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The National Institute for Health and Care Excellence (NICE) has recommended in a published draft guidance, polatuzumab vedotin with rituximab and bendamustine as a treatment option for adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma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.
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