Sun Pharma and includes its subsidiaries or associate companies) announced that one of its wholly owned subsidiaries has received approval from the US Food and Drug Administration (FDA) for a new label for Odomzo® (sonidegib), 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.
Odomzo® was approved by the 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). The new label now incorporates long-term data from the 30-month analysis of BOLT trial, in which Odomzo® continued to show sustained durable tumor response of 26 months with no new safety concerns.
“We are pleased to incorporate the additional data to the Odomzo® label, as they show that Odomzo® is the only clinically proven hedgehog inhibitor which, by independent central review, maintains lasting tumor response for 26 months,” said Kirti Ganorkar, Global Head – Business Development at Sun Pharma. “The rigor of the BOLT study design and results analyses should reassure patients and physicians that Odomzo® can treat this devastating and sometimes disfiguring disease over the long term.”
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%. 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%) and AEs leading to discontinuation (30.4%).
