Abstract 908P
Background
Penpulimab is a newly developed programmed cell death-1 monoclonal antibody with complete elimination of FcγR binding and ADCC/ADCP. A phase II study (ALTN-AK105-II-01, NCT04203719) was designed to explore the efficacy and safety of penpulimab plus anlotinib, a multikinase inhibitor blocking angiogenesis and proliferation, in the treatment of patients (pts) with several advanced cancers. Here we report the preliminary results for the cohort of recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC).
Methods
ALTN-AK105-II-01 was a single arm, open-label, multi-cohort, phase II study. In the HNSCC cohort, eligible pts were diagnosed with histologically confirmed R/M HNSCC and have failed prior platinum based chemotherapy. Other inclusion criteria included age ≥18 years, ECOG PS 0-1, and previous anti-angiogenic agents or immune checkpoint inhibitors naïve. Anlotinib (12mg QD) was given orally on D1∼D14 and Penpulimab (200 mg) was given intravenously on D1, 3 weeks a cycle. The primary endpoint was objective response rate (ORR) based on RECIST 1.1 per investigators. Secondary endpoints included disease control rate (DCR), duration of response (DoR), progression-free survival (PFS) and safety.
Results
From June 10, 2020 to April 16, 2021, 30 pts were enrolled and received treatment. A total of 25 pts received radiographic assessments and the confirmed ORR (confirmed at least 4 weeks after initial response) was 28% (partial response [PR]: 7 pts, complete response: 0 pt), and 14 pts obtained stable disease lasting at least 4 weeks, with a DCR of 84%. At the data cutoff date on April 28, 2021, the median treatment duration was 4 cycles. 9 pts met the PD and the PFS at 6 months was 64.3%. For 7 pts with PR, only 2 observed the PD and the longest duration of response was 7.2 months. 93.3% pts experienced treatment-related adverse events (TRAEs). The ≥ grade 3 TRAEs occurred in 36.7% pts and the most common ≥ grade 3 TRAEs included hypothyroidism (6.7%) and hypertension (6.7%).
Conclusions
The combination of anlotinib and penpulimab showed promising efficacy and was well tolerated in treatment of pts with R/M HNSCC who failed standard first-line chemotherapy. Further investigation is warranted.
Clinical trial identification
NCT04203719.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Chia Tai Tianqing Pharmaceutical Group Co. Ltd.
Disclosure
All authors have declared no conflicts of interest.