MIAMI, June 27, 2014 (GLOBE NEWSWIRE) -- TESARO, Inc. (Nasdaq: TSRO ), an oncology-focused biopharmaceutical company, today announced that three oral presentations detailing the final results from the rolapitant registration program were delivered today at the MASCC/ISOO International Symposium on Supportive Care in Cancer annual meeting in Miami. Rolapitant is an investigational neurokinin-1 (NK-1) receptor antagonist in development for the prevention of chemotherapy-induced nausea and vomiting (CINV).
Dr. Lee S. Schwartzberg, M.D., FACP, Division Chief, Hematology/Oncology and Clinical Instructor at the University of Tennessee Health Sciences Center, presented results of the Phase 3 trial of rolapitant that enrolled 1,369 patients receiving moderately emetogenic chemotherapy (MEC), approximately half of whom were treated with anthracycline-based regimens for breast cancer. This trial successfully achieved the primary endpoint of complete response (CR), defined as no emesis and no use of rescue medication, during the delayed phase following administration of chemotherapy (71.3% for rolapitant-treated patients vs. 61.6% for control, p<0.001). Over the entire 120 hour period the rolapitant group also achieved higher rates of complete response (68.6% vs. 57.8%, p<0.001), no emesis (78.7% vs. 65.3%; p<0.001) and complete protection, defined as no emesis, no use of rescue medication and no significant nausea (62.0% vs. 53.2%, p=0.001). Improved quality of life reported as higher rates of no impact on daily life (73.2% vs. 67.4%, p=0.027) were also shown in the rolapitant group. Approximately one-third of the participants (n=457/1,369) in this trial were enrolled at U.S.-based clinical sites, and a subset analysis of these patients showed that the rolapitant group had higher CR rates in the delayed (61.6% vs. 48.0%, p=0.005), acute (84.7% vs. 75.1%; p=0.012) and overall (59.3% vs. 44.1%, p=0.002) phases. In addition, for the entire 120 hour at risk period, patients had higher rates of complete protection (54.2% vs. 39.7%, p=0.042), no significant nausea (68.1% vs. 58.5%, p=0.003), and no emesis (78.7% vs. 65.3%, p<0.001). Treatment-emergent adverse events were similar between the rolapitant and control arms, and the most frequently observed adverse events in this trial that enrolled patients receiving chemotherapy were fatigue, alopecia and constipation.
Dr. Bernardo Rapoport, M.D., Medical Oncologist with Medical Oncology Center of Rosebank in Johannesburg, South Africa, presented the results of two phase 3 trials of rolapitant that together enrolled a total of 1,070 patients receiving cisplatin-based highly emetogenic chemotherapy (HEC). Both Phase 3 studies conducted in patients receiving cisplatin at a dose equal to or greater than 60 mg/m 2 met the primary endpoint of complete response in the delayed phase (72.7% vs. 58.4%, p<0.001; 70.1% vs. 61.9%, p=0.043), and results indicated that protection from CINV was maintained over the full five day at-risk period in both trials. The rolapitant group achieved significantly higher or numerically higher rates for all additional CINV assessments, including endpoints of no significant nausea, no nausea, complete protection and no emesis in both cisplatin-based trials. The most frequently observed adverse events in these trials that enrolled patients receiving chemotherapy were constipation, asthenia, fatigue and neutropenia.
Dr. Allen Poma, M.D., Senior Medical Director at TESARO, presented results of a Phase 1 positron emission tomography (PET) study that assessed rolapitant NK-1 receptor occupancy in the brain, the intended site of action. Rolapitant has a plasma half-life of approximately 180 hours and is a highly selective, high affinity NK-1 receptor (Ki = 0.7 nM) antagonist. PET scans performed five days following administration of a single 200 milligram dose of rolapitant demonstrated dose dependent receptor occupancy with a direct relationship to plasma concentration. Greater than 90% NK-1 receptor occupancy was maintained at 120 hours following rolapitant administration.
A poster presentation describing safety and tolerability data across the three Phase 3 trials of rolapitant was also presented. The overall incidence of treatment-emergent adverse events (TEAEs), including related-TEAEs, grade ≥3 TEAEs, and TEAEs leading to study drug discontinuation, were similar between groups in each study. The majority of adverse events were considered by investigators to be related to chemotherapy or underlying cancer.
New Drug Application (NDA) Submission on Track for Mid-2014
Preparations continue in support of a submission of an NDA for oral rolapitant to the U.S. Food and Drug Administration (FDA) in mid-2014. This NDA will include data from one Phase 3 study in patients receiving MEC, in addition to one Phase 2 and two Phase 3 trials in patients receiving cisplatin-based HEC. The top-line results of each of the Phase 3 trials of rolapitant were previously announced by TESARO and were also presented in detail at the American Society for Clinical Oncology (ASCO) annual meeting in June 2014.
Rolapitant is an investigational agent and, as such, has not been approved by the U.S. FDA or any other regulatory agency. The p values presented above are unadjusted.
About Rolapitant
Rolapitant is a potent and selective NK-1 receptor antagonist with an extended plasma half-life that is being developed for the prevention of CINV. NK-1 receptors are highly concentrated in the brain and bind the neurokinin substance P. Activation of NK-1 receptors plays a central role in nausea and vomiting induced by emetogenic stimuli, including certain cancer chemotherapies. NK-1 receptor antagonists have been demonstrated to improve the management of nausea and vomiting experienced by cancer patients undergoing chemotherapy. The safety and tolerability of single and repeat doses of rolapitant have been assessed in more than 2,500 healthy volunteers and patients. Rolapitant is being developed both in oral and intravenous formulations. TESARO licensed exclusive rights for the development, manufacture, commercialization and distribution of rolapitant from OPKO Health, Inc.
About Chemotherapy-Induced Nausea and Vomiting (CINV)
CINV is estimated to afflict over 70% of cancer patients undergoing chemotherapy and, if not prevented, may possibly result in a delay or even discontinuation of chemotherapy treatment. Prolonged nausea and vomiting may result in unwanted weight loss, dehydration and malnutrition, as well as hospitalization.
About TESARO
TESARO is an oncology-focused biopharmaceutical company dedicated to improving the lives of cancer patients by acquiring, developing and commercializing safer and more effective therapeutics. For more information, visit www.tesarobio.com .
To the extent that statements contained in this press release are not descriptions of historical facts regarding TESARO, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "anticipate," "estimate," "intend," and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements in this release involve substantial risks and uncertainties that could cause our clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in submissions for regulatory approvals, and other matters that could affect the availability or commercial potential of our drug candidates. TESARO undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the Company in general, see TESARO's Annual Report on Form 10-K for the year ended December 31, 2013 and other filings TESARO makes with the Securities and Exchange Commission.
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