Post by tomsylver on Aug 25, 2017 13:27:09 GMT
WALTHAM, Mass., Aug. 25, 2017 (GLOBE NEWSWIRE) -- TESARO, Inc. (TSRO), an oncology-focused biopharmaceutical company, today announced that data from nine abstracts will be presented at the 2017 European Society for Medical Oncology (ESMO) annual meeting, September 8 to September 12, 2017, in Madrid.
"We are excited that a wealth of data from the landmark ENGOT-OV16/NOVA trial will be presented at this year`s ESMO Annual Meeting," said Mary Lynne Hedley, Ph.D., President and COO of TESARO. "Patient-reported quality of life data for patients treated with niraparib versus placebo will be featured in an oral presentation and the results of two post-hoc analyses, the observed exposure-response relationship of niraparib in gBRCAmut and non-gBRCAmut patients, and the safety and efficacy of niraparib in elderly patients, will be subjects for poster discussions. In addition, data from the Phase 1/2 trial of niraparib plus pembrolizumab in patients with triple-negative breast cancer or recurrent platinum-resistant ovarian cancer (TOPACIO) will be highlighted in a poster discussion. Finally, a poster will be presented detailing results from the Phase 1 study of TSR-042, our anti-PD-1 antibody."
Please plan to visit TESARO at Booth #53 for information about VARUBY® and our pipeline.
Presentation Details (all times local):
ZEJULA® (niraparib)
Friday, September 8, 2017, 4:00 PM to 5:30 PM
Quality of life in recurrent ovarian cancer patients treated with niraparib: Results from the ENGOT-OV16/NOVA TRIAL
Proffered Paper Session, Abstract: 930O, Location: Cordoba Auditorium
Saturday, September 9, 2017, 9:15 AM to 10:45 AM
Safety and efficacy of niraparib in elderly patients (Pts) with recurrent ovarian cancer (OC)
Poster Discussion Session, Abstract: 934PD, Location: Cartagena Auditorium
Saturday, September 9, 2017, 9:15 AM to 10:45 AM
The exposure-response relationship of niraparib in patients (pts) with gBRCAmut and non-gBRCAmut: results from the Phase 3 ENGOT-OV16/NOVA Trial
Poster Discussion Session, Abstract:933PD, Location: Cartagena Auditorium
Saturday, September 9, 2017, 1:15 PM to 2:15 PM
Modeling and impact of organ function on the population pharmacokinetics (PK) of niraparib, a selective poly (ADP-ribose) polymerase (PARP)-1 and -2 inhibitor
Poster Display Session, Abstract: 964P, Location: Hall 8
Saturday, September 9, 2017, 1:15 PM to 2:15 PM
A randomized, double-blind, placebo-controlled multicenter phase 3 trial of niraparib maintenance treatment in patients with advanced ovarian cancer following frontline chemotherapy (PRIMA)
Poster Display Session, Abstract: 986TiP, Location: Hall 8
Saturday, September 9, 2017, 1:15 PM to 2:15 PM
A phase 1 study to evaluate the safety and tolerability of bevacizumab-niraparib combination therapy and determine the recommended phase 2 dose (RP2D) in women with platinum-sensitive epithelial ovarian cancer (ENGOT-OV24/AVANOVA1)
Poster Display Session, Abstract: 953P, Location: Hall 8
Saturday, September 9, 2017, 1:15 PM to 2:15 PM
Disease burden during the "watchful waiting" period in patients with recurrent ovarian cancer
Poster Display Session, Abstract: 962P, Location: Hall 8
Monday, September 11, 2017, 9:15 AM to 10:45 AM
Dose-finding combination study of niraparib and pembrolizumab in patients (pts) with metastatic triple-negative breast cancer (TNBC) or recurrent platinum-resistant epithelial ovarian cancer (OC) (TOPACIO/Keynote-162)
Poster Discussion Session, Abstract: 1143PD, Location: Bilbao Auditorium
Niraparib is marketed in the United States under trade name ZEJULA®. Niraparib has not been approved by any regulatory agencies outside of the United States.
The TOPACIO trial is being conducted in collaboration with Merck Sharp & Dohme B.V., a subsidiary of Merck & Co., Inc., which is providing support for the trial.
TSR-042 (anti-PD-1 antibody)
Sunday, September 10, 2017, 1:15 PM to 2:15 PM
Safety, pharmacodynamic, and pharmacokinetic profile of TSR-042, an anti-PD-1 monoclonal antibody, in patients with advanced solid tumors
Poster Display Session, Abstract: 1185P, Location: Hall 8
About ZEJULA® (Niraparib)
Niraparib is marketed in the United States under trade name ZEJULA®. ZEJULA (niraparib) is a poly(ADP-ribose) polymerase (PARP) inhibitor indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. In preclinical studies, ZEJULA concentrates in the tumor relative to plasma, delivering greater than 90% durable inhibition of PARP 1/2 and a persistent antitumor effect. Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML), including some fatal cases, was reported in patients treated with ZEJULA. Discontinue ZEJULA if MDS/AML is confirmed. Hematologic adverse reactions (thrombocytopenia, anemia and neutropenia), as well as cardiovascular effects (hypertension and hypertensive crisis) have been reported in patients treated with ZEJULA. Monitor complete blood counts to detect hematologic adverse reactions, as well as to detect cardiovascular disorders, during treatment. ZEJULA can cause fetal harm and females of reproductive potential should use effective contraception. Please see full prescribing information, including additional important safety information, available at www.zejula.com.
About TSR-042
TSR-042 is a monoclonal antibody targeting PD-1 and was developed as part of the collaboration between TESARO and AnaptysBio, Inc. This collaboration was initiated in March of 2014, and is focused on the development of monospecific antibody drugs targeting PD-1, TIM-3 (TSR-022), and LAG-3 (TSR-033), in addition to a bi-specific antibody drug candidate targeting PD-1/LAG-3.
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.
Investor/Media Contact:
Jennifer Davis
Vice President, Corporate Communications & Investor Relations
+1.781.325.1116 or jdavis@tesarobio.com
This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: TESARO, Inc. via GlobeNewswire
HUG#2129216
"We are excited that a wealth of data from the landmark ENGOT-OV16/NOVA trial will be presented at this year`s ESMO Annual Meeting," said Mary Lynne Hedley, Ph.D., President and COO of TESARO. "Patient-reported quality of life data for patients treated with niraparib versus placebo will be featured in an oral presentation and the results of two post-hoc analyses, the observed exposure-response relationship of niraparib in gBRCAmut and non-gBRCAmut patients, and the safety and efficacy of niraparib in elderly patients, will be subjects for poster discussions. In addition, data from the Phase 1/2 trial of niraparib plus pembrolizumab in patients with triple-negative breast cancer or recurrent platinum-resistant ovarian cancer (TOPACIO) will be highlighted in a poster discussion. Finally, a poster will be presented detailing results from the Phase 1 study of TSR-042, our anti-PD-1 antibody."
Please plan to visit TESARO at Booth #53 for information about VARUBY® and our pipeline.
Presentation Details (all times local):
ZEJULA® (niraparib)
Friday, September 8, 2017, 4:00 PM to 5:30 PM
Quality of life in recurrent ovarian cancer patients treated with niraparib: Results from the ENGOT-OV16/NOVA TRIAL
Proffered Paper Session, Abstract: 930O, Location: Cordoba Auditorium
Saturday, September 9, 2017, 9:15 AM to 10:45 AM
Safety and efficacy of niraparib in elderly patients (Pts) with recurrent ovarian cancer (OC)
Poster Discussion Session, Abstract: 934PD, Location: Cartagena Auditorium
Saturday, September 9, 2017, 9:15 AM to 10:45 AM
The exposure-response relationship of niraparib in patients (pts) with gBRCAmut and non-gBRCAmut: results from the Phase 3 ENGOT-OV16/NOVA Trial
Poster Discussion Session, Abstract:933PD, Location: Cartagena Auditorium
Saturday, September 9, 2017, 1:15 PM to 2:15 PM
Modeling and impact of organ function on the population pharmacokinetics (PK) of niraparib, a selective poly (ADP-ribose) polymerase (PARP)-1 and -2 inhibitor
Poster Display Session, Abstract: 964P, Location: Hall 8
Saturday, September 9, 2017, 1:15 PM to 2:15 PM
A randomized, double-blind, placebo-controlled multicenter phase 3 trial of niraparib maintenance treatment in patients with advanced ovarian cancer following frontline chemotherapy (PRIMA)
Poster Display Session, Abstract: 986TiP, Location: Hall 8
Saturday, September 9, 2017, 1:15 PM to 2:15 PM
A phase 1 study to evaluate the safety and tolerability of bevacizumab-niraparib combination therapy and determine the recommended phase 2 dose (RP2D) in women with platinum-sensitive epithelial ovarian cancer (ENGOT-OV24/AVANOVA1)
Poster Display Session, Abstract: 953P, Location: Hall 8
Saturday, September 9, 2017, 1:15 PM to 2:15 PM
Disease burden during the "watchful waiting" period in patients with recurrent ovarian cancer
Poster Display Session, Abstract: 962P, Location: Hall 8
Monday, September 11, 2017, 9:15 AM to 10:45 AM
Dose-finding combination study of niraparib and pembrolizumab in patients (pts) with metastatic triple-negative breast cancer (TNBC) or recurrent platinum-resistant epithelial ovarian cancer (OC) (TOPACIO/Keynote-162)
Poster Discussion Session, Abstract: 1143PD, Location: Bilbao Auditorium
Niraparib is marketed in the United States under trade name ZEJULA®. Niraparib has not been approved by any regulatory agencies outside of the United States.
The TOPACIO trial is being conducted in collaboration with Merck Sharp & Dohme B.V., a subsidiary of Merck & Co., Inc., which is providing support for the trial.
TSR-042 (anti-PD-1 antibody)
Sunday, September 10, 2017, 1:15 PM to 2:15 PM
Safety, pharmacodynamic, and pharmacokinetic profile of TSR-042, an anti-PD-1 monoclonal antibody, in patients with advanced solid tumors
Poster Display Session, Abstract: 1185P, Location: Hall 8
About ZEJULA® (Niraparib)
Niraparib is marketed in the United States under trade name ZEJULA®. ZEJULA (niraparib) is a poly(ADP-ribose) polymerase (PARP) inhibitor indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. In preclinical studies, ZEJULA concentrates in the tumor relative to plasma, delivering greater than 90% durable inhibition of PARP 1/2 and a persistent antitumor effect. Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML), including some fatal cases, was reported in patients treated with ZEJULA. Discontinue ZEJULA if MDS/AML is confirmed. Hematologic adverse reactions (thrombocytopenia, anemia and neutropenia), as well as cardiovascular effects (hypertension and hypertensive crisis) have been reported in patients treated with ZEJULA. Monitor complete blood counts to detect hematologic adverse reactions, as well as to detect cardiovascular disorders, during treatment. ZEJULA can cause fetal harm and females of reproductive potential should use effective contraception. Please see full prescribing information, including additional important safety information, available at www.zejula.com.
About TSR-042
TSR-042 is a monoclonal antibody targeting PD-1 and was developed as part of the collaboration between TESARO and AnaptysBio, Inc. This collaboration was initiated in March of 2014, and is focused on the development of monospecific antibody drugs targeting PD-1, TIM-3 (TSR-022), and LAG-3 (TSR-033), in addition to a bi-specific antibody drug candidate targeting PD-1/LAG-3.
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.
Investor/Media Contact:
Jennifer Davis
Vice President, Corporate Communications & Investor Relations
+1.781.325.1116 or jdavis@tesarobio.com
This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: TESARO, Inc. via GlobeNewswire
HUG#2129216