Ovarian

IMV Moves to Develop DPX-Survivac as Monotherapy for Recurrent Ovarian Cancer

(Markets Insider) Nov 20, 2018 - IMV Inc., a clinical stage immuno-oncology corporation, today announced an amendment to its phase 1b/2 clinical trial evaluating the safety and efficacy of IMV’s lead candidate, DPX-Survivac, in combination with either 100 mg or 300 mg of epacadostat in patients with recurrent ovarian cancer.

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Merck KGaA And Pfizer Say Drug Failed To Meet Primary Endpoints In Late-Stage Ovarian Cancer Trial

(MarketWatch) Nov 19, 2018 - Merck KGaA and Pfizer Inc. said early Monday that the cancer immunotherapy avelumab did not meet the primary endpoints of a phase 3 ovarian cancer trial. The trial, JAVELIN Ovarian 200, tested avelumab both alone and in combination with chemotherapy. It specifically focused on individuals with platinum-resistant or -refractory ovarian cancer, or cancers that did not respond to prior chemotherapy treatment, "a population known to have disease that is challenging to treat; as such, this group of patients in typically not included in Phase 3 ovarian cancer trials," Dr. Chris Boshoff, Pfizer's senior vice president and head of immuno-Oncology, early development and translational oncology, said.

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Merck KGaA, Darmstadt, Germany, and Pfizer Provide Update on Avelumab in Platinum-Resistant/Refractory Ovarian Cancer

(Merck KGaA) Nov 19, 2018 - Merck KGaA, Darmstadt, Germany, and Pfizer Inc. today announced that the Phase III JAVELIN Ovarian 200 trial evaluating avelumab* alone or in combination with pegylated liposomal doxorubicin (PLD), a type of chemotherapy, compared with PLD did not meet the prespecified primary endpoints of overall survival (OS) or progression-free survival (PFS) in patients with platinum-resistant or -refractory ovarian cancer. Signals were observed in the combination arm relative to PLD, and further analyses of the trial are warranted (HR for the primary PFS endpoint for avelumab + PLD vs PLD alone: 0.78 [repeated confidence interval (RCI): 0.587, 1.244; one-sided p-value: 0.0301]; HR for the primary OS endpoint for avelumab + PLD vs PLD alone: 0.89 [RCI: 0.744, 1.241; one-sided p-value: 0.2082]; HR for the primary PFS endpoint for avelumab alone vs PLD alone: 1.68 [RCI: 1.320, 2.601; one-sided p-value: >0.99]; HR for the primary OS endpoint for avelumab alone vs PLD alone: 1.14 [RCI: 0.948, 1.580; one-sided p-value: 0.8253]; objective response, a secondary endpoint: 13.3% [95% CI 8.8, 19.0] for avelumab + PLD; 3.7% [95% CI 1.5, 7.5] for avelumab alone; and 4.2% [95% CI 1.8, 8.1] for PLD alone). No new safety signals were observed for avelumab alone or in combination, and the safety profile for avelumab in this trial was consistent with that observed in the overall JAVELIN clinical development program. The data are currently being analyzed, and detailed results will be shared with the scientific community.

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Syros Announces Dose Escalation Data from Phase 1 Trial of SY-1365 Demonstrating Proof-of-Mechanism at Tolerable Doses in Patients with Advanced Solid Tumors

(Morningstar) Nov 15, 2018 - Dose selected for ongoing expansion cohorts in ovarian and breast cancers supported by tolerability profile and early signs of clinical activity; data highlighted in oral plenary session at EORTC-NCI-AACR Meeting.

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Determining Indirect Costs of Ovarian Cancer

(Journal Of Clinical Pathways) Nov 13, 2018 - A recent study presented at AMCP assessed indirect work loss costs, including absenteeism, short-term disability, and long-term disability, in patients with ovarian cancer.

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US FDA Accepts Regulatory Submission For Lynparza Maintenance Therapy In Newly-Diagnosed, BRCA-Mutated Advanced Ovarian Cancer And Grants Priority Review

(MarketWatch) Nov 12, 2018 - AstraZeneca and Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for priority review for the approval of LYNPARZA tablets as a maintenance treatment in patients with newly-diagnosed, BRCA-mutated (BRCAm) advanced ovarian cancer who were in complete or partial response following first-line standard platinum-based chemotherapy. A Prescription Drug User Fee Act (PDUFA) date is set for the first quarter of 2019. This is the first U.S. regulatory submission acceptance for a poly ADP-ribose polymerase (PARP) inhibitor in the first-line maintenance setting for advanced ovarian cancer, and, if approved, will be the fourth indication for LYNPARZA in the U.S.

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FDA Grants Lynparza Priority Review for Frontline Maintenance in Ovarian Cancer

(Curetoday.com) Nov 12, 2018 - The FDA has granted a priority review designation to a supplemental new drug application (sNDA) for Lynparza (olaparib) tablets for use as a maintenance therapy in patients with newly-diagnosed, BRCA-positive advanced ovarian cancer who achieved a complete or partial response to standard frontline platinum-based chemotherapy. The sNDA is based on data from the phase 3 SOLO-1 trial, in which the PARP inhibitor Lynparza significantly improved progression-free survival (PFS) as frontline maintenance for this patient population. With a median follow-up of 41 months, the median PFS by independent central review was not reached in the Lynparza arm (260 patients), versus 14.1 months in the placebo arm (131 patients). The investigator-assessed PFS in the Lynparza arm was not reached, compared to 13.8 months in the placebo arm.

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It’s Too Early To Take Baby Aspirin To Cut Ovarian Cancer Risk, But Not Too Early To Improve Your Diet

(Washington Post) Nov 12, 2018 - A study published last month offers some new hope for helping prevent ovarian cancer — in the form of a baby aspirin — and may add to the growing body of evidence that inflammation plays a role in the disease. But researchers caution that more study is needed.

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Celyad Presents Update on CYAD-01 Solid Tumor Clinical Program at the SITC 33rd Annual Meeting

(NASDAQ) Nov 9, 2018 - Celyad today announced updated clinical results for the CYAD-01 program in solid tumors as well as translational research data presented at the Society for Immunotherapy of Cancer (SITC) 33rd Annual Meeting.

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Fate Therapeutics Announces Encouraging Dose-Escalation Clinical Data of FATE-NK100 and Provides Regulatory Update on Landmark IND Application for FT500

(NASDAQ) Nov 11, 2018 - Fate Therapeutics, Inc. announced new clinical data for FATE-NK100, an investigational, first-in-class, allogeneic donor-derived natural killer (NK) cell cancer immunotherapy, and provided a regulatory update on the development of FT500, a universal, off-the-shelf NK cell product candidate derived from a master induced pluripotent stem cell (iPSC) line, on November 10, 2018.

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NICE Fail To Recommend AstraZeneca's Cancer Drug Olaparib On Cost Effectiveness Basis

(Pharmafile [UK]) Nov 9, 2018 - Britain’s cost effectiveness body the National Institute of Health and Care Excellence (NICE) has chosen not to recommend AstraZeneca’s Olaparib for women with advanced ovarian cancer who had previously responded to platinum chemotherapy for six months or longer. The non-departmental public body commented: “Clinical trials show that olaparib extends the time until cancer progresses compared with routine surveillance. However, the cost-effectiveness estimates are substantially above the range normally considered cost effective. Olaparib does not meet NICE’s end-of-life or Cancer Drugs Fund criteria. Therefore, it is not recommended.”

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NICE Rejects AZ’s Lynparza Tablets in Ovarian Cancer Maintenance

(Pharmaphorum [UK]) Nov 9, 2018 - AstraZeneca has said it will continue pricing negotiations with the NHS and NICE after the cost-effectiveness body said the tablet formulation of Lynparza (olaparib) is too expensive for regular funding on the health service as a maintenance therapy for some ovarian cancer patients. In a first draft decision NICE said Lynparza was not cost effective as a maintenance therapy for relapsed, platinum sensitive high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer, that is in response to platinum-based chemotherapy in adults regardless of BRCA status. In a decision that applies to England, NICE’s independent appraisal committee said that clinical trials show the drug extends the time until cancer progresses compared with routine surveillance, and the benefit appears to be greater in a group of patients with the BRCA mutations.

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Ovarian Ca Risk Reduced with Postmenopausal Statins

(MedPage Today) Nov 6, 2018 - All histologic types of ovarian cancer risk lowered in statin versus non-statin users.

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Novel Technique Can Potentially Improve Success of Ovarian Cancer Treatment, Study Reveals

(University of Guelph [Canada]) Oct 30, 2018 - Instead of destroying a tumour’s blood supply, a first-ever U of G study has proven that opening up the vessels is potentially more effective when it comes to fighting ovarian cancer.

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Study in JNCCN Identifies Significant Factors for Reducing the Risk of Immunosuppression and Fever in People Being Treated with Chemotherapy

(NCCN) Oct 30, 2018 - Researchers find the timing and length of use for corticosteroids has a particularly strong impact on the likelihood of severe, life-threatening adverse events for people with cancer.

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ESMO ’18: Precision Meds, Breast, Lung, and More from the Cancer Front

(Xconomy National) Oct 23, 2018 - The European Society for Medical Oncology is wrapping up its annual conference today, replete with clinical data from cancer’s front lines. We’ve sorted the headlines into a few big categories: immunotherapy combinations, breast cancer, lung cancer, the growing class of drugs called PARP inhibitors, and new drugs that treat tumors based on genetic signature. Patients with two different types of breast cancer got promising news at ESMO from studies exploring relatively new methods of treatment. Drugs that boost a patient’s immune system to fight back against cancer have been approved to fight several types of cancer and have even become a first-line option against some advanced lung and kidney cancers. But experimental results unveiled over the weekend are the first in immunotherapy to show a survival benefit in breast cancer, which causes the second-most cancer deaths among U.S. women.

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TESARO Announces Data Presentations at ESMO 2018 Congress

(NASDAQ) Oct 20, 2018 - Data presented indicate that TSR-042 (anti-PD-1 antibody) is well tolerated and has robust activity in patients with MSI-H endometrial cancer; PRIMA safety data for individualized niraparib dose regimen presented; Top-line results for PRIMA trial of niraparib in first-line ovarian cancer regardless of biomarker status expected in late 2019.

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Ovarian Cancer 'Breakthrough' Drug Prevents Disease Returning For Years

(The Telegraph [UK]) Oct 21, 2018 - A new ovarian cancer treatment dramatically reduces the chances of the disease returning, a study has shown. Doctors have hailed the results of a “breakthrough” trial which they say opens the possibility that many more women suffering the hard-to-treat disease can be cured. Ovarian cancer has one of the worst survival rates, with just 35 per cent of women living 10 years or more after their diagnosis.

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Olaparib Maintenance Extends Progression-free Survival By Estimated 3 Years In Advanced Ovarian Cancer

(ESMO 2018 Congress) Oct 21, 2018 - Two-year maintenance therapy with olaparib, a PARP (poly ADP ribose polymerase) inhibitor, olaparib, led to a substantial, unprecedented improvement in progression-free survival (PFS) in newly diagnosed patients with advanced ovarian cancer and a BRCA1 or 2 mutation, results from the phase 3 SOLO-1 trial show. “The median PFS for patients who received placebo was only 13.8 months while the median PFS for those who received olaparib was not reached but looks to be approximately three years longer than the placebo group [HR was 0.30; 95% CI: 0.23, 0.41; p<0.0001],” reported Dr Kathleen Moore, Associate Professor at the Stephenson Cancer Center, University of Oklahoma, US, presenting the results at ESMO 2018 Congress.

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Myriad’s BRACAnalysis CDx® Test Identifies Patients with Newly Diagnosed Advanced Ovarian Cancer Who May Benefit from Maintenance Treatment with Lynparza®

(Morningstar) Oct 22, 2018 - Myriad Genetics, Inc., a leader in molecular diagnostics and personalized medicine, today announced that its BRACAnalysis CDx® test accurately identified patients with newly-diagnosed, advanced-stage, BRCA-mutated (BRCAm) ovarian cancer who may benefit from treatment with Lynparza® (olaparib).

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