Can PADCEV (enfortumab vedotin-ejfv) Show Similar Effectiveness in Head and Neck Cancer as it Did in Bladder Cancer?

PADCEV for Head and Neck Cancer

With a median survival of less than 1 year, there is a significant unmet need for effective treatment options for patients with head and neck squamous cell carcinoma. Targeting Nectin-4 with antibody–drug conjugate (ADC) may be a novel treatment strategy as it is expressed in a majority of HNC cases. The drug is currently approved for the treatment of urothelial cancer across various lines of therapy.

The head and neck cancer cohort included 46 patients, who had progressed/relapsed/discontinued treatment for toxicity after first-line of platinum-based therapy for locally advanced/metastatic (la/m) disease and no more than two lines of cytotoxic therapy in the locally advanced or metastatic (la/m) setting. PADCEV 1.25 mg/kg was administered intravenously on days 1, 8, and 15 of a 28-day cycle until disease progression/discontinuation criteria were met.

According to the results presented at the ASCO 2023 conference, the median PFS and OS were 3.94 months and 5.98 months, respectively. Although the median DOR was not reached, ORR was 23.9%, and DCR was 56.5%.

As far as the safety profile is concerned, Grade III adverse events (AEs) that occurred in more than one patient were anemia, decreased neutrophil count, and disease progression. Common adverse events were fatigue, alopecia, and peripheral sensory neuropathy. Other treatment-related AEs of special interest were skin reactions occurring in 45.7% of patients, peripheral neuropathy in 32.6%, and hyperglycemia in 4.3%.

KOL insights

“Similar to urothelial cancer, Nectin-4 is found frequently in head and neck squamous cell carcinoma. Hence, there was a dire need for a study to check the effect of PADCEV would have on head and neck cancer patients '. -Expert Opinion.


PADCEV showed significantly improved antitumor activity, with manageable side effects, in patients with extensively pretreated head and neck cancer. These findings were comparable to findings in other studies, where PADCEV showed superior antitumor effects, especially when used in the treatment of urothelial carcinoma. 

A recently added group, referred to as cohort 9, within the EV-202 study aims to examine the impact of combining enfortumab vedotin with pembrolizumab in patients with head and neck squamous cell carcinoma (HNSCC)