Exit Interview Data from Participating Patients Completing the Randomized Treatment Portion of the Phase 3 TELESTAR Study Presented at the 2015 Neuroendocrine Tumor Society Annual Symposium
THE WOODLANDS, Texas, Oct. 19, 2015 /PRNewswire/ — 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.
About the TELESTAR Study
The exit interviews followed the randomized treatment portion of the TELESTAR Phase 3 study, which enrolled 135 patients with carcinoid syndrome that was not adequately controlled on SSA therapy, the current standard of care. The three-arm study evaluated two doses of oral telotristat etiprate – 250 mg and 500 mg, each taken three times daily – against placebo over a 12-week period and measured the reduction from baseline in the average number of daily bowel movements. Patients in both the treatment and placebo arms continued their SSA therapy throughout the study.
Also during the Symposium, TELESTAR primary investigator, Matthew H. Kulke, M.D., provided an oral presentation, entitled “Results of TELESTAR: A Phase 3, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy and Safety of Telotristat Etiprate in Patients with Carcinoid Syndrome Not Adequately Controlled by Somatostatin Analog.”
Data showed that patients who added telotristat etiprate to the standard of care at both the 250 mg and 500 mg doses experienced a statistically significant reduction from baseline compared to placebo in the average number of daily bowel movements over the 12-week study period (p < 0.001), meeting the study’s primary endpoint.
Patients who received 250 mg of telotristat etiprate experienced a reduction of 1.71 bowel movements (29 percent) in the average number of daily bowel movements during the final week of the study compared to baseline, and those in the 500 mg arm experienced a reduction of 2.11 bowel movements (35 percent); the placebo group showed a reduction of 0.87 bowel movements (17 percent). The 12-week study period is being followed by a 36-week open-label extension where all patients receive telotristat etiprate 500 mg three times daily.
About Telotristat Etiprate
Discovered using Lexicon’s unique approach to gene science, telotristat etiprate is the first investigational drug in clinical studies to target tryptophan hydroxylase, an enzyme that triggers the excess serotonin production within metastatic neuroendocrine tumor cells that leads to carcinoid syndrome. While existing treatments for carcinoid syndrome work to reduce the release of serotonin outside tumor cells, telotristat etiprate works at the source to reduce serotonin production within the tumor cells. By specifically inhibiting serotonin production, telotristat etiprate seeks to control this important driver of carcinoid syndrome and, in turn, provide patients with more control over their disease.
Lexicon retains rights to market telotristat etiprate in the U.S. and Japan, and is building the in-house commercial infrastructure to serve the U.S. market. Lexicon has a license and collaboration agreement with Ipsen to commercialize telotristat etiprate in Europe and other countries outside the U.S. and Japan.
Lexicon is a fully integrated biopharmaceutical company that is applying a unique approach to gene science based on Nobel Prize-winning technology to discover and develop precise medicines for patients with serious, chronic conditions. Through its Genome5000™ program, Lexicon scientists have studied the role and function of nearly 5,000 genes over the last 20 years and have identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to safely and effectively treat disease. Lexicon has a pipeline of promising drug candidates in clinical and pre-clinical development in oncology, diabetes and metabolism. For additional information please visit www.lexpharma.com.
Safe Harbor Statement
This press release contains “forward-looking statements,” including statements relating to Lexicon’s clinical development of telotristat etiprate (LX1032) and the results of and projected timing of clinical trials and the potential therapeutic and commercial potential of telotristat etiprate. In addition, this press release also contains forward-looking statements relating to Lexicon’s growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management’s current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including the risk that clinical studies of telotristat etiprate may be halted, delayed or otherwise not demonstrate safety or efficacy, the risk that Lexicon and its licensees may be unable to file for regulatory approval of telotristat etiprate with the FDA and other regulatory authorities in accordance with its currently anticipated timelines, the risk that the FDA and other regulatory authorities may not grant regulatory approval of telotristat etiprate in accordance with Lexicon’s currently anticipated timelines or at all, and the risk that such regulatory approvals, if granted, may have significant limitations on the approved use of telotristat etiprate. As a result, telotristat etiprate may never be successfully commercialized. Other risks include Lexicon’s ability to meet its capital requirements, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of its other potential drug candidates, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its drug candidates. Any of these risks, uncertainties and other factors may cause Lexicon’s actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under “Risk Factors” in Lexicon’s annual report on Form 10-K for the year ended December 31, 2014, as filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.
1Beaumont JL, Cella D, Phan AT, Choi S, Liu Z, Yao JC. Comparison of health-related quality of life in subjects with neuroendocrine tumors with quality of life in the general US population. Pancreas. 2012;41 (3):461-466.
2Zuetenhorst JM, Taal BG. Metastatic carcinoid tumors: a clinical review. Oncologist. 2005;10 (2):123-131.
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