clinical trial results

  •   Emma Shtivelman, PhD

    Excerpt from OncLive:

    “Findings from the MONALEESA-3 trial dispelled the theory that a CDK4/6 inhibitor had to be reserved following recurrence on hormone therapy in postmenopausal patients with hormone receptor (HR)-positive, HER2-negative breast cancer, explained Dennis J. Slamon, MD, PhD.

    “In the phase III trial, postmenopausal patients with HR-positive, HER2-negative advanced disease who received up to 1 prior line of therapy were randomized 2:1 to ribociclib (Kisqali) plus fulvestrant (Faslodex) or placebo.”

    Go to full article published by OncLive on Sep 18, 2018.

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  •   Emma Shtivelman, PhD

    Excerpt from OncLive:

    “Treatment with apalutamide (Erleada) was not associated with a significant impact on health-related quality of life (HRQoL) in patients with high-risk nonmetastatic castration-resistant prostate cancer, according to patient-reported outcome (PRO) data from the phase III SPARTAN trial.

    “In the study overall, patients treated with the addition of apalutamide to standard hormone therapy also had an improvement in metastasis-free survival (MFS) and longer time to symptomatic progression compared with those who were treated with placebo.”

    Go to full article published by OncLive on Sep 17, 2018.

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  •   Emma Shtivelman, PhD

    Excerpt from Cancer Network:

    “Magnetic resonance imaging-guided laser interstitial thermal therapy (LITT) appears to be safe and effective for glioblastomas in select patients and may add an average of 2 months to life expectancy compared with the current standard of care, according to a new report published in the journal Neurosurgery.

    ” ‘We showed that the procedure is well tolerated and that recurrent patients had a meaningful clinical benefit that seems to be better when compared with previously published data on the current standard of care,’ said Eric Leuthardt, MD, senior study author and a professor of neurosurgery, neuroscience, biomedical engineering, and mechanical engineering & applied science at Washington University School of Medicine in St. Louis, Missouri.”

    Go to full article published by Cancer Network on Sep 7, 2018.

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  •   Emma Shtivelman, PhD

    Excerpt from The ASCO Post:

    In patients with advanced BRAF V600–mutant melanoma, combining the BRAF inhibitor encorafenib (Braftovi) with the MEK inhibitor binimetinib (Mektovi) improved overall survival compared to vemurafenib (Zelboraf) or encorafenib as monotherapy, with a favorable toxicity profile, according to updated results from the phase III COLUMBUS trial.

    “Combined BRAF/MEK inhibitor therapy is standard of care in advanced BRAF V600–mutant melanoma, but approved combinations have unique toxicities that may impact the ability to deliver optimal treatment (ie, vemurafenib/cobimetinib [Cotellic] is associated with photosensitivity).”

    Go to full article published by The ASCO Post on Sep 10, 2018.

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  •   Emma Shtivelman, PhD

    Excerpt from Healio:

    “A trial assessing the alpha-specific PI3K inhibitor alpelisib with fulvestrant met its primary endpoint of PFS among patients with hormone receptor-positive, HER-2-negative advanced breast cancer with a PIK3CA mutation, according to the agent’s manufacturer.

    “Alpelisib (BYL719, Novartis) is an inhibitor of the PI3K pathway. About 40% of patients with hormone receptor-positive breast cancer harbor PIK3CA mutations.

    “The phase 3 global, double-blind SOLAR-1 study included 572 women and men with PIK3CA-mutated hormone receptor-positive, HER-2-negative advanced or metastatic breast cancer that progressed on or following prior aromatase inhibitor treatment with or without a CDK4/6 inhibitor.”

    Go to full article published by Healio on Aug 24, 2018.

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  •   Emma Shtivelman, PhD

    Excerpt from Medscape:

    “The now-published results from the EMBRACA study confirm that  talazoparib (Pfizer), a poly-adenosine diphosphate-ribose polymerase (PARP) inhibitor,  prolongs progression-free survival (PFS) in patients with advanced BCRA-positive breast cancer compared with single-agent chemotherapy alone, and that it also significantly improves quality of life.

    ” ‘This is the largest randomized trial in BRCA mutation carriers [ever undertaken] and demonstrates PARP efficacy,’ Jennifer Litton, MD, associate professor in the Department of Breast Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, told Medscape Medical News in an email.”

    Go to full article published by Medscape on Aug 15, 2018.

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  •   Emma Shtivelman, PhD

    Excerpt from The ASCO Post:

    “In a phase II trial funded by the European Organisation for Research and Treatment of Cancer and reported in The Lancet Oncology, van den Bent et al found no evidence of a survival benefit with the addition of bevacizumab (Avastin) to temozolomide in patients with a first recurrence of World Health Organization grade II or III glioma without the 1p/19q codeletion.

    “In the open-label trial, conducted at 32 European centers, 155 patients were randomized between February 2011 and July 2015 to receive either temozolomide at 150 to 200 mg/m² on days 1 to 5 every 4 weeks for a maximum of 12 cycles (n = 77) or the same temozolomide regimen plus bevacizumab at 10 mg/kg every 2 weeks until disease progression (n = 78). Previous chemotherapy must have been stopped at least 6 months before enrollment, and radiotherapy, at least 3 months before enrollment. Overall, 44% of patients in the combination group and 47% in the temozolomide group had grade III disease.”

    Go to full article published by The ASCO Post on Aug 20, 2018.

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  •   Emma Shtivelman, PhD

    Excerpt from The ASCO Post:

    “In a planned subgroup analysis of the phase III AURA3 trial reported in the Journal of Clinical Oncology, Wu et al found that the third-generation EGFR tyrosine kinase inhibitor osimertinib (Tagrisso) produced higher central nervous system (CNS) response rates vs platinum plus pemetrexed (Alimta) in patients with advanced EGFR T790M-positive non–small cell lung cancer (NSCLC).

    “In AURA3, 419 patients with disease progression on prior EGFR tyrosine kinase inhibitor treatment were randomized 2:1 to receive osimertinib at 80 mg once daily or platinum plus pemetrexed. The current subgroup analysis was conducted in patients with measurable or nonmeasurable CNS lesions on baseline brain scan by blinded independent central neuroradiologic review.”

    Go to full article published by The ASCO Post on Aug 13, 2018.

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  •   Emma Shtivelman, PhD

    Excerpt from MedPage Today:

    “Adding abiraterone acetate (Zytiga) to enzalutamide (Xtandi) did not improve progression-free survival (PFS) after prostate-specific antigen (PSA) progression in men on enzalutamide monotherapy for chemotherapy-naive metastatic castration-resistant prostate cancer (mCRPC), researchers found.

    “In the randomized, double-blind PLATO trial, the median PFS in patients treated with enzalutamide plus abiraterone and prednisone was 5.7 months. By comparison, the PFS was 5.6 months in the control group treated with abiraterone and prednisone plus placebo (hazard ratio [HR] 0.83; P=0.22).”

    Go to full article published by MedPage Today on July 28, 2018.

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  •   Emma Shtivelman, PhD

    Excerpt from Healio:

    “First-line atezolizumab plus nab-paclitaxel improved PFS compared with placebo among patients with metastatic or unresectable locally advanced triple-negative breast cancer, according to interim results from the IMpassion130 trial released by the manufacturer.

    “Researchers observed prolonged PFS in both the intention-to-treat population and the PD-L1-positive population.”

    Go to full article published by Healio on July 2, 2018.

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