Details

Autor(en) / Beteiligte

• Adotévi, Olivier
• Vernerey, Dewi
• Jacoulet, Pascale
• Meurisse, Aurélia
• Laheurte, Caroline
• Almotlak, Hamadi
• Jacquin, Marion
• Kaulek, Vincent
• Boullerot, Laura
• Malfroy, Marine
• Orillard, Emeline
• Eberst, Guillaume
• Lagrange, Aurélie
• Favier, Laure
• Gainet-Brun, Marie
• Doucet, Ludovic
• Teixeira, Luis
• Ghrieb, Zineb
• Clairet, Anne-Laure
• Guillaume, Yves
• Kroemer, Marie
• Hocquet, Didier
• Moltenis, Mélanie
• Limat, Samuel
• Quoix, Elisabeth
• Mascaux, Céline
• Debieuvre, Didier
• Fagnoni-Legat, Christine
• Borg, Christophe
• Westeel, Virginie

Titel

Safety, Immunogenicity, and 1-Year Efficacy of Universal Cancer Peptide-Based Vaccine in Patients With Refractory Advanced Non-Small-Cell Lung Cancer: A Phase Ib/Phase IIa De-Escalation Study

Ist Teil von

• Journal of clinical oncology, 2023-01, Vol.41 (2), p.373-384

Ort / Verlag

United States: American Society of Clinical Oncology

Erscheinungsjahr

2023

Link zum Volltext

Quelle

MEDLINE

Beschreibungen/Notizen

• Universal cancer peptide-based vaccine (UCPVax) is a therapeutic vaccine composed of two highly selected helper peptides to induce CD4+ T helper-1 response directed against telomerase. This phase Ib/IIa trial was designed to test the safety, immunogenicity, and efficacy of a three-dose schedule in patients with metastatic non-small-cell lung cancer (NSCLC). Patients with refractory NSCLC were assigned to receive three vaccination doses of UCPVax (0.25 mg, 0.5 mg, and 1 mg) using a Bayesian-based phase Ib followed by phase IIa de-escalating design. The primary end points were dose-limiting toxicity and immune response after three first doses of vaccine. Secondary end points were overall survival (OS) and progression-free survival at 1 year. A total of 59 patients received UCPVax; 95% had three prior lines of systemic therapy. No dose-limiting toxicity was observed in 15 patients treated in phase Ib. The maximum tolerated dose was 1 mg. Fifty-one patients were eligible for phase IIa. The third and sixth dose of UCPVax induced specific CD4+ T helper 1 response in 56% and 87.2% of patients, respectively, with no difference between three dose levels. Twenty-one (39%) patients achieved disease control (stable disease, n = 20; complete response, n = 1). The 1-year OS was 34.1% (95% CI, 23.1 to 50.4), and the median OS was 9.7 months, with no significant difference between dose levels. The 1-year progression-free survival and the median OS were 17.2% (95% CI, 7.8 to 38.3) and 11.6 months (95% CI, 9.7 to 16.7) in immune responders ( = .015) and 4.5% (95% CI, 0.7 to 30.8) and 5.6 months (95% CI, 2.5 to 10) in nonresponders ( = .005), respectively. UCPVax was highly immunogenic and safe and provide interesting 1-year OS rate in heavily pretreated advanced NSCLC.