Table 2:
Pathology and Disease Characteristics
| TKI-Naïve ROS1-positive NSCLC (Pooled EXP-1) |
TKI-Pretreated ROS1-positive NSCLC (Pooled EXP-4) |
|
|---|---|---|
| Total (N = 71) |
Total (N = 56) |
|
| Histology, n (%) | ||
| Adenocarcinoma | 69 (97.2) | 53 (94.6) |
| Adenosquamous carcinoma | 1 (1.4) | 1 (1.8) |
| Squamous | 1 (1.4) | 1 (1.8) |
| Mucoepidermal carcinoma | 0 | 1 (1.8) |
| Disease at Study Entry | ||
| Metastatic | 67 (94.4) | 55 (98.2) |
| Locally Advanced | 4 (5.6) | 1 (1.8) |
| Brain Metastasis by BICR, n (%) | ||
| Yes | 18 (25.4) | 24 (42.9) |
| No | 53 (74.6) | 32 (57.1) |
| Prior Therapy, n (%) | ||
| Prior TKI Therapy | 0 | 56 (100.0) |
| Platinum-based Chemotherapy | 20 (28.2) | 0 |
| Immunotherapy Alone | 2 (2.8) | 0 |
| Other Targeted Therapy | 1 (1.4) | 0 |
| Prior TKI Therapy, n (%) | ||
| Crizotinib | NA | 46 (82.1) |
| Entrectinib | NA | 9 (16.1) |
| Ceritinib | NA | 1 (1.8) |
| Resistance Mutations, n (%) | ||
| Solvent Front (G2032R) | NA | 6 (10.7) |
| Gatekeeper (L2026M) | NA | 1 (1.8) |
| Other (S1986F/Y) | NA | 1 (1.8) |
| Not Detected/QC Failure | NA | 5 (8.9) |
| Not tested | NA | 43 (76.8) |
Source: U.S. Food and Drug Administration. NDA Multi-disciplinary Review and Evaluation and Approval packages, repotrectinib.21
Abbreviations: BICR: Blinded Independent Central Review, EXP: expansion cohort, max: maximum, min: minimum, NA: Not Applicable, NSCLC: non-small cell lung cancer, ROS1: receptor tyrosine kinase encoded by the ROS1 gene, TKI: tyrosine kinase inhibitor.
Notes: Data cutoff date of June 20, 2022.