Giving hope to those affected
by secondary breast cancer
Research. Support. Education.
Giving hope to those affected
by secondary breast cancer
The European Society for Medical Oncology (ESMO) is a leading professional organisation with more than 25,000 members from over 160 countries. The 2022 ESMO congress took place in Paris, France in a hybrid manner between the 9th - 13th September with an estimated 29,300 attendees. The latest findings in cancer treatments and research are presented at ESMO.
This blog article focuses on the presentation of new result data from the phase III TROPiCS-02 study in patients with HR+/HER2- metastatic breast cancer.
TROPiCS-02 is a global, open label, randomised, phase III clinical trial sponsored by Gilead Sciences that recruited 543 participants. In TROPiCS-02 the drug Sacituzumab Govitecan-hziy (also known as Trodelvy®) was compared to Treatment of Physician's Choice in patients with Hormonal Receptor-Positive (HR+) Human Epidermal Growth Factor Receptor 2 Negative (HER2-) metastatic breast cancer.
Recruited patients received prior endocrine therapy, CDK4/6 inhibitors and two to four lines of chemotherapy and so were regarded as a heavily treated population that had become endocrine therapy resistant. 95% of patients had visceral metastases. Patients who have HR+/HER2- metastatic breast cancer that has progressed despite conventional therapies represent an unmet clinical need and have limited treatment options, which is why the TROPiCS-02 study was undertaken.
Sacituzumab Govitecan-hziy (also known as Trodelvy®) is an antibody combined with a chemotherapy drug. Trodelvy® enables the delivery of the chemotherapy to cancer cells in a more targeted manner.
Trodelvy® has already been shown as an effective targeted treatment against metastatic triple negative breast cancer. In March 2022 the SMC recommended Trodelvy® as an NHS treatment in Scotland for inoperable metastatic triple negative breast cancer. Similarly, in July 2022 NICE recommended Trodelvy® as an NHS treatment in England for this same patient cohort.
Primary results from TROPiCS-02 were presented at the American Society of Clinical Oncology (ASCO) Congress in June 2022. This included the Progression Free Survival results but the Overall Survival results were not fully available and the second interim Overall Survival data was the new TROPiCS-02 data presented at ESMO 2022.
Progression Free Survival is the length of time during and after treatment that a patient lives with the disease, but it does not get worse. Overall Survival is the length of time from the start of treatment that patients are still alive.
Data presented at ASCO 2022 showed that median Progression Free Survival was statistically greater in patients who received Trodelvy® (5.5 months) compared to those who received Treatment of Physicians Choice (4.0 months). A higher proportion of patients treated with Trodelvy® were disease progression-free at 6, 9 and 12-months.
The Overall Survival data presented at ESMO 2022 showed that Overall Survival was statistically greater in patients who received Trodelvy® (14.4 months) vs those who received Treatment of Physicians Choice (11.2 months).
The safety of Trodelvy® in this patient population was consistent with prior reports with no new safety signals identified. Similar to previous studies, in TROPiCS-02, there were higher rates of grade ≥3 Neutropenia and Diarrhoea in patients treated with Trodelvy® compared to Treatment of Physicians Choice.
Although these significant differences in Progression Free (5.5 vs 4.0 months) and Overall Survival (14.4 vs 11.2 months) of Trodelvy® compared to Treatment of Physician's Choice might not seem large, TROPiCS-02 recruited a heavily pre-treated population of patients who have limited treatment options available to them. Thereby, these positive results may enable Trodelvy® to become an additional treatment option to HR+/HER2- metastatic breast cancer patients in the future. Trodelvy® is already approved for NHS usage in Scotland and England for certain metastatic triple negative breast cancer patients.
It is important to note that these are new research findings and that as of writing Trodelvy® has not yet been approved by any regulatory agency for the treatment of HR+/HER2- metastatic breast cancer with its safety and efficacy not yet being fully established. Gilead Sciences notes they have submitted a supplemental Biologics Licence Application to the U.S. Food and Drug Administration (FDA) based on the TROPiCS-02 data and that this data will be shared with health authorities outside America.
This means that after further regulatory checks (and FDA approval) Trodelvy® might be submitted to the SMC and NICE in the UK for treatment of HR+/HER2- metastatic breast cancer patients. Although these necessary regulatory checks will take some time Trodelvy®may become available as a new treatment option to HR+/HER2- metastatic breast cancer patients in the future in the UK.
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