MedSIR has enrolled the first patient in PALMIRA study, “PALbociclib rechallenge in horMone receptor-posItive/HER2-negative Advanced breast cancer”. This first patient has been enrolled at site Hospital Arnau de Vilanova in Valencia, Spain and started to receive the study treatment on 08-May-2019.
PALMIRA study is an international, multicenter, randomized, open-label, phase II clinical trial with the objective to evaluate the efficacy and safety of continuation of palbociclib in combination with second-line endocrine therapy (fulvestrant or letrozole) in hormone receptor-positive/HER2-negative Advanced Breast Cancer patients who have achieved clinical benefit during first-line palbociclib-based treatment.
This trial will enroll a total of 198 patients in 5 European countries (Spain, France, Italy, UK and Germany) during an estimated recruitment period of 24 months.
The primary objective is to compare the efficacy, defined as progression-free survival (PFS), of continuation of palbociclib treatment combined with second-line endocrine therapy (fulvestrant or letrozole) versus endocrine therapy alone in pre- and post-menopausal women with HR+/HER2- advanced breast cancer.
Secondary objectives will evaluate safety-related outcomes and efficacy measures defined as objective response rate, duration of response, time to response, clinical benefit rate, time to progression, overall survival, patient reported global quality of life, functioning and symptoms, time to first chemotherapy in the intention-to-treat population and in stratified groups of patients.
Exploratory objectives include a correlation between the intrinsic molecular subtypes and efficacy/safety findings and the identification of new predictive markers.
The study is currently approved in Spain, France and Italy. We expect to receive all the regulatory approvals in UK and Germany within the upcoming weeks.
We highly appreciate the whole investigator team’s involvement especially in the set-up procedure of PALMIRA study.
“BARBICAN” is a new trial on board. This time, thanks to Professor Peter Schmidt´group and the Queen Mary University of London. BARBICAN is an international, randomised, open-label, Phase II study to determine the contribution of ipatasertib to neoadjuvant chemotherapy plus atezolizumab in women with triple-negative breast cancer.
Triple-negative breast cancer (TNBC) cells do not express both the estrogen and the progesterone receptor. In addition, these cancer cells do not express the HER2 protein. TNBC accounts for approximately 15-25% of all breast cancer cases, and the current standard of care of these tumors is very limited. Although some previous studies have reported benefit in the use of targeted therapies in metastatic disease, newly diagnosed, non-metastatic TNBC patients have very few therapeutic options.
The BARBICAN study evaluates the application of a specific therapeutic combination to non-metastatic TNBC patients, where the only current treatment available is chemotherapy.
This trial compares the addition of ipatasertib (an AKT-inhibitor) to atezolizumab (an anti-PD-L1) plus neoadjuvant chemotherapy (NACT). The main objectives of this study include two different primary endpoints. Clinical endpoint: compares the pathologic complete response (pCR) rates of NACT plus atezolizumab with NACT plus atezolizumab plus ipatasertib in patients with or without PIK3CA/AKT1/PTEN genetic alterations. Biological endpoint: determine whether adding the AKT-inhibitor ipatasertib to atezolizumab and chemotherapy increases the probability of an immune response over adding atezolizumab to chemotherapy in all treated patients.
Overall, we expect to recruit 142 patients in the UK, Germany and Spain. We also expect a total of 40 patients within 15 different sites of Spain, with an estimated accrual period of 12 months. We believe that this trial will open new perspectives in the use of targeted therapies in TNBC patients.
A very expected milestone was achieved this month by MedSIR! The BioPER study has finalized the enrolment of its 33 patients, an amazing feat, considering the difficult target population.
The BioPER trial is part of a broad strategy of MedSIR within palbociclib-based therapies that also includes Parsifal study and the brand-new PALMIRA. BioPER, a proof of concept trial, has a double goal: clinical and molecular. From a clinical point of view, the objective is to assess the clinical benefit of the combination of palbociclib and hormonotherapy in patients with advanced breast cancer that had previously received endocrine therapy in combination with palbociclib and had achieved clinical benefit during palbociclib treatment with subsequent disease progression. From a biological point of view, the challenge is to define a molecular profile that allows identifying patients that could benefit more from continuing on palbociclib after progression on a prior palbociclib-containing regimen.
One of the main hurdles in recruitment was the need to obtain a biopsy at the time of progression to the previous palbociclib line to be eligible, making the screening and selection of participants a very stringent process. However, these samples would be essential and will help to elucidate the molecular mechanisms behind treatment efficacy and resistance as well. In parallel, liquid biopsies at different timepoints within treatment period were taken to complement and compare the tissue biopsy data. Robust and complete molecular studies have already been planned to be carried out on patient’s biological samples, and we are confident that this information will no doubt help to better select future patients for CDK inhibitor administration and to better determine the optimal therapeutic option following palbociclib.
Congratulations to the entire Investigator team, without their perseverance and continuous surveillance of potential candidates this objective would never be achieved. Specially, we would like to thank Dr. Gil at ICO L’Hospitalet and Dr. Curigliano at IEO and all their teams as top recruiters of the study. And to Pfizer for palbociclib and financial support. Last, but not least, to all patients and their families for their trust.
From now on, we will focus on analyzing the results, including the biological samples, with an expected database lock by the end of December 2019 and Final Study Report by February 2020.
The last week of March 2019 brought MedSIR a double dose of events in Vienna the form of EBCC 2019 and Bio Europes Spring edition.
Both were successful albeit quite different. EBCC represented MedSIR’s core business of developing strategic clinical trials for Breast Cancer. Activity was intense as the MedSIR Project Development Team met with half a dozen of the major companies currently established in Breast Cancer, such as Roche, Novartis, Lilly, Pfizer and also with some of the new kids on the block, such as MacroGenics and Seattle Genetics. Hopefully these meetings will evolve into the development of collaborations that may one day have a positive impact on patients with breast cancer.
BioEurope represented the other side of the coin. If Breast Cancer is MedSIR’s main area, Biotech remains mostly uncharted territory. However, the MedSIR team believes that their project development model can also help some of these very young companies in their very early stages of drug development. After all, failure rates in Oncology sit at around 95%, so we believe it is essential to provide our expertise as soon as we can in order to guarantee that future potentially beneficial drugs can reach Doctor’s offices and benefit their patients in the right way. We will keep our fingers crossed that one day this new domain becomes a daily reality in our activities.
Bring your idea to life 💡
This is our celebration month!
In these 7 years, we have experimented a lot of things. First of all, we have recruited in our studies about 1.470+ patients. We have more than 20 projects ongoing, and we reach more than 300 ideas from researchers. MedSIR is growing fast and we are very proud to say that we are a totally international company with our new operations office in New York, USA.
At this point, we know that new challenges are right of the corner, but we believe in our dynamic, flexible, out-of-the-box thinking, multifunctional, proactive team of professionals, to achieve new goals. Since its creation, MedSIR has carried out projects in metastatic breast cancer, endometrial cancer, and lung cancer, while in the process of designing trials for a number of other tumors such as prostate and ovarian. The MedSIR concept is now expanding into other pathologies and diseases.
From MedSIR, we would like to thanks to all the persons involved and who helped us to become in what we are today. A huge thank you as well to all the participating centers, study teams, and the individual investigators who have confidently sent us their ideas to develop into better lives for cancer patients. And, of course, an even bigger thank you to those 1.470+ patients and their families who have put their trust and hope in our many trials. Together we can do more!
Bring your idea to life 💡