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Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

3608 - Sonidegib Preplanned Subgroups Analyses of Objective Response Rates: Final 42-Month Results from the BOLT Study

Date

21 Oct 2018

Session

Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

Presenters

Reinhard Dummer

Citation

Annals of Oncology (2018) 29 (suppl_8): viii442-viii466. 10.1093/annonc/mdy289

Authors

R. Dummer

Author affiliations

  • Dermatology, University Hospital Zürich-Dermatology, 8091 - Zürich/CH
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Resources

Abstract 3608

Background

Based on results of the phase 2 BOLT study (NCT01327053), sonidegib 200 mg once daily (QD) was approved in the US for patients with locally advanced basal cell carcinoma (laBCC) not amenable to curative surgery or radiotherapy and in Switzerland and Australia also for metastatic BCC (mBCC). Here we report the final 42-month results—the longest follow-up data available from a hedgehog inhibitor (HHI) clinical trial—for a preplanned prespecified subgroup analysis for the primary endpoint, the objective response rate (ORR), in patients receiving 200 mg.

Methods

BOLT was a double-blind phase 2 study where HHI treatment–naïve patients with laBCC not amenable to curative surgery/radiotherapy, or with metastatic BCC (mBCC) were randomized 1:2 to sonidegib 200 or 800 mg QD, respectively. The primary endpoint was ORR. Analyses were performed at 12, 30, and 42 months after the last patient was randomized.

Results

For prespecified groups at 42 months, the ORRs for 200 mg QD were consistent for laBCC aggressive (59.5%; n = 37) and laBCC nonaggressive (51.7%; n = 29) histologies; male (43.8%; n = 48) and female (54.8%; n = 31); patients aged <65 years (59.4%; n = 32) and those aged ≥65 years (40.4%; n = 47); white (49.3%; n = 71) and nonwhite patients (37.5%; n = 8); and for patients not receiving (51.8%; n = 56) and those receiving (39.1%; n = 23) gastric pH agents. Subgroup analyses by disease strata (laBCC [56.1%; n = 66] vs mBCC [7.7%; n = 13]) and Eastern Cooperative Oncology Group performance status (0 [60%; n = 50] vs ≥ 1 [29.6%; n = 27;]) for the primary ORR endpoint showed heterogeneous results like those reported at 30 months. The safety/tolerability profile was consistent across 42 months with no new AEs emerging.

Conclusions

These results confirmed the consistency of treatment effect for sonidegib 200 mg QD at 42 months across several preplanned subgroups, including age, disease histology, gender, race, and use of gastric pH agents.

Clinical trial identification

NCT01327053.

Legal entity responsible for the study

Sun Pharmaceuticals Ltd.

Funding

Sun Pharmaceuticals Ltd.

Editorial Acknowledgement

Leonard Lionnet, PhD, CMPP of Lev Medical Communications provided medical writing support for this abstract.

Disclosure

R. Dummer: Consultant: Novartis Pharmaceuticals, Sun Pharma.

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