Table 1.
Selected Completed Immunotherapy Trials
| Reference | Disease | Phase | No. of Patients | Line of Therapy | Antigen/Strategy | Clinical End Point |
|---|---|---|---|---|---|---|
| Marshall et al36 | CEA-expressing cancers | I | 58* | 36 of 58 received more than two lines |
CEA | Increased survival trend for patients receiving rF CEA + TRICOM + GM-CSF; rV CEA-TRICOM + rF CEA; TRICOM + GM-CSF |
| Morse et al37 | Metastatic CRC | II† | 74 | Minimum of 2 months perioperative chemotherapy |
CEA-MUC1; DC- poxvirus PANVAC v PANVAC + GM-CSF |
Recurrence-free survival at 2 years was similar (47% and 55%); hepatic or lung metastases completely resected |
| Beatty et al42 | First-line metastatic pancreatic cancer |
I | 22 | First line | CD40 agonist | Median PFS, 5.2 months |
| Royal et al43 | Locally advanced metastatic pancreatic cancer |
II | 27 | Chemotherapy refractory |
Ipilimumab | No responses |
| Brahmer et al44 | Multiple tumors | I | 207 (18 CRC, 14 pancreatic cancer, 7 gastric cancer) |
Chemotherapy refractory |
Anti-PD-1, BMS- 936559 |
Durable responders in melanoma, non–small-cell lung, renal, and ovarian cancer |
| Muro et al45 | Gastric cancer | Ib | 39 (PD-L1– positive |
Chemotherapy refractory |
Pembrolizumab | Response rate, approximately 32% |
| Le et al39 | Mesothelin-expressing cancers |
I | 22 | Refractory | Mesothelin- Listeria |
Median OS, 8.4 months; 37% of patient population survived more than 15 months |
| Le et al38 | Metastatic pancreatic cancer |
II† | 30 | Refractory | Ipilimumab v GVAX- ipilimumab |
OS, 3.6 v 5.7 months; 1-year survival, 7% v 27% |
| Le et al40 | Metastatic pancreatic cancer |
II† | 90 | Refractory; 51% had more than two regimens |
2:1 GVAX-CRS- 207 v GVAX |
OS, 6.1 v 3.9 months (GVAX- ipilimumab v GVAX for patients who received at least three doses [two GVAX and one CRS- 207 or three GVAX]); OS, 9.7 v 4.6 months (GVAX-ipilumumab v GVAX) |
| Hardacre et al41 | Resected pancreatic cancer | II | 70 | Adjuvant | Alpha Gal | 1-year DFS, 62% |
| Tran et al46 | Metastatic bile duct | Single Patient |
1 | Refractory | erbb2IP-TIL adoptive cell transfer |
Maximum reduction of 30% target liver and lung lesions at 7 months; stable for 13 months |
Abbreviations: alpha Gal, alpha(1,3)Galactosyl epitope; CEA, carcinoembryonic antigen; CRC, colorectal cancer; CRS-207, live-attenuated Listeria-expressing mesothelin; DC, dendritic cell; DFS, disease-free survival; erbb2IP, erbb2 interacting protein; GM-CSF, granulocyte-macrophage colony-stimulating factor; GVAX, whole-cell pancreatic tumor vaccine; MUC1, mucin 1; OS, overall survival; PD-1, programmed cell death protein 1; PD-L1, programmed death-ligand 1; PFS, progression-free survival; rF, recombinant fowlpox; rV, recombinant vaccinia; TIL, tumor-infiltrating lymphocyte; TRICOM, triad of costimulatory molecules B&-1, ICAM-1, LFA-3.
Cohorts: rF CEA + TRICOM ± GM-CSF, rV CEA-TRICOM + rF CEA, and TRICOM ± GM-CSF.
Randomized.