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MEDSIR presents the results of three new studies at ESMO 2023: LUPER, focusing on lung cancer, and two translational studies of PHERGain in breast cancer

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. 


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.


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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