Differential pharmacology and clinical utility of sonidegib in advanced basal cell carcinoma

Figures & data

Table 1 Comparison of response rates of patients administered 200 and 800 mg sonidegib to evaluate its activity against laBCC in the primary efficacy and intent-to-treat populations

Activity of sonidegib for the treatment of locally advanced basal cell carcinoma in the primary efficacy and intent-to-treat populations
Parameter studied	Primary efficacy population (laBCC)		Intent-to-treat population (laBCC)
	Sonidegib (200 mg); n=42	Sonidegib (800 mg); n=93	Sonidegib (200 mg); n=66	Sonidegib (800 mg); n=128
Central review
Proportion of patients (objective response) [95% CI]	18 (43%) [28–59]	35 (38%) [28–48]	31 (47%) [35–60]	45 (35%) [27–44]
Complete response	2 (5%)	0	2 (3%)	0
Partial response	16 (38%)	35 (38%)	29 (44%)	45 (35%)
Disease control	39 (93%)	74 (80%)	60 (91%)	100 (78%)
Time to tumor response, months (95% CI)	3.9 (2.1–4.0)	3.7 (2.0–3.8)	3.9 (3.6–4.2)	3.7 (2.6–3.8)
Duration of tumor response
Number of events	3	1	4	3
Event-free probability (after 9 months of randomization) [95% CI]	82% [44–95]	92% [56–99]	83% [54–94]	83% [54–94]
Progression-free survival
Number of events	5	8	7	10
Duration (months)	NR	NR	NR	NR
Event-free probability (after 12 months of randomization) [95% CI]	84% [59–94]	83% [67–91]	84% [65–93]	86% [73–93]
Investigator review
Proportion of patients (objective response) [95% CI]	28 (67%) [50–80]	54 (58%) [48–68]	43 (65%) [52–76]	73 (57%) [48–66]
Complete response	3 (7%)	12 (13%)	5 (8%)	15 (12%)
Partial response	25 (60%)	42 (45%)	38 (58%)	58 (45%)
Disease control	39 (93%)	82 (88%)	59 (89%)	110 (86%)
Time to tumor response, months (95% CI)	1.9 (1.2–3.7)	1.8 (1.1–2.0)	1.9 (1.8–3.7)	1.9 (1.2–2.0)
Duration of tumor response
Number of events	5	6	10	10
Event-free probability (after 9 months of randomization) [95% CI]	84% [58–95]	81% [58–92]	74% [52–87]	77% [59–88]
Progression-free survival
Number of events	9	13	15	17
Duration (months)	22	NR	17	NR
Event-free probability (after 12 months of randomization) [95% CI]	74% [50–87]	70% [52–82]	69% [51–81]	71% [57–882]

Abbreviations: CI, confidence interval; laBCC, locally advanced basal cell carcinoma; NR, not recorded.