Genexine said that the combination therapy of its Hyleukin-7 and MSD’s Keytruda (ingredient: pembrolizumab) in breast cancer patients showed to be safe and well-tolerated with no dose-limiting toxicity (DLT).
The company released the study results at the online poster session of the American Society for Clinical Oncology (ASCO) 2020. The research team checked the safety and tolerance of its combined therapy for refractory or recurrent metastatic triple-negative breast cancer.
Genexine, a biotechnology company, has been conducting phase 1b/2 clinical trials on mTNBC. The study is in phase 1b in search of the optimal dose of combination therapy and evaluation of safety and tolerance.
In the trials, patients received Keytruda with a commercially available fixed dose of 200 milligrams while gradually increasing Hyleukin-7 administration from 360 to 720, 960, 1200, and 1440 micrograms per kilograms to find the optimal dose for phase 2 trials. The two drugs were evaluated in sequentially and simultaneously administrated cohorts.
According to Genexine’s analysis of anticancer efficacy, Hyleukin-7 showed a better therapeutic effect as the dosage increased. Most patients showed grade 1 and 2 treatment-related mild adverse effects, confirming the safety of the therapy.
Among the nine participants who received 1,200 micrograms per kilograms of Hyleukin-7 with Keytruda, the cancer was controlled in seven patients, and they did not show DLT. The overall response rate of 1,200 micrograms per kilograms group was 50 percent. Three patients in the group partially responded to the therapy, and cancer stabilized in four patients.
Considering that the response rate was 5.3 percent when only Keytruda was administered previously, the treatment response rate increased in Genexine’s study.
Also, Hyleukin-7 significantly increased the number of T cells in combination with Keytruda in patients with or without cyclophosphamide (CPA).
“We intend to apply the selected optimal dose of combined therapy in this study to other cancers that are less likely to be treated with mono-administration of immune checkpoint inhibitors,” Genexine CEO Sung Young-chul said.
Genexine said that the market for immune checkpoint inhibitors reached 25 trillion won ($20.4 billion) in 2019 and is expected to grow to 70 trillion won by 2025. The company forecast that the market for combination treatment would significantly grow thanks to its high treatment rate.
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