Exhibit 99.1

 

 

TESARO ANNOUNCES FIRST-QUARTER 2018 OPERATING RESULTS

 

·                  ZEJULA Q1 net sales totaled $49 million

·                  Enrollment completed in Phase 3 PRIMA first-line ovarian cancer monotherapy trial

·                  TOPACIO platinum-resistant ovarian cancer and triple-negative breast cancer data accepted for oral presentations at ASCO

·                  Initial data from two TSR-042 (anti-PD-1) GARNET expansion cohorts presented at AACR; regulatory submission for MSI-high tumors planned in 2019

 

WALTHAM, Mass., May 3, 2018

— TESARO, Inc. (NASDAQ: TSRO), an oncology-focused biopharmaceutical company, today reported operating results for first-quarter 2018, and provided an update on the Company’s commercial products and development programs.

 

“2018 is off to an excellent start for TESARO, as ZEJULA continues to penetrate the recurrent ovarian cancer market,” said Lonnie Moulder, CEO of TESARO. “We expect to expand the market for ZEJULA to the front-line setting with PRIMA, our Phase 3 trial for patients with first-line ovarian cancer regardless of biomarker status, with data expected late next year. In March, data presented from our TOPACIO trial of ZEJULA in combination with an anti-PD-1 antibody surpassed historical monotherapy benchmarks in difficult-to-treat platinum-resistant and refractory ovarian cancer patients, and we look forward to presentations from both the ovarian and triple-negative breast cancer cohorts of TOPACIO at ASCO. Our immuno-oncology pipeline is advancing quickly and we are on track to submit a biologic license application for TSR-042, our anti-PD-1 antibody, for patients with MSI-high tumors in 2019. Enrollment continues in our AMBER trial of TSR-022, our anti-TIM-3 antibody, in combination with TSR-042, and data from this trial in tumor-specific expansion cohorts are expected to be presented at a medical meeting later this year.”

 

Recent Business Highlights

 

·                  ZEJULA is the most utilized PARP inhibitor among ovarian cancer patients in the U.S., with more than 5,000 patients treated since launch in April 2017. The European launch of ZEJULA continues in Germany.

 

·                  Enrollment was completed in the Phase 3 PRIMA trial for patients with first-line ovarian cancer regardless of biomarker status. Data from this study are anticipated in late 2019.

 

·                  Data were presented from the ovarian cancer cohort of the TOPACIO trial of ZEJULA in combination with an anti-PD-1 monoclonal antibody at the Society for Gynecologic Oncology (SGO) Annual Meeting in March. Data demonstrated activity of ZEJULA in combination with an anti-PD-1 antibody in difficult-to-treat types of ovarian cancer.

 

·                  Results from a retrospective analysis of the NOVA trial were presented at the SGO Annual Meeting, which identified two characteristics, patient body weight and platelet counts, to be predictors of dose modification.

 

·                  In April, preliminary Phase 1 data from expansion cohorts of the GARNET trial of TSR-042 were presented at the American Association for Cancer Research (AACR) Annual Meeting. Activity of TSR-042 monotherapy was demonstrated in patients with MSI-high endometrial

 

1


The following information was filed by Tesaro, Inc. (TSRO) on Thursday, May 3, 2018 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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