MEDSIR's PRIMED Study Shows Promise in Preventing Side Effects of Sacituzumab Govitecan for HER2-negative Advanced Breast Cancer Treatment

CHICAGO, June 2, 2024 — MEDSIR, a global leader in medical research, unveiled significant findings from the PRIMED clinical trial at the 2024 ASCO Annual Meeting. Conducted as an Investigator-Initiated Trial (IIT) under MEDSIR's collaborative research model, the study demonstrated an effective method for mitigating treatment-related side effects in patients using sacituzumab govitecan, an antibody-drug conjugate targeting Trop-2. This drug has previously shown to improve overall survival in advanced breast cancer patients in the ASCENT and TROPiCS-02 Phase 3 studies.

The primary goal of the PRIMED study was to investigate whether early administration of preventative drugs could alleviate the common side effects of neutropenia and diarrhea, which often necessitate dose reductions, treatment interruptions, or permanent discontinuations. By incorporating granulocyte colony-stimulating growth factors (G-CSF) and loperamide during the first two treatment cycles, the study observed a noteworthy reduction in these adverse effects. Specifically, the incidence of neutropenia was reduced to 28%, compared to 63% and 70% in the ASCENT and TROPiCS-02 studies, respectively. Similarly, the occurrence of diarrhea dropped to 34%, from 59% and 57% in the previous trials.

Dr. Antonio Llombart-Cussac, MEDSIR's Senior Scientific Leader, emphasized the significance of these findings. He highlighted the potential of prophylactic strategies in minimizing side effects and maintaining patients on effective treatments. The study underscores the value of MEDSIR's partnership model that blends the strengths of company-sponsored research with the innovation of IITs, thereby advancing cancer treatment solutions safely and efficiently.

The PRIMED study, still ongoing to gather long-term safety and efficacy data, enlisted 50 patients across 10 sites in Spain from February to September 2023. Participants received G-CSF and loperamide during their first two cycles of sacituzumab govitecan treatment. The researchers aimed to determine if preemptive drug administration could lower the incidence of neutropenia and diarrhea and subsequently affect the need for dose adjustments or treatment discontinuations.

Broadening Horizons: Additional Studies Presented at ASCO

Beyond PRIMED, MEDSIR showcased several other promising studies at the ASCO Annual Meeting. For instance, the PHERGain Phase II trial, recently published in The Lancet, revealed that approximately one-third of patients with HER2-positive early breast cancer could safely avoid chemotherapy. A subanalysis presented at ASCO compared PET scans and MRIs for assessing tumor evolution, suggesting MRI as a viable alternative when PET scans are unavailable.

Another significant study, PATHFINDER, explored the combination of ipatasertib with non-taxane chemotherapy in patients with advanced triple-negative breast cancer. Results indicated that while the combination of ipatasertib with capecitabine and eribulin was safe, adding it to carboplatin and gemcitabine was intolerable. The combination with eribulin showed promising efficacy, meriting further research.

Ongoing clinical trials like TUXEDO-3 are also noteworthy. This study, conducted in Austria and Spain, assesses the effectiveness and safety of patritumab deruxtecan in treating metastatic breast cancer, advanced non-small cell lung cancer with brain metastases, and metastatic solid tumors with leptomeningeal disease. Positive results could pave the way for HER3-DXd as a new treatment option for these patients.

Addressing Unmet Cancer Needs

Unmet cancer needs encompass gaps in treatment, support, and resources available to patients. Addressing these needs is vital for improving patient outcomes and quality of life. Through collaborative efforts of healthcare providers, policymakers, and advocacy groups, these gaps can be identified and addressed to provide comprehensive care.

About MEDSIR

Founded in 2012, MEDSIR is an innovative oncology research company based in Spain and the United States. It manages all aspects of clinical trials, from design to publication, leveraging a global network of experts and integrated technology. MEDSIR's approach combines industry-based research with investigator-driven trials, fostering independent cancer research worldwide. In partnership with Oncoclínicas, Brazil's leading oncology group, MEDSIR continues to drive advancements in cancer treatment.

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