(Gastric Cancer) Is Pembrolizumab Plus Lenvatinib Effective?

• July 20, 2020
• Reading time: 2 minutes

On June 23, 2020, Akihito Kawazoe published in the medical journal The Lancet the EPOC1706 Phase 2 trial results verifying the efficacy and safety of first-line pembrolizumab (Keytruda) plus lenvatinib — a multikinase tyrosine kinase inhibitor — in patients with advanced gastric cancer.

Trial Design

This Phase 2 trial enrolled 29 patients with advanced gastric cancer and administered pembrolizumab (200 mg, 3-week cycles) plus lenvatinib (20 mg once daily) as first-line treatment. The primary endpoint was objective response rate (ORR). Secondary endpoints included adverse event rate, progression-free survival (PFS), and overall survival (OS).

Background: Anti-PD-1 antibody pembrolizumab alone achieves approximately 15% antitumor activity in advanced gastric cancer. Preclinical results confirmed that combining a multikinase tyrosine kinase inhibitor lenvatinib with an anti-PD-1 antibody enhanced antitumor efficacy, providing the rationale for this trial.

Efficacy Results

At a median follow-up of 12.6 months, the primary endpoint ORR was 69%.

Safety Profile

Grade 3 adverse events confirmed in most patients:

• Hypertension: 38%
• Proteinuria: 17%
• Thrombocytopenia: 7%

No patient deaths due to adverse events were confirmed.

Conclusions

Based on the Phase 2 trial results, Akihito Kawazoe concluded that first-line pembrolizumab plus lenvatinib in patients with advanced gastric cancer demonstrated sufficient antitumor activity with acceptable tolerability.

Source: Lenvatinib plus pembrolizumab in patients with advanced gastric cancer in the first-line or second-line setting (EPOC1706): an open-label, single-arm, phase 2 trial. Lancet Oncol. 2020 Jun 23.

• Clinical trial drug
• Immunotherapy

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