Rajneesh Nath, MD

Rajneesh Nath, MD, the section chief of Cellular Therapy/Stem Cell Transplant and Leukemia at Banner MD Anderson Cancer Center, discusses what is in store regarding treatment for elderly patients with relapsed/refractory acute myeloid leukemia (AML).

The SIERRA trial (NCT02665065) trial enrolled and evaluated 133 patients over the age of 55 with relapsed/refractory AML who had a fully matched donor. According to Nath, participants were randomized into either the experimental arm where they were given lomab-B after transplant, or the standard of care arm.

Additionally, Nath emphasizes the positive advancements and new treatments within the AML field, including use of the combination of hypomethylating agents and venetoclax (Venclexta). This combination has been seen to help elderly patients by giving them a pathway to stem cell transplantation and to remission.

 It's an exciting time to be treating elderly patients with acute myeloid leukemia. Until a couple of years ago, we didn't have anything for them, we would just see which patients would be eligible for induction which many of these patients were not. We recently had several new approvals for this disease.

 One of the particular areas that I'm excited about is the use of a combination of hypomethylating agents with venetoclax. This combination is able to free a lot of elderly patients and put them into remission. It serves as a pathway to take them to stem cell transplant because the outcomes of stem cell transplant are better if they are done in remission. On one hand, we are able to put an increasing number of patients into remission and provide them a pathway for stem cell transplant. On the other hand, if this study works out, we will be having a pathway for patients who do not go into remission, also to proceed with an allergenic stem cell transplant.

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Rajneesh Nath, MD, discusses what is in store regarding treatment for elderly patients with relapsed/refractory acute myeloid leukemia.

Future Directions for Elderly Patients With Relapsed/Refractory AML

Rajneesh Nath, MD, a medical oncologist at the Banner MD Anderson Cancer Center, discusses the early results of the phase III SIERRA trial (NCT02665065) investigating the efficacy of Iomab-B and protocol-specified allogeneic hematopoietic stem cell transplant (HCT) versus the standard of care in older patients with active, relapsed or refractory acute myeloid leukemia (AML).

Nath says that the safety of the Iomab-B, a reduced intensity conditioning regimen, and HCT combination was 1 of the most important parts of this multicenter trial. The study investigators looked at data after half of the patients on the trial were randomized. Thus far, they have reported that about 80% of the patients in the Iomab-B arm were unable to undergo transplant. They also had fully engrafted neutrophils and platelets.

In the conventional arm, about 20% of patients were able to undergo the standard-of-care transplant. However, this study allowed patients who did not go into remission to crossover from convention chemotherapy to the HCT and Iomab-B regimen, which was about 80% of patients, according to Nath.

Rajneesh Nath, MD, discusses the early results of the phase III SIERRA trial investigating the efficacy of Iomab-B and protocol-specified allogeneic hematopoietic stem cell transplant versus the standard of care in older patients with active, relapsed or refractory acute myeloid leukemia.

SIERRA Trial Delivers Initial Data for Older Patients With AML

Rajneesh Nath, MD, a medical oncologist at the Banner MD Anderson Cancer Center, discusses the rationale for phase III SIERRA trial, which evaluated the anti-CD45 monoclonal antibody apamistamab (Iomab-B, day-12) followed by fludarabine/total body irradiation and allogeneic hematopoietic cell transplantation (HCT) in patients with relapsed/refractory acute myeloid leukemia (AML).

Patients with AML who have never gone into remission or those who have gone into remission with standard chemotherapy but subsequently relapse tend to have a very poor prognosis. The only cure for these patients, according to Nath, is allogeneic stem cell transplant (SCT), but this is particularly challenging for patients over the age of 55.

Older patients over the age of 55 will initially receive induction chemotherapy, and if they achieve remission, they then undergo SCT. However, the toxicity associated with SCT is high and this patient population does not typically go into remission. Because of this, most of these patients are not offered curative SCT.

The SIERRA trial evaluates the ability of allogeneic HCT to induce remission in patients who are over the age of 55 with relapsed/refractory AML.

Rajneesh Nath, MD, discusses the rationale for phase III SIERRA trial, which evaluated the anti-CD45 monoclonal antibody apamistamab followed by fludarabine/total body irradiation and allogeneic hematopoietic cell transplantation in patients with relapsed/refractory acute myeloid leukemia.

Evaluating Older Patients With Acute Myeloid Leukemia in SIERRA Trial

Rajneesh Nath, MD, director, stem cell transplant and AML program, Banner MD Anderson Cancer Center, discusses the ongoing phase III SIERRA trial, which is evaluating targeted conditioning of Iomab-B prior to allogeneic hematopoietic cell transplantation versus conventional care in patients with relapsed/refractory acute myeloid leukemia (AML).

This trial focuses on elderly patients who have relapsed or refractory AML that is not responding to standard therapy, Nath explains. Patients who are elderly, as well as patients who have active disease at the time of transplant, generally do not do well. Both of these patient groups will be included on this trial.

Rajneesh Nath, MD, director, stem cell transplant and acute leukemia program, Banner MD Anderson Cancer Center, discusses the ongoing&nbsp;phase III SIERRA trial, which is evaluating targeted conditioning of Iomab-B prior to allogeneic hematopoietic cell transplantation versus conventional care in patients with relapsed/refractory acute myeloid leukemia (AML).<br />
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Rajneesh Nath, MD | Authors

Articles

Future Directions for Elderly Patients With Relapsed/Refractory AML

SIERRA Trial Delivers Initial Data for Older Patients With AML

Evaluating Older Patients With Acute Myeloid Leukemia in SIERRA Trial

An Overview of the Ongoing SIERRA Trial in Relapsed/Refractory AML