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NICE recommends polatuzumab vedotin with rituximab and bendamustine for R/R diffuse large B-cell lymphoma

Aug 21, 2020
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The National Institute for Health and Care Excellence (NICE) has recommended in a published draft guidance, polatuzumab vedotin with rituximab and bendamustine as a treatment option for adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who are not eligible for hematopoietic stem cell transplant.

In February 2020, NICE rejected the treatment because of the uncertain cost-effectiveness, but since then a new updated analysis of the GO29365 trial (NCT02257567) has been published and a new price has been submitted.

The GO29365 trial is a multicenter, randomized, open-label trial, evaluating the safety, tolerability, and anti-tumor activity of polatuzumab vedotin with rituximab and bendamustine, compared with rituximab and bendamustine alone, in patients with R/R DLBCL.

Data from the GO29365 trial showed higher complete response rates with the combination of polatuzumab vedotin, bendamustine and rituximab compared with rituximab and bendamustine alone. After a follow-up of 30 months, 23% of patients in the triplet arm were in disease remission (n = 8, complete remission; n = 1, partial remission) compared with 5% in the rituximab with bendamustine arm. In addition, the triplet therapy demonstrated better progression-free and overall survival.

The appraisal committee concluded that a longer follow-up is needed to establish the long-term benefit of the treatment. However, initial data suggest that the triplet therapy may lead to a durable response. The submitted cost-effectiveness analysis was within the range considered to be cost-effective for life-extending treatments for patients at the end of life.

The final guidance from NICE on this triplet combination is expected to be published in September 2020.

  1. NICE. Final appraisal document: Polatuzumab vedotin with rituximab and bendamustine for treating relapsed or refractory diffuse large B-cell lymphoma. https://www.nice.org.uk/guidance/gid-ta10463/documents/final-appraisal-determination-document. Published Aug 20, 2020. Accessed Aug 21, 2020.

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