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S-1 Improves iDFS in HR+, HER2- Breast Cancer

In Clinical Studies News by Barbara Jacoby

By: Jason Harris From: onclive.com Adding the novel oral fluoropyrimidine derivative S-1 (Teysuno) to adjuvant endocrine therapy significantly improved invasive disease-free survival (iDFS) for Japanese patients with HR-positive, HER2-negative breast cancer, according to findings from the phase III POTENT trial presented at the 2019 San Antonio Breast Cancer Symposium (SABCS). At a median follow-up of 51.4 months, 10.6% of patients …

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Margetuximab Update Elucidates Clinical Benefit in HER2+ Metastatic Breast Cancer

In Clinical Studies News by Barbara Jacoby

By: Jason M. Broderick From: onclive.com Margetuximab continued to show a clear progression-free survival (PFS) benefit and a trend toward an overall survival (OS) benefit versus trastuzumab (Herceptin) when either agent was combined with chemotherapy in patients with HER2-positive metastatic breast cancer who had received prior anti-HER2 therapies, according to updated findings from the phase III SOPHIA trial. Data from …

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FDA Approves Frontline Atezolizumab Plus Carboplatin/Nab-Paclitaxel for Nonsquamous NSCLC

In Clinical Studies News by Barbara Jacoby

By: Gina Columbus From: onclive.com The FDA has approved atezolizumab (Tecentriq) in combination with carboplatin and nab-paclitaxel (Abraxane) for the first-line treatment of adult patients with metastatic nonsquamous non–small cell lung cancer (NSCLC) who do not harbor EGFR or ALK molecular aberrations.1 The approval was based on data from the phase III IMpower130 study, which showed that the combination of atezolizumab/chemotherapy …

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Novel HER2-Targeted Agent May Improve Options in Recurrent Metastatic Breast Cancer

In Clinical Studies News by Barbara Jacoby

By: Rachel Narozniak, MA From: onclive.com In an effort to expand treatment options for patients with recurrent HER2-positive breast cancer, investigators are testing a novel antibody-drug conjugate (ADC): [fam-] trastuzumab deruxtecan (DS-8201a). The drug has achieved breakthrough therapy status. The phase III DESTINY-Breast02 study (NCT03523585) is recruiting 600 women with advanced disease who were previously treated with standard-of-care (SOC) ado-trastuzumab …

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Biosimilar for HER2+ breast cancer achieves similar overall response rate to reference drug

In Clinical Studies News by Barbara Jacoby

Source: European Society for Medical Oncology From: news-medical.net The trastuzumab biosimilar HLX02 achieved similar overall response rate to reference trastuzumab in women with human epidermal growth factor receptor 2-positive (HER2+) recurrent or previously untreated metastatic breast cancer, according to a large, randomised phase III study reported at the ESMO Asia 2019 Congress. The anti-HER2 antibody trastuzumab given in combination with …

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Phase III Trial Explores Combination of Tucatinib and T-DM1 in HER2+ Breast Cancer

In Clinical Studies News by Barbara Jacoby

By: Lisa Astor From: targetedonc.com A phase III trial, HER2CLIMB-02, has been initiated to investigate the combination of tucatinib and ado-trastuzumab emtansine (T-DM1, Kadcyla) in patients with locally advanced or metastatic HER2-positive breast cancer (NCT03975647).1 The results of the trial will support registration for tucatinib in the United States. “We are building a comprehensive strategy for tucatinib in combination with …

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Polynoma Presenting Interim Phase III Data for Its Investigational Melanoma Vaccine, Seviprotimut-L

In Clinical Studies News by Barbara Jacoby

From: PR Newswire MAVIS Study Identifies Most Responsive Patient Subpopulations, Supporting the Continued Study of Adjuvant Treatment in Localized Melanoma Patients Polynoma LLC, a U.S. immuno-oncology focused biopharmaceutical company and wholly-owned subsidiary of Hong Kong-listed CK Life Sciences Int’l., (Holdings) Inc., is presenting clinical data from MAVIS (Melanoma Antigen Vaccine Immunotherapy Study), its ongoing Phase III clinical study of seviprotimut-L, …

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AstraZeneca reports promising lung cancer results from Phase III immunotherapy drug trial

In Clinical Studies News by Barbara Jacoby

By: Alaric DeArment From: medcitynews.com The company said Imfinzi and chemotherapy, with or without tremelimumab, extended progression-free survival in first-line non-small cell lung cancer versus chemotherapy, setting up Imfinzi as a potential competitor to Merck’s Keytruda. Overall survival data are expected next year A British drugmaker’s program to develop an immunotherapy combination for a type lung cancer that could compete …

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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 …