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.
ONIVYDE®, also known as nal-IRI, MM-398 or PEP02, is a novel encapsulation of irinotecan in a liposomal formulation. PharmaEngine, Inc. has Taiwan exclusive commercial rights, Ipsen (Euronext: IPN; ADR: IPSEY) acquired the US exclusive new indication development and commercial rights, the exclusive rights for rest of the world are owned by Servier. ONIVYDE® has been approved in Taiwan, US, EU, Australia, Canada, Japan, South Korea and Singapore since 2011. It also received orphan drug designations in the US, EU, and other countries.
LONSURF® is an oral combination anticancer drug consisted of trifluridine and tipiracil, indicated for the treatment of patients with previously treated metastatic colorectal cancer. LONSURF® has been approved under this indication in Japan since 2014, followed by US, EU, and Australia. In Taiwan, the drug obtained approval in 2017. Additionally, LONSURF® has been approved as a treatment for metastatic gastric cancer in the US and multiple countries (including Taiwan) since 2019.
About PharmaEngine (TWO: 4162)
PharmaEngine, Inc. is a commercial stage oncology company headquartered in Taipei, focusing on the development of new medications for the treatment of cancer. PharmaEngine, Inc. has two ongoing projects: ONIVYDE® (Irinotecan Liposome Injection) has received marketing authorizations more than 40 countries worldwide, including Taiwan, US, EU, Australia, Canada, Japan, South Korea and Singapore, for the treatment of metastatic pancreatic cancer patients who have progressed on gemcitabine; PEP07, a CHK1 inhibitor, is under development at pre-clinical stage. For further information, please visit the company website (http://www.pharmaengine.com).