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ASCO 2021 | ELEVATE-TN: 4-year follow-up shows PFS benefit of A or A+O over O+Clb for CLL

John Byrd, MD, Ohio State University, Columbus, OH, outlines the four-year follow-up data from the ELEVATE CLL TN trial (NCT02475681), which previously demonstrated superior efficacy of acalabrutinib (A) monotherapy or acalabrutinib plus obinutuzumab (A+O) compared to obinutuzumab plus chlorambucil (O+Clb) for patients with chronic lymphocytic leukemia (CLL). At a median follow-up 26.9 months, the median progression-free survival (PFS) was not reached for A+O and A patients. The PFS for O+Clb patients was 27.8 months. The median overall survival was not reached in any arm. The overall response rate was significantly higher in the A+O arm (96.1%; 95% CI 92.1–98.1) compared to the O+Clb arm (82.5%; 95% CI 76.2–87.4; P = less than 0.0001). This interview took place at the virtual European Hematology Association (EHA) Congress 2021.

Transcript (edited for clarity)

The ELEVATE treatment-naïve study is the first head-to-head comparison of either acalabrutinib or acalabrutinib plus obinutuzumab – two distinct arms – to chlorambucil obinutuzumab, a former standard therapy for CLL. This study is updated from the publication in Lancet which it demonstrated an improved response and improved progression-free survival with both of the experimental arms, acalabrutinib and acalabrutinib plus obinutuzumab as compared to chlorambucil plus obinutuzumab...

The ELEVATE treatment-naïve study is the first head-to-head comparison of either acalabrutinib or acalabrutinib plus obinutuzumab – two distinct arms – to chlorambucil obinutuzumab, a former standard therapy for CLL. This study is updated from the publication in Lancet which it demonstrated an improved response and improved progression-free survival with both of the experimental arms, acalabrutinib and acalabrutinib plus obinutuzumab as compared to chlorambucil plus obinutuzumab.

The data continues showing that the progression-free survival is being sustained with acalabrutinib or acalabrutinib plus obinutuzumab and that the safety profile of this treatment as compared to chlorambucil obinutuzumab is quite favorable. These results continue to demonstrate that a BTK inhibitor with or without a CD20 inhibitor are superior therapies for CLL patients in the treatment-naïve setting.

This study also in the Lancet paper and continuing, although it was a post hoc analysis, demonstrates that there might be advantage in second-generation BTK inhibitors to adding CD20 antibodies to getting deeper remissions that could translate for a subset of patients the opportunity to stop therapy.

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Disclosures

John Byrd, MD, has received honoraria from AstraZeneca, Novartis, Pharmacyclics, Syndax and Trillium Therapeutics; has participated in a consultancy or advisory role for Acerta Pharma, Genentech, Pharmacyclics and Jazz Pharmaceuticals; and has received research funding from Acerta Pharma and Pharmacyclics.