Table 3.
Demographics and efficacy results among responders
| Patient number | 1 | 3 | 4 | 5 | 9 |
|---|---|---|---|---|---|
| Gender/Age in years | Female/67 | Male/35 | Female/46 | Female/41 | Female/29 |
| Brain metastases at baseline (measurable or non‐measurable) | Absent | Present | Present | Present | Absent |
| Total lines of prior therapy in the order received |
1. Chemotherapy 2. Alectinib |
1. Alectinib |
1. Chemotherapy 2. Crizotinib 3. Alectinib |
1. Chemotherapy 2. Crizotinib 3. Alectinib |
1. Alectinib 2. Chemotherapy |
| ALK mutation(s) in archival tumor sample (T) or ctDNA at C1D1 |
NA (T) None (ctDNA) |
NA (T) None (ctDNA) |
NA (T) None (ctDNA) |
L1196M (T and ctDNA) | None (T and ctDNA) |
| Alectinib therapy | |||||
| Duration of alectinib treatment (months) | 50.96 | 11.63 | 14.39 | 8.74 | 8.31 |
| Best response to alectinib | PR | PR | PR | PR | PR |
| Duration of response to alectinib (months) | 50.0 | 10.61 | 5.98 | 5.06 | 4.60 |
| Reason for alectinib discontinuation | PD | PD | PD | PD | PD |
| Ceritinib therapy | |||||
| Time from last dose of alectinib (days) | 3 | 1 | 1 | 1 | 345 |
| Best overall response | PR | PR | CR | PR | PR |
| Time to response (months) | 1.87 | 1.77 | 1.84 | 1.97 | 1.77 |
| DOR (months) | 9.17 | 5.55a | 3.52 | 3.52 | 2.63a |
ALK, anaplastic lymphoma kinase; CR; complete response; ctDNA at C1D1, circulating tumor DNA at cycle 1 day 1; DOR, duration of response; NA, not available; PD, progressive disease; PR, partial response.
a
Censored observations (Patient 9 due to addition of new cancer therapy and Patient 3 due to ongoing study treatment without an event).