European Society of Medical Oncology Congress (ESMO) 2022
The ESMO Congress is one of the largest and most important cancer conferences worldwide, and brings together around 30,000 clinicians, researchers, patient advocates and healthcare industry representatives from approximately 140 countries.
The latest research and advancements in cancer treatment, prevention and care are presented at the ESMO Congress, which allows medical professionals to work together and translate these results into better patient care worldwide.
We have collated some of the important breast cancer research presented at ESMO 2022 which was held in Paris, France and have provided a summary below:
The MonarcHER Clinical Trial: Evaluating the Effectiveness of Abemaciclib
The MonarcHER clinical trial, is evaluating the effectiveness of abemaciclib (a CDK 4/6 cell cycle inhibitor) in advanced hormone receptor-positive (ER+), HER2-positive breast cancer.
Results from the MonarcHER clinical trial displayed that the combination of abemaciclib plus trastuzumab improved progression-free survival in women with ER+, HER2-positive breast cancer, compared to the current standard treatment of chemotherapy plus trastuzumab. However, this updated analysis did not show a statistically significant improvement in overall survival, despite there being a trend towards a survival benefit. Tumour gene analyses showed that patients with ‘luminal-type’ tumours had greater improvements than those with ‘non-luminal’ tumours.
A total of 237 patients were randomized 1:1:1 to receive 150 mg of abemaciclib twice a day plus trastuzumab, either alone, with fulvestrant or with chemotherapy.
With a median follow-up of 52.9 months, progression free survival for patients receiving abemaciclib and trastuzumab was consistent with previously reported benefits.
These results indicate support for a new treatment option, which may allow avoidance of the initial use of chemotherapy in patients with advanced hormone receptor positive, HER2-positive breast cancer.
TROPiCS-02: Assigned Patients to Receive Sacituzumab Govitecan vs Physician’s Choice of Chemotherapy
TROPiCS-02 is a global, phase 3 study which randomly assigned 543 patients with hormone-receptor positive, HER2-negative metastatic breast cancer to receive sacituzumab govitecan vs physician’s choice of chemotherapy. Patients enrolled in the TROPiCS-02 study had received two to four prior lines of therapy, including endocrine therapy and CDK4/6 inhibitors.
The primary endpoint of the TROPiCS-02 study is progression-free survival, while the secondary endpoints include overall survival, response rate, safety, tolerability, and quality of life. This presentation was of much anticipated overall survival results.
This phase 3 study showed that overall survival improved, with a median overall survival of 14.4 months in the sacituzumab govitecan arm and 11.2 months in the chemotherapy arm, representing a 21% reduction in the risk of death. As presented previously, there was also a statistically significant improvement in progression-free survival, meeting the primary endpoint. Sacituzumab govitecan, a novel antibody-drug conjugate, reduced the risk of disease progression or death by 30% in patients with HR+, HER2 negative, metastatic breast cancer.
Professor Hope Rugo is a lead clinician in the TROPiCS-02 clinical trial and was a recent international guest speaker at Breast Cancer Trials 43rd Annual Scientific Meeting. We spoke with Professor Rugo on her presentation topic: New Options in HR+ Breast Cancer – TROPiCS-02 and Beyond. For more information click here.
The Monarch 3 Clinical Trial: Interim Analysis of Results
The Monarch 3 clinical trial is a first-line trial that randomly assigned 493 postmenopausal patients with HR+, HER2-negative metastatic breast cancer. Patients were assigned 2:1 abemaciclib twice daily or placebo, combined with anastrozole or letrozole daily, until disease progression.
Investigators assessed progression-free survival as the primary endpoint, with overall survival, response rates and safety as key secondary endpoints. This analysis also investigated the impact of the treatment combination in patients with visceral disease, meaning that the cancer has spread to organs such as liver or lung.
Results from this interim analysis of this trial showed that abemaciclib combined with an aromatase inhibitor in metastatic breast cancer, appears to prolong survival compared with an aromatase inhibitor alone. Results showed a median overall survival of 67.1 months with the abemaciclib combination vs 54.5 months with the placebo combination. Patients with visceral disease appeared to benefit as much as those in the overall analysis. However, ongoing follow-up is required to confirm this finding in a final overall survival analysis.
Immunotherapy Route of Delivery: Intravenous vs Subcutaneous Delivery of Immunotherapy Drug, Nivolumab
The immunotherapy drug, Nivolumab, has demonstrated clinical efficacy across patients with various tumour types when administered intravenously. Now, a new formulation for subcutaneous administration removes the need for intravenous administration, potentially reducing treatment complications and risk of infections. SC delivery also reduces the time required for dose preparation and administration, potentially reducing treatment burden for patients, and improving healthcare resource utilisation.
This study showed that patients preferred the subcutaneous administration route over intravenous across a range of patient-reported outcome measures. There were few adverse effects.
Nivolumab was used intravenously in Breast Cancer Trials Neo-N clinical trial, which aims to investigate if using immunotherapy in combination with chemotherapy, is safe and effective in treating breast cancer before surgery in women and men with early triple-negative breast cancer. Neo-N is yet to report results.
Other Breast Education and Discussion Sessions:
- Current Status and Future Needs with Immunotherapy in Triple-Negative Breast Cancer: Presented by Professor Peter Dubsky, recent data displays the potential of immunotherapy treatment, in changing the outcomes of triple-negative breast cancer, where previously chemotherapy has been the only option. For more information click here.
- Minimal Residual Disease (MRD) and Adjuvant Clinical Trial Design: Presented by Professor Sarah-Jane Dawson, this session discussed early detection of cancer and identification of minimal residual disease (MRD), post-treatment, being key in the timely treatment and cure of early-stage breast cancer. This relates to circulating tumour DNA in deciding if there is residual cancer that requires additional treatment.
- The Microenvironment in Early Breast Cancer – TILs and Beyond: Presented by Professor Sherene-Loi, Tumour Infiltrating Lymphocytes (TILs) are becoming prominent as a biomarker of prognosis and a therapeutic target in breast cancer, and other cancers. For more information about TILs, click here.