Table 2:
Summary of clinical activity
| Cohort 1, EGFR+/ALK+ |
Cohort 2, EGFR−/ALK−* |
Cohort 3, EGFR−/ALK−* (≥90%†) |
|||
|---|---|---|---|---|---|
| <25%† | ≥25%†‡ | <25%† | ≥25%†‡ | ||
| Patients evaluable for response per independent central review§ | |||||
| Total | 28 | 74 | 93 | 146 | 68 |
| Confirmed objective response | 1 (3·6%, 0·1–18·3) | 9 (12·2%, 5·7–21·8) | 7 (7·5%, 3·1–14·9) | 24 (16·4%, 10·8–23·5) | 21 (30·9%, 20·2–43·3) |
| Confirmed disease control at 6 months¶ | 2 (7·1%, 0·9–23·5) | 15 (20·3%, 11·8–31·2) | 19 (20·4%, 12·8–30·1) | 42 (28·8%, 21·6–36·8) | 26 (38·2%, 26·7–50·8) |
| Best overall response | |||||
| Complete response | 0 | 0 | 0 | 1 (1%) | 0 |
| Partial response | 1 (4%) | 9 (12%) | 7 (8%) | 23 (16%) | 21 (31%) |
| Stable disease∥ | 5 (18%) | 23 (31%) | 27 (29%) | 51 (35%) | 12 (18%) |
| Progressive disease | 22 (79%) | 40 (54%) | 59 (63%) | 70 (48%) | 35 (51%) |
| Not evaluable | 0 | 2 (3%) | 0 | 1 (1%) | 0 |
| TTR, months | 1·8 (1·8–1·8) | 1·8 (1·8–1·8) | 2·1 (1·8–3·7) | 1·9 (1·8–3·7) | 1·9 (1·8–3·5) |
| DoR, months | 7·9 (7·9–7·9) | 7·4 (5·6–9·2) | NR (7·2–NR) | 12·3 (7·5–NR) | NR (NR–NR) |
| Full analysis set** | |||||
| Total | 30 | 77 | 94 | 149 | 67 |
| PFS, months | 1·9 (1·8–1·9) | 1·9 (1·8–3·6) | 1·9 (1·8–1·9) | 3·3 (1·9–3·7) | 2·4 (1·8–5·5) |
| OS, months | 9·9 (4·2–13·0) | 13·3 (8·1–NC) | 9·3 (5·9–10·8) | 10·9 (8·6–13·6) | NR (5·9–NC) |
| OS at 1 year | 40·0% (22·1–57·4) | 54·8% (41·5–66·3) | 34·5% (25·0–44·1) | 47·7% (39·3–55·5) | 50·8% (36·9–63·2) |
| OS follow-up, months | 8·2 (3·0–13·3) | 6·5 (2·5–10·9) | 9·3 (3·8–15·3) | 9·4 (4·2–15·9) | 7·0 (3·4–9·7) |
Data are n, n (%, 95% CI), n (%), median (IQR), or % (95% CI). EGER+=EGER mutated. ALK+=anaplastic lymphoma kinase (ALK) rearrangements. EGER−=EGER wild type. ALK−=ALK rearrangement negative. TTR=time to response. DoR=duration of response. NR=not reached. PFS=progression-free survival. OS=overall survival. NC=not calculated.
Includes patients with unknown EGER/ALK status.
Tumour cells with membrane staining for programmed cell death ligand-1 (PD-L1). Four patients in cohort 1 and 21 patients in cohort 2 had an unknown or missing PD-L1 expression status.
Patients with ≥90% of tumour cells expressing PD-L1 are included within the ≥25% group.
All treated patients who had a baseline tumour assessment and measurable disease at baseline according to the independent central review.
Confirmed complete or partial response, or stable disease for 6 months or more.
Unconfirmed complete or partial response, or stable disease for at least 8 weeks.
All treated patients who had a baseline tumour assessment and had measurable disease at baseline according to the investigator site assessment.