ALX Oncology Presents First Evorpacept Combination Data with an Antibody-Drug Conjugate from Phase 1 ASPEN-07 Clinical Trial in Patients with Advanced Bladder Cancer
SOUTH SAN FRANCISCO, Calif. June 02, 2024 - ALX Oncology Holdings Inc. (ALX Oncology), a leading immuno-oncology company focused on developing therapies that target the CD47 immune checkpoint pathway, unveiled promising data from its Phase 1 ASPEN-07 clinical trial at the 2024 American Society of Cancer Oncology (ASCO) Annual Meeting in Chicago. This study explored the combination of ALX Oncology’s drug, Evorpacept, with the antibody-drug conjugate (ADC) PADCEV (enfortumab vedotin) in patients suffering from advanced bladder cancer.
The ASPEN-07 trial is an ongoing, open-label, single-arm clinical trial that aims to evaluate the safety and effectiveness of Evorpacept in combination with PADCEV in patients with locally advanced or metastatic urothelial cancer (la/m UC). This groundbreaking study represents the first-ever combination of Evorpacept and an ADC, marking a significant step forward in immuno-oncology research.
Evorpacept is a novel CD47 blocker, with an inactive Fc effector domain specifically designed to minimize associated toxicity. CD47 is an immune checkpoint protein that is overexpressed in several types of cancer and is known to suppress the body’s immune response against cancer cells. By blocking CD47, Evorpacept aims to unleash the patient’s immune system to effectively identify and destroy cancer cells.
PADCEV is a targeted therapy developed by Astellas Pharma Inc. and Seattle Genetics, which consists of an anti-Nectin-4 monoclonal antibody linked to a microtubule-disrupting agent called MMAE. It has previously shown promising results in treating patients with advanced urothelial carcinoma.
The preliminary findings from the ASPEN-07 trial demonstrated encouraging results in terms of efficacy and safety. The combination of Evorpacept and PADCEV exhibited promising anti-cancer activity, with partial responses observed in a significant proportion of patients, suggestive of tumor shrinkage. Additionally, the therapy demonstrated a manageable safety profile, with adverse events consistent with those reported for the individual agents.
We are excited to present these preliminary data from the ASPEN-07 trial, said Dr. Mark Eckstrand, Chief Medical Officer of ALX Oncology. The combination of Evorpacept and PADCEV represents a potentially synergistic approach to treating advanced bladder cancer. These initial findings support further investigation of this combination therapy as a potential treatment option for patients with locally advanced or metastatic urothelial cancer.
Bladder cancer is the sixth most common cancer in the United States and often presents with few symptoms in its early stages. However, once the cancer has advanced, treatment options become limited and patient outcomes are often poor. Consequently, there is an urgent need for innovative therapies that can effectively target advanced bladder cancer and improve patient outcomes.
ALX Oncology is dedicated to revolutionizing cancer treatment by developing therapies that target the CD47 immune checkpoint pathway. By presenting the initial positive results from the ASPEN-07 trial, the company has taken a significant step forward in realizing its mission to transform the lives of patients suffering from advanced bladder cancer.
In conclusion, the combination of Evorpacept and PADCEV in the Phase 1 ASPEN-07 clinical trial has shown promising anticancer activity and a manageable safety profile in patients with advanced bladder cancer. These results lay the foundation for further investigation into this combination therapy as a potential treatment option for patients with locally advanced or metastatic urothelial cancer. ALX Oncology is poised to revolutionize cancer treatment by targeting the CD47 immune checkpoint pathway, and the ASPEN-07 trial is a significant milestone in its mission to transform the lives of patients battling bladder cancer.
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