Background
Methods
Study design and treatment
Key eligibility criteria
Assessments
Efficacy assessments
Safety assessments
Analysis
Results
Patient characteristics
Erivance BCC (N = 104) | EAS (N = 119) | ||||||
---|---|---|---|---|---|---|---|
laBCC | mBCC | laBCC | mBCC | ||||
BCCNS (n = 22) | Non-BCCNS (n = 49) | Non-BCCNS (n = 33) | BCCNS (n = 12) | Non-BCCNS (n = 50) | BCCNS (n = 7) | Non-BCCNS (n = 50) | |
Median age, years (range) | 47 (21–71) | 67 (38–101) | 62 (38–92) | 52 (26–79) | 67 (40–92) | 58 (37–71) | 63 (24–100) |
Female, n (%) | 10 (45) | 22 (45) | 9 (27) | 6 (50) | 13 (26) | 3 (43) | 9 (18) |
WCBP, n (%) | 3 (33) | 1 (2) | 2 (6) | 4 (33) | 2 (4) | 1 (14) | 1 (2) |
ECOG PS, n (%) | |||||||
0–1 | 22 (100) | 44 (90) | 32 (97) | 12 (100) | 46 (92) | 7 (100) | 45 (90) |
2 | 0 | 5 (10) | 1 (3) | 0 | 4 (8) | 0 | 5 (10) |
Target lesions, n (%) | |||||||
1 | 13 (59) | 35 (71) | 9 (27) | 4 (33) | 30 (60) | 4 (57) | 20 (40) |
2 | 4 (18) | 8 (16) | 4 (12) | 2 (17) | 11 (22) | 0 | 10 (20) |
≥3 | 5 (23) | 6 (12) | 20 (61) | 6 (50) | 9 (18) | 3 (43) | 20 (40) |
Prior treatment, n (%) | |||||||
Surgery | 21 (96) | 41 (84) | 32 (97) | 12 (100) | 45 (90) | 7 (100) | 47 (94) |
Radiotherapy | 1 (5) | 21 (43) | 19 (58) | 1 (8) | 19 (38) | 2 (29) | 33 (66) |
Systemic therapy | 5 (23) | 3 (6) | 10 (30) | 2 (17) | 9 (18) | 2 (29) | 18 (36) |
Surgery contraindicated, n (%) | 18 (82) | 25 (51) | NA | 7 (58) | 28 (56) | NA | NA |
Treatment exposure
Best overall response rate
Erivance BCC (N = 96) | EAS (N = 95) | ||||||
---|---|---|---|---|---|---|---|
laBCC | mBCC | laBCC | mBCC | ||||
BCCNS (n = 21) | Non-BCCNS (n = 42) | Non-BCCNS (n = 33) | BCCNS (n = 12) | Non-BCCNS (n = 44) | BCCNS (n = 6) | Non-BCCNS (n = 33) | |
BORR, n (%) [95 % CI] | 17 (81) [58–95] | 21 (50) [34–66] | 15 (46) [28–64] | 4 (33) [10–65] | 22 (50) [35–65] | 3 (50) [12–88] | 9 (27) [13–46] |
Complete response | 8 (38) | 12 (29) | 0 | 1 (8) | 5 (11) | 2 (33) | 0 |
Partial response | 9 (43) | 9 (21) | 15 (46) | 3 (25) | 17 (39) | 1 (17) | 9 (27) |
Stable disease | 3 (14) | 12 (29) | 15 (46) | 6 (50) | 21 (48) | 3 (50) | 17 (52) |
Progressive disease | 1 (5) | 5 (12) | 2 (6) | 2 (17) | 0 | 0 | 3 (9) |
Not evaluable or missing | 0 | 4 (10) | 1 (3) | 2 (17) | 1 (2) | 0 | 4 (12) |
Safety
Selected AEs, n (%) | Erivance BCC (N = 104) | EAS (N = 119) | ||
---|---|---|---|---|
BCCNS (n = 22) | Non-BCCNS (n = 82) | BCCNS (n = 19) | Non-BCCNS (n = 100) | |
Any AE | 22 (100) | 82 (100) | 18 (95) | 98 (98) |
Grade 3–5 AE | 9 (41) | 35 (43) | 3 (16) | 32 (32) |
Alopecia | 19 (86) | 47 (57) | 11 (58) | 58 (58) |
Muscle spasms | 17 (77) | 54 (66) | 12 (63) | 72 (72) |
Weight decreased | 15 (68) | 33 (40) | 1 (5) | 18 (18) |
Dysgeusia | 13 (59) | 40 (49) | 14 (74) | 70 (70) |
Nausea | 9 (41) | 21 (26) | 3 (16) | 20 (20) |
Fatigue | 8 (36) | 29 (35) | 7 (37) | 16 (16) |
Diarrhea | 7 (32) | 16 (20) | 3 (16) | 27 (27) |
Arthralgia | 5 (23) | 11 (13) | 2 (11) | 2 (2) |