In a systematic review and meta-analysis reported in JAMA Network Open, Yajima et al found that both pembrolizumab plus enfortumab vedotin-ejfv and enfortumab vedotin alone were active in the first-line setting and later lines of therapy, respectively, in metastatic urothelial carcinoma.
Study Details
The analysis included 11 studies (3 randomized clinical trials and 8 nonrandomized prospective studies) involving 2,128 patients. Of these patients, 563 (26.5%) received enfortumab vedotin plus pembrolizumab, 814 (38.3%) received enfortumab vedotin without pembrolizumab, and 751 (35.3%) received chemotherapy. The primary outcome measures were disease control rate, objective response rate, and 1-year survival.
Key Findings
All enfortumab vedotin plus pembrolizumab studies (n = 3) were first-line treatments, whereas all enfortumab vedotin monotherapy studies (n = 7) were second-line or later treatments.
Enfortumab vedotin plus pembrolizumab was associated with a pooled disease control rate of 86% (95% confidence interval [CI] = 83%–89%), objective response rate of 68% (95% CI = 64%–71%), and 1-year survival of 79% (95% CI = 75%–82%).
Enfortumab vedotin monotherapy was associated with a pooled disease control rate of 73% (95% CI = 70%–76%), objective response rate of 43% (95% CI = 40%–47%), and 1-year survival of 52% (95% CI = 48%–56%).
On network meta-analysis, enfortumab vedotin plus pembrolizumab was associated with significantly better objective response rate (odds ratio [OR] = 3.47, 95% CI = 1.49–8.09, P = .004) and 1-year survival (OR = 2.32, 95% CI = 1.75–3.06, P < .001) vs chemotherapy. Enfortumab vedotin monotherapy was associated with significantly better 1-year survival vs chemotherapy (OR = 1.60, 95% CI = 1.18–2.15, P = .002).
The investigators concluded: “In this systematic review and meta-analysis, enfortumab vedotin plus pembrolizumab showed high response rates in first-line settings, while enfortumab vedotin monotherapy was associated with clinical benefit in later lines of therapy. These findings underscore the importance of personalized treatment approaches, and future research is warranted to refine enfortumab vedotin–based therapies for [metastatic urothelial carcinoma.
Shugo Yajima, MD, of National Cancer Center Hospital East, Kashiwa City, Chiba, Japan, is the corresponding author for the JAMA Network Open article.
Disclosure: For full disclosures of all study authors, visit jamanetwork.com.
