The American Society of Cancer Oncology held the 2024 ASCO Annual Meeting from May 31 through June 4, 2024. The Meeting brought together the brightest minds in oncology to discuss research advances, treatment trends, and burgeoning technologies within this field. During this time, researchers from immuno-oncology company ALX Oncology Holdings Inc. shared data from a Phase 1 clinical study evaluating a combination treatment of evorpacept and PADCEV (enfortumab vedotin) for people living with locally advanced or metastatic urothelial cancer. Urothelial carcinoma begins in tissues that line your urinary system. It may also be called transitional cell carcinoma or bladder cancer.
According to the company’s news release, the poster presentation (which you can find here if you’re so inclined) examined available data from the Phase 1 ASPEN-07 study with a cut-off date of April 3, 2024. 28 participants enrolled in the study. These participants typically underwent three or more prior treatments but had not yet been treated with PADCEV. Prior treatments had also been ineffective; all participants experienced cancer progression while taking checkpoint inhibitors and chemotherapy. By the time of trial enrollment, 93% of participants had metastatic cancer, which means the cancer spread (metastasized) from its original location elsewhere.
What is Evorpacept?
Before we dive into the study results, let’s look at what evorpacept is. ALX Oncology explains that:
Cancer cells leverage CD47, a cell surface protein, as a “don’t eat me” signal to evade macrophage phagocytosis or as a “don’t activate T-cell” signal that prevents activation of T-cells by dendritic cells. Evorpacept is a highly differentiated anti-CD47 blocker [that] we believe…will have a wide therapeutic window to block the “don’t eat me” signal and “don’t activate T-cell” signal on cancer cells, and will enhance the immune activation of broadly used anti-cancer agents.
Essentially, evorpacept helps the immune system identify and attack cancer cells. The therapy is also designed to improve responses to cancer treatment, which is why researchers wanted to explore evorpacept in combination with PADCEV. Findings from the study show that:
- Researchers administered up to 30mg/kg evorpacept to participants, but the maximum tolerated dose was not reached. This provides helpful insights for future study design and implementation.
- By the data cut-off date, the overall response rate was 59%. This means that 59% of participants experienced some response to treatment, such as a reduction in tumor size. Following data cut-off, four more participants showed signs of response. Altogether, there were six confirmed partial responses (meaning some response to treatment was observed) and two confirmed complete responses (meaning there was no more evidence of cancer).
- The treatment combination was both safe and well-tolerated. No deaths occurred due to this treatment. Although some individuals experienced side effects, these were usually mild-to-moderate and included altered taste, high blood sugar, itchiness, nausea, diarrhea, and a low-grade fever.
ALX Oncology plans to continue evaluating the treatment moving forward. More data will be available at a later date.
About Urothelial Cancer
Urothelial cancer forms in urothelial cells in the bladder, urethra, renal pelvis, and ureters. As the cancerous cells proliferate, tumors or masses can form. Men and people assigned male at birth (AMAB) are 4x more likely than women or people assigned female at birth (AFAB) to develop urothelial cancer. This cancer is also more common in older individuals and people who smoke. In early stages of cancer development, people may not show any symptoms. When symptoms do develop, these can include hematuria (blood in the urine), fatigue, back pain, painful urination, appetite and weight loss, bone pain, inability to urinate, and changes in bladder habits such as more or less frequent urination.
bladder cancer clinical trial evorpacept medical research PADCEV urothelial cancer urothelial carcinoma
Last modified: June 20, 2024
