- Phase 3 results from ENGOT-OV16/NOVA trial of niraparib accepted for oral presentation during Presidential Symposium and inclusion in ESMO Press Programme
- TESARO to webcast Investor and Analyst Briefing on Saturday, October 8
WALTHAM, Mass., Sept. 06, 2016 (GLOBE NEWSWIRE) -- TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, today announced that data from six abstracts will be presented at the 2016 European Society for Medical Oncology (ESMO) annual meeting, October 7 to October 11, 2016, in Copenhagen. In addition, TESARO will webcast an investor and analyst briefing from Copenhagen on Saturday, October 8 at 7:00 PM local time in conjunction with the ESMO annual meeting.
Please plan to visit TESARO at Booth #415 for information about our pipeline.
Presentation Details (all times local):
Niraparib
Saturday, October 8, 2016, 4:30 PM to 6:00 PM – Presidential Symposium 1
A randomized, double-blind phase 3 trial of maintenance therapy with niraparib vs placebo in patients with platinum-sensitive recurrent ovarian cancer (ENGOT-OV16/NOVA trial)
Presentation: LBA3_PR, Presidential Symposium 1, Location: Copenhagen Room, Time: 5:30 PM
Results selected for inclusion in the ESMO Press Programme
Sunday, October 9, 2016, 1:00 PM to 2:00 PM
Modeling maintenance therapy in ovarian cancer
Poster: 1043P, Location: Hall E
Niraparib is an investigational product candidate that has not been approved by any regulatory agencies.
Rolapitant
Sunday, October 9, 2016, 1:00 PM to 2:00 PM
Efficacy and safety of rolapitant in the prevention of chemotherapy-induced nausea and vomiting (CINV) in elderly patients
Poster: 1441P, Location: Hall E
Sunday, October 9, 2016, 1:00 PM to 2:00 PM
Efficacy of rolapitant for prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with gastrointestinal and colorectal cancers
Poster: 1440P, Location: Hall E
Sunday, October 9, 2016, 1:00 PM to 2:00 PM
Safety of rolapitant for prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving Breast Cancer Resistant Protein (BCRP) substrate chemotherapy agents
Poster: 1442P, Location: Hall E
Sunday, October 9, 2016, 1:00 PM to 2:00 PM
Systematic review of the efficacy and safety of neurokinin-1 receptor antagonists for chemotherapy-induced nausea and vomiting: identification of the relevant clinical trials
Poster: 1443P, Location: Hall E
Rolapitant is marketed in the United States under trade name VARUBI®. Rolapitant has not been approved by any regulatory agencies outside of the United States.
Investor Briefing and Webcast
TESARO will webcast an investor and analyst briefing in Copenhagen on Saturday, October 8 at 7:00 PM local time in conjunction with the ESMO annual meeting. At this briefing, TESARO management will review the niraparib development program and data presented at ESMO and answer questions from investors and analysts. This event will be webcast live and archived for 30 days, and may be accessed from the TESARO Investor Events and Presentations webpage at www.tesarobio.com.
About Niraparib
Niraparib is an oral, once-daily PARP inhibitor that is currently being evaluated in four ongoing pivotal trials. TESARO is building a robust niraparib franchise by assessing activity across multiple tumor types and by evaluating several potential combinations of niraparib with other therapeutics. The ongoing development program for niraparib includes the Phase 3 trial in patients with recurrent ovarian cancer (the NOVA trial); a registrational Phase 2 treatment trial in patients with ovarian cancer (the QUADRA trial); a Phase 3 trial for the treatment of patients with BRCA-positive breast cancer (the BRAVO trial); and a Phase 3 trial in patients with first-line ovarian cancer (the PRIMA trial). Several collaborator-sponsored studies are also underway, including combination trials of niraparib plus pembrolizumab and bevacizumab. Janssen Biotech has licensed rights to develop and commercialize niraparib specifically for patients with prostate cancer worldwide, except in Japan.
About VARUBI® (Rolapitant)
Rolapitant is marketed in the United States under trade name VARUBI®. VARUBI is a substance P/neurokinin-1 (NK-1) receptor antagonist indicated in the U.S. in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. VARUBI is contraindicated in patients receiving thioridazine, a CYP2D6 substrate. The inhibitory effect of a single dose of VARUBI on CYP2D6 lasts at least seven days and may last longer. Avoid use of pimozide; monitor for adverse events if concomitant use with other CYP2D6 substrates with a narrow therapeutic index cannot be avoided. Please see full prescribing information, including additional important safety information, available at www.varubirx.com.
An intravenous formulation of rolapitant is also being developed. TESARO licensed exclusive rights for the development, manufacture, commercialization, and distribution of VARUBI (rolapitant) from OPKO Health, Inc.
About TESARO
TESARO is an oncology-focused biopharmaceutical company devoted to providing transformative therapies to people bravely facing cancer. For more information, visit www.tesarobio.com, and follow us on Twitter and LinkedIn.