230MO - Pembrolizumab plus anlotinib as first-line treatment in patients of CPS≥1 with recurrent or metastatic head and neck squamous-cell carcinoma: A prospective phase II study

Background

At present, pembrolizumab is the first-line standard treatment for recurrent/ metastatic head and neck squamous cell carcinoma(R/M HNSCC). According to existing studies, it is found that the combination of multi-target kinase inhibitor and pembrolizumab has a good objective response rate. There is great need to explore the efficacy of pembrolizumab in combination with anlotinib in the first-line treatment for patients with R/M HNSCC.

Methods

Patients with untreated CSP≥1 R/M HNSCC and with ≥1 measurable lesion according to RECIST 1.1 were included. Patients received pembro 200mg on day 1 and anlotinib 12mg p.o. day 1-14, every 21 days until progression or unacceptable toxicity or 35 cycles, whichever occurred first. The primary endpoint was overall response rate (ORR). Secondary endpoints comprised safety, disease control rate (DCR), overall survival (OS) and progression free survival (PFS).

Results

From July 28, 2021 until May 15, 2022, 15 patients were enrolled. Median age was 55 (range 39-74). There were 5 patients (33.3%) with distant metastatic disease, 9 (60.0%) with local disease, 1 (6.7%) with distant and local diseases at enrollment. The ORR was 46.7%(7/15) and the DCR was 100%. Median follow-up was 8.2 months, the median PFS and the median OS was not reached. 4 patients were excluded from the group due to disease progression. The most common treatment related adverse event(TRAE) were hypertension (25%). One patient(6.7%) died because of myocardial infarction, and one patient(6.7%) died of the disease. There was no treatment-related adverse event leading to treatment discontinuation.

Conclusions

Pembrolizumab combined with anlotinib shows encouraging antitumor activity accompanied with a manageable side effect profile in untreated R/M HNSCC patients.

Clinical trial identification

NCT04999800, Release date: August 11, 2021.

Editorial acknowledgement

We thank MSD China Medical Affair oncology team for giving scientific support to the study.

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.