POST ASCO GU 2019

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The MedSIR Project Development team attended the 2019 Genitourinary (GU) Cancers Symposium held in San Francisco, CA on February 14-16. It was a great opportunity to meet our scientific collaborators, business partners, and friends, and catch up with the latest news and developments in the genitourinary cancer space.

Highlights of this year´s ASCO GU include:

    • Final analysis of the LATITUDE phase III study was presented. Treatment with abiraterone acetate and prednisone with androgen deprivation therapy (ADT) in men with newly-diagnosed, castration sensitive, metastatic prostate cancer continues to demonstrate a significant OS advantage than ADT alone.
    • Efficacy and safety data of the ARAMIS study, which looks at darolutamide in nonmetastatic castration-resistant prostate cancer (nmCRPC), was presented. Based on these results, darolutamide appears safe and effective for men with nmCRPC, increasing both metastasis-free survival and overall survival at this interim analysis. Darolutamide will be the third drug to join the nmCRPC space, along with apalutamide and enzalutamide.
    • Data from the phase 3 ARCHES trial shows that enzalutamide significantly improved radiographic progression-free survival in men with metastatic hormone-sensitive prostate cancer.
    • The JAVELIN Renal 101 subgroup analysis demonstrated longer PFS and higher ORR with avelumab plus axitinib compared to sunitinib for treatment-naïve patients with advanced RCC.
    • Treatment with chemotherapy and radiotherapy after surgery improves disease free survival and overall survival in advanced urothelial carcinoma as demonstrated by results from a randomized phase III trial of adjuvant sequential chemotherapy plus radiotherapy versus adjuvant radiotherapy alone for locally advanced bladder cancer after radical cystectomy.
 

ASCO GU 2019 was a great, successful meeting and we can´t wait till next year to see what new advances in the treatment of genitourinary cancers are presented! These are indeed exciting times!

MedSIR will attend The BCC 2019

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We are very happy to announce that the 16th St. Gallen International Breast Cancer Conference will be held in Vienna, Austria, better known as “the city of dreams” or “city of music” from March 20-23, 2019. Vienna is a treasure trove of culture and history, and MedSIR is happy to be back!

Experts of virtually all major research centers worldwide actively engaged in basic and clinical research as well as in clinical management of breast cancer will present their latest data, critically reviewed by leading specialists in the field. The conference, which attracts close to 3.000 delegates, has set the benchmark in primary therapy of early breast cancer (EBC).

The BCC represents a great opportunity for MedSIR to share its knowledge in the domain of EBC, thanks in part to designing and managing various important trials in this setting, most notably the PHERGAIN trial which is quickly nearing its goal of accruing 400 patients with HER2+ EBC in 6 countries in Europe.

We are very excited about what may lie ahead for us at this conference, which is full of researchers and clinicians from all over the world. Additionally, MedSIR has set up multiple meetings with some of the top BioPharma companies to discuss potentially ground-breaking new ideas for clinical research.

If you are a clinician, researcher or company and are looking for guidance for developing your research ideas in breast cancer, don’t hesitate to contact us for a meeting in Vienna. It would be our pleasure to meet!

See you at BBC Vienna 2019!

ASCO-GU

MedSIR is back to San Francisco for ASCO GU 2019

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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.

GU19

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!

PREPARATORY PROJECTS FOR H2020 PROPOSALS (HORIZONTE-CV)

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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.

The MERIBEL Trial

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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.