Tesaro INC A1J0WH

Data expected from TSR-042 (anti-PD-1) GARNET NSCLC and MSI-high endometrial expansion cohorts in 2H 2018; regulatory submission planned for 2019

Key Development Milestones

Gynecologic Cancer:

• Submit QUADRA sNDA for treatment of late-line ovarian cancer beyond BRCAmut patients in Q4 2018
• Initiate registrational trial of ZEJULA in combination with TSR-042 in platinum-resistant/refractory ovarian cancer in Q4 2018
• Initiate enrollment in FIRST, a Phase 3 clinical trial of ZEJULA in combination with TSR-042 ± bevacizumab in first-line ovarian cancer, in September 2018
• AVANOVA Phase 2 data of ZEJULA in combination with bevacizumab for treatment of recurrent ovarian cancer to be submitted for presentation at a medical meeting in 1H 2019
• Report Phase 2 OVARIO data of ZEJULA in combination with bevacizumab in first-line ovarian cancer maintenance in late 2019
• Report Phase 3 PRIMA data of ZEJULA in first-line ovarian cancer maintenance in late 2019
• Report additional data from MSI-high endometrial cohort of the GARNET trial of TSR-042 at the ESMO Annual Meeting in October and submit a BLA to FDA in 2H 2019

Lung Cancer:

• Initiate Phase 2 registration enabling trial of TSR-042 versus standard of care in first-line NSCLC in early 2019
• Report additional data from lung cancer cohort of the GARNET trial of TSR-042 in NSCLC at the Society for Immunotherapy of Cancer (SITC) Annual Meeting in November
• Report initial data from the AMBER trial of TSR-022 in combination with TSR-042 at the SITC Annual Meeting
• Following availability of initial data in Q4 2018 from Phase 2 JASPER study of ZEJULA in combination with an anti-PD-1 inhibitor, submit data for presentation at a medical meeting in 1H 2019

Breast Cancer:

• Submit BRAVO data for publication in Q4 2018
• Complete protocol development for registration study of ZEJULA in combination with TSR-042 in breast cancer

Prostate Cancer:

• Janssen is advancing trials of ZEJULA in prostate cancer to support U.S. and EU regulatory filings in 2019

Immuno-oncology Pipeline:

• Continue to enroll CITRINO trial (combination of TSR-033 plus TSR-042) and report Phase 1 monotherapy dose-escalation data for TSR-033 at the SITC Annual Meeting
  
• Advance IND-enabling studies of PD-1/LAG-3 bi-specific antibody (TSR-075)
  
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http://ir.tesarobio.com/news-releases/...arter-2018-operating-results 

GSK übernimmt TSRO für 75$

https://endpts.com/...ial-oncology-and-beefs-up-cancer-drug-pipeline/

Beim CEO von Tesaro klingelt die Kasse

https://endpts.com/...304m-windfall-from-5-1b-glaxosmithkline-buyout/