A phase II study cohort of penpulimab plus anlotinib in patients with recurrent or metastatic non-squamous cell carcinomas of head and neck.

Changgong Zhang Department of Medical Oncology, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing Key Laboratory of Clinical Study On Anticancer Molecular Targeted Drugs, Beijing, China info_outline Changgong Zhang, Yan Sun, Jun Wang, Zhigang Liu, Haichuan Su, Jianhua Chen, Youxin Tian, Huijuan Wu, Liying Gao, Yuankai Shi

Authors Changgong Zhang Department of Medical Oncology, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing Key Laboratory of Clinical Study On Anticancer Molecular Targeted Drugs, Beijing, China info_outline Changgong Zhang, Yan Sun, Jun Wang, Zhigang Liu, Haichuan Su, Jianhua Chen, Youxin Tian, Huijuan Wu, Liying Gao, Yuankai Shi Organizations Department of Medical Oncology, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing Key Laboratory of Clinical Study On Anticancer Molecular Targeted Drugs, Beijing, China, Peking University Cancer Hospital and Institute, Beijing, China, Gansu Provincial Cancer Hospital, Lanzhou, China, The Fifth Affiliated Hospital of Sun Yat-Sen University, Zhuhai, Guangdong, China, Tangdu Hospital, The Fourth Military Medical University, Xi'an, China, Hunan Cancer Hospital, Changsha, China, The Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China, Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing Key Laboratory of Clinical Study On Anticancer Molecular Targe, Beijing, China Abstract Disclosures Research Funding No funding received None. Background: Recurrent or metastatic non-squamous cell carcinoma of head and neck (R/M non-SCCHN) lack effective systemic treatment. The feasibility of the combination of immune checkpoint inhibitor and anti-angiogenic agents in the treatment of R/M non-SCCHN was unknown. Penpulimab is a novel anti-programmed cell death-1 (PD-1) antibody with complete elimination of FcγR binding activity. Anlotinib is a multi-kinase inhibitor blocking angiogenesis and tumor cell proliferation simultaneously. ALTN-AK105-II-01 is a single-arm, multi-cohort, multi-center phase II study to investigate the efficacy and safety of penpulimab plus anlotinib in the treatment of various advanced cancers. Here we report the results of the cohort 2 for patients (pts) with R/M non-SCCHN. Methods: Eligible pts were aged 18 years or older and diagnosed with histologically confirmed R/M non-SCCHN. Other inclusion criteria included ECOG PS 0-1 and having at least one measurable lesion according to RECIST 1.1, and anti-angiogenic agents or immune checkpoint inhibitor treatment-naïve. Pts were given penpulimab 200mg intravenously on day 1 and oral anlotinib 12mg once daily from day 1 to day 14 every 3 weeks until disease progression or unacceptable toxicities. The primary endpoint was objective response rate (ORR). Secondary endpoints included disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety. Results: From May 21, 2020 to October 14, 2020, 21 pts were enrolled in 7 centers in China. The most common site of primary tumor was salivary gland (15/21, 71.4%) and the most common pathological types included adenoid cystic carcinoma (7/21, 33.3%) and duct carcinoma (4/21, 19.0%). 15 pts (71.4%) had distant metastatic lesions and 12 pts (57.1%) had prior chemotherapy history. As of October 20, 2022 (data cut-off), 4 pts achieved confirmed partial response and the ORR was 19.0%. Stable disease (SD) was observed in 17 pts and the DCR was 100%. The median follow-up for PFS was 14.2 months (95%CI: 7.8, 20.6), 9 pts suffered disease progression and the median PFS was 10.6 months (95%CI: 0.0, 22.4). 14 pts (66.7%) experienced at least one ≥grade 3 treatment-related adverse events (TRAEs) and the most common ≥grade 3 TRAEs was hypertension (15.0%). No treatment-related death was reported. Conclusions: The combination of penpulimab and anlotinib showed encouraging efficacy and favorable safety profile in R/M non-SCCHN and is worthy of further investigation. Clinical trial information: NCT04203719.

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