Handok's partner company, US-based Compass Therapeutics, announced the topline results of the global Phase 2/3 clinical trial 'COMPANION-002' of Tovecimig for patients with metastatic or recurrent cholangiocarcinoma on the 1st (local time).
Handok and Compass Therapeutics have been collaborating on the development of Tovecimig (HDB001A·CTX-009·ABL001), an innovative bispecific antibody drug with high potential as a treatment for cholangiocarcinoma. Compass Therapeutics has been conducting the global Phase 2/3 clinical trial COMPANION-002 based on the Korean Phase 2 clinical trial conducted by Handok.
Cholangiocarcinoma has a 5-year survival rate of 29.4%, the second lowest among all cancers. Currently, there is no effective second-line therapy after failure of first-line treatment, resulting in a high unmet medical need for new treatments. Early diagnosis of cholangiocarcinoma is difficult, with only about 25% of patients eligible for surgery at the time of diagnosis, and even after surgery, there is a high recurrence rate of about 60%. However, second-line treatment for cholangiocarcinoma has relied on outdated chemotherapy, which has shown low response rates and poor prognosis for patients.
COMPANION-002 is a clinical trial designed to evaluate the potential of Tovecimig as a second-line treatment for cholangiocarcinoma patients. It was designed to compare and analyze the combination therapy of Tovecimig and Paclitaxel versus Paclitaxel monotherapy in patients with metastatic or recurrent cholangiocarcinoma.
A total of 168 adult patients were enrolled in COMPANION-002 and randomly assigned in a 2:1 ratio to receive either Tovecimig plus Paclitaxel (n=111) or Paclitaxel monotherapy (n=57). The analysis of the primary endpoint showed that Tovecimig demonstrated a significant objective response rate. The combination therapy of Tovecimig and Paclitaxel showed an overall response rate (ORR), including one complete remission, of 17.1%.
In contrast, the objective response rate for Paclitaxel monotherapy was 5.3%. The primary endpoint of the study, the objective response rate between the two treatment groups, was more than three times higher in the Tovecimig group compared to the Paclitaxel group and was statistically significant (P=0.031). Additionally, progressive disease (PD) was observed in 16.2% of patients treated with the combination of Tovecimig and Paclitaxel, whereas 42.1% of patients treated with Paclitaxel alone showed PD. The safety profile was consistent with previous studies, and the independent data monitoring committee recommended continuing the study without modifications after review.
Youngjin Kim, Chairman of Handok, stated, "Considering that the objective response rate of the currently used second-line treatment FOLFOX for cholangiocarcinoma is 4.9%, the objective response rate of Tovecimig confirmed in this trial is very encouraging," adding, "We will do our best to provide new and innovative treatment options to cholangiocarcinoma patients as soon as possible."
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