Neoadjuvant lenvatinib plus pembrolizumab in Merkel cell carcinoma: an investigator-initiated, open-label phase II trial.
1/5 보강
PICO 자동 추출 (휴리스틱, conf 3/4)
유사 논문P · Population 대상 환자/모집단
26 patients were enrolled, including 5 (19.
I · Intervention 중재 / 시술
6 weeks of neoadjuvant therapy with lenvatinib 20 mg orally daily plus pembrolizumab 200 mg intravenous dose every 3 weeks
C · Comparison 대조 / 비교
추출되지 않음
O · Outcome 결과 / 결론
Further investigation of these promising findings is warranted. [TRIAL REGISTRATION NUMBER] NCT04869137.
[BACKGROUND] Given the success of checkpoint inhibitor therapy in the advanced Merkel cell carcinoma (MCC) setting, there is interest in exploring immunotherapy as a neoadjuvant approach.
- 추적기간 20.0 months
APA
Brohl AS, Sondak VK, et al. (2026). Neoadjuvant lenvatinib plus pembrolizumab in Merkel cell carcinoma: an investigator-initiated, open-label phase II trial.. Journal for immunotherapy of cancer, 14(1). https://doi.org/10.1136/jitc-2025-013939
MLA
Brohl AS, et al.. "Neoadjuvant lenvatinib plus pembrolizumab in Merkel cell carcinoma: an investigator-initiated, open-label phase II trial.." Journal for immunotherapy of cancer, vol. 14, no. 1, 2026.
PMID
41534900
Abstract
[BACKGROUND] Given the success of checkpoint inhibitor therapy in the advanced Merkel cell carcinoma (MCC) setting, there is interest in exploring immunotherapy as a neoadjuvant approach. We report the primary results of a neoadjuvant study of lenvatinib plus pembrolizumab in resectable MCC.
[METHODS] In this single-center, phase II open-label trial, resectable stage II-IV MCC patients received 6 weeks of neoadjuvant therapy with lenvatinib 20 mg orally daily plus pembrolizumab 200 mg intravenous dose every 3 weeks. Following local therapy, patients received continued adjuvant pembrolizumab monotherapy to complete a total treatment duration of 1 year. Pathological complete response (pCR) rate was the primary endpoint of the study.
[RESULTS] 26 patients were enrolled, including 5 (19.2%) with clinical stage II disease, 20 (76.9%) with stage III, and 1 (3.8%) with stage IV. Following neoadjuvant treatment, 2 patients (7.7%) were unable to undergo planned surgery, one due to progressive disease and one due to toxicity. On intention to treat, 15 of the 26 patients (57.7%) achieved pCR. Among 22 radiographically evaluable patients, 16 (72.7%) achieved an objective response. At a median follow-up of 20.0 months, median progression-free survival (PFS) has not been reached. PFS significantly correlated with radiographic response to neoadjuvant therapy. pCR was associated with superior PFS, though this result was not statistically significant (p=0.22). Grade 3 treatment-related adverse events (TRAEs) occurred in 14 patients (53.8%), most commonly grade 3 hypertension in 11 patients (42.3%). No grade 4-5 TRAEs were observed.
[CONCLUSIONS] Lenvatinib plus pembrolizumab demonstrated encouraging efficacy with anticipated toxicity when used as neoadjuvant therapy for MCC. Further investigation of these promising findings is warranted.
[TRIAL REGISTRATION NUMBER] NCT04869137.
[METHODS] In this single-center, phase II open-label trial, resectable stage II-IV MCC patients received 6 weeks of neoadjuvant therapy with lenvatinib 20 mg orally daily plus pembrolizumab 200 mg intravenous dose every 3 weeks. Following local therapy, patients received continued adjuvant pembrolizumab monotherapy to complete a total treatment duration of 1 year. Pathological complete response (pCR) rate was the primary endpoint of the study.
[RESULTS] 26 patients were enrolled, including 5 (19.2%) with clinical stage II disease, 20 (76.9%) with stage III, and 1 (3.8%) with stage IV. Following neoadjuvant treatment, 2 patients (7.7%) were unable to undergo planned surgery, one due to progressive disease and one due to toxicity. On intention to treat, 15 of the 26 patients (57.7%) achieved pCR. Among 22 radiographically evaluable patients, 16 (72.7%) achieved an objective response. At a median follow-up of 20.0 months, median progression-free survival (PFS) has not been reached. PFS significantly correlated with radiographic response to neoadjuvant therapy. pCR was associated with superior PFS, though this result was not statistically significant (p=0.22). Grade 3 treatment-related adverse events (TRAEs) occurred in 14 patients (53.8%), most commonly grade 3 hypertension in 11 patients (42.3%). No grade 4-5 TRAEs were observed.
[CONCLUSIONS] Lenvatinib plus pembrolizumab demonstrated encouraging efficacy with anticipated toxicity when used as neoadjuvant therapy for MCC. Further investigation of these promising findings is warranted.
[TRIAL REGISTRATION NUMBER] NCT04869137.