Erivedge® has a well-established safety profile and manageable tolerability across more than 5 years of clinical practice1–3

  • In clinical trials, the most common adverse events occurring in ≥30% of patients were muscle spasms (74.6%), alopecia (65.9%), dysgeusia (58.7%), weight decreased (50.0%), fatigue (47.1%), nausea (34.8%) and diarrhoea (33.3%)4
  • The chronic nature of low-grade adverse events commonly observed with Hedgehog pathway inhibitors, including muscle spasms, ageusia/dysgeusia, alopecia, weight loss, and fatigue, can decrease quality of life, leading to treatment discontinuation that impacts clinical outcomes, especially in patients requiring long-term treatment3

 

ERIVANCE BCC: Safety outcomes

In the pivotal phase II trial ERIVANCE BCC, reported adverse events were consistent to those observed in Erivedge® phase I study5,6

  • All patients (N=104) experienced ≥1 adverse event
  • Grade 1 or grade 2 adverse events were reported in 57% of patients
  • Serious adverse events were reported in 26 patients (25%); the most common being muscle spasms, reported in two patients
  • Adverse events leading to the discontinuation were reported in 13 (12%) patients

STEVIE: Safety outcomes 

In the phase II clinical trial STEVIE, Erivedge® demonstrated a clinically manageable safety profile consistent with the phase II pivotal trial ERIVANCE1,2,4,5*

  • 1192 (98%) patients experienced ≥1 treatment-emergent adverse event (TEAE)
  • Serious TEAEs were reported in 289 (23.8%) patients
  • TEAEs leading to treatment discontinuation were reported in 380 (31%) patients; these were primarily grade 1/2

 

TEAEs by length of exposure

176103853_Erivedge_Occuring_Graph_Desktop.svg

More information is available on the study design and efficacy outcomes from STEVIE

  • The most common adverse reactions to Erivedge® are mild to moderate and can be managed by treatment interruptions without compromising efficacy1–3,7–9
    • For patients who require long-term treatment, including patients with multiple BCC or Gorlin syndrome, vismodegib treatment interruptions can be introduced to manage TEAEs and improve tolerability to treatment without compromising on efficacy.3,4,7–9 Treatment interruptions of up to 4–8 weeks based on individual tolerability were allowed in clinical studies2,4
  • A pregnancy test should be performed but no other laboratory tests are required before starting Erivedge®. The Erivedge® Pregnancy Prevention Programme provides important information about pregnancy, prevention, contraception and teratogenicity, please refer to: https://www.erivedge.net/home/resources/pregnancy-prevention-programme.html
  • Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at: https://www.roche.com/products/local_safety_reporting.htm

*STEVIE primary endpoints: Percentage of participants who experienced any adverse events, Grade 3 or 4 adverse events, adverse events leading to drug interruptions or discontinuations and any serious adverse events2

 

References

  1. 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
  2. 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
  3. Lacouture M et al. Oncologist 2016;21:1218–1229. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5061532/
  4. Erivedge® SPC. June 2022. Available at: https://www.ema.europa.eu/documents/product-information/erivedge-epar-product-information_en.pdf
  5. Sekulic A et al. N Engl J Med 2012;366:2171–2179. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5278761/
  6. Von Hoff DD et al. N Engl J Med 2009;361:1164–1172. Available at: https://www.nejm.org/doi/full/10.1056/NEJMoa0905360
  7. Fife K et al. Future Oncol 2017;13:175–184. Abstract available at: https://www.futuremedicine.com/doi/abs/10.2217/fon-2016-0296?rfr_dat=cr_pub%3Dpubmed&url_ver=Z39.88-2003&rfr_id=ori%3Arid%3Acrossref.org&journalCode=fon
  8. Dummer R et al. J Clin Oncol 2015;33(15 suppl):9024. Abstract available at: https://ascopubs.org/doi/abs/10.1200/jco.2015.33.15_suppl.9024
  9. Dréno B et al. Lancet Oncol 2017;18:404–412. Available at: https://www.jaad.org/article/S0190-9622(15)01395-X/pdf