The following article features coverage from the American Society of Clinical Oncology 2020 meeting. Click here to read more of Cancer Therapy Advisor‘s conference coverage.

The combination of lenvatinib and pembrolizumab is a promising new antitumor regimen for patients with unresectable hepatocellular carcinoma as evidenced by a high overall response rate and disease control rate, according to the results of a phase 1b trial. Andrew X. Zhu, MD, of Massachusetts General Hospital Cancer Center in Boston, presented the results during the ASCO20 Virtual Scientific Program.

Lenvatinib is currently approved as a first-line treatment for unresectable HCC. Pembrolizumab is approved in this patient population after sorafenib therapy. This phase 1b trial was designed to assess the combination.

The study included 104 patients who received lenvatinib 12 mg per day or 8 mg per day (if body weight was less than 60 kg) plus pembrolizumab 200 mg on day 1 of a 21-day cycle. Six patients were enrolled in the dose-limiting toxicity evaluation (part 1); 98 patients were enrolled in the dose expansion part of the study (part 2). The primary endpoints were safety and tolerability in part 1 and overall response rate and duration of response in part 2.

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With a median follow-up of 10.6 months, 37 patients continued on treatment. At that time, no dose-limiting toxicities were reported.

The majority of patients had radiological evidence of tumor shrinkage. The median overall survival was 22 months with a median progression-free survival of 8.6 months.

Overall, 36% of patients responded to treatment per RECIST version 1.1 per independent imaging review. The median duration of response ranged from 8.6 to 12.6 sing different types of response assessment. Disease control rate was about 88%.

The majority of patients experienced treatment-emergent and treatment-related adverse events, with about two-thirds experiencing grade 3 or worse. The most common grade 3 or worse treatment-emergent and treatment-related adverse event was hypertension.

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Three patients died from a treatment-related adverse events: 1 from acute respiratory failure/acute respiratory distress syndrome, 1 from intestinal perforation, and 1 from abnormal hepatic function.

A phase 3 trial is currently assessing lenvatinib monotherapy compared with lenvatinib plus pembrolizumab as a first-line option for patients with unresectable HCC.

Read more of Cancer Therapy Advisor‘s coverage of the ASCO 2021 meeting by visiting the conference page.


Zhu AX, Finn RS, Ikeda M, et al. A phase Ib study of Lenvatinib (LEN) plus pembrolizumab (PEMBRO) in unresectable hepatocellular carcinoma (uHCC). Presented at: ASCO20 Virtual Scientific Program. J Clin Oncol. 2020;38(suppl):abstr 4519.