Shares of TESARO Inc (NASDAQ:TSRO) are super hot today today on Ovarian Cancer results and the rally could continue to be hot until phase 3 results in the fall. The stock is up at the time of this written by over $40, 110%, destroying the shorts (at least for today). The sell side are panicing to play catch up with price targets here is what they are saying.
This morning TESARO Inc (NASDAQ:TSRO reported long-waited Ph3 NOVA data, showing s.s. PFS benefits in both cohorts; plans to file for U.S. & EU approval in 4Q16. Contrary to our cautious stance on non-gBRCAm/HRD+ arm following experts’ discussions, this arm also showed s.s clinically meaningful PFS benefits of ~9mo. AE profile was consistent with Ph1 data (most common Gr3/4 AEs thrombocytopenia, anemia & neutropenia). Full data to be presented at ESMO on 10/7-10/11.
NOVA Results Bode Well Other Studies: The outstanding NOVA results, in our view, bode well for other ongoing and planned studies involving niraparib. We note that other clinical programs involving niraparib continue to progress well: (i) QUADRA, 4th line ovarian; (ii) PRIMA, 1st line ovarian; (iii) BRAVO, BRCA+ breast cancer; and (iv) combination trials involving: (a) niraparib plus KEYTRUDA, triple negative breast cancer and ovarian indications; and AVANOVA – niraparib plus bevacizumab, ovarian cancer.
We expect broad use across ovarian cancer maintenance and niraparib looks clinically meaningful across BRCA and non-germline BRCA groups: Our peak ovarian cancer niraparib sales are $1.2B across 2nd line maintenance. Total ovarian sales across all lines of therapy on an adjusted basis are $1.8B (unadjusted $2.4B). In the BRCA cohort, the difference vs placebo was 15.5 mos. In the HRD/non-germline cohort, the difference vs placebo was 9 mos and the non-germline group difference was 5.4 months. Adverse events looked consistent with prior niraparib data. Rates of MDS/AML were consistent at 1.3% in niraparib and 1.2% in placebo. Discontinuation rates difference vs. placebo was 12%. This is roughly in-line with other ovarian trials that like OCEAN, CALYPSO, and ICON4 from speaking to mgmt.