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Sonidegib offers long-term disease control in basal cell carcinoma

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NEW YORK — The hedgehog pathway inhibitor sonidegib conferred long-term clinical benefit to patients with metastatic basal cell carcinoma, according to updated data from the phase 2 BOLT study presented at HemOnc Today Melanoma and Cutaneous Malignancies.

Initial results of the study showed durable clinical benefit of sonidegib (Odomzo, Novartis) in patients with metastatic basal cell carcinoma.

Colin Morton, MD, of Stirling Community Hospital in the United Kingdom, and colleagues presented efficacy data collected up to 18 months after randomization.

The trial included 36 patients with metastatic basal cell carcinoma randomly assigned to sonidegib (Odomzo, Novartis) in doses of 200 mg daily (n = 13) or 800 mg daily (n = 23).

Overall response rate, duration of response and PFS served as primary endpoints. Median follow-up was 26.6 months.

Researchers reported median baseline tumor burden of 4.6 cm (range, 1.5-14.6), and most patients had more than one lesion. The most common metastases sites were the lung (200-mg cohort, 71%; 800-mg cohort, 52%) and bone (200-mg cohort, 14%; 800-mg cohort, 22%).

Results showed higher ORRs in the 800-mg group than the 200-mg group (investigator review, 34.8% vs. 23.1%; central review, 17.4% vs. 7.7%).

Central review revealed tumor shrinkage in 92% of patients assigned the 800-mg dose vs. 84% of patients assigned the 200-mg dose.

Researchers reported high disease control rates in both the 200-mg cohort (central review, 92.3%; investigator review, 84.6%) and the 800-mg cohort (central review, 91.3%; investigator review, 82.6%).

Central review showed median PFS of 13.1 months in the 200-mg cohort and 11.1 months in the 800-mg cohort.

Tumor responses appeared durable, with patients assigned the 200-mg dose achieving a longer median duration of response than those assigned the 800-mg dose (17.7 months vs. 10.2 months).

“Despite most patients having extensive disease at baseline, sonidegib provided meaningful clinical benefit and disease control in patients with metastatic basal cell carcinoma,” Morton and colleagues wrote. “Durable tumor responses, extended PFS, and encouraging biomarker and quality-of-life data support the potential use of sonidegib as a new treatment option for metastatic basal cell carcinoma, a rare and difficult-to-treat disease.” – by Kristie L. Kahl

Disclosure: HemOnc Today was unable to confirm the researchers’ relevant financial disclosures at the time of reporting.

Reference: Morton C, et al. Efficacy of sonidegib in patients with metastatic basal cell carcinoma. Presented at: HemOnc Today Melanoma and Cutaneous Malignancies; March 18-19, 2016; New York.