Lexicon Pharmaceuticals, Inc.'s (Nasdaq: LXRX) telotristat etiprate, the first oral therapy in development for the treatment of carcinoid syndrome (CS), was associated with patient-reported improvements in social and physical function and emotional well-being according to new exit interview data from the Phase 3 TELESTAR study presented at the 2015 Neuroendocrine Tumor Society Annual Symposium in Austin, Texas.
Telotristat etiprate, Lexicon's most advanced product candidate, met the TELESTAR study's primary endpoint with clinically meaningful reductions in bowel movement frequency in cancer patients whose carcinoid syndrome was not adequately controlled by somatostatin analog (SSA) therapy. New data released from interviews with participating patients who completed the randomized treatment portion of the TELESTAR study demonstrated that these reductions were meaningful to those patients and led to improvements in social and physical function and emotional well-being.
"Many patients with metastatic neuroendocrine tumors are now able to live longer lives. Unfortunately, uncontrolled carcinoid syndrome often makes daily life difficult for those patients," said Pablo Lapuerta, M.D., Lexicon Executive Vice President and Chief Medical Officer. "We are pleased that these patient-reported experiences suggest that telotristat etiprate may offer a meaningful benefit to the quality of life of those patients."
Carcinoid syndrome is a rare disease affecting thousands of cancer patients with metastatic neuroendocrine tumors that have spread to the liver and other organs from the gastrointestinal tract. The condition is characterized by frequent and debilitating diarrhea, facial flushing, abdominal pain, fatigue and other serious consequences that prevent patients from leading active, predictable lives. 1,2
About the Exit Interview Study
TELESTAR clinical sites in five countries (Australia, Canada, England, Germany, and the United States) invited patients prior to enrollment in the TELESTAR study to participate in a blinded, qualitative telephone exit interview upon conclusion of the randomized treatment portion of the study. A total of 35 patients from 16 clinical sites participated in the TELESTAR exit interview study and interviews were conducted with participating patients between weeks 12 (end of double-blind treatment phase) and 14 (open-label extension).
Participating patients were interviewed about baseline symptoms and clinical trial experiences. Participants were also asked about the most important and most bothersome symptoms of CS and their daily impact, as well as about symptom improvement and its importance. Interview data were analyzed with standard qualitative methods using field notes and interview transcripts to examine the responses to questions and changes in BM frequency.
Participants reported experiencing a large number of CS symptoms before initiating the TELESTAR study. Of these, diarrhea (n = 17), bowel movement (BM) frequency (n = 9), and urgency (n = 5) were consistently identified as the most bothersome and important symptoms of CS. The most frequently reported daily impact of these symptoms was patients' inability to engage in social or physical activities or hobbies, followed closely by the emotional impact of CS symptoms.
According to the exit interview data, participating patients treated with telotristat etiprate noted a reduction in BM frequency, which they characterized as the most bothersome symptom of CS.
"Ninety-five percent of participants – 20 out of 21 – who reported reductions in bowel movement frequency said this reduction was meaningful to them and allowed them to better enjoy life, leave the house, and participate in social and other activities," said the poster's lead author, Lowell Anthony, M.D., FACP, Chief, Division of Medical Oncology at University of Kentucky Markey Cancer Center in Lexington. "This response is very encouraging."
Furthermore, among the 33 participants (placebo:250:500 = 9:9:15) answering the interview question about treatment satisfaction, 55 percent across all arms reported being somewhat or very satisfied with the treatment they received during TELESTAR, with a correlation (R = 0.66, p < 0.001) between reported change in BM frequency and treatment satisfaction. Reports of "very satisfied" were none (0/9) on placebo and 50 percent (12/24) on telotristat etiprate, with similar results in the two telotristat etiprate dosage groups.
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