Table 3.
Summary of best overall response in patients
| HNSCC(N = 40a) | NSCLC(N = 37b) | |
|---|---|---|
| Best overall response [CR + PR], n (%) per RECIST v1.1 and iRECIST | 6c,d (15) | 7 (19) |
| [90% CI] | [6.7–27.5] | [9.2–32.6] |
| CR | 0 | 1 (3) |
| PR | 6c (15) | 6 (16) |
| SD | 17 (43) | 13 (35) |
| Objective response rate [CR + PR], n (%) per RECIST v1.1 and iRECIST | 5c,d (13) | 7 (19) |
| [90% CI] | [5.1–24.5] | [9.2–32.6] |
| Confirmed CR | 0 | 1 (3) |
| Confirmed PR | 5c (13) | 6 (16) |
| PD-L1 + [≥ 1%], n (%) | 19 (48) | 16 (43) |
| Objective response rate [CR + PR], n (%) per RECIST v1.1 and iRECIST | 3 (16) | 2 (13) |
| [90% CI] | [4.5–35.9] | [2.3–34.4] |
| Confirmed CR | 0 | 0 |
| Confirmed PR | 3 (16) | 2e (13) |
| PD-L1 + [> 50%], n (%) | 7 (18) | 7 (19) |
| Objective response rate [CR + PR], n (%) per RECIST v1.1 and iRECIST | 1 (14) | 2 (29) |
| [90% CI] | [0.7–52.1] | [5.3–65.9] |
| Confirmed CR | 0 | 0 |
| Confirmed PR | 1 (14) | 2 (29) |
| Median DOR, months per RECIST v1.1 | 9.4 | 10.1 |
| [95% CI] | [1.9–NE] | [7.8–13.1] |
| 6-mo KM estimate of DOR per RECIST v1.1 | 0.8 | 1.0 |
| [95% CI] | [0.20–0.97] | [NE–NE] |
| Median PFS, months per RECIST v1.1 | 3.6 | 1.9 |
| [95% CI] | [1.7–4.7] | [1.7–3.7] |
| 6-mo KM estimate of PFS per RECIST v1.1 | 0.27 | 0.27 |
| [95% CI] | [0.14–0.42] | [0.14–0.42] |
aOne patient discontinued budigalimab prior to week 8 secondary to grade 5 acute respiratory distress syndrome unrelated to budigalimab. bTwo patients discontinued budigalimab secondary to clinical progression; 1 patient discontinued budigalimab secondary to grade 5 upper respiratory infection, unrelated to budigalimab. cIncludes 1 patient meeting criteria for PR per iRECIST. dOne patient discontinued budigalimab for disease progression on study day 166 following unconfirmed PR on study day 110. eBoth patients with confirmed PR had PD-L1 expression > 50%
CR complete response; DOR duration of response; HNSCC head and neck squamous cell carcinoma; iRECIST immune Response Evaluation Criteria In Solid Tumors; KM Kaplan–Meier; NE not estimable; NSCLC non-small cell lung cancer; PD-L1 + , programmed cell death protein 1 ligand 1 positive; PFS progression-free survival; PR partial response; RECIST Response Evaluation Criteria In Solid Tumors; SD stable disease; v version