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FDA Approves Acalabrutinib for CLL

In Clinical Studies News by Barbara Jacoby

By: Jason M. Broderick From: onclive.com The FDA has approved acalabrutinib (Calquence) for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).1,2 The approval, which was done under the FDA’s Project Orbis initiative, was based on 2 phase III randomized trials—ELEVATE-TN and ASCEND. “Today, as part of a US, Australian, and Canadian collaboration known …

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Breast Cancer Drugs More Effective Than Hormone Therapy For Some Prostate Cancers

In Clinical Studies News by Barbara Jacoby

Source: The Institute of Cancer Research From: technologynetworks.com A drug used for breast and ovarian cancer is more effective than modern targeted hormone treatments at slowing progression and improving survival in some men with advanced prostate cancer, Phase III clinical trial findings reveal. The PROfound trial compared the genetically targeted cancer drug olaparib – already licensed for women with breast …

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Overall Survival Benefit in HR+ Advanced Breast Cancer

In Clinical Studies News by Barbara Jacoby

By: Gina Columbus From: targetedonc.com Results from the phase III MONARCH 2 trial showed that the addition of the CDK4/6 inhibitor abemaciclib (Verzenio) to fulvestrant (Faslodex) improved overall survival by 9.4 months compared with fulvestrant and placebo in patients with hormone receptor (HR)–positive, HER2-negative advanced breast cancer who progressed on prior endocrine therapy, according to data presented at the 2019 …

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High Marks for Proton-Beam RT in Breast Cancer

In Clinical Studies News by Barbara Jacoby

By: Charles Bankhead From: medpagetoday.com Women with locally advanced breast cancer requiring regional lymph node irradiation had similar disease control with less toxicity with proton-beam radiation therapy (RT) as compared with historical patients treated with conventional radiotherapy, investigators in a small prospective study reported. The 69 evaluable patients had a 5-year locoregional failure rate of 1.5% and 5-year overall survival …

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AstraZeneca’s flagship Tagrisso helps lung cancer patients live longer in pivotal study

In Clinical Studies News by Barbara Jacoby

By: Natalie Grover From: endpts.com AstraZeneca is off to a good start in August. After its PARP inhibitor Lynparza scored in a prostate cancer trial earlier this week, the British drugmaker on Friday disclosed that its star cancer drug Tagrisso helped patients with a certain type of lung cancer live longer in a late-stage study. The overall survival data follows …

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Where Does T-DM1 Fit In First-Line Treatment for HER2-Positive Breast Cancer?

In Clinical Studies News by Barbara Jacoby

By: Dave Levitan From: www.cancernetwork.com Trastuzumab emtansine (T-DM1) with or without pertuzumab yielded good overall survival in patients with HER2-positive metastatic breast cancer according to the results of a phase III trial published in Cancer. Though these were not superior to survival seen with taxane-based therapy, T-DM1 should be considered an option for first-line therapy in patients deemed unsuitable for …

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Novartis Kisqali significantly prolongs life in women with HR+/HER2- advanced breast cancer now in two distinct Phase III trials

In Clinical Studies News by Barbara Jacoby

In MONALEESA-3, Kisqali plus fulvestrant achieved statistically significant improvement in overall survival in post-menopausal women in first- and second-line setting Kisqali is the only CDK4/6 inhibitor proven to prolong life with multiple combination partners These results build on the unique MONALEESA-7 data presented at ASCO 2019 showing overall survival benefit of Kisqali plus aromatase inhibitor in pre-/peri-menopausal women Full results …

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Inivata to Test Liquid Biopsy Against Tissue Sequencing in French Prospective Clinical Trial

In Clinical Studies News by Barbara Jacoby

By: Staff Reporter From: genomeweb.com Liquid biopsy firm Inivata said today that it is launching a prospective clinical study with France’s Centre Léon Bérard cancer center to test whether its InVisionFirst-Lung test can get patients on appropriate treatment more quickly than tissue-based genetic testing. The randomized Phase III interventional trial is called LIquid Biopsy for the Early detection of LUng …

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Key Trials Showcase the Utility of Neratinib in HER2+ Breast Cancer

In Clinical Studies News by Barbara Jacoby

By: Caroline Seymour From: onclive.com Given the number of prophylactic interventions that are now available, counseling patients with early-stage HER2-positive breast cancer on the benefit of extended adjuvant therapy with neratinib (Nerlynx) or considering its use in those with central nervous system metastases could be beneficial, said Michel Velez, MD. “We know that neratinib has value in the extended adjuvant …

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Phase III Shows Benefit With Olaparib in Platinum-Sensitive BRCA+ Relapsed Ovarian Cancer

In Clinical Studies News by Barbara Jacoby

By: Danielle Ternyila From: targetedonc.com According to topline findings from the multicenter, open-label, phase III SOLO3 trial, the overall objective response rate (ORR) was 72% with single-agent olaparib (Lynparza) versus 51% with chemotherapy in patients with platinum-sensitive, relapsed, germline BRCA-mutant ovarian cancer who were previously treated with at least 2 chemotherapy regimens. Further, in patients with only 2 prior lines …