Date: 2016-01-22
Type of information: Presentation of results at a congress
phase: 1-2
Announcement: presentation of results at the 2016 Gastrointestinal Cancers Symposium (ASCO GI)
Company: NewLink Genetics (USA - IO)
Product: indoximod
Action
mechanism: IDO inhibitor/immunomodulating agent. Indoximod is an orally available small molecule that has shown the potential to interfere with multiple targets within the indoleamine 2,3-dioxygenase (IDO) pathway. It is designed to be used in combination with other therapeutic agents to maximize the body's immune response against a range of tumor types.
Disease: metastatic pancreatic cancer
Therapeutic area: Cancer - Oncology
Country: USA
Trial
details: This phase I/II trial is designed to efficiently identify the regimen limiting toxicity (RLT) and recommended phase 2 dose (RP2D) for the combination of the immunotherapeutic agent indoximod when administered in combination with standard of care chemotherapy gemcitabine plus nab-paclitaxel in subjects with metastatic adenocarcinoma of the pancreas. All subjects will receive the same standard gemcitabine plus nab-paclitaxel regimen, plus indoximod in doses increasing from 600 mg twice daily to, potentially, 1200 mg twice daily. (NCT02077881)
Latest
news: * On January 22, 2016, NewLink Genetics announced the presentation of data that describe a combination therapy of indoximod, an IDO pathway inhibitor, plus gemcitabine/nab-paclitaxel, for patients with metastatic pancreatic cancer. This combination immunotherapeutic approach was well tolerated and shows encouraging durable responses with a delayed pattern and a 42 percent objective response rate, including one complete response (CR), according to data presented at the 2016 Gastrointestinal Cancers Symposium (ASCO GI) in San Francisco. These data come from the Phase 1b portion of the trial that included 12 patients who were evaluable for a response. To date, this Phase 1/2 trial has enrolled 50 patients, with a target enrollment of 80 patients in the Phase 2 portion. In the Phase 1b portion of the trial, the combination therapy with indoximod had an objective response rate of 42 percent (5/12), including one CR. The MPACT study, which established gemcitabine/nab-paclitaxel as standard of care for patients with metastatic pancreatic cancer, demonstrated an objective response rate of 23 percent.
