Author Archive

The Beginning of the LUZERN Study

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MedSIR has a new trial on board!

Last 11th November 2019, it was submitted the LUZERN study to AEMPS and CEIm with the participation of 10 different sites in Spain.

Overall, LUZERN study will recruit a total of 23 patients in 10 sites in SpainEnrolment is planned to open in February 2020.

LUZERN study is focused in ER+/ HER2-, locally advanced or metastatic breast cancer patients harboring either germline BRCA (gBRCA) mutations or wild type BRCA with homologous recombination deficiency (HRD). Patients will be treated  with Niraparib (PARP inhibitor) in combination with  aromatase inhibitors to evaluate the efficacy and safety of this strategy (The LUZERN Strategy).

About 5% of ER+/ HER2-  breast cancer patients present  gBRCA mutations, and 10 to 20%  other HRD alterations.  Up to now, PARP inhibitors in breast cancer have been explored in late-line treatment settings, beyond endocrine therapy. The LUZERN strategy aims to investigate the potential benefit of targeting homologous recombination deficiencies in an endocrine scenario, at earlier treatment settings.

From MedSIR, we would like to thank all the study investigators for their interest in participating in the LUZERN study.

A New Trial On Board: The ORPHEUS Study

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MedSIR will soon begin the ORPHEUS study“A Multicenter, Open-Label, Single-Arm, Phase II Clinical Trial to Evaluate the Efficacy and Safety of INCMGA00012 in Advanced Penile Squamous Cell Carcinoma”.

This proposal is presented by MedSIR to Incyte Corporation with Dr. Xavier Garcia del Muro from the Catalan Institute of Oncology as Principal Investigator.

The goal of this trial is to explore the benefit of using an immunotherapeutic approach in patients with advanced penile squamous cell carcinoma (PSCC). Previous data showed that other squamous cell carcinomas, such as head and neck and lung cancers, have responded well to immunotherapies. We thereby hypothesize that patients suffering from PSCC will benefit from immunotherapy using the INCMGA00012 drug.

The project aims to explore the efficacy and safety of INCMGA00012 in patients with advanced penile squamous cell carcinoma. The life expectancy of these patients is pretty low due to limited treatment options. Therefore, there is a clear need for novel molecular and immunotherapeutic targets for these patients.

We expect to recruit 18 patients in 3 European countries (Spain, Germany, and Italy) with an estimated accrual period of 12 months. The first regulatory approval in Spain is planned by the beginning of next year.

We believe that this trial represents a great opportunity for a target population with very poor prognosis, significant morbidity and mortality, and where few treatment options currently exist.

Last Patient Last Visit for Interim Analysis in PHERGain Study

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A new milestone of PHERGain study-Chemotherapy-free trastuzumab and pertuzumab in HER2-positive breast cancer: FDG-PET response-adapted strategy-has been achieved.

The last patient recruited in the PHERGain study has completed surgery, so the study has reached another important milestone – Last Patient Last Visit for Interim Analysis – 100% surgery!

The first co-primary analysis, occurring after last patient’s surgery, is to evaluate the rate of pCR (pathological complete response) as defined by the absence of invasive disease in the breast and axilla (ypT0/isN0) at the time of surgery achieved with the combination of trastuzumab and pertuzumab (± endocrine therapy) as exclusive neoadjuvant treatment in PET responders patients (cohort B/PET responders) [PET/CT positive predictive value (PPV) for a pCR among patients who are PET responders].

To guarantee a high-quality of the study data and results for this first co-primary analysis, the data is being cleaned and has been SDVed and reviewed and we expect the database lock by the end of November.

In the meanwhile, the data management works closely with the statistic team, to run listings and tables. Our commitment is to obtain the results of the Interim Analysis for ASCO 2020.

We believe the results derived from this first co-primary analysis will be highly positive and this will help justify the investigation of this strategy in further clinical trials. Moreover, this will bring an enormous benefit for many breast cancer patients worldwide, who can achieve pCR without the need of chemotherapy.

We couldn’t get to this stage without the continuous support of all the site teams in the PHERGain study, and especially all the study coordinators and data entries who helped us achieve a clean database for the Interim analysis. Thank you all for your collaboration!

Liquid biopsy and ctDNA: the winner tandem

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Precision medicine is an approach to patient care that allows doctors to select treatments that are most likely to help patients based on a genetic understanding of their disease. Recent advances in science and technology have helped speed up the pace of this area of research, making precision medicine the new paradigm of healthcare.

In recent years, there has been a revolutionary expansion in technologic advances in cancer medicine. State-of-the-art next-generation DNA sequencing (NGS) and genomics bioinformatics analysis allows a shift from microscopic levels of histologic diagnostics to molecular genomics levels of cancer molecular diagnostic. This change has enabled better treatment selection, reduces adverse events, rendering in an improvement of patient´s quality of life and survival.

Traditional tumor biopsy is still considered the gold standard in diagnostic oncology. However, the static nature of this technique is one of its main limits, because is not able to follow the dynamics adaptations triggered by anticancer therapies. Not to comment on the clinical complications of tissue sampling and its impact on patient´s life. As body fluids can be easily obtained in a non-invasive way, liquid biopsy is an attractive alternative approach that allows, among other things, a dynamic assessment of specific molecular markers, intercept the onset of disease recurrence, treatment resistance, potentially predict response and prognosis. Tumor cells are constantly releasing to the bloodstream DNA of different forms, such as cell-free DNA (cfDNA), circulating tumor DNA (ctDNA), micro RNAs (miRNAs), and more. These sources could be used for rapid and effective molecular characterization of the tumor molecular profile.

The utility of liquid biopsy and ctDNA analysis in breast cancer would be the base for the development of personalized medicine in the future. In the neoadjuvant and adjuvant settings, because of its curative nature, the possibility of detecting minimal disease is vital to assess treatment response and guide therapeutic options. In addition, for early detection of recurrence, the identification of useful biomarkers to detect micrometastatic disease or post-surgical tumor residues is paramount. ctDNA analysis might play an important role in these scenarios. In the metastatic disease, liquid biopsy has the potential to overcome several practical issues such as hardly accessible primary and metastatic lesions, patient´s refusal to invasive procedures, not feasible serial sampling or inadequate or insufficient material for molecular analysis. In addition, because ctDNA levels are associated with tumor burden, a longitudinal plasma-based assessment may represent an indirect measure of treatment response and predict clinical outcome. Furthermore, ctDNA dynamics not only has a significant prognostic impact but also has a higher sensitivity with respect to tumor markers, making possible to anticipate imaging-based disease progression.

With the current expansion of clinical applications of genomics-matching personalized cancer therapy, it has also become increasingly evident that the need to obtain a large amount of tumor tissue through invasive tumor-needle or surgical biopsy procedures is untenable. In the last years, liquid biopsy techniques as a source of material for assaying ctDNAs for genetic/genomic marker alterations are being increasingly applied. Undoubtedly, liquid biopsy and ctDNA analysis are beginning to pave the way to a growingly individualized cancer care.

50% Recruitment Achieved in BARBICAN Study

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A new milestone achieved in BARBICAN Study!

20 Spanish patients have been successfully randomized in the study, reaching 50% recruitment in Spain.

The last patient to be randomized by Dr. Stradella and her team from ICO Hospitalet on 7th October 2019 and have started treatment.

The BARBICAN study compares the addition of ipatasertib to atezolizumab plus neoadjuvant chemotherapy in patients with triple-negative breast cancer. The primary clinical endpoint is to compare pCR rates in the two treatment arms and determine whether adding the AKT-inhibitor ipatasertib to atezolizumab and chemotherapy increases the probability of an immune response over adding atezolizumab alone. In addition, a biological co-primary endpoint would determine whether adding the AKT-inhibitor ipatasertib to atezolizumab and chemotherapy increases the probability of immune response over adding atezolizumab to chemotherapy in all treated patients.

Globally, the trial will enroll a total of 142 patients in three countries, (UK, Germany, and Spain) with an estimated accrual period of 12 months.

We would like to thank all the study teams for their interest and commitment in the study, especially top recruiters in Hospital Clínico de Valencia (Dr. Begoña Bermejo), Hospital Virgen del Rocío (Dr. Javier Salvador) and ICO Hospitalet (Dr. Agostina Stradella). Together we can do more!