| Added by | celine.gongora |
|---|---|
| Group name | EquipeCG |
| Item Type | Journal Article |
| 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 |
| Creator | Italiano et al. |
| Author | Antoine Italiano |
| Author | Philippe A. Cassier |
| Author | Chia-Chi Lin |
| Author | Tuomo Alanko |
| Author | Katriina J. Peltola |
| Author | Anas Gazzah |
| Author | Her-Shyong Shiah |
| Author | Emiliano Calvo |
| Author | Andrés Cervantes |
| Author | Desamparados Roda |
| Author | Diego Tosi |
| Author | Bo Gao |
| Author | Michael Millward |
| Author | Lydia Warburton |
| Author | Minna Tanner |
| Author | Stefan Englert |
| Author | Stacie Lambert |
| Author | Apurvasena Parikh |
| Author | Daniel E. Afar |
| Author | Gregory Vosganian |
| Author | Victor Moreno |
| Abstract | BACKGROUND: Budigalimab is a humanized, recombinant immunoglobulin G1 monoclonal antibody targeting programmed cell death protein 1 (PD-1). We present the safety, efficacy, pharmacokinetic (PK), and pharmacodynamic data from patients enrolled in the head and neck squamous cell carcinoma (HNSCC) and non-small cell lung cancer (NSCLC) expansion cohorts of the phase 1 first-in-human study of budigalimab monotherapy (NCT03000257; registered 15 December 2016). PATIENTS AND METHODS: Patients with recurrent/metastatic HNSCC or locally advanced/metastatic NSCLC naive to PD-1/PD-1-ligand inhibitors were enrolled; patients were not selected on the basis of oncogene driver mutations or PD-L1 status. Budigalimab was administered at 250 mg intravenously Q2W or 500 mg intravenously Q4W until disease progression/unacceptable toxicity. The primary endpoints were safety and PK; the secondary endpoint was efficacy. Exploratory endpoints included biomarker assessments. RESULTS: 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, respectively. The most frequent grade???3 treatment-emergent adverse event was anemia (HNSCC: n?=?9, 22%; NSCLC: n?=?5, 13%). Both dosing regimens had comparable drug exposure and increased interferon gamma-induced chemokines, monokine induced by gamma interferon, and interferon-gamma-inducible protein 10. 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. CONCLUSIONS: The safety, efficacy and biomarker profiles of budigalimab are similar to other PD-1 inhibitors. Development of budigalimab in combination with novel anticancer agents is ongoing. |
| Publication | Cancer immunology, immunotherapy: CII |
| Volume | 71 |
| Issue | 2 |
| Pages | 417-431 |
| Date | 2022-02 |
| Journal Abbr | Cancer Immunol Immunother |
| Language | eng |
| DOI | 10.1007/s00262-021-02973-w |
| ISSN | 1432-0851 |
| Library Catalog | PubMed |
| Extra | PMID: 34216247 PMCID: PMC8783908 |
| Tags | Adult, Aged, Aged, 80 and over, Antibodies, Monoclonal, Humanized, Budigalimab, Carcinoma, Non-Small-Cell Lung, clinic, Female, Follow-Up Studies, Head and Neck Neoplasms, Head and neck squamous cell cancer, Humans, Lung Neoplasms, Male, Maximum Tolerated Dose, Middle Aged, Non-small cell lung cancer, PD-1 inhibitor, Prognosis, Programmed Cell Death 1 Receptor, Squamous Cell Carcinoma of Head and Neck, Tissue Distribution |
| Date Added | 2022/08/29 - 15:37:16 |
| Date Modified | 2022/08/29 - 16:35:03 |
| Notes and Attachments | PubMed entry (Attachment) Texte intégral (Attachment) |
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