On September 27, 2014 Endocyte reported that the small molecule drug conjugate (SMDC) vintafolide in combination with docetaxel extended overall survival (OS) for patients with folate receptor (FR) positive recurrent non-small cell lung cancer (NSCLC) compared to patients receiving monotherapy docetaxel in its TARGET Phase 2b clinical trial (Filing 8-K , Endocyte, OCT 1, 2014, View Source [SID:1234500798]). The late-breaking TARGET trial data will be presented today at the European Society for Medical Oncology Congress (ESMO) (Free ESMO Whitepaper), by Rohit Lal, M.D., consultant medical oncologist at Guys and St Thomas’ Hospital and an Honorary Consultant Medical Oncologist for Kings College Hospital, London.
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The data show that patients in the predefined adenocarcinoma subgroup treated with the vintafolide plus docetaxel combination had a 27 percent reduction in risk of the disease worsening or death (HR=0.73, p=0.0899, one-sided test), and a 30 percent reduction in the risk of death (HR=0.70, p=0.1018) compared to docetaxel monotherapy. Stratified analysis, which adjusts for pre-defined patient characteristics in the trial, reflect a 49 percent reduction in the risk of death in patients with adenocarcinoma (HR=0.51, p=0.0147). These data include approximately 78 percent of the targeted number of events in the overall survival analysis. Overall survival in all patients, including those with squamous disease, reflect a 12 percent reduction in the risk of death (HR=0.88, p=0.2874) or 25 percent reduction when stratified (HR=0.75, p=0.1066). The primary endpoint of the study, as presented previously, showed that risk of disease worsening or death (progression-free survival, or PFS) was reduced by 25 percent for patients who received vintafolide plus docetaxel (HR=0.75, p=0.0696).
"We were pleased to see favorable results in the adenocarcinoma subgroup, where intensity of FR expression is approximately 20-fold higher than in squamous cell disease," said Ron Ellis, president and CEO at Endocyte. "We are currently evaluating the development plan for vintafolide in NSCLC in this patient population to determine if we will advance vintafolide quickly to a phase 3 trial after the OS data is fully mature. In the meantime, we continue to progress in the phase 1 studies of two other SMDCs. Our financial strength enables us to explore moving forward with more than one of our wholly-owned pipeline agents in select indications should it be the most beneficial path for the company and patients."
Dr. Rohit Lal said, "These results are very promising for patients receiving second-line treatment for this challenging disease. The folate receptor is a promising target, particularly in NSCLC, where the majority of patients are positive for this receptor. In particular, the consistency of results among patients with adenocarcinoma, including improved tumor response, delayed disease progression, and extended overall survival, support continued study of vintafolide in this patient population."
The study enrolled and treated 199 patients whose target tumors were all positive for the folate receptor, as determined with the companion imaging agent etarfolatide. Patients were randomized between three arms: vintafolide monotherapy, a combination of vintafolide and docetaxel, and docetaxel monotherapy. The independent data safety monitoring board determined before the completion of the trial that the vintafolide monotherapy arm was not likely to demonstrate increased benefit in the delay of disease progression compared to docetaxel alone.