Endocyte Inc. announced results from the Phase 2b TARGET trial, which showed that the study met the primary endpoint for the combination of vintafolide (EC145/MK-8109) and docetaxel in folate receptor (FR)-positive recurrent non-small cell lung cancer (NSCLC) patients. As a randomized Phase 2b study, the pre-defined statistical threshold for significance was a p-value of less than 0.10. The data showed that risk of disease worsening or death was reduced by 25% for patients treated with the vintafolide/docetaxel combination versus docetaxel alone. Detailed trial results, including data regarding overall survival (OS), will be presented at an upcoming medical conference. 

 

The TARGET Phase 2b trial was conducted in 199 patients, randomized to one of three arms: vintafolide alone, vintafolide/docetaxel combination, or docetaxel alone. Secondary endpoints, including overall response rate and OS, also showed trends in favor of the combination arm. Median OS has been reached for the vintafolide and docetaxel single-agent arms but has not yet been reached in the combination arm. In addition, the investigational combination regimen showed better activity in patients with adenocarcinoma, a subset analysis pre-specified in the trial design.

 

The safety profile of the combination arm was consistent with those observed with docetaxel alone and vintafolide alone, though a higher rate of hematologic and peripheral neuropathy adverse events were observed in the combination arm. There were no drug-related deaths in the combination arm. Single-agent vintafolide at the schedule evaluated in this study demonstrated less activity than single-agent docetaxel. 

 

“We are pleased with the results of this study, as the vintafolide/docetaxel combination showed meaningful activity in patients with recurrent NSCLC, meeting the primary endpoint of the trial,” said Binh Nguyen, vice president of medical affairs at Endocyte. “This is our second randomized study in a very challenging indication, where vintafolide has met the primary endpoint when used in patients selected with the companion imaging agent etarfolatide. These results provide further validation of our targeted approach to treatment using companion imaging and our SMDC technology. We were especially pleased with the results in the adenocarcinoma population and early OS trends, and we have learned important information about the dosing schedule. We look forward to reviewing additional analysis of this study when the OS data has matured later this year to help inform potential further development of the vintafolide/docetaxel combination in NSCLC.”

 

“We are encouraged by the results from the TARGET trial which show activity with vintafolide in these difficult-to-treat patients, and look forward to reviewing still maturing data from TARGET later this year,” said Dr. Eric Rubin, vice president, clinical development for oncology, Merck Research Laboratories.

 

Date: March 21, 2014

Source: Endocyte