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ESMO 2020: First-Line Pembrolizumab, Chemotherapy, and Lenvatinib in Metastatic NSCLC

By: Sarah Campen, PharmD
Posted: Friday, October 9, 2020

Makoto Nishio, MD, of the Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, and colleagues have reported preliminary evidence of antitumor activity in patients with metastatic nonsquamous cell non–small cell lung cancer (NSCLC) treated with first-line lenvatinib plus pembrolizumab and platinum-based chemotherapy. The initial data from part one of the phase III LEAP-006 trial, presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 (Abstract 1313P), also indicated the treatment regimen appears to be safe and tolerable.

For the safety portion of the study, 13 patients with metastatic, treatment-naive, nonsquamous NSCLC were enrolled to receive lenvatinib at 8 mg/day plus pembrolizumab at 200 mg, pemetrexed at 500 mg/m2, and either carboplatin or cisplatin every 3 weeks in cycles 1 to 4. Subsequently, up to 31 more cycles of pembrolizumab with lenvatinib and pemetrexed were given until progressive disease or toxicity.

Two patients receiving cisplatin experienced grade 3 hyponatremia, a dose-limiting toxicity. In all, 10 patients (77%) had grade 3 to 5 adverse events: 7 patients had treatment-related adverse events, 6 had immune-mediated adverse events, and 1 patient died of an adverse event not related to study treatment.

After a median follow-up of 7.5 months, patients received a median of 10 cycles of therapy. The overall rate of response was 69.2%, with all responses being partial responses. Additionally, three patients had stable disease. At the time of the blinded independent central review, 11 patients were alive, and 10 were free of disease progression. Enrollment into part 2—the double-blind, placebo-controlled portion of the study in which patients randomly receive the study regimen with either lenvatinib or placebo—is now underway.

Disclosure: For full disclosure of the study authors, visit esmo.org.



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