Padcev to Be Studied in Advanced Bladder Cancer

The first patient has been dosed with Padcev (enfortumab vedotin-ejfv) in the phase 1 ASPEN-07 clinical trial, evaluating the drug in patients with locally advanced or metastatic bladder cancer that is not eligible for resection (surgical removal), ALX Oncology, the manufacturer of Padcev announced.

The trial will study the safety and tolerability of Padcev, as well as how the drug moves through the body (pharmacokinetics) and how it works within the body (pharmacodynamics).

“Outcomes for patients diagnosed with locally advanced or metastatic (bladder cancer) remain poor, and treatment options after initial chemotherapy and immunotherapy are limited," said Dr. Sophia Randolph, ALX Oncology’s chief medical officer, in a statement.

Padcev, which was approved for metastatic bladder cancer that has been treated with immunotherapy, is an antibody drug conjugate — commonly referred to as an ADC. ADCs work by bringing chemotherapy directly to cancer cells by targeting Nectin-4, a type of protein found on tumors.

Researchers plan on enrolling approximately 30 patients on the study, which will take place in cancer centers in Connecticut, Florida, Illinois, Massachusetts, New York, North Carolina, Oregon Tennessee, Texas and Washington.

To be eligible, patients must have unresectable locally advanced or metastatic urothelial carcinoma (bladder cancer); have had prior treatment with a checkpoint inhibitor; have received prior treatment with platinum-based chemotherapy; had progression or recurrence; have adequate bone marrow, kidney and live function.

"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,” Randolph said.

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