Percentages of patients with confirmed Composite Assessment of Index Lesion Severity (CAILS) response1
A CAILS score is obtained by adding the severity score of each of the following categories for 5 index lesions: erythema, scaling, plaque elevation, and surface area. A response was defined as a ≥50% reduction from baseline CAILS score, which was confirmed at the next visit at least 4 weeks later. A complete response was defined as a confirmed CAILS score of 0 (none).
Comparable CAILS response to compounded nitrogen mustard1
- 60% of VALCHLOR patients (n=119) had an overall response compared with 48% of patients treated with compounded mechlorethamine HCl 0.02% ointment (n=123)
- VALCHLOR was comparable (non-inferior) to compounded mechlorethamine 0.02% based on a CAILS overall response rate ratio of 1.24 (95% confidence interval, 0.98 to 1.58)
CAILS overall response for both treatment arms showed a wide range from 1 to 11 months1
Percentages of patients with confirmed Severity Weighted Assessment Tool (SWAT) response1
The SWAT score is derived by measuring each involved area as a percentage of total body surface area (% BSA) and multiplying it by a severity weighting factor (1=patch, 2=plaque, 3=tumor or ulcer). A response was defined as a ≥50% reduction from baseline in SWAT score, which was confirmed at the next visit at least 4 weeks later.
Comparable SWAT response to compounded nitrogen mustard1
- 50% of VALCHLOR patients (n=119) had an overall response compared with 46% of patients treated with compounded mechlorethamine HCl 0.02% ointment (n=123)
Study design: The efficacy of VALCHLOR was assessed in a randomized, multicenter, observer-blind, non-inferiority trial of 260 patients. Patients were stratified based on Stage (IA vs IB and IIA) and then randomized to receive VALCHLOR gel 0.016% w/w of mechlorethamine (equivalent to 0.02% mechlorethamine HCl) or Aquaphor®-based mechlorethamine HCl 0.02% ointment (compounded mechlorethamine). Patients had received at least one prior skin-directed therapy. Qualifying prior therapies included topical corticosteroids, phototherapy, Targretin® gel, and topical nitrogen mustard. Patients were not required to be refractory to or intolerant of prior therapies. Treatments were applied topically on a daily basis for 12 months. Please note that while Stage IIA patients were included in the trial population, VALCHLOR is only indicated for Stage IA and IB MF‑CTCL.1