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Soo Park, MD
Soo Park, MD
Posted: Friday, January 23, 2026
According to Andrew S. Brohl, MD, of the H. Lee Moffitt Cancer Center and Research Institute, Tampa, and colleagues, in patients with Merkel cell carcinoma, neoadjuvant treatment with the multitargeted tyrosine kinase inhibitor lenvatinib plus the anti–PD-1 monoclonal antibody pembrolizumab demonstrated “encouraging” efficacy. The primary results from their investigator-initiated, single-center, open-label phase II trial, which were published in the Journal for ImmunoTherapy of Cancer, also revealed a manageable safety profile for the regimen.
“This is the first prospective trial to evaluate the combination of lenvatinib plus pembrolizumab in Merkel cell carcinoma and the first prospective trial to evaluate neoadjuvant combination systemic therapy in this disease,” the investigators commented. “This regimen provided clinically meaningful antitumor activity, with pathologic and radiographic response rates exceeding historical expectations of anti–PD-1 monotherapy.”
A total of 26 patients with resectable stage II to IV disease were enrolled and were intended to receive 6 weeks of neoadjuvant therapy with 20 mg of oral lenvatinib daily plus 200 mg of intravenous pembrolizumab every 3 weeks. After local therapy, they received adjuvant pembrolizumab monotherapy to complete a total treatment duration of 1 year.
A total of 57.7% of patients in the intention-to-treat population achieved a pathologic complete response. Among radiographically evaluable patients (n = 22), 72.7% achieved an objective response. At a median follow-up of 20.0 months, the median duration of progression-free survival was not reached. Progression-free survival was found to significantly correlate with radiographic response to neoadjuvant therapy. Although pathologic complete response seemed to be associated with superior progression-free survival, according to the investigators, this result was not statistically significant (P = .22).
Grade 3 treatment-related adverse events were observed in 53.8% of patients; hypertension was reported most frequently (42.3%). No grade 4 to 5 treatment-related adverse events were documented.
“Further investigation of these promising findings is warranted,” the investigators concluded.
Disclosure: For full disclosures of the study authors, visit jitc.bmj.com.
Journal for ImmunoTherapy of Cancer
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