STEVIE: Efficacy outcomes

Largest study conducted so far in BCC setting representative of clinical practice, demonstrating confidence in experience with Erivedge®1,4

Study Design

Phase II, post-approval, open-label, non-comparative, multicentre clinical trial1,4

study design stevie desktop.jpg
 
  • Monitoring of Erivedge® safety was assessed at baseline and then every 4 weeks.
    All patients had a follow-up visit 30 days after the last dose of Erivedge®, and following  a protocol amendment a subset of patients also had follow-up visits at 3, 6, 9  and 12 months after the last dose
  • Response to Erivedge® was assessed every 4-8 weeks, with computed tomography  or magnetic resonance imaging every 8-16 weeks if necessary

 

Efficacy outcomes with Erivedge® reflected the experience seen in ERIVANCE, the Phase II Pivotal Trial2-4

response table stevie desktop.jpg

CI, confidence interval; laBCC, locally advanced BCC; mBCC, metastatic BCC; NE, not estimable
*Based on patients with measurable disease at baseline, n=1077 for laBCC and n=84 for mBCC
†Based on patients with a response to Erivedge® treatment, n=738 for laBCC and n=31 for mBCC

------

Progression-free survival

176103853_Erivedge_Metastatic_Graph_Desktop.png

 

  • In STEVIE, Erivedge® has demonstrated efficacy in patients with multiple BCC lesions and Gorlin syndrome requiring long-term treatment
    • Response rates in patients with Gorlin syndrome and histologically confirmed measurable disease were 81.7% (95% confidence interval [CI], 75.8–86.7) and 80.0% (95% CI, 28.4–99.5) in patients with laBCC and mBCC, respectively4
  • Erivedge® can provide clinically meaningful benefit for patients with advanced BCC and preserve organ function in critical or functionally sensitive areas2,3,5–7

Erivedge® demonstrated a clinically manageable safety profile (primary endpoint) consistent with the phase II pivotal trial ERIVANCE. Access  more information about safety information.2–4

 

References

 

1. Erivedge® SPC. June 2022. Available at: https://www.ema.europa.eu/documents/product-information/erivedge-epar-product-information_en.pdf

2. Sekulic A et al. N Engl J Med 2012;366:2171–2179. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5278761/

3. Sekulic A et al. J Eur Acad Dermatol Venereol 2017;31(suppl 3):42,FC3.5. Available at: https://bmccancer.biomedcentral.com/track/pdf/10.1186/s12885-017-3286-5

4. Basset-Séguin N et al. Eur J Cancer 2017;86:334–348. Available at: https://www.ejcancer.com/article/S0959-8049(17)31247-9/fulltext

5. Sagiv O et al. Br J Ophthalmol 2019;103:775–780. Available at: https://bjo.bmj.com/content/bjophthalmol/early/2018/07/18/bjophthalmol-2018-312277.full.pdf

6. Shi Y et al. Onco Targets Ther 2017;10:2483–2489. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5428761/

7. Peris K et al. Future Oncol 2015;11:703–712. Abstract available: https://www.ncbi.nlm.nih.gov/pubmed/25686123