POLIVY (polatuzumab védotine) - Lymphome non hodgkinien (LDGCB)

Key points

Disapproval of reimbursement of POLIVY (polatuzumab vedotin), in association with rituximab, cyclophosphamide, doxorubicin and prednisone, for the treatment of previously untreated adult diffuse large B cell lymphoma patients.

Role in therapeutic strategy?

The therapeutic management of diffuse large B cell lymphoma (DLBCL) patients involves, as a first-line treatment, an association of chemotherapy with an anti-CD20 monoclonal antibody, namely the R-CHOP regimen, leading to complete remission in two-thirds of cases. Despite existing first-line therapeutic options (immunochemotherapy), 30 to 40% of DLBCL patients have refractory or relapsed disease with an unfavourable prognosis.

Role of the medicinal product

Considering:

• the effect size deemed to be modest on progression-free survival in the POLARIX randomised, double-blind, phase III study, assessing polatuzumab Vedotin in association with rituximab/cyclophosphamide/prednisone/doxorubicin versus the current conventional treatment (R-CHOP): HR = 0.73; CI95% = [0.57; 0.95] and the medians not yet reached in both groups compared, 
• the lack of evidence of superiority in terms of complete response assessed by an independent review committee by PET-CT (ranked secondary outcome measure),
• the lack of evidence of a benefit on overall survival (other ranked secondary outcome measure), on the date of analysis,
• the lack of formal evidence of lower toxicity or of improvement in terms of quality of life considering the exploratory nature of the data,

the Committee deems that, based on the data currently available, POLIVY (polatuzumab vedotin), in association with rituximab/cyclophosphamide/doxorubicin/prednisone, has no role in the therapeutic strategy for the treatment of previously untreated adult diffuse large B cell lymphoma patients.