TESARO and ENGOT Announce Presentation of Successful Niraparib Phase 3 ENGOT-OV16/NOVA Trial Results During ESMO 2016
- Simultaneous presentation of data at ESMO and publication online in the New England Journal of Medicine
- TESARO Investor Webcast to be Held at 7:00 PM CET / 1:00 PM EDT
COPENHAGEN, Oct. 08, 2016 (GLOBE NEWSWIRE) -- TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, 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.
An infographic accompanying this announcement is available at
ENGOT-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 Cohort
Among 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 Tumors
For 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.
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 Webcast
TESARO 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 firstname.lastname@example.org in order to attend.
About the Phase 3 ENGOT-OV16/NOVA Clinical Trial of Niraparib
NOVA is a double-blind, placebo-controlled, international Phase 3 trial of niraparib that enrolled 553 patients with recurrent ovarian cancer who were in a response to their most recent platinum-based chemotherapy. Patients were enrolled into one of two independent cohorts based on germline BRCA mutation status. One cohort enrolled patients who were germline BRCA mutation carriers (gBRCAmut), and the second cohort enrolled patients who were not germline BRCA mutation carriers (non-gBRCAmut) and included patients with HRD-positive and HRD-negative tumors. Within each cohort, patients were randomized 2:1 to receive niraparib or placebo and were treated continuously with placebo or 300 milligrams of niraparib, dosed as three 100 milligram tablets once per day, until progression. The primary endpoint of this study was progression-free survival (PFS). Secondary endpoints include patient-reported outcomes, chemotherapy-free interval length, PFS 2, overall survival, and other measures of safety and tolerability. More information about this trial is available athttp://clinicaltrials.gov/show/NCT01847274.
Niraparib is an oral, once-daily PARP inhibitor that is currently being evaluated in four ongoing pivotal trials. TESARO is building a robust niraparib franchise by assessing activity across multiple tumor types and by evaluating several potential combinations of niraparib with other therapeutics. The ongoing development program for niraparib includes a Phase 3 trial in patients with platinum-sensitive, recurrent ovarian cancer (the NOVA trial); a Phase 3 trial in patients with first-line ovarian cancer (the PRIMA trial); a registrational Phase 2 treatment trial in patients with ovarian cancer (the QUADRA trial); and a Phase 3 trial for the treatment of patients with BRCA-mutant breast cancer (the BRAVO trial). Several combination studies are also underway, including trials of niraparib plus pembrolizumab and bevacizumab. Janssen Biotech has licensed rights to develop and commercialize niraparib specifically for patients with prostate cancer worldwide, except in Japan.
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to niraparib for the treatment of patients with recurrent platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer. TESARO has initiated a rolling submission of a New Drug Application (NDA) for niraparib to the FDA, and intends to complete this submission during the fourth quarter. The Marketing Authorization Application (MAA) for niraparib is planned for submission to the European Medicines Agency (EMA) in the fourth quarter.
Niraparib is an investigational agent and, as such, has not been approved by the U.S. FDA, the European Medicines Agency (EMA), or any other regulatory agencies.
About Ovarian Cancer
Approximately 22,000 women are diagnosed each year with ovarian cancer in the United States, and more than 65,000 women are diagnosed annually in Europe. Ovarian cancer is the fifth most frequent cause of cancer death among women. Despite high response rates to platinum-based chemotherapy in the second-line advanced treatment setting, approximately 85% of patients will experience recurrence within two years. If approved, niraparib may address the difficult “watchful waiting” periods experienced by patients with recurrent ovarian cancer in between cycles of platinum-based chemotherapy.
TESARO is an oncology-focused biopharmaceutical company devoted to providing transformative therapies to people bravely facing cancer. For more information, visit www.tesarobio.com, and follow us on Twitter and LinkedIn.
To the extent that statements contained in this press release are not descriptions of historical facts regarding TESARO, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "anticipate," "estimate," "intend," and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. Examples of forward-looking statements contained in this press release include, among others, statements regarding our expectation to complete the rolling NDA submission and submit the MAA for niraparib in the fourth quarter of 2016. Forward-looking statements in this release involve substantial risks and uncertainties that could cause our research and pre-clinical development programs, clinical development programs, future results, performance, or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, risks related to our intellectual property, the uncertainties inherent in the execution and completion of clinical trials, uncertainties surrounding the timing of availability of data from our clinical trials, risks regarding ongoing discussions with and actions by regulatory authorities, patient accrual rates for clinical trials, risks from competitors, and other matters that could affect the timing of availability of data from or initiation of our clinical trials, uncertainties regarding regulatory approvals, uncertainties regarding certain expenditures, risks related to manufacturing and supply, and other matters that could affect the availability or commercial potential of our drug candidates. TESARO undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the Company in general, see TESARO's Annual Report on Form 10-K for the year ended December 31, 2015 and its Quarterly Report on Form 10-Q for the quarter ended June 30, 2016.
- Mirza MR, et al. Niraparib Maintenance Therapy in Platinum-Sensitive, Recurrent Ovarian Cancer. New England Journal of Medicine. 8 October 2016.
Sr. Director, Corporate Development & Investor Relations
+1.781.325.1116 or email@example.com
Om Nasdaq GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York
+1 212 401 8700http://www.nasdaqomx.com
NASDAQ (NASDAQ: NDAQ) is a leading provider of trading, exchange technology, information and public company services across six continents.
Følg saker fra Nasdaq GlobeNewswire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Nasdaq GlobeNewswire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Nasdaq GlobeNewswire
Standard Lithium Announces Closing of $21.6 million Bought Deal Private Placement of Units16.2.2018 19:25 | Pressemelding
THIS NEWS RELEASE IS INTENDED FOR DISTRIBUTION IN CANADA ONLY AND IS NOT INTENDED FOR DISTRIBUTION TO UNITED STATES NEWSWIRE SERVICES OR DISSEMINATION IN THE UNITED STATES. VANCOUVER, British Columbia, Feb. 16, 2018 (GLOBE NEWSWIRE) -- Standard Lithium Ltd. ("Standard Lithium" or the "Company") (TSX-V:SLL) (OTCQX:STLHF) (FRA:S5L) announced today that it has closed its previously announced bought deal private placement of 10,312,821 units of the Company (the "Units"), at a price of $2.10 per Unit, for aggregate gross proceeds to the Company of $21,656,924, including the issuance and sale of the Underwriters' (as defined below) option (the "Offering"). Each Unit consists of one common share of the Company and one-half of one common share purchase warrant (each whole common share purchase warrant, a "Warrant"). Each Warrant is exercisable to acquire one common share of the Company (a "Warrant Share") until February 16, 2020 at an exercise price of $2.60 per Warrant Share, subject to adjus
Cisco Offers Cloud-Based Endpoint Security Solutions for Managed Security Service Providers16.2.2018 14:00 | Pressemelding
Cisco's comprehensive cloud-based security endpoint portfolio provides advanced malware protection, internet security, and enterprise mobility management SAN JOSE, Calif., Feb. 16, 2018 (GLOBE NEWSWIRE) -- Cisco today is helping address the challenges of Managed Security Service Providers (MSSP) and their customers by offering MSSPs comprehensive security, visibility, and control of customer endpoints without added hardware or complexity. The Cisco endpoint security portfolio includes three industry-leading solutions-Cisco AMP for Endpoints, Cisco Umbrella, and Meraki Systems Manager to offer protection against advanced malware and threats. Security teams know the endpoints in their environments are being targeted by advanced threats, but often lack the security talent, tools, and budget to address those challenges. As a result, organizations of all sizes are choosing to augment their in-house IT security with managed security services. Nearly half of SMBs and enterprises in the US1 ar
Aurora Solar Adds Heterojunction Cell Characterization to Decima Gemini Family16.2.2018 14:00 | Pressemelding
Aurora Solar Technologies Inc. / Aurora Solar Adds Heterojunction Cell Characterization to Decima Gemini Family . Processed and transmitted by Nasdaq Corporate Solutions. The issuer is solely responsible for the content of this announcement. NORTH VANCOUVER, British Columbia, Feb. 16, 2018 (GLOBE NEWSWIRE) -- Aurora Solar Technologies Inc. ("Aurora") ("Company") (TSX.V:ACU) (OTCBB:AACTF) (FSE:A82) is pleased to provide an update on the further development of its Decima Gemini(TM) infrared measurement technology for applications in the rapidly developing heterojunction (HJT) cell manufacturing market. HJT is an ultra high-efficiency solar cell design pioneered by Japan's Panasonic Corp., who is now also partnered with Tesla Inc. for solar products. According to Solar Media Ltd., HJT production capacity is expected to increase by 20 percent this year. To produce the electrical structure of a HJT cell, it is necessary to apply thin layers of amorphous silicon on both sides of a crystallin
Nasdaq Cited as a Leader in Governance, Risk, and Compliance Platforms by Independent Research Firm16.2.2018 13:35 | Pressemelding
NEW YORK, Feb. 16, 2018 (GLOBE NEWSWIRE) -- Nasdaq (Nasdaq:NDAQ) was among the select companies that Forrester invited to participate in its 2018 Forrester Wave(TM) evaluation, Governance, Risk, And Compliance (GRC) Platforms, Q1 2018. In this evaluation, Nasdaq was cited as a Leader in Governance, Risk, and Compliance Platforms and received the maximum score of 5 for the evaluation criteria "Risk & Control Management", "Audit Management", "Dashboard and Reporting" and "Integration capabilities" for its BWise solutions. "We feel the strong scores we obtained in important functional areas provide assurance to our clients that they have selected a robust and future-proof software platform," said Tom Passon, Head of Product Innovation & Global Standards, Nasdaq BWise. "We are proud of this recognition that encourages us to further execute on our strategy to provide user-friendly, pre-configured best practice solutions that combine our innovative GRC software platform with leading expertis
Apricus Biosciences Receives Complete Response Letter from FDA for Vitaros(TM)16.2.2018 13:00 | Pressemelding
Company Evaluating Deficiencies and Potential Path Forward SAN DIEGO, Feb. 16, 2018 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, today announced that the U.S. Food and Drug Administration ("FDA") has issued a complete response letter ("CRL") for the New Drug Application ("NDA") of Vitaros(TM) (alprostadil, DDAIP.HCl), a topical cream for the treatment of erectile dysfunction. The CRL indicates that the FDA cannot approve the NDA for Vitaros in its present form, identifying deficiencies related to Chemistry, Manufacturing and Control ("CMC") and certain safety concerns specific to the 2.5% concentration of DDAIP.HCl contained in the current formulation. "We are disappointed with the outcome of the review given the substantial amount of CMC, clinical and non-clinical data and analysis provided to the FDA in the Vitaros resubmission. We are assessing the content of the complete response
SEMAFO: Positive Mana PFS and Reserve Additions at Mana and Boungou16.2.2018 03:36 | Pressemelding
5-Year Average Target of 413,000 Ounces of Annual Production, AISC $696 MONTREAL, Quebec, Feb. 15, 2018 (GLOBE NEWSWIRE) -- SEMAFO Inc. (TSX:SMF) (OMX:SMF) today announced positive pre-feasibility study (PFS) results at Mana, the addition of 188,000 ounces of reserves, primarily at Siou underground, and an increase of 203,000 ounces of reserves at Boungou. As a result, the Corporation is providing the following consolidated five-year operational targets. Table 1 - Five-Year Operational Targets ---------------------------------------------------- 2019-2023 2019 2020 2021 2022 2023 Average ---------------------------------------------------- Production(1,2,3) Mana ('000 oz) 192 213 213 213 214 209 Boungou ('000 oz) 226 226 201 186 180 204 418 439 414 399 394 413 AISC(1,2,4,5) Mana ($/oz) 906 1,079 887 823 660 871 Boungou ($/oz) 419 405 527 606 626 516 643 733 712 721 643 696 Operating Cash Flow (at $1,300/oz) Total Revenue ($M) 543 571 539 518 512 2,683 AISC ($M) 268 321 295 287 253 1,42
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom