On February 16, 2023 ALX Oncology Holdings Inc., ("ALX Oncology") (Nasdaq: ALXO), a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, reported the first patient has been dosed in the ASPEN-07 study evaluating evorpacept, a next generation CD47 blocker, in combination with PADCEV (enfortumab vedotin-ejfv), an antibody drug conjugate ("ADC"), in patients with urothelial cancer ("UC") (Press release, ALX Oncology, FEB 16, 2023, View Source [SID1234627290]).
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ASPEN-07 is a phase 1, open-label, multi-center study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of evorpacept in combination with enfortumab vedotin-ejfv in subjects with unresectable locally advanced or metastatic UC (NCT05524545).
"Outcomes for patients diagnosed with locally advanced or metastatic UC remain poor, and treatment options after initial chemotherapy and immunotherapy are limited," said Sophia Randolph, M.D., Ph.D., ALX Oncology’s Chief Medical Officer. "We are excited to initiate ASPEN-07 to investigate this novel combination therapy that has the potential to change the treatment course of advanced UC. We are encouraged that PADCEV is the first ADC therapy to demonstrate meaningful clinical activity in these difficult-to-treat patients, and the addition of a CD47 blocker is expected to act through different but complementary mechanisms to positively impact efficacy without increasing toxicity."
About Bladder and Urothelial Cancer
As estimated by the National Cancer Institute, bladder cancer is the sixth most common cancer type in the United States. Urothelial cancer is the most common type of bladder cancer and accounts for approximately 90% of all bladder cancer cases. 81,000 new cases of bladder cancer will be diagnosed in the United States in 2022 with over 17,000 deaths. The five-year survival for patients with metastatic bladder cancer is less than 8%. Worldwide, over 573,000 new cases of bladder cancer and over 212,000 deaths occurred in 2020 according to The Global Cancer Observatory