Tandem Meetings 2023 | LBA: SIERRA results – Iomab-B prior to allogeneic transplantation vs conventional care in R/R AML
Sergio Giralt, MD, Memorial Sloan Kettering Cancer Center, New York City, NY, shares the results of SIERRA (NCT02665065), a Phase III study of Iomab-B prior to allogeneic transplantation versus conventional care in elderly patients with active, relapsed/refractory (R/R) acute myeloid leukemia (AML). The study reported a significant improvement in the durability of complete remission (CR), event-free survival (EFS), and one-year survival in patients who received Iomab-B. In addition, patients who did not achieve remission following induction therapy in the conventional care arm and were switched to receive Iomab-B had a similar survival to patients who were initially randomized to Iomab-B. These results suggest Iomab-B as a highly promising strategy for bridging elderly patients to allogeneic transplantation. This interview took place at the 2023 Transplantation & Cellular Therapy Meetings of ASTCT™ and CIBMTR® held in Orlando, FL.
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Transcript (edited for clarity)
The other important late-breaking abstract that was presented on Saturday at the Tandem meetings was the SIERRA trial. The SIERRA trial was a randomized trial of Iomab-B, which is a CD45 radio-immune conjugate that targets hematopoietic stem cells, and against conventional chemotherapy. The main endpoint was durable complete remissions at six months.
I think it’s important to note that in this randomized trial, 76 patients were randomized to Iomab-B, 77 patients were randomized to conventional care...
The other important late-breaking abstract that was presented on Saturday at the Tandem meetings was the SIERRA trial. The SIERRA trial was a randomized trial of Iomab-B, which is a CD45 radio-immune conjugate that targets hematopoietic stem cells, and against conventional chemotherapy. The main endpoint was durable complete remissions at six months.
I think it’s important to note that in this randomized trial, 76 patients were randomized to Iomab-B, 77 patients were randomized to conventional care. At the end, 66 patients on the Iomab-B arm got transplanted while only 14 patients got a conventional transplant in the control arm. However, 44 patients in the control arm that failed to achieve a remission to re-induction treatment went on to cross over to Iomab, which 40 were transplanted. The important adult disease characteristics were similar across all groups.
I think the durable complete remission rate was significantly better for the Iomab-B arm, with a durable complete remission rate of 28% versus 0.2% in the conventional chemotherapy arm. Overall, durable complete remission was defined at six months, but even patients are now continuing in remission, with 58% of those patients in remission now for two years or more. The event-free survival was significantly better for patients randomized to Iomab-B, 28% versus 0.2%. The one-year survival was also better, 26% for Iomab-B versus 13%. It’s important that survival for Iomab-B patients were doubled compared to the conventional chemotherapy controls that did not want crossover. The patients on the crossover arm actually had a survival that was similar to those who were randomized initially to Iomab-B.
Again, I think this is a game-changer. It’s a potential new and novel strategy for bridging patients with active disease. Remember, to be eligible patients that have more than 5% blast, the median blast was 30%. Many of these patients would not even be considered candidates for allotransplant because of their tumor burden. So Iomab-B is a unique strategy that allows us to bridge elder patients with active disease to an allogeneic transplant.
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Disclosures
Dr. Sergio Giralt receives research funding from Miltenyi Biotec, Takeda Pharmaceutical Co., Celgene Corp., Amgen Inc., Sanofi, Johnson and Johnson, Inc., Actinium Pharmaceuticals, Inc., and is on the Advisory Boards for: Kite Pharmaceuticals, Inc., Celgene Corp., Sanofi, Novartis, Johnson and Johnson, Inc., Amgen Inc., Takeda Pharmaceutical Co., Jazz Pharmaceuticals, Inc., Actinium Pharmaceuticals, Inc.
