PharmaEngine, Inc. (TWO: 4162) today announced the data from dose-finding portion of Phase 1 study (NCT03810742) evaluating ONIVYDE® in combination with LONSURF® in refractory solid tumors were presented at the 2022 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO-GI 2022). This study is performed at 3 medical centers in Taiwan and enrolled 43 patients in a dose-escalation phase (n=28) followed by an expansion phase (n=15).

The data from dose-finding phase showed that the recommended phase II dose (RP2D) of the combination was ONIVYDE® 80 mg/m2 plus LONSURF® 30 mg/m2. The combination was well tolerated across different dose levels and the majority of adverse events were mild as Grade 1/2. Clinical activity was also observed where 4 subjects reached partial response (PR) and 17 subjects reached stable disease (SD). For further information, please visit the conference website (https://meetings.asco.org/abstracts-presentations/205091).

Through this study, PharmaEngine, Inc. expects to identify the suitable dosing regimen and the cancer type to treat with for Phase 2 studies. We seek collaborations with potential partners to accelerate the development of new indications to offer more treatment options for oncology patients.