A Phase 3 study evaluating pembrolizumab in combination with enfortumab vedotin for untreated locally advanced or metastatic urothelial cancer reached primary completion on 2023-08-08. The combination demonstrated significantly improved outcomes, with a median overall survival of 31.5 months compared to 16.1 months for standard of care chemotherapy.

Background

The study investigated pembrolizumab (Keytruda), an immunotherapy, in combination with enfortumab vedotin for patients with untreated locally advanced or metastatic urothelial cancer. This patient population has cancer that has spread from their urinary system to other parts of their body.

Trial design

The Phase 3 study (NCT04223856) enrolled 886 participants with untreated locally advanced or metastatic urothelial cancer. The trial compared the combination of enfortumab vedotin and pembrolizumab against standard of care chemotherapy, which included either cisplatin, carboplatin, or gemcitabine. Key outcomes measured included Progression-Free Survival (PFS) and Overall Survival (OS).

Key results

The trial reported significant improvements in both progression-free survival (PFS) and overall survival (OS) for the combination arm. For PFS, the median was 12.5 months for the enfortumab vedotin + pembrolizumab group, compared to 6.3 months for the standard of care group. The hazard ratio for PFS was 0.45 (95% Confidence Interval: 0.377 to 0.538), with a p-value of 1e-05. For OS, the median was 31.5 months in the enfortumab vedotin + pembrolizumab arm, versus 16.1 months in the standard of care arm. The hazard ratio for OS was 0.468 (95% Confidence Interval: 0.376 to 0.582), with a p-value of 1e-05.

What this means

The results from this Phase 3 study indicate that the combination of enfortumab vedotin and pembrolizumab offers a substantial clinical benefit for patients with untreated locally advanced or metastatic urothelial cancer. The significant improvements in both progression-free survival and overall survival, as evidenced by the median values and hazard ratios, suggest that this regimen could become an important treatment option for this patient population, potentially altering current treatment paradigms.

Source

The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The primary completion status for the study NCT04223856, titled "Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer", was posted on 2023-08-08 on clinicaltrials.gov.