Cancer vaccine galinpepimut-S may improve AML survival: Analysis
Treatment shows promise in interim analysis of Phase 3 trial data
Treatment with the cancer vaccine galinpepimut-S (GPS) is showing promise to potentially improve survival in people with acute myeloid leukemia (AML), a type of blood cancer, according to an interim analysis from an ongoing clinical trial.
“I am thrilled by the positive outcome of the interim analysis of our Phase 3 REGAL trial, marking the successful achievement of the most significant milestone for our GPS program to date,” Angelos Stergiou, MD, president and CEO of developer Sellas Life Sciences, said in a company press release.
Galinpepimut-S is being tested in AML patients who are in remission after at least two prior lines of study. Participants are assigned to receive either GPS or their doctor’s choice of best available treatment, with the main goal of testing whether GPS improves survival outcomes. According to Sellas, patients in this stage of AML historically have a median survival of only about six months.
Clinical trials like REGAL have an independent data monitoring committee, or IDMC, which is a group of experts independent of a therapy’s developer tasked with ensuring the safety of trial participants and the integrity of the study’s data. The REGAL trial’s IDMC was scheduled to conduct an interim analysis once 60 of the trial’s 128 participants had died. Unlike Sellas, the IDMC has access to unblinded data, meaning they know whether or not patients have received GPS.
In addition to assessing safety data, a major goal of this interim analysis was for the IDMC to check for futility. In other words, the experts assessed the trial data to see if there’s a reasonable likelihood that the trial will hit its goal of showing that GPS improves survival. Trials that are unlikely to hit their goals are often stopped early so that patients can avoid long-term therapy with treatments that are likely ineffective.
Panel recommends trial continue without modification
Following its analysis, the IDMC recommended that the trial should continue without any modification — meaning that, so far, the data suggest there’s a reasonable likelihood that final results will show that GPS improves survival.
“The IDMC’s recommendation to support the continued advancement of GPS in our REGAL trial brings us one step closer towards potential approval for the treatment of AML,” Stergiou said.
Although Sellas does not have access to the unblinded data used for the IDMC analysis, the company noted that fewer than half of the patients in the REGAL trial have died after nearly a year of follow-up, suggesting that participants in the trial are living longer than the historical median survival.
“Based on all available data, we believe that GPS could become a transformative treatment option for AML, offering hope to patients with limited choices, especially those with relapsed or refractory disease,” Stergiou said.
GPS is designed to trigger an immune response targeting WT1, a protein that’s found at high levels in cancer cells. The therapy aims to guide the immune system to attack and destroy AML cells. According to Sellas, data from a subset of participants in REGAL suggest that 80% have experienced a GPS-specific immune response.
“The interim results represent a major step forward in the treatment of AML, offering hope for patients in remission,” said Yair Levy, MD, director of hematologic malignancies research at Texas Oncology-Baylor University Medical Center. “I am very hopeful that we will see a new standard of care in treating AML patients based on the outcomes we have observed in previous GPS trials.”
The REGAL study will continue until 80 of the participants have died, at which point final analyses will be conducted. In the meantime, based on the REGAL data so far as well as promising data from earlier studies, Sellas has begun the process of preparing a biologics license application to ask the U.S. Food and Drug Administration (FDA) to approve GPS for AML.
“We are optimistic about the IDMC’s recommendation to continue the study without modifications, and diligently preparing for the Biologics License Application (BLA),” Stergiou said. “Importantly, the REGAL trial provides a clear and straightforward path toward seeking regulatory approval for patients with AML in their second complete remission. We look forward to completing the trial with the final analysis to be conducted once 80 events are reached.”
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