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Association details:
Evidence:
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Association of Baseline and Pharmacodynamic Biomarkers With Outcomes in Patients Treated With the PD-1 Inhibitor Budigalimab

Published date:
01/17/2022
Excerpt:
PD-1 inhibitor naive patients with advanced HNSCC (n=41) or NSCLC (n=40) received budigalimab intravenously...best overall response of 15% in HNSCC and 18% in NSCLC was observed in all treated patients; both cohorts reported responses in PD-L1+ and PD-L1– tumors.
DOI:
10.1097/CJI.0000000000000408
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Title:

First-in-human phase 1 study of budigalimab, an anti-PD-1 inhibitor, in patients with non-small cell lung cancer and head and neck squamous cell carcinoma

Published date:
07/03/2021
Excerpt:
In total, 81 patients were enrolled (HNSCC: N = 41 [PD-L1 positive: n = 19]; NSCLC: N = 40 [PD-L1 positive: n = 16]); median treatment duration was 72 days (range, 1–617) and 71 days (range, 1–490) for the HNSCC and NSCLC cohorts...Objective response rates were 13% (90% CI, 5.1–24.5) in the HNSCC cohort and 19% (90% CI, 9.2–32.6) in the NSCLC cohort. Median progression-free survival was 3.6 months (95% CI, 1.7–4.7) and 1.9 months (95% CI, 1.7–3.7) in the HNSCC and NSCLC cohorts...The safety, efficacy and biomarker profiles of budigalimab are similar to other PD-1 inhibitors.
DOI:
10.1007/s00262-021-02973-w
Trial ID: