Table 1.
Baseline Clinical and Demographic Characteristics of Patients.*
| Characteristic | Intention-to-Treat–Pembrolizumab Population | Overall Intention-to-Treat Population | ||
|---|---|---|---|---|
| Selpercatinib (N = 129) | Control (N = 83) | Selpercatinib (N = 159) | Control (N=102) | |
| Age — yr | ||||
| Median | 60.0 | 62.0 | 61.0 | 62.5 |
| Range | 31–84 | 31–83 | 31–87 | 31–83 |
| Age distribution — no. (%) | ||||
| <65 yr | 82 (64) | 49 (59) | 100 (63) | 57 (56) |
| ≥65 yr | 47 (36) | 34 (41) | 59 (37) | 45 (44) |
| Sex — no. (%) | ||||
| Female | 65 (50) | 48 (58) | 86 (54) | 57 (56) |
| Male | 64 (50) | 35 (42) | 73 (46) | 45 (44) |
| Race — no. (%)† | ||||
| Asian | 76 (59) | 41 (49) | 92 (58) | 52 (51) |
| White | 49 (38) | 37 (45) | 58 (36) | 43 (42) |
| Black | 2 (2) | 0 | 2 (1) | 0 |
| Other‡ | 2 (2) | 1 (1) | 3 (2) | 1 (1) |
| Missing data | 0 | 4 (5) | 4 (3) | 6 (6) |
| Region of enrollment — no. (%) | ||||
| East Asia | 75 (58) | 41 (49) | 91 (57) | 51 (50) |
| Europe | 31 (24) | 36 (43) | 42 (26) | 42 (41) |
| North America | 4 (3) | 1 (1) | 6 (4) | 2 (2) |
| Other§ | 19 (15) | 5 (6) | 20 (13) | 7 (7) |
| Smoking status — no. (%) | ||||
| Never smoked | 85 (66) | 59 (71) | 108 (68) | 68 (67) |
| Former smoker | 40 (31) | 22 (27) | 45 (28) | 32 (31) |
| Current smoker | 4 (3) | 2 (2) | 6 (4) | 2 (2) |
| ECOG performance-status score — no. (%)¶ | ||||
| 0 | 45 (35) | 27 (33) | 58 (36) | 40 (39) |
| 1 | 81 (63) | 52 (63) | 97 (61) | 58 (57) |
| 2 | 3 (2) | 4 (5) | 4 (3) | 4 (4) |
| NSCLC histologic type — no. (%) | ||||
| Adenocarcinoma | 128 (99) | 80 (96) | 158 (99) | 99 (97) |
| NSCLC not otherwise specified | 1 (1) | 3 (4) | 1 (1) | 3 (3) |
| Stage of disease — no. (%) | ||||
| IIIB or IIIC | 7 (5) | 7 (8) | 9 (6) | 8 (8) |
| IVA | 51 (40) | 35 (42) | 67 (42) | 45 (44) |
| IVB | 71 (55) | 41 (49) | 83 (52) | 49 (48) |
| Metastases identified at baseline — no. (%) | ||||
| Brain metastases | ||||
| No or unknown | 104 (81) | 65 (78) | 129 (81) | 81 (79) |
| Yes | 25 (19) | 18 (22) | 30 (19) | 21 (21) |
| Liver metastases | ||||
| No | 109 (84) | 65 (78) | 137 (86) | 80 (78) |
| Yes | 19 (15) | 17 (20) | 21 (13) | 20 (20) |
| PD-L1 status — no. (%) | ||||
| Negative | 31 (24) | 12 (14) | 38 (24) | 20 (20) |
| Positive | 55 (43) | 39 (47) | 66 (42) | 47 (46) |
| <1% | 8 (6) | 8 (10) | 8 (5) | 9 (9) |
| 1–49% | 25 (19) | 17 (20) | 29 (18) | 21 (21) |
| ≥50% | 22 (17) | 14 (17) | 29 (18) | 17 (17) |
| Missing data | 43 (33) | 32 (39) | 55 (35) | 35 (34) |
| RET fusion result — no. (%) | ||||
| Positive∥ | 58 (45) | 31 (37) | 69 (43) | 39 (38) |
| KIF5B–RET | 54 (42) | 41 (49) | 70 (44) | 50 (49) |
| CCDC6–RET | 13 (10) | 8 (10) | 16 (10) | 9 (9) |
| NCOA4–RET | 0 | 1 (1) | 0 | 2 (2) |
| KIF13A–RET | 0 | 1 (1) | 0 | 1 (1) |
| KIAA1549L–RET | 1 (1) | 0 | 1 (1) | 0 |
| KIAA1468–RET | 1 (1) | 0 | 1 (1) | 0 |
| PRKAR1A–RET | 0 | 1 (1) | 0 | 1 (1) |
| Other** | 2 (2) | 0 | 2 (1) | 0 |
Percentages may not total 100 because of rounding. The intention-to-treat–pembrolizumab population included patients whose physicians had planned to treat them with pembrolizumab in the event that they were assigned to the control group. Treatment in the control group was the investigator’s choice of platinum-based chemotherapy plus pembrolizumab (intention-to-treat–pembrolizumab population) or the investigator’s choice of platinum-based chemotherapy with or without pembrolizumab (intention-to-treat population). NSCLC denotes non–small-cell lung cancer, and PD-L1 programmed death ligand 1.
Race was reported by the patients. Data are missing for patients who did not disclose their race.
“Other” included American Indian or Alaska Native, Native Hawaiian or other Pacific Islander, and multiple races.
“Other” included the following countries of enrollment: Argentina, Australia, Brazil, Israel, and Turkey.
Eastern Cooperative Oncology Group (ECOG) performance-status scores range from 0 to 5, with higher numbers reflecting greater disability.
In this category, RET fusion was indicated by molecular analysis but the RET fusion partner was not identified.
Two patients had multiple RET fusion partners identified (KIF5B–RET and CDKAL1–RET in one patient and NCOA4–RET and ZNF32-AS3–RET in the other).