MADRID, Oct. 21,
2023 /PRNewswire/ -- MEDSIR, a company
specializing in the strategic design of independent clinical
research, today presented the results of three new studies at the
European Society for Medical Oncology (ESMO 2023), one of the most
prestigious oncology platforms for clinicians, researchers and
healthcare industry representatives in Europe and with global influence: LUPER,
focused on patients with small-cell lung cancer; and two
translational studies extending the results of the
PHERGain study, focused on HER2-positive breast cancer.
The pan-tumor research company reached a major milestone with
the presentation of the landmark results of the PHERGain study at
ASCO 2023, the American Society of Clinical Oncology, in June.
These results showed that approximately one third of patients with
early-stage HER2-positive breast cancer could be treated without
chemotherapy and remain free of breast cancer for up to three years
after surgery. PHERGain is a groundbreaking trial that uses a
personalized treatment strategy for each patient.
LUPER: Efficacy and safety through a combination of
lurbinectedin and pembrolizumab in patients with small cell lung
cancer
The LUPER trial, which was presented during an oral session
at the congress, is being led by Dr. Antonio Calles, a medical oncologist at the
Gregorio Marañón Hospital in Madrid.
The LUPER trial is evaluating the efficacy of the combination of
lurbinectedin (a drug that promotes tumor cell death and regulates
the ecosystem surrounding a tumor in the body) and pembrolizumab
(an immunotherapy drug) in patients with small-cell lung cancer
(SCLC) who have relapsed after initial platinum-based chemotherapy.
A total of 28 patients with SCLC who had not previously received
immunotherapy were enrolled in the LUPER trial.
The analysis of results from the ongoing LUPER study shows that
the combination of lurbinectedin and pembrolizumab is effective in
treating patients with SCLC who have relapsed after platinum-based
chemotherapy without prior immunotherapy. The main results of the
study were presented at ESMO and show that more than 46% of
patients experienced a reduction in tumor size (objective response
rate), in some cases with strong and durable responses lasting more
than 12 months.
Lurbinectedin is approved by the US Food and Drug Administration
(FDA) for the treatment of metastatic small-cell lung cancer
patients with progressive disease on or after platinum-based
chemotherapy. The results of the LUPER study presented at this
edition of ESMO encourage further research into this drug in
combination with immunotherapy.
It is therefore a cancer with a clear unmet need for innovative
treatment options that may be viable for patients with small-cell
lung cancer whose cancer has progressed on first-line
chemotherapy.
PHERGain TRANSLATIONAL STUDIES in breast cancer
Trop-2, a biomarker for treatment resistance in HER2-positive
breast cancer patients?
In the first of the translational studies presented by MEDSIR at
ESMO, we analyzed the expression levels of the Trop-2 protein in
tumor samples from patients with HER2-positive early breast cancer.
The aim is to determine whether there is a link between the levels
of this protein prior to treatment and pathological complete
response (the absence of residual cancer cells) to the standard
treatment for this type of cancer. The study is being led by Dr
María Gion.
The Trop-2 protein is present at low levels in healthy cells,
but elevated levels of this protein have been found in many cancers
and is associated with increased tumor aggressiveness, metastasis
and poor outcome. However, the role of Trop-2 in HER2-positive
breast cancer patients and whether Trop-2 is able to predict
disease progression or response to treatment (two important
parameters for clinicians) remains largely unexplored.
Researchers found that patients who had high levels of the
Trop-2 protein prior to treatment had lower pathological complete
response rates, meaning they were less likely to respond to
treatment, while patients who did not have high levels of Trop-2
protein were significantly more likely to achieve a response.
Therefore, Trop-2 could potentially be used in future research to
identify patients who are most likely to benefit from treatment.
This also opens up the possibility of it becoming a target for
future therapeutic combinations.
HER2DX®: a genomic test for predicting patient
survival
Another study presented, with the aim of identifying strategies
to select the most appropriate treatment for patients with early
HER2-positive breast cancer, compared the association between the
HER2DX® test prediction of pathological complete
response with actual pathological complete response observed in the
PHERGain clinical trial; and the HER2DX® risk
(prognostic) score with actual clinical data on invasive
disease-free survival 3 years after surgery. This study was
performed on samples and clinical data from 292 patients who
participated in the PHERGain clinical trial (82% of the total
number of participants).
This project was led by Dr Antonio
Llombart-Cussac, in collaboration with Dr Javier Cortés (both co-founders of MEDSIR), with
REVEAL GENOMICS, S.L. as the main scientific partner, led by Dr
Aleix Prat.
HER2DX ® is an in vitro diagnostic test
developed by REVEAL GENOMICS, S.L. HER2DX ® is the first
genomic tool for patients with early-stage HER2-positive breast
cancer. The test measures the expression of 27 cancer-related genes
and combines this information with clinical characteristics such as
tumor size and lymph node involvement. This personalized data is
then processed by an algorithm that calculates two independent
scores: one indicating a patient's likelihood of relapse
(prognosis) after treatment with trastuzumab-based chemotherapy
(risk score) and another indicating the likelihood of response to
anti-HER2 treatment (pathological complete response probability
score).
The HER2DX® genomic test may prove to be a valuable
tool to guide healthcare professionals and patients in
personalizing treatment for HER2-positive early breast cancer.
About MEDSIR
Established in 2012, MEDSIR prides itself on working closely
with its strategic partners to drive innovation in oncology
research. Operating in Spain and
the United States, the company
provides end-to-end clinical trial management, from study design to
publication, with an extensive global network of experts and
integrated technology to streamline the process.
With the aim of promoting independent research worldwide, MEDSIR
has formed a strategic alliance with Oncoclínicas, the leading
oncology group in Brazil, which
offers outstanding research potential in South America.
For further information: www.medsir.org
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