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Concomitant medication use does not appear to alter long-term efficacy of sonidegib for advanced basal cell carcinoma: a post hoc analysis based on the 42-month BOLT study

  • Therapy
  • Published:
European Journal of Dermatology

Abstract

Background

Sonidegib is approved to treat locally advanced basal cell carcinoma (laBCC) in patients not amenable to surgery or radiation. The BOLT trial demonstrated durable efficacy of sonidegib in laBCC patients over 42 months. BCC is most common in the elderly, who often take chronic medications.

Objectives

We evaluated the efficacy of sonidegib (200 mg daily) in laBCC patients on select concomitant medications.

Materials & Methods

In the Phase II BOLT study, laBCC patients were randomized 1:2 to sonidegib 200 mg:800 mg daily. The primary endpoint was objective response rate (ORR) per central review. Post hoc assessments included ORR and duration of response (DOR) per investigator review for patients on concomitant medications.

Results

At 42 months, ORR for laBCC patients taking sonidegib 200 mg daily (n=66) was 71.2% and DOR was 15.7 months according to investigator review. Patients on select concomitant medications (n=37) had an ORR of 73.0%; DOR was not estimable.

Conclusion

Administration of sonidegib with concomitant medications, excluding strong cytochrome P450 3A4/5 inhibitors/inducers, does not appear to alter its efficacy in laBCC patients.

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Acknowledgements

Statistical analysis was provided by Dr. Li Liu of Sun Pharmaceutical Industries, Inc. Medical writing and editorial assistance were provided by Jennifer Masucci, VMD, of AlphaBioCom, a Red Nucleus company, under the direction of the authors.

Funding

Financial support: This study was sponsored and funded by Novartis. All publication fees were supported by Sun Pharma.

Author information

Authors and Affiliations

  1. Manchester Academic Health Science Centre, University of Manchester, Manchester, UK

    John T. Lear

  2. Salford Royal NHS Foundation Trust, Salford, UK

    John T. Lear

  3. Department of Dermatology, Institut Gustave Roussy and Paris-Saclay University, Villejuif, France

    Caroline Robert

  4. Department of Dermatology and Oncology, University of Aix-Marseille, Timone Hospital, Marseille, France

    Jean-Jacques Grob

  5. Skin Cancer Center University Hospital, Zürich, Switzerland

    Reinhard Dummer

  6. Department of Oncology, Royal North Shore Hospital, St Leonards, Australia

    Alexander Guminski

  7. The University of Sydney, Sydney, Australia

    Alexander Guminski

  8. Medical Affairs Oncology, Sun Pharmaceutical Industries, Inc., Princeton, NJ, USA

    Nicholas Squittieri

  9. Departments of Dermatology, Division of Internal Medicine, and Head and Neck Surgery, Division of Surgery, University of Texas MD Anderson Cancer Center, Houston, TX, USA

    Michael Migden

Authors
  1. John T. Lear
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  2. Caroline Robert
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  3. Jean-Jacques Grob
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  4. Reinhard Dummer
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  5. Alexander Guminski
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  6. Nicholas Squittieri
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  7. Michael Migden
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Corresponding author

Correspondence to John T. Lear.

Ethics declarations

Conflicts of interest: JTL has received personal fees from Novartis Pharmaceuticals Corporation. CR has received consulting fees from Amgen, Array BioPharma; Bristol-Myers Squibb; Merck, Merck Serono; Novartis; Pierre Fabre; and Roche. JG has received personal fees from Amgen; BMS; Merck/Pfizer; MSD, Novartis; Pierre Fabre; and Roche. RD has participated on advisory boards and consulted for Amgen; Bristol-Myers Squibb; Catalym; Merck Sharpe & Dohme; Novartis; Pierre Fabre; Roche; Sanofi; Second Genome; Sun Pharmaceutical Industries, Inc.; and Takeda. AG has participated on advisory boards for Bristol-Myers Squibb; Merck KGaA; MSD; Pfizer; and Sanofi; received honoraria from Novartis; received travel support from Astellas; Bristol-Myers Squibb; and Sun Pharmaceutical Industries, Inc.; and received unrestricted research support from Sun Pharmaceutical Industries, Inc. NS is an employee of Sun Pharmaceutical Industries, Inc. MM has participated on advisory boards and received honoraria from Genentech; Novartis; Sun Pharmaceutical Industries, Inc.; and Regeneron.

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Cite this article

Lear, J.T., Robert, C., Grob, JJ. et al. Concomitant medication use does not appear to alter long-term efficacy of sonidegib for advanced basal cell carcinoma: a post hoc analysis based on the 42-month BOLT study. Eur J Dermatol 33, 280–286 (2023). https://doi.org/10.1684/ejd.2023.4498

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  • DOI: https://doi.org/10.1684/ejd.2023.4498

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