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LIVE BLOG: Transform the Treatment of Advanced Basal Cell Carcinoma – The Role of an Oral Hedgehog Pathway Inhibitor in Dermatology [Product Theater]

In this live blog from the 11th Annual SDPA Conference, Dr. Michael Paul Loosemore spoke on the use of Erivedge for the Treatment of Advanced Basal Cell Carcinoma.  The lecture on the role of this Oral Hedgehog Pathway Inhibitor was presented on behalf Genentech. The drug is intended for those with BCC recurring post-surgery, or for those who are not candidates for either surgery or radiation.

 

Erivedge is the first FDA approved oral drug for the treatment of Basal Cell Carcimoma for non-surgery and non-radiation candidates.

Black Box Warning

Embryo-Fetal Death and Severe Birth Defects

Because the drug inhibits a crucial embryonic developmental pathway, it is important to verify pregnancy in patients before the drug is prescribed. Warn women who may be pregnant or who may come into sexual contact with a partner who is on the drug.

How Erivedge Works.

Erivedge is an oral Hedgehog pathway inhibitor.  The Hedgehog Pathway regulates cell proliferation and survival.  PTCH is a membrane receptor that suppresses the membrane protein SMO.  In the presence of Hh PTCH inhibition of SMO is removed.  Erivedge inhibits the Hedgehog pathway by helping turn off cell replication.

Pivotal Phase II Study of Erivedge in Patients With Advanced BCC

  • The safety and efficacy of Erivedge in the treatment of patients with advanced BCC were assessed in an international, single-arm, multicenter, open-label 2-cohort trail.
  • Traditional therapeutics do not work well on slow-growing tumors

Efficacy

  • Nonrandomized phase II trial
  • laBCC pts= 71
  • mBCC pts= 33
  • 150 mg Erivedge orally until disease progression or unacceptable toxicity
  • Objective response rate by independent review

Characteristics of Participants

  • Median age was 62
  • All Caucasian
  • Patients with prior therapies on current or past BCC were allowed to participate

Definition of Objective Response in the laBCC Cohort

  • Absence of disease progression
  • 30% reduction in lesion size
  • Complete resolution of laceration in all target lesions
  • Complete response: Absence
  • Partial response: Reduced size
  • Metastatic BCC had more Partial Responses

Adverse Effects

  • Muscle spasms
  • Alopecia
  • Change in Taste
  • Weight Loss
  • Fatigue
  • Nausea
  • Diarrhea
  • This are almost “expected events”: Hedgehog pathways are helpful in hair follicles and taste buds, and so this drug will affect these areas.

Birth Defect Warning

  • Not for pregnant women.
  • After negative pregnancy test, female should initiate a highly effective contraceptive.
  • Male should use condoms during medication use and for an extended period after Erivedge use.
  • Do not donate blood during for 7 months after the medication use.

Results

43% ORR laBCC

30% ORR mBCC

 

Image: Kit