On October 9, 2018 TESARO, Inc. (NASDAQ: TSRO), an oncology-focused biopharmaceutical company, reported that data from six abstracts will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress from October 19-23, 2018 in Munich, Germany (Press release, TESARO, OCT 9, 2018, View Source [SID1234529855]).
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"At this year’s ESMO (Free ESMO Whitepaper) Congress, blinded, pooled interim safety data from PRIMA will be presented, which demonstrated that an individualized starting dose of ZEJULA resulted in a favorable tolerability profile compared to a fixed starting dose of 300 milligrams. PRIMA is a fully-enrolled Phase 3 trial for patients with first-line ovarian cancer regardless of biomarker status and we expect top-line results to be available in late 2019," said Mary Lynne Hedley, Ph.D., President and COO of TESARO. "TESARO is also advancing a robust immuno-oncology portfolio. Data will be presented in a poster discussion from the MSI-H endometrial cohort of the GARNET trial of TSR-042, our anti-PD-1 antibody, for which we are planning to submit a biologic license application (BLA) next year."
Please plan to visit TESARO at Booth #212 for information about ZEJULA and our pipeline.
Details of TESARO’s poster presentations are as follows (all times local):
All posters will be on display beginning Saturday, October 20, 7:30 AM.
ZEJULA (niraparib)
Saturday, October 20, 2018, 9:15 AM – 10:45 AM; Lecture time: 9:59 AM
A prospective evaluation of tolerability of niraparib dosing based upon baseline body weight (wt) and platelet (plt) count: Blinded pooled interim safety data from the PRIMA Study
Poster Discussion, Abstract: 941PD, Location: ICM – Room 13, Poster Displayed: Hall B4
Saturday, October 20, 2018, 12:30 PM – 1:30 PM
QUADRA: A phase 2, open-label, single-arm study to evaluate niraparib in patients with relapsed ovarian cancer in 4th or later line of therapy: results from the tBRCAmut subset
Poster Session, Abstract: 944P, Location: Hall A3
Saturday, October 20, 2018, 12:30 PM – 1:30 PM
OVARIO: A single-arm, open-label phase 2 study of maintenance therapy with niraparib + bevacizumab in patients with advanced ovarian cancer after response to frontline platinum-based chemotherapy
Poster Session, Abstract: 999TiP, Location: Hall A3
Saturday, October 20, 2018, 12:30 PM – 1:30 PM
Real world occurrence of top three clinical-trial reported adverse events of PARP inhibitor niraparib maintenance therapy in platinum-sensitive recurrent ovarian cancer, a national retrospective observational study of a 200 mg/day starting-dose cohort
Poster Session, Abstract: 986P, Location: Hall A3
Saturday, October 20, 2018, 12:30 PM – 1:30 PM
Brain metastases in primary ovarian cancer: real-world data
Poster Session, Abstract: 946P, Location: Hall A3
TSR-042 (anti-PD-1)
Saturday, October 20, 2018, 9:15 – 10:45 AM; Lecture time: 9:15 AM
Preliminary safety, efficacy, and PK/PD characterization from GARNET, a phase 1 clinical trial of the anti–PD-1 monoclonal antibody, TSR-042, in patients with recurrent or advanced MSI-H endometrial cancer
Poster Discussion, Abstract: 935PD, Location: ICM – Room 13, Poster displayed: Hall B4
Niraparib is marketed in the United States and Europe under trade name ZEJULA.
About ZEJULA (Niraparib)
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 U.S. 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 (TSR-075).