New Label Reflects Sustained Response for Sun Pharma's Odomzo in BCC
Sun Pharma’s new Odomzo® (Sonidegib) label incorporates long-term data showing sustained duration of response of 26 months in treatment of locally advanced basal cell carcinoma.
Odomzo® is an oral hedgehog inhibitor indicated for the treatment of patients with locally advanced basal cell carcinoma (laBCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy.
It was approved by the US Food and Drug Administration (FDA) in July 2015, based on 12-month follow-up results from the pivotal Phase II Basal Cell Carcinoma Outcomes with LDE225 Treatment (BOLT) clinical trial, a multicenter, double-blind study involving 194 patients with laBCC and 36 patients with metastatic basal cell carcinoma (mBCC).
BOLT Clinical Trial Overview
The BOLT trial enrolled 230 patients who were randomized 1:2 to receive either a 200-mg/day dose (laBCC, n = 66; mBCC, n = 13) or an 800-mg/day dose (laBCC, n = 128; mBCC, n = 23) of Odomzo®. Tumor response to Odomzo® was assessed via central review, based on the BCC-modified Response Evaluation Criteria In Solid Tumors (mRECIST), the most stringent response criteria for studying treatment efficacy in laBCC. The primary efficacy outcome was objective response rate (ORR), which was defined as the proportion of patients with a best overall response of complete response (CR) or partial response (PR). Duration of Response (DoR) was a key secondary outcome measure.
With 30 months of follow-up in the pivotal BOLT trial, Odomzo® treatment continued to demonstrate sustained antitumor activity and prolonged clinical benefit in patients with laBCC. Among patients treated with the 200-mg dose (approved dose), the ORR was 56 percent. The median duration of response was 26.1 months.
As in the primary (12 month) analysis, the 200-mg Odomzo® dose exhibited a low rate of grade 3/4 adverse events (AEs; 43.0 percent) and AEs leading to discontinuation (30.4 percent).
The 30-month BOLT data, which were presented as a poster at the 2016 annual meeting of the American Society of Clinical Oncology (ASCO), were recently published online in the Journal of the European Academy of Dermatology and Venereology on August 28, 2017.