Pivotal study demonstrating clinically meaningful benefit of Erivedge^® in advanced BCC^1–3

Study Design

Phase II, international, single-arm, multicentre, two-cohort study^1–3

Erivedge® reduced disease burden in both laBCC and mBCC patients^{2, 3}

Objective response rate by independent review (primary analysis)²

Erivedge® treatment has demonstrated clinically meaningful lesion reductions after 9 months, with a 43% and 30% objective response rate for patients with laBCC and mBCC, respectively.

CI, confidence interval; NE, not estimable

Objective response rate by site investigators (long-term analysis):³

Erivedge® treatment has demonstrated clinically meaningful and lasting lesion reductions, with a 32% complete response rate and 49% objective response rate for patients with laBCC and mBCC, respectively

• In the laBCC group for both ≥9 and ≥39 months of follow-up, 15 patients had stable disease, 6 patients had progressive disease and 4 patients had data missing or could not be evaluated
• In the mBCC group after ≥9 months of follow-up, no patient had a complete response to treatment, 15 patients had stable disease, 2 patients had progressive disease and 1 patient had data missing or could not be evaluated. After ≥39 months of follow-up, no patient had a complete response to treatment, 14 patients had stable disease, 2 patients had progressive disease and 1 patient had data missing or could not be evaluated

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Erivedge® treatment has demonstrated clinically meaningful and lasting lesion reductions, with a duration of response of more than 2 years and 1 year for patients with laBCC and mBCC, respectively

CI, confidence interval; laBCC, locally advanced BCC; mBCC, metastatic BCC; NE, not estimable
*Based on patients with a response to Erivedge^® treatment: n=38 after ≥9 and ≥39 months’ follow-up for laBCC; n=15 after ≥9 months’ and n=16 after ≥39 months’ follow-up for mBCC

References

1. eMC. Erivedge® 150 mg hard capsules - Summary of Product Characteristics, June 2022; available at: https://www.ema.europa.eu/documents/product-information/erivedge-epar-product-information_en.pdf.
2. Sekulic A, Migden MR, Oro AE, Dirix L, Lewis KD, Hainsworth JD, et al. Efficacy and safety of vismodegib in advanced basal-cell carcinoma. N Engl J Med. 2012;366(23):2171-9.
3. Sekulic A, Migden MR, Basset-Seguin N, Garbe C, Gesierich A, Lao CD, et al. Long-term safety and efficacy of vismodegib in patients with advanced basal cell carcinoma: final update of the pivotal ERIVANCE BCC study. BMC Cancer. 2017;17(1):332.
4. Basset-Seguin N, Hauschild A, Kunstfeld R, Grob J, Dreno B, Mortier L, et al. Vismodegib in patients with advanced basal cell carcinoma: Primary analysis of STEVIE, an international, open-label trial. Eur J Cancer. 2017;86:334-48.