TABLE 1.
Baseline demographics and disease characteristics—study Part 1 and Part 2
| Characteristic | Part 1 | Part 2 |
|---|---|---|
| (n = 9) | (n = 30) a | |
| Age | ||
| Median (range), years | 58.0 (52–86) | 68.5 (39–86) |
| <65 years, n (%) | 6 (66.7) | 12 (40.0) |
| ≥65 years, n (%) | 3 (33.3) | 18 (60.0) |
| Gender, n (%) | ||
| Female | 2 (22.2) | 6 (20.0) |
| Male | 7 (77.8) | 24 (80.0) |
| Race, n (%) | ||
| White | 9 (100) | 24 (80.0) |
| Asian | 0 | 2 (6.7) |
| American Indian/Alaska Native | 0 | 1 (3.3) |
| Other | 0 | 4 (13.3) b |
| ECOG PS, n (%) | ||
| 0 | 1 (11.1) | 8 (26.7) |
| 1 | 6 (66.7) | 17 (56.7) |
| 2 | 2 (22.2) | 5 (16.7) |
| Recurrent tumor location, n (%) c | ||
| Neck | 4 (44.4) | 13 (43.3) |
| Oral cavity | 2 (22.2) | 9 (30.0) |
| Oropharynx | 5 (55.6) | 7 (23.3) |
| Skin | 0 | 3 (10.0) |
| Hypopharynx | 0 | 2 (6.7) |
| Sinus | 0 | 2 (6.7) |
| Nasal cavity | 0 | 1 (3.3) |
| Larynx | 0 | 0 |
| Other d | 4 (44.4) | 1 (3.3) |
| Prior lines of therapy, n (%) e | ||
| 1 | 1 (11.1) | 3 (10.0) |
| 2 | 2 (22.2) | 16 (53.3) |
| 3 | 1 (11.1) | 7 (23.3) |
| ≥4 | 5 (55.6) | 4 (13.3) |
| Prior therapy, n (%) | ||
| Cancer‐related surgery f | 8 (88.9) | 30 (100) |
| Radiotherapy | 9 (100) | 30 (100) |
| Chemotherapy | 7 (77.8) | 21 (70.0) |
| Immunotherapy g | 3 (33.3) | 11 (36.7) |
| Pembrolizumab | 0 | 6 (20.0) |
| Nivolumab | 3 (33.3) | 4 (13.3) |
| Other h | 0 | 2 (6.7) |
| Biological g /hormonal g /other g | 5 (55.6) | 8 (26.7) |
| Cetuximab | 5 (55.6) | 7 (23.3) |
| Other i | 1 (11.1) | 1 (3.3) |
Abbreviations: ECOG, Eastern Co‐operative Oncology Group; PS, performance status.
Thirty‐one patients enrolled but one patient did not receive RM‐1929 photoimmunotherapy due to cetuximab reaction observed during a test dose.
One patient was mixed race and was counted twice.
Some patients had more than one recurrent tumor locations.
Other: nasopharynx (2), parotid (2), occipital.
Lines of therapy were determined by a sponsor clinical expert and were based on the prior treatments reported on study (includes systemic therapy, surgery, and radiotherapy).
Surgery for reconstruction or biopsy not included here.
Categories of prior therapy were determined by a sponsor clinical expert based on reported prior treatment report on study.
Other: Rituximab and MEDI0562.
Other: BKM120 and RM‐1929 photoimmunotherapy.