Table 3 Selected phase II-III clinical trials of peptide/protein-based cancer vaccines
Platform | Vaccine: targets | Year, Phase, reference | Target cancer | Route | Results |
|---|---|---|---|---|---|
Sample number | |||||
Lipo-peptide | Tecemotide (L-BLP25): MUC1 | 2014, phase III, NCT00409188 [301] | Unresectable stage III NSCLC after chemoradiotherapy/1239 | Subcutaneous | No improvement compared to placebo |
Peptide | IMA901: ten tumor-associated peptides | 2016, phase III, NCT01265901 [95] | HLA-A*02-positive, metastatic and/or locally advanced cell renal cell carcinoma/1171 | Intradermal | No improvement compared to sunitinib |
Peptide | Nelipepimut-S: E75 with GM-CSF | 2019, phase III, NCT01479244 [101] | T1–T3, HER2 IHC 1 + /2 + , node-positive BC/758 | Intradermal | No improvement compared to placebo |
2020, phase IIb, NCT01570036 [102] | HER2 IHC 1 + /2 + , FISH nonamplified BC, node positive and/or hormone receptor-negative BC/275 | No improvement compared to GM-CSF alone | |||
Peptide | GP2 with GM-CSF | 2021, phase IIb, NCT00524277 [99] | HER2 1–3 + , node-positive and high-risk node-negative BC/168 | Intradermal | 100% 5-year DFS in HER2 IHC 3 + BC |
Peptide | OSE2101: peptides targeting five TAAs plus PADRE | 2023, phase III, NCT02654587 [97] | HLA-A2-positive advanced NSCLC with resistance to immunotherapy/219 | Subcutaneous | Improved median OS (11.1 vs 7.5Â months) compared to chemotherapy |
Peptide | IO102-IO103: IDO and PD-L1 | 2023, Phase II, NCT03047928 [105] | Anti-PD-1 naïve patients with metastatic melanoma/30 | Subcutaneous | ORR: 80%, median PFS: 25.5 months |
Peptide | GV1001: 16 amino acids from human telomerase reverse transcriptase | 2024, phase III, NCT02854072 [302] | Untreated advanced PDAC with high serum eotaxin levels/148 | Intradermal | Improved median OS (11.3Â months) compared to chemotherapy alone (7.5Â months) |
Protein | MAGE-A3 protein combined with AS15 | 2016, phase III, NCT00480025 [303] | Resected stage IB, II, and IIIA MAGE-A3-positive NSCLC/2312 | Intramuscular | No improvement compared to placebo |
2018, phase III, NCT00796445 [304] | Resected, stage IIIB or IIIC, MAGE-A3-positive cutaneous melanoma/1345 | No improvement compared to placebo |