The 2019 Annual Meeting of the American Society of Clinical Oncology (ASCO) was characterized by a great number of presentations of novel and potentially practice-changing clinical trial data. The event was held from May the 30th till the 5th of June at the McCormick Place (Chicago), which is the largest convention center in North America.
One of the highlights of the Congress was the presentation by Roche of the results from a pre-specified exploratory analysis from the Phase III IMpower150 study. This data showed that the addition of Tecentriq to the combination of avastin and chemotherapy gave patients with chemotherapy-naïve non-small cell lung cancer (NSCLC) a striking survival benefit. After a disappointing high-profile phase III failure in ovarian cancer last year, lurbinectedin has become a therapeutic alternative for patients with small cell lung cancer (SCLC), a pathology with no second-line option for more than 20 years.
But not everything was related to lung cancer! An inhibitor of CDK4/6 from Novartis (Kisqali) in combination with hormone therapy extended the life of women with luminal metastatic breast cancer in the Phase III MONALEESA-7 trial. OS rates in the intent-to-treat population at 42 months were 70% in comparison to 46% for hormone therapy alone. Moreover, the addition of Kisqali to an aromatase inhibitor or tamoxifen reached 30% and 20.9% of the survival benefit of both combinations respectively.
Besides the highlights mentioned above, we also started to explore new cooperations with potentially interesting medical experts and different pharma/biotech companies while catching up with our existing partners. Most importantly, we will continue creating a robust network of professionals dedicated to improving the lives of cancer patients worldwide. We look forward to meeting you at the next ASCO congress!
Once again, an unforgettable date in our calendars that the MedSIR team couldn’t miss out: The IV Foro en Oncología Médica en 3 Días (OM3d)!
Year by year, the annual Foro is turning into one of the most important oncology congresses, where the brightest minds in this field come to present the latest updates in clinical research.
This year the event was celebrated at the beginning of May in Madrid and we could proudly say that we learned too many important things. First of all, the amazing presentation by Dr. Esther Holgado talking about innovation in the management of pain in cancer patients. She said: “we must understand the pain that may suffer our cancer patients. If a patient said that it hurts is because it really hurts”.
We had the opportunity to hear about the benefits of selecting and targeting the best biomarkers to effectively kill breast cancer cells, conducted by Dr. Aleix Prat. And Dr. Jose Manuel Perez Garcia gave us a nice shoot about all the therapeutic strategies to defeat HER2-positive breast cancer tumors depending on the subtype and phenotypic characteristics.
From Dr. Antonio Llombart we understood the reason to find a good biomarker to choose between chemotherapy and hormone therapy in neoadjuvancy. And of course, a terrific presentation by Dr. Javiér Cortés very focused on the explanation of the best treatment options when treating HER2+ breast tumors.
What an amazing team-training experience, we keep the nice taste of learning from the greatest minds in Spanish oncology. See you all next year to keep learning how to bring new ideas to life, and how to improve our cancer patient’s quality of life.
Dr. Javier Cortés
Dr. Aleix Prat
MedSIR has enrolled the first patient in DxCARTES: Neoadjuvant letrozole and palbociclib in patients with stage II-IIIB breast cancer, HR[+]/HER2[-] phenotype and pre-treatment Recurrence Score® (RS) result 18-25 or 26-100 by the Oncotype Dx breast RS assay. Analysis of RS and Pathological changes at surgery.
This first patient has been enrolled at site Hospital Arnau de Vilanova de Valencia, Spain and started to receive the study treatment on 28-May-2019.
DxCARTES study is an international, multicenter, open-label, non-comparative, Simon´s two-stage design, phase II clinical trial with the objective to explore the ability of palbociclib in combination with letrozole to induce global molecular changes measured by either the Oncotype DX Breast Recurrence Score® (the “Assay”) test result at surgery (post-treatment Recurrence Score (RS) result), or pathological Complete Response (pCR) in patients with aggressive luminal tumors (intermediate or high pre-treatment RS result and Ki67>20) after 6 months of treatment.
This trial will enroll a total of 66 patients in 2 European countries (Spain and Portugal) during an estimated recruitment period of 24 months.
The primary objective is to explore the ability of palbociclib in combination with letrozole to induce global molecular changes measured by either the Oncotype DX Breast Recurrence Score® (the “Assay”) test result at surgery (post-treatment Recurrence Score (RS) result), or pathological Complete Response (pCR) in patients with aggressive luminal tumors (intermediate or high pre-treatment RS result and Ki67>20) after 6 months of treatment.
Secondary objectives are to explore the ability of palbociclib in combination with letrozole to induce global molecular changes measured by post-treatment RS result, in patients with aggressive luminal tumors (pre-treatment RS result 18-25 and Ki67≥ 20) after 6 months of treatment. To explore the ability of palbociclib in combination with letrozole to induce global molecular reduction measured by either the post-treatment RS result, and/or Residual Cancer Burden (RCB), and/or Ki67 in patients with aggressive luminal tumors (pre-treatment RS result 18-25 or 26-100 and Ki67 ≥ 20) after 6 months of treatment, to induce global molecular reduction (measured as either post-treatment RS≤25 or RCB score of 0-I) in >35% of patients in cohort B with pre-treatment RS 26-100; verify the ability of palbociclib in combination with letrozole to induce increase in RS result (measured as post-treatment RS 26-100) in <3% of patients in cohort A with pre-treatment RS 18-25; and determine the change in RS result as measured by median absolute value or median percentage after 6 months of treatment: from pre-treatment RS 18-25 to post-treatment RS 0-17 for patients in cohort A and from pre-treatment RS 26-100 to post-treatment RS≤25 for patients in cohort B.
The study is currently approved in Spain. We expect to receive all the regulatory approvals in Portugal within the upcoming weeks.
We highly appreciate the whole investigator team’s involvement especially in the set-up procedure of DxCARTES study.
Neoadjuvant endocrine therapy (NET) is a standard approach for elderly – unfit patients with an Endocrine Receptor positive Early Breast Cancer (EBC). However, for younger – fit patients this option is not generally considered because of scientific limitations when compared to chemotherapy. In fact, endocrine therapy, even in combination with other agents has not shown significant pathologic complete responses in this scenario.
In recent years, the role of chemotherapy has been questioned in patients with EBC luminal phenotype (ER[+], HER2[-]) because of its modest benefit for the whole population. Molecular tests to identify patients achieving the greatest or modest benefit from chemotherapy have been generated. The Oncotype DX Breast Recurrence Score® test is the only to show both a prognostic and predictive value. In general, a low Recurrence Score (RS) (<26 for postmenopausal and <21 for premenopausal) identifies patients that will not achieve significant benefit from adjuvant chemotherapy.
DxCARTES is an international, multicentre, open-label, non-comparative, Simon’s two-stage design, phase II clinical trial. The study explores the late molecular-prognostic RS changes achieved with palbociclib, a Cyclin Dependent Kinase 4 and 6 inhibitor (CDK4/6i), in combination with letrozole in patients with Early Breast Cancer (EBC).
Patients require to have a non-previously treated Stage II-III EBC with ER/PR[+] and HER2[-] criteria as well as a high KI67 (>20%). All candidate tumor samples will be tested with the Oncotype DX Breast Recurrence Score®; and those with an aggressive RS (>18) will be finally selected for the study. Two cohorts will be recruited according to RS results (18-25 and 26-100).
All patients will complete a 6-month neoadjuvant palbociclib-letrozole treatment (with LHRH-Ag if premenopausal) in the absence of early progression. At surgery, a second tumor sample will be required (in the absence of pCR) for a second Oncotype DX Breast Recurrence Score® test. The pathology report will also be captured, including PEPI and RCB analysis. The primary objective is to analyze Intra-patient RS changes in both intermediate and high-risk RS groups.
The hypothesis behind the study design relates to the lack of pathological tumor downstaging observed with NET (with or without CDK4/6i) in several clinical trials. In contrast, the benefit of ET in this population is much greater than the one obtained with chemotherapy, meaning that the mechanism driven this benefit may be related to molecular changes that decrease the aggressiveness of the tumor.
The DxCARTES trial poster was presented at the American Association for Cancer Research Congress (AACR) hold in Atlanta on March 29 to April 3, 2019.
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.