South Korea-based Hanmi Pharmaceutical has reported positive outcomes from a Phase I/II clinical trial of Tivumecirnon alongside MSD’s Keytruda (pembrolizumab) for advanced or metastatic gastric cancer.
The company carried out the trial in partnership with MSD and RAPT Therapeutics.
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Tevumecirnon’s development has been a collaborative effort, with RAPT Therapeutics introducing it to Hanmi in 2019 and a subsequent clinical collaboration agreement with MSD in 2020.
In the trial, subjects were divided into two cohorts based on their Epstein-Barr virus (EBV) status.
The first cohort consisted of ten EBV-negative subjects who showed no objective response rate while the second included ten EBV-positive subjects who displayed a 60% objective response rate, including five partial responses and one complete response.
The data indicated that the median time to response (mTTR) was 2.7 months, with a median duration of response of 17.3 months while the second cohort’s median progression-free survival was 10.4 months.
For the 20 subjects, a safety analysis showed that most of the treatment-related adverse events were ‘manageable’, without any new safety concerns observed.
Tivumecirnon is an oral C-C chemokine receptor 4 (CCR4) antagonist claimed to improve immune activity within the tumour microenvironment.
The drug is designed to block the CCR4 receptor protein, which is known to suppress immune responses by facilitating the regulatory T cell migration into tumours.
Principal study investigator and Seoul National University Hospital haematology and oncology professor Do-Youn Oh said: “Tivumecirnon in combination with Keytruda demonstrated significant antitumor effects in patients with EBV-positive gastric cancer.
“The high objective response rate and sustained duration of response highlight new possibilities for cancer immunotherapy.
“These results represent a critical advancement, underscoring the innovative potential of CCR4 receptor-targeted therapies.”
Last year, Hanmi Pharmaceutical and MSD agreed to progress the clinical research of Hanmi’s immuno-oncology drug, BH3120, into a Phase I clinical trial.
