Author Interviews, Cancer Research, Immunotherapy / 05.12.2020

MedicalResearch.com Interview with: Dr. Corina Dutcus MD Vice President of Clinical Research Oncology Business Group Eisai MedicalResearch.com: What is the background for this study? Would you briefly explain how lenvatinib works? Is it used for any other malignancies, ex. thyroid cancer? Dr. Corina Dutcus Response: LENVIMA (lenvatinib), discovered and developed by Eisai, is an orally available multiple receptor tyrosine kinase inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4). LENVIMA inhibits other kinases that have been implicated in pathogenic angiogenesis, tumor growth, and cancer progression in addition to their normal cellular functions, including fibroblast growth factor (FGF) receptors FGFR1-4, the platelet derived growth factor receptor alpha (PDGFRα), KIT, and RET. LENVIMA is approved in combination with everolimus for the treatment of patients with advanced renal cell carcinoma (RCC) following one prior anti-angiogenic therapy. The approved starting dose for LENVIMA is 18 mg daily. The objective of Study 218, a randomized, open-label, Phase 2 trial, was to assess whether the lower starting dose of LENVIMA (14 mg daily) in combination with everolimus (5 mg daily) would provide similar efficacy with an improved safety profile compared to the FDA-approved starting dose of LENVIMA (18 mg daily) plus everolimus (5 mg daily) in patients with advanced renal cell carcinoma (RCC) following prior treatment with an antiangiogenic therapy. In the US, LENVIMA is also indicated for:
  • the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (RAI-refractory DTC);
  • for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC);
  • and in combination with pembrolizumab, for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior systemic therapy, and are not candidates for curative surgery or radiation. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial.
Please see Prescribing Information for LENVIMA (lenvatinib) at http://www.lenvima.com/pdfs/prescribing-information.pdf. (more…)
Author Interviews, BMJ, Breast Cancer, Cancer Research, Radiation Therapy / 10.11.2020

MedicalResearch.com Interview with: Professor Jayant S Vaidya MBBS MS DNB FRCS PhD Professor of Surgery and Oncology University College London MedicalResearch.com: What is the background for this study? What type of single dose radiation is used? Response: The findings of the large international randomised trial (TARGIT-A trial), published in the British Medical Journal (BMJ 2020;370:m2836), confirm the long-term effectiveness of Targeted Intraoperative Radiotherapy (TARGIT-IORT): a breast cancer treatment which is increasingly available throughout the world. For most women with early breast cancer, a single dose of targeted radiotherapy during surgery is just as effective as conventional radiotherapy, which requires several visits to hospital after surgery. Conventional external beam radiotherapy (EBRT) is delivered from outside the body via a radiotherapy machine (linear accelerator), and consists of a daily treatment session (known as fractions) to the whole breast, over a period between three to six weeks. Each of these treatments is given over a few minutes, but requires 15 to 30 hospital visits, which could be a significant distance from where the patient lives. TARGIT-IORT is delivered immediately after lumpectomy (tumour removal), via a small ball-shaped device placed inside the breast, directly where the cancer had been. The single-dose treatment lasts for around 20 to 30 minutes and replaces the need for extra hospital visits, benefiting both patient safety and well-being. The device used is called INTRABEAM. More details are described on the BMJ and UCL webpages: https://www.bmj.com/company/newsroom/single-dose-radiotherapy-as-good-as-conventional-radiotherapy-for-most-women-with-early-breast-cancer/ https://www.ucl.ac.uk/news/2020/aug/single-dose-radiotherapy-effective-treating-breast-cancer https://blogs.bmj.com/bmj/2020/08/20/targeted-intraoperative-radiotherapy-for-early-breast-cancer-new-evidence/ (more…)
ASCO, AstraZeneca, Author Interviews, Cancer Research, Ovarian Cancer / 02.06.2020

MedicalResearch.com Interview with: Mark Sims US Franchise Head Women’s Cancer & DNA Damage Response AstraZeneca MedicalResearch.com: What is the background for this study? What are the main findings? Response: SOLO2 is a Phase III, randomized, double-blind, multicenter trial designed to determine the efficacy and safety of LYNPARZA tablets as a maintenance monotherapy compared with placebo, in patients with platinum-sensitive relapsed or recurrent gBRCA-mutated (BRCAm) ovarian cancer. The trial included 295 patients with germline BRCA1 or BRCA2 mutations who had received at least 2 prior lines of platinum-based chemotherapy and were in complete or partial response. The trial met its primary endpoint in October 2016, showing maintenance treatment with LYNPARZA significantly improved progression-free survival to a median of 19.1 months vs 5.5 months with placebo (a hazard ratio of 0.30; a 95% confidence interval of 0.22 to 0.41; a p value of <0.0001). (more…)
Author Interviews, Cancer Research, Endocrinology, Nutrition / 18.01.2018

MedicalResearch.com Interview with: Benedikt Warth, PhD, Assistant Professor Department of Food Chemistry and Toxicology University of Vienna Vienna, Austria MedicalResearch.com: What is the background for this study? Response: The palbociclib/letrozole combination therapy was granted accelerated approval by the U.S. Food and Drug Administration in 2015 after a clinical trial showed it doubled the progression-free survival time in postmenopausal women with estrogen receptor (ER) positive, metastatic breast cancer. Letrozole blocks the production of estrogen, thus reducing the growth-promoting stimulation of ERs on breast cancer cells. Palbociclib blocks a different signaling pathway to impede cell division. The combination is now one of the standard therapies for ER-positive breast cancers. The aim of our study was twofold: Firstly, we investigated the drugs synergism at the metabolome level in MCF-7 cells to unravel the unknown underlying metabolic effects of palbociclib/letrozole mechanism of action. We used a global metabolomics approach to analyze the effects of palbociclib and letrozole individually and in combination on breast cancer cells. Metabolomics studies detail cells’ metabolomes—populations of metabolites, the small-molecule end products of cellular processes. Secondly, we aimed at deciphering the impact of the two model xenoestrogens frequently present in our diet, zearalenone and genistein, on this chemotherapy. Since these chemicals interact with the estrogen receptor we hypothesized that they may interfere with the new treatment. (more…)