1177P - Assessment of tumour burden reduction per photography vs magnetic resonance imaging in patients with locally advanced basal cell carcinoma receiving sonidegib 200 mg

Background

Sonidegib is a Hedgehog pathway inhibitor approved for the treatment of locally advanced basal cell carcinoma (laBCC) in the US, EU, Switzerland, and Australia, and metastatic BCC (mBCC) in Switzerland and Australia not amenable to curative surgery or radiotherapy. This analysis compared tumour burden reduction using photography or magnetic resonance imaging (MRI) in patients with laBCC that had a time to first tumour response (TFTR) within 6 months of starting treatment.

Methods

The double-blind, multicentre, phase II BOLT study assessed the efficacy and safety of sonidegib 200 mg with laBCC. Tumour burden reduction was assessed using both colour photography and MRI by central review. Tumour response was defined as a >10 mm unidimensional decrease in tumour size. Safety assessments included adverse event (AE) monitoring.

Results

Overall, among 66 patients with laBCC receiving sonidegib 200 mg, TFTR <3 months was achieved by 31 patients per photography and 11 patients per MRI assessment; TFTR from 3 to <6 months was achieved by 8 patients per photography and 12 per MRI. For patients with a TFTR of <3 months, the median (minimum, maximum) percent change from baseline in tumour size was −18.5 (−100.0, 35.9) vs −23.8 (−100.0, −11.9) at 9 weeks, −33.4 (−100.0, 38.5) vs −54.0 (−100.0, −27.1) at 25 weeks, −30.7 (−100.0, 12.0) vs −82.1 (−100.0, −52.9) at 41 weeks, and −29.0 (−100.0, 57.8) vs −82.1 (−100.0, −58.8) at 61 weeks per photography vs MRI, respectively. For patients with a TFTR from 3 to <6 months, the median (minimum, maximum) percent change from baseline in tumour size was not available at 9 weeks, −16.0 (−100.0, 18.1) vs −37.0 (−77.3, −12.5) at 25 weeks, −32.9 (−54.7, 22.3) vs −79.2 (−100.0, −41.5) at 41 weeks, and −35.1 (−46.8, −23.4) vs −77.3 (−100.0, −31.6) at 61 weeks per photography vs MRI, respectively. Sonidegib was well tolerated, and most AEs were Grade 1/2 in severity.

Conclusions

In patients with a TFTR within 6 months of starting treatment with sonidegib, an overall greater reduction in tumour size was reported per MRI assessment vs photography, with photography underestimating the extent of tumour response.

Clinical trial identification

NCT01327053.

Editorial acknowledgement

Writing and editorial support were provided by Duncan McCloskey, PhD, of AlphaBioCom, a Red Nucleus company, and funded by Sun Pharma.

Legal entity responsible for the study

Sun Pharma.

Funding

Sun Pharma.

Disclosure

R. Gutzmer: Non-Financial Interests, Personal, Speaker, Consultant, Advisor: Almirall, Amgen, Bristol Myers Squibb, Immunocore, Merck Serono, Merck Sharp & Dohme, Novartis, Pfizer, Pierre Fabre, Roche, Sanofi Genzyme, Sun Pharmaceutical Industries, Inc., 4SC, Bayer; Non-Financial Interests, Personal, Research Funding: Amgen, Johnson & Johnson, Merck Serono, Novartis; Financial Interests, Advisory Board: Sun Pharmaceutical Industries, Inc. F. Kiecker: Financial Interests, Personal, Research Grant: Amgen, Bristol Myers Squibb, Merck Sharp & Dohme, Novartis, Pierre Fabre, Roche, Sanofi. C. Loquai: Non-Financial Interests, Personal, Advisory Board: Bristol Myers Squibb, Roche, Novartis, Merck Sharp & Dohme. R. Dummer: Non-Financial Interests, Personal, Advisory Board: Amgen, Bristol Myers Squibb, CatalYm, Merck Sharp & Dohme, Novartis, Pierre Fabre, Roche, Sanofi, Second Genome, Sun Pharmaceutical Industries, Inc., Takeda. A. Hauschild: Non-Financial Interests, Personal, Speaker, Consultant, Advisor: Roche, Novartis, Amgen, Celgene, GSK, MedImmune, MelaSciences, Merck Serono, OncoSec, Eisai; Non-Financial Interests, Personal, Research Funding: Roche, Novartis, Amgen, Celgene, GSK, MedImmune, MelaSciences, Merck Serono, OncoSec, Eisai. N. Squittieri, R. Arntz, S. Martelli, J. Dierlamm: Financial Interests, Personal, Full or part-time Employment: Sun Pharmaceutical Industries Inc. C. Robert: Non-Financial Interests, Personal, Speaker, Consultant, Advisor: Amgen, Array BioPharma, Bristol Myers Squibb, Merck, Merck Serono, Novartis, Pierre Fabre, Roche.