Dana-Farber Cancer Institute's Jennifer Brown, MD, PhD, shared results at #ASH24 from the Phase 3 AMPLIFY trial: novel oral regimens show promise for CLL with durable, deep responses.
Amplify is a multi-center phase 3 randomized trial testing the combination of a calibrini and veneta plaques with or without the anti CD20 antibody of bentuzumab in CLL. The patient population of previously untreated fit patients. With low comorbidity scores and who do not have deletion 17P or P53 aberration. And AS this year, we're presenting the first interim analysis, which is a 40.8 month follow-up, three-year landmark estimates for the survival curves. And the primary endpoint of the study was progression-free survival comparing the caliber nymphinneta plaques to the chemo immunotherapy arm. There was a statistical hierarchy where there are a number of key secondary endpoints. The next one was the AVO, a calibertoclaxabintuzumab, compared to chemo immunotherapy, followed by minimal residual disease endpoints for AV and AVO and then overall survival endpoints for AV and AVO. So the progression free survival for AV was significantly improved compared to the chemotherapy arm. This was by Independent Central Review and also for AVVO as well. The 3-year landmark estimates were 83% for Avo, 76.5% for AV and 66.5% for the chemo immunotherapy arm. Both experimental arms, as I said, were significantly improved compared to the chemo immunotherapy. There was no planned comparison of the two experimental arms. Obviously, the point estimate looks a little higher for AO compared to AV. This was not translated in the overall survival though, where overall survival was best for AV and was in fact statistically significantly improved compared to the chemo immunotherapy. Some of that may be due to the fact that the study was carried on at the height of the pandemic and there were COVID deaths which were more on the AVO and chemo immunotherapy arms compared to the AV probably because of the anti-CD20 antibodies. The AVR was also extremely well tolerated. Only about 25% of patients had serious adverse events. The most common toxicity was neutropenia, which was generally easily manageable. There were only low rates of BTK related toxicity such as cardiac events or hemorrhage. So overall, Amplify showed a statistically significantly improved progression-free survival for AB and ABO compared to FCRBR in fit treatment that patients with CLL. The trial is registrational, so we hope that these regimens will be approved sometime next year.
