TESARO Summarizes TSR-042 Clinical Data Presented at AACR

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CHICAGO, April 16, 2018 (GLOBE NEWSWIRE) -- TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, today summarized initial data from the Phase 1 GARNET trial of TSR-042 (anti-PD-1 antibody) in patients with microsatellite instability high (MSI-H) endometrial cancer and non-small cell lung cancer (NSCLC) presented during the American Association for Cancer Research (AACR) Annual Meeting.

“Preliminary results from GARNET presented today at AACR are the first clinical data from expansion cohorts for TSR-042, our anti-PD-1 antibody,” said Mary Lynne Hedley, Ph.D., President and COO of TESARO. “These results demonstrate the clinical activity of TSR-042 and support our unique patient-centric dosing regimen that includes dosing every 6 weeks. We expect to complete enrollment in the MSI-H endometrial cohort of the GARNET trial by the end of the year. A regulatory submission for TSR-042 is planned in 2019. The breadth of TESARO’s immuno-oncology portfolio, which also includes antibodies targeting TIM-3 and LAG-3, enables us to evaluate both monotherapy and novel combination approaches with a goal of providing transformative therapies for people living with cancer.”

At the time of data cutoff, 15 patients with MSI-H endometrial cancer and 24 patients with NSCLC had at least 1 tumor assessment. Among the 15 patients with MSI-H endometrial cancer, 7 had partial responses by immune related RECIST (irRECIST) criteria (ORR 47%). Eleven patients continue on therapy, including one patient with a partial response who has thus far received over 42 weeks of TSR-042. Three additional patients (20%) had stable disease.

Among the 24 patients with NSCLC, 7 had partial responses by irRECIST criteria (ORR 29%). Twelve patients continue on therapy, including one patient with a partial response who has thus far received over 36 weeks of TSR-042. Ten additional patients had stable disease (42%), one of whom has continued treatment for over 36 weeks.

Preliminary safety findings among the 120 evaluable patients (including patients with MSI-H endometrial, NSCLC, and other tumor types) indicate TSR-042 is well-tolerated. Grade ≥3 treatment-related treatment-emergent adverse events (TEAEs) were reported in 9 of 120 patients (7%).

Serum concentrations of TSR-042 observed 6 weeks after the 1000 milligram dose were comparable to those observed 3 weeks after the 500 milligram dose, and maximal receptor occupancy was maintained throughout the 6-week dosing interval.

The GARNET study is intended to support a Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA) for patients with MSI-H cancers in 2019.

Monday, April 16, 2018, 8:00 AM to 12:00 PMPoster Session, Abstract: 1687, Location: Exhibit Hall A, Poster Section 31, Poster Board 12

Monday, April 16, 2018, 8:00 AM to 12:00 PMPoster Session, Abstract: 1681, Location: Exhibit Hall A, Poster Section 31, Poster Board 6

Monday, April 16, 2018, 1:00 PM to 5:00 PMPoster Session, Abstract: 2722, Location: Exhibit Hall A, Poster Section 32, Poster Board 14

Wednesday, April 18, 2018, 8:00 AM to 12:00 PMPoster Session, Abstract: 5690, Location: Exhibit Hall A, Poster Section 31, Poster Board 26

Kate RauschAssociate Director, Investor Relations+1.781.257.2505 or

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Globe Newswire: 14:00 GMT Monday 16th April 2018

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