VALCHLOR® (mechlorethamine) gel is an alkylating drug indicated for the topical treatment of Stage IA and IB mycosis fungoides–type cutaneous T-cell lymphoma (MF-CTCL) in patients who have received prior skin-directed therapy

VALCHLOR—proven clinical efficacy

More than half of patients achieved a response with VALCHLOR gel

60% overall response rate by CAILS score (primary endpoint)1,2

The primary study objective was noninferiority comparing VALCHLOR gel to compounded mechlorethamine based on a CAILS overall response rate. VALCHLOR gel was noninferior to compounded mechlorethamine based on the ORR ratio of 1.24 (95% CI 0.98, 1.58).1,2

60% Overall Response

45%

14%

Partial response Complete response

VALCHLOR geln=119

48% Overall Response

37%

11%

Partial response Complete response

Compounded mechlorethaminen=123

Overall response defined as complete response plus partial response. Eighteen patients were excluded from both the CAILS and SWAT efficacy analysis due to protocol violations involving randomization at a single site.1

CAILS Score1: Sum severity score of each of the following categories for 5 index lesions: Erythema, scaling, plaque elevation, and surface area

Response1: Partial response: ≥50% reduction from baseline CAILS score (confirmed after ≥4 weeks)
Complete response: Score of 0

In the noninferiority trial, a secondary endpoint analysis showed the time to a 50% response by CAILS score was achieved at 6.5 months with VALCHLOR as compared to 10.5 months with compounded mechlorethamine.2,3

Half of patients achieved an overall response by SWAT score1,2

Strong response was confirmed by the secondary efficacy endpoint1

50% Overall Response

43%

7%

Partial response Complete response

VALCHLOR geln=119

46% Overall Response

43%

3%

Partial response Complete response

Compounded mechlorethaminen=123

Overall response defined as complete response plus partial response.1

SWAT Score1: Measuring each involved area as a percentage of total BSA (body surface area), then multiplying it by a severity weighting factor: Patch=1; Plaque=2; Tumor or ulcer=3

Response1.2: Partial response: ≥50% reduction from baseline SWAT score (confirmed after ≥4 weeks) Complete esponse: Score of 0

Studied in the largest trial of Stage IA/IB MF-CTCL

The efficacy of VALCHLOR was assessed in a randomized, multicenter, observer-blinded, 12-month noninferiority trial1,2

Patients with MF-CTCL (N=260)

  • Stage IA, IB, IIA*,†
  • ≥1 prior skin-directed therapy
  • Median years of age
    (gel: 57 years; ointment: 58 years)

Randomization (1:1)

VALCHLOR gel 0.016 w/w (Equivalent to 0.02% mechlorethamine HCl) Once daily (n=130)

Mechlorethamine HCl 0.02% ointment Compounded in Aquaphor® once daily (n=130)

Patients were stratified before randomization by Stage (IA vs IB and IIA).1 Efficacy was demonstrated by 2 different response scales: CAILS (Composite Assessment of Index Lesion Severity) score and SWAT (Severity Weighted Assessment Tool). Patients were evaluated monthly for the first 6 months, then every 2 months until trial completion.1

*Stage IA (58.5% gel; 50% ointment), IB (40% gel; 48.5% ointment).2

While Stage IIA patients were included in the trial population, VALCHLOR is only indicated for Stage IA and IB MF-CTCL.1

Patients were not required to be refractory to or indolent of prior skin-directed therapies.1

Concomitant use of topical corticosteroids was not permitted during the study1,2

Baseline patient characteristics1,2 VALCHLOR gel, %
(n=130)
Compounded mechlorethamine HCl, %
(n=130)
BSA involvement, median 8.5% (1% to 61%) 9% (1% to 76%)
Received prior topical corticosteroids 86.2% 86.9%
Received prior phototherapy 38.5% 40.8%
Received Bexarotene (topical and oral) 17.7% 17.7%
Received topical mechlorethamine >2 years before study 12.3% 10.0%
Male gender 59.2% 59.2%
White race 74.6% 73.8%
Age 18-64 years 71.5% 66.2%

BSA, body surface area.

Concomitant use of topical corticosteroids was not permitted during the study.1,2


References:

  1. VALCHLOR [package insert]. Iselin, NJ: Helsinn Therapeutics US, Inc.; November 2018.
  2. Lessin SR, Duvic M, Guitart J, et al. Topical chemotherapy in cutaneous T-cell lymphoma: positive results of a randomized, controlled, multicenter trial testing the efficacy and safety of a novel mechlorethamine, 0.02%, gel in mycosis fungoides. Arch Dermatol. 2012;E1-E8.
  3. Data on File. VALC-001. Helsinn Therapeutics (U.S.), Inc.