, including patients from diverse regions, affirmed comparability with the global intent-to-treat population.
Currently, Polivy with R-CHP is sanctioned for first-line therapeutic use against DLBCL in over 90 nations, spanning the US, EU, UK, Japan, Canada, and China. Roche is actively engaging with global health authorities to extend this regimen to additional patients.
Roche is committed to offering diverse DLBCL treatment options, aligning with patient needs and healthcare system requirements. It is exploring Polivy in combination with innovative compounds, including bispecific antibodies. Ongoing trials include the phase III SUNMO study on the effectiveness and safety of subcutaneous Lunsumio (mosunetuzumab) with intravenous Polivy compared to intravenous MabThera/Rituxan and gemcitabine plus oxaliplatin (R-GemOx) in second-line DLBCL, and the phase III SKYGLO trial, which investigates Polivy with R-CHP and Columvi (glofitamab) against Polivy and R-CHP in initial DLBCL treatment.
The international POLARIX study [NCT03274492] is a phase III randomized, double-blind, placebo-controlled assessment of the efficacy and safety of Polivy (polatuzumab vedotin) with MabThera/Rituxan (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) compared to rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) in individuals with untreated diffuse large B-cell lymphoma (DLBCL). Random assignments involved 879 patients receiving either Polivy plus R-CHP or Polivy-less R-CHOP, each for six cycles followed by two cycles of additional rituximab. The primary result measured was progression-free survival (PFS), a meaningful index for patients with untreated DLBCL as it signifies the premier therapeutic goal: reducing the possibility of disease worsening. Overall survival serves as a secondary endpoint in POLARIX.
DLBCL is the most prevalent non-Hodgkin lymphoma, representing a third of NHL variants. It is a fast-spreading form of NHL, responsive in initial treatments; however, up to 40% may relapse or develop refractory conditions, limiting treatment options and reducing survival. Exploring superior early-stage treatments offers hope for enhanced long-term patient outcomes, affecting an estimated 160,000 DLBCL diagnoses annually worldwide.
As a pioneering anti-CD79b antibody-drug conjugate (ADC), Polivy holds promise for NHLs with B-cell affinity, specifically targeting these cells and delivering anti-cancer agents while sparing healthy cells. Developed by Roche employing Pfizer ADC technology, Polivy is under investigation for multiple NHL applications.
Roche brings over 25 years of experience in hematological research, drawing upon an extensive portfolio of approved treatments including MabThera/Rituxan, Gazyva/Gazyvaro (obinutuzumab), Polivy, and others, while investing further to innovate patient care in this field. Its research pipeline features various investigational possibilities, offering unique combined regimens aimed at improved patient futures.