TESARO (TSRO) Presents Statistically Significant Phase 3 ENGOT-OV16/NOVA Trial Results at ESMO

October 10, 2016 6:40 AM EDT

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Over the weekend, TESARO, Inc. (NASDAQ: TSRO) and ENGOT, the European Network for Gynaecological Oncological Trial groups, today announced the presentation of the niraparib Phase 3 ENGOT-OV16/NOVA clinical trial results at the ESMO 2016 Congress, the congress of the European Society for Medical Oncology (ESMO), by Dr. Mansoor Raza Mirza, M.D., Medical Director of the Nordic Society of Gynecologic Oncology (NSGO) and principal investigator on the ENGOT-OV16/NOVA trial. These data were discussed during the ESMO press briefing in Copenhagen as part of the congress, and were simultaneously published online in the New England Journal of Medicine.1 The results will also be presented by Dr. Mirza later today during Presidential Symposium 1 (Abstract #LBA3_PR) at ESMO.

NGOT-OV16/NOVA is a double-blind, placebo-controlled, international Phase 3 trial of niraparib that enrolled 553 patients with recurrent ovarian cancer who were in response to their most recent platinum-based chemotherapy. This trial was designed to assess progression free survival (PFS) in a broad population of patients who were assigned to one of two cohorts based upon germline BRCA mutation status. The ENGOT-OV16/NOVA trial successfully achieved its primary endpoint in both cohorts, demonstrating that niraparib treatment significantly prolonged PFS compared to control in patients who were germline BRCA mutation (gBRCAmut) carriers and in patients who were not germline BRCA mutation (non-gBRCAmut) carriers. In addition, within the non-gBRCA cohort, niraparib treatment significantly prolonged PFS compared to control for the prospectively defined patient population with tumors deficient in homologous recombination (HRDpos) as determined by the Myriad myChoice® HRD test. A high proportion of patients in both treatment groups in both cohorts had received three or more prior lines of chemotherapy.

“These landmark results are extremely encouraging for the ovarian cancer community,” said Dr. Mirza. “The effectiveness of platinum-based chemotherapy diminishes over time, and PFS and platinum-free intervals generally become shorter after each round of platinum treatment. In addition, the incidence of infection and risk of neuropathy and hypersensitivity with certain chemotherapy agents rises with subsequent cycles. An oral maintenance treatment that could lengthen the PFS interval between rounds of platinum-based chemotherapy would be very meaningful for patients with ovarian cancer, who often live with a fear of recurrence after ending active treatment.”

“We would like to thank the patients, their families and the caregivers that participated in the ENGOT-OV16/NOVA study, as well as our partners at ENGOT for their diligence in executing this trial,” said Mary Lynne Hedley, Ph.D., President and COO of TESARO. “We believe the results of this Phase 3 study demonstrated a meaningful benefit for women with platinum sensitive, recurrent ovarian cancer.”

Primary Endpoint Results:

Statistically Significant PFS Results in the gBRCAmut CohortAmong patients who were germline BRCA mutation carriers, the niraparib arm successfully achieved statistical significance over the control arm for the primary endpoint of PFS, with a hazard ratio of 0.27 (95% CI, 0.173-0.410). The median PFS for patients treated with niraparib was 21.0 months, compared to 5.5 months for control (p<0.0001).

Statistically Significant PFS Results in the non-gBRCAmut Cohort Niraparib showed statistical significance for patients in the non-germline BRCA mutant cohort. The niraparib arm successfully achieved statistical significance over the control arm for the primary endpoint of PFS, with a hazard ratio of 0.45 (95% CI, 0.338-0.607). The median PFS for patients treated with niraparib was 9.3 months, compared to 3.9 months for control (p<0.0001).

Statistically Significant PFS Results in non-gBRCAmut Cohort for Patients with HRD-Positive TumorsFor patients who were not germline BRCA mutation carriers but whose tumors were determined to be HRD positive using the Myriad myChoice® HRD test, the niraparib arm successfully achieved statistical significance over the control arm for the primary endpoint of PFS, with a hazard ratio of 0.38 (95% CI, 0.243-0.586). The median PFS for patients with HRD-positive tumors who were treated with niraparib was 12.9 months, compared to 3.8 months for control (p<0.0001).

Secondary Endpoint Results:

Secondary endpoint analyses, including chemotherapy-free interval, time to first subsequent treatment, and PFS 2 were all statistically significant and favored niraparib over control for patients in both the gBRCAmut and non-gBRCAmut cohorts. Patient-reported outcome results from validated survey tools indicated that niraparib-treated patients reported no difference from control in measures associated with quality of life. Data for overall survival are immature (HR 0.73; 95% CI, 0.480 to 1.125; p=0.1545), as fewer than 20% of events had occurred at the time of analysis.

Safety Results:

The most common (≥10%) treatment-emergent grade 3/4 adverse events in the niraparib arm were thrombocytopenia (33.8%), anemia (25.3%), and neutropenia (19.6%) with treatment discontinuation for these events of 3.3%, 1.4% and 1.9%, respectively. Thrombocytopenia was not associated with grade 3/4 bleeding events. The majority of these hematological laboratory abnormalities occurred within the first three cycles; following dose modifications the incidence of these lab abnormalities decreased and thrombocytopenia and neutropenia were infrequent beyond cycle 3. The rates of MDS/AML in the niraparib (1.4%) and control (1.1%) arms were similar. There were no deaths among patients during study treatment.

“Despite diagnostic and treatment advances, ovarian cancer remains the deadliest gynecologic cancer, and the need for new therapeutic options that prolong response remains critical,” said David Barley, CEO of the National Ovarian Cancer Coalition. “The results of the NOVA trial are encouraging, and could offer patients and their families a treatment option during the stressful period that follows platinum-based chemotherapy where the majority of patients receive no treatment.”

Investor Briefing and WebcastTESARO will webcast an investor and analyst briefing in Copenhagen on Saturday, October 8 at 7:00 PM local time in Copenhagen in conjunction with the ESMO annual meeting. At this briefing, TESARO management will review the niraparib development program and data presented at ESMO and answer questions from investors and analysts. This event will be webcast live and archived for 30 days, and may be accessed from the TESARO Investor Events and Presentations webpage at www.tesarobio.com. A reception will begin at 6:30 PM local time for those institutional investors and analysts attending this event in Copenhagen; please RSVP to krausch@tesarobio.com in order to attend.



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