MedSIR will attend the Genitourinary Cancers Symposium (ASCO GU) for the second time in a row. The GU Symposium, now in its 15th year, will take place in San Francisco, CA from February 14 to 16, 2019. More than 4,500 attendants are expected at the Moscone Center, one of the largest convention and exhibition complexes in San Francisco. An array of multidisciplinary sessions covering prostate, renal, penile, testicular, urothelial and adrenal are to be featured.
From Breast Cancer to GU Tumors, via Digestive Tumors and Lung Cancer, MedSIR is on quite a ride since last year. This represents the organic (and fun) result of extrapolating its project acquisition and clinical trial management model from its core activity (breast cancer) to other tumor types.
While the goal of attending ASCO GU last year was to just get our feet wet, this time around MedSIR has a much clearer agenda including several key meetings regarding specific projects that we hope will translate into helping GU patients in the very near future. These projects span bladder, kidney, prostate and penile squamous cell carcinoma.
We are indeed very enthusiastic to be part of such an important symposium and look forward to meeting the individuals, institutions, and companies at the forefront of research in GU malignancies. These are the brilliant minds that are generating great ideas that could ultimately result in novel treatments that could benefit numerous patients worldwide – and MedSIR wants to be right there with them!
If you are a clinician, researcher or company in the GU domain and are looking for guidance for developing your research ideas, don’t miss out on the chance to meet with MedSIR these days at ASCO GU. Likewise, if you are a patient attending the conference and would like to get in touch, please do so – It would be our pleasure!
MEDICA SCIENTIA INNOVATION RESEARCH SL, has received financial support from IVACE through the HORIZONTE-CV Program and financial support from the European Union for having been selected in the framework of the ERDF Operational Program of the Valencian Region 2014-2020 with file number IMAPEA/2018/41 for the presentation of the RANDOMIZED, DOUBLE-BLIND PHASE II STUDY TO EVALUATE THE POTENTIAL OF HERICIUM ERINACEUS IN PREVENTING AND MANAGING ACUTE AND LONG-TERM CHEMOTHERAPY-INDUCED PERIPHERAL NEUROPATHY (CIPN) IN CHEMOTHERAPY (HECTOR) project to the “Horizon 2020” program.
First-line Eribulin Therapy for Taxane-Pretreated HER2-Negative Metastatic Breast Cancer
Since its foundation in 2012, MedSIR has embarked on a journey to improve the lives of cancer patients by designing and developing innovative clinical trials in Medical Oncology. One of our initial projects was the MedSIR-designed and MedSIR-sponsored MERIBEL study and we are very pleased to announce that the results of this study have just been published in the latest edition of Clinical Breast Cancer.
The MERIBEL trial is a good example of how MedSIR seeks -in a very patient-focused manner- to find new niches for established drugs, like eribulin, outside of their current indications. Here, we look to assess the efficacy and safety of first-line single-agent eribulin in patients with aggressive taxane-pretreated Human Epidermal Growth Factor Receptor 2 (HER2)-negative metastatic breast cancer (MBC) with a short disease-free interval (DFI).
Eribulin is a non-taxane microtubule dynamic inhibitor that has demonstrated significant clinical benefit through two large, randomized, comparative phase III studies: the EMBRACE trial and the 301 Study. Prior to the MERIBEL study, eribulin had been approved as monotherapy for the treatment of patients with MBC who have previously received at least 1 and up to 5 prior chemotherapeutic regimens, including a taxane and an anthracycline.
In patients with HER2-negative MBC, taxanes and anthracyclines have been the standard front-line chemotherapy. However, these agents have been frequently used as neoadjuvant or adjuvant therapy. Consequently, the number of patients previously exposed to taxanes and anthracyclines by the time they have developed MBC has been increasing.
A short DFI and previous exposure to a taxane-based regimen in the neoadjuvant or adjuvant setting have been associated with worse overall survival (OS) for patients receiving first-line chemotherapy for HER2-negative MBC. Thus, new therapeutic options are urgently needed for this poor-prognosis population.
Since September 2013, 53 patients were enrolled in 12 sites in Spain and Portugal. The findings demonstrated that the median time to progression was 4.1 months, and the clinical benefit rate was 26.4%. Moreover, eribulin monotherapy demonstrated a manageable toxicity profile.
Based on these results, we conclude that eribulin monotherapy has substantial antitumor activity and an acceptable safety profile as first-line therapy for patients with aggressive taxane-pretreated HER2-negative MBC, with a short DFI after completing adjuvant taxane-based chemotherapy.
It was a long journey with many challenges, but the perseverance and effort of the site investigators and collaborators from Spain and Portugal –as well as the MedSIR Operations team– were key in delivering the much-anticipated data. On behalf of MedSIR, we would like to thank all the patients who have participated in the MERIBEL trial as well as their families and support groups.
This multicenter, international trial was designed and sponsored by MedSIR and funded by EISAI Farmacéutica SA
Also, MedSIR is currently evaluating eribulin in two other MedSIR-designed trials in patients with Hormone Receptor-positive/HER2-negative, unresectable locally advanced or MBC: (1) The KELLY trial assessing efficacy of eribulin in combination with pembrolizumab in patients who have previously received an anthracycline and a taxane; (2) The REVERT trial exploring the efficacy of eribulin in combination with hormone therapy in patients who had previously shown progression while on an aromatase inhibitor-containing regimen.
REtrospective Study to Evaluate the Molecular Differences Between PET-POsitive and PET-Negative Tumor Samples from HER2-Positive Breast Cancer Patients within the PHERGain Trial (The RESPONSE Study).
About 14,69% of patients screened for PHERGain study had failed to enter because of non-measurable disease by Positron Emission Tomography (PET) criteria (PERCIST). Early PET-SCAN evaluation has shown to be a strong predictor of pathological Complete Response (pCR) to neoadyuvant chemotherapy in early breast cancer.
As initial estimations on screening failures by PET were underestimated, we need to explore the clinical, pathological and molecular characteristics of these screening failures in order to manage a more adequate patient selection. Several hypotheses can be suggested, from the high heterogeneity in term of molecular signatures and metabolic pathways, to a strong relationship between smaller or more indolent tumors and molecular or pathological characteristics.
In order to prove our hypothesis, firstly we will review retrospectively all clinical, radiological and pathological characteristics of the first 60 patients with a screening failure by PET criteria. This revision will include: i) a centralized and independent imaging analysis for Magnetic Resonance Imaging (MRI) (in order to confirm the tumor size ≥1.5 centimeter) and PET (Standardized Uptake Value maximum [SUVmax] value detected); ii) collection of data about Estrogen Receptor (ER) and Progesterone Receptor (PgR) status, Ki67 proliferation marker and fluorescence in situ hybridization (FISH)-HER2 status. Then, on the basis of clinicopathological characteristics we will match the first 60 screening failures to the first 200 patients included in order to identify potential markers of screening failure by PET.
Secondly, if consistency data is not obtained, we will analyze the molecular and metabolic profiles of those tumors from both cohorts of patients. Considering the clinically and biologically heterogeneous status of HER2-positive disease, the characterization of the metabolome, which constitutes the downstream products of cellular functions, together with the genotype and phenotype can provide a better understanding of which subgroup of patients might not need chemotherapy if treated with dual HER2 blockade, and endocrine therapy if necessary.
We are glad to announce that PHERGain study “Chemotherapy-free Trastuzumab and Pertuzumab in HER2-positive (Human Epidermal Receptor) Breast Cancer: FDG-PET Response-adapted Strategy” has achieved 65% of recruitment!! (266/400 patients).
The study assesses the early metabolic effects of neoadjuvant treatment with trastuzumab and pertuzumab (± endocrine therapy) on the primary tumor and axillary lymph nodes and their predictive value for a pathologic complete response (pCR) in the breast and axilla.
50 sites are active and recruiting in 7 countries (Spain, France, Italy, Portugal, Belgium, UK and Germany) only 5 sites pending in Portugal to participate in the study and a total of 266 patients have been recruited (453 patients screened, 165 screening failure) since June 2017. It’s a very interesting study that involves collaboration from Oncology, Radiology and Pathological Anatomy services. Thank you very much to all of them and specially to Hospital Virgen del Rocío – Dr Manuel Ruiz Borrego (31 patients randomized), Hospital Clínic Universitari de Valencia – Dr Begoña Bermejo (18 patients randomized), Hospital Vall Hebrón – Dr Santiago Escrivà (16 patients randomized), Hospital Ramón y Cajal – Dr Noelia Martinez (15 patients randomized) and ICO L’Hospitalet – Dr Agostina Stradella (19 patients randomized) as top 5 recruiters. The research team was supported by an unrestricted fellowship from Roche.
In March 2019 we expect to have 400 patients enrolled in the study thanks to continuing working with your collaboration. We will make it!