[Asia Economy Reporter Hyunseok Yoo] Pamfexin, a company specializing in antibody drug development, announced on the 19th that it has signed a global Phase 2 joint clinical trial collaboration agreement with Merck & Co., Inc. in the United States for the combination therapy of Olinvesimab and Keytruda (pembrolizumab) targeting metastatic triple-negative breast cancer (mTNBC).
This is the second joint clinical trial following the positive interim results of the ongoing Phase 1b clinical trial of the combination therapy of Olinvesimab and Keytruda currently underway in Australia. Pamfexin and Merck have continuously monitored the results of the Phase 1b trial and, after discussions on additional clinical trials, have agreed to proceed with the global Phase 2 clinical trial.
Pamfexin will receive Keytruda necessary for the clinical trial free of charge. Based on the experience accumulated since Phase 1b, they have gained the driving force to successfully conduct Phase 2 as well.
The Phase 2 trial is planned to be conducted in Korea and Australia. It is designed to evaluate the safety and efficacy of the combination administration of Olinvesimab 16 mg/kg and Keytruda 200 mg.
The Phase 1b clinical trial of the combination administration of Olinvesimab and Keytruda is currently underway targeting patients with metastatic triple-negative breast cancer in Australia. According to the latest interim data from the Phase 1b trial presented at the San Antonio Breast Cancer Symposium (SABCS 2020) in the United States last December, safety was confirmed, and the objective response rate (ORR) in the high-dose group of Olinvesimab was 50%, with 67% of patients receiving clinical benefit.
Metastatic triple-negative breast cancer is inoperable and unresponsive to radiation therapy, and targeted therapies are difficult to use, resulting in fewer treatment options compared to other breast cancers. Consequently, the patient survival rate is only 30%, with an expected lifespan of approximately 13 to 18 months. Additionally, among various breast cancers, it has a poor prognosis and high unmet medical needs, and the prognosis is worse in metastatic cases, making effective treatments absolutely necessary.
Yujin San, CEO of Pamfexin, said, “We are very pleased to be able to actively prepare for Phase 2 clinical trials with this contract signing. We have high expectations for Olinvesimab based on the positive results shown in the high-dose group of the Phase 1b trial,” adding, “If good results are also shown in Phase 2, it will present the potential of Olinvesimab as a new treatment in the difficult-to-treat metastatic triple-negative breast cancer market, while also enhancing its value in the global new drug market.”
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