Promising Phase 1/2 Trial Data for Evorpacept Combined with Standard Treatment in Relapsed or Refractory B-cell NHL Patients
In a recent clinical trial, 20 patients suffering from relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL) were administered a combination treatment of evorpacept, rituximab, and lenalidomide, commonly referred to as the "R2" regimen. The study, which included 18 patients with indolent and 2 with aggressive forms of the disease, demonstrated that the addition of evorpacept to the R2 regimen was well-tolerated and exhibited a safety profile comparable to that of R2 alone.
Notably, this combined therapy yielded an overall response rate (ORR) of 94% and a complete response rate (CRR) of 83% in patients with indolent B-NHL, which significantly exceeds the historical CRR benchmark of 34% for R2 treatment. The results were announced by ALX Oncology Holdings Inc., a company specializing in immuno-oncology therapies that target the CD47 immune checkpoint pathway. The data were showcased at the 2024 American Association for Cancer Research Annual Meeting in an oral presentation. The trial involved patients who had previously received rituximab, with the majority also having undergone chemoimmunotherapy.
Evorpacept was administered at dosages of either 30 mg/kg every two weeks or 60 mg/kg every four weeks, alongside the standard R2 treatment. The maximum tested dose for evorpacept was 60 mg/kg every four weeks, and the most frequently reported adverse effects were fatigue, increased ALT, anemia, and increased AST, which were predominantly mild in severity. There were no treatment-related fatalities during the study. Dr. Paolo Strati, the principal investigator of the trial and an Assistant Professor at The University of Texas MD Anderson Cancer Center, highlighted the importance of exploring novel combinations with evorpacept to enhance the innate immune response against tumors.
Dr. Sophia Randolph, Chief Medical Officer at ALX Oncology, emphasized the unique drug design of evorpacept, which has shown anti-cancer activity while minimizing hematologic toxicities associated with other CD47 blocking agents. The Phase 1/2 investigator-sponsored trial is ongoing and is open-label, focusing on the evaluation of evorpacept's safety, tolerability, and efficacy when combined with R2 in patients with R/R B-cell NHL. The trial is currently enrolling patients for the Phase 2 portion, which is examining those with untreated indolent B-NHL. Non-Hodgkin lymphoma is the seventh most common cancer in the U.S., with over 80,000 new cases estimated in 2023.
Evorpacept, ALX Oncology's leading product candidate, is a next-generation CD47 blocking therapeutic that has shown promising activity and a favorable safety profile in combination with various anti-cancer treatments. The company is focused on combining evorpacept with anti-cancer antibodies, antibody-drug conjugates, and PD-1/PD-L1 immune checkpoint inhibitors to enhance cancer treatment outcomes.
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