NATALEE Trial Highlights Kisqali's Consistent Reduction in Recurrence Risk for Early Breast Cancer Patients.
Novartis presented the new data showing the efficacy of Kisqali (ribociclib) in patients with early-stage breast cancer. A subgroup analysis of the trial reveals that the drug consistently improves invasive disease-free survival (iDFS) across various patient subgroups, including those with stage II tumours, node-negative disease, and patients aged 65 or older.
iDFS results of Kisqali plus endocrine therapy versus endocrine therapy
3-year iDFS rate (%)
AJCC Stage II
94 vs 91
AJCC Stage III
87 vs 84
women & men
91 vs 89
90 vs 86
<65 years old
90 vs 87
≥65 years old
90 vs 86
These results reaffirm the previously presented data, emphasizing that using Kisqali with endocrine therapy (ET) significantly reduces the risk of cancer recurrence in a wide range of patients with stage II and III HR+/HER2- early breast cancer (EBC).
October 20, 2023
Lilly presented long-term data on Verzenio in breast cancer patients, showing sustained efficacy and safety.
Eli Lilly announced the results of a significant five-year analysis from the Phase 3 monarchE study, which assessed the impact of two years of adjuvant Verzenio (abemaciclib) combined with endocrine therapy (ET) compared to ET alone. The study focused on patients with HR+ (hormone receptor-positive), HER2- (human epidermal growth factor receptor 2-negative), and node-positive early breast cancer (EBC) at a high risk of recurrence.
This analysis, with a median follow-up of 4.5 years, included data from patients who had completed the Verzenio treatment course, with over 80% being followed for at least two years post-treatment.
In the intent-to-treat (ITT) population, the risk of developing invasive disease was significantly reduced by 32%, with Verzenio demonstrating a considerable benefit.
The absolute increases in invasive disease-free survival (IDFS) and distant relapse-free survival (DRFS) continued to deepen over the five years, showing improvements from the two-, three-, and four-year rates.
Treatment with Verzenio reduced the risk of distant recurrence or death by 32.5%.
While overall survival (OS) data are still considered premature, there were fewer deaths in the Verzenio group compared to the control group. More patients in the ET-only group developed metastatic disease than those who received Verzenio.
Crucially, no new safety concerns emerged during this analysis, and the overall results remained consistent with the established safety profile of Verzenio. These findings underscore the long-term impact and efficacy of Verzenio in reducing the risk of recurrence and improving survival outcomes for patients with high-risk early breast cancer.
October 23, 2023
Datopotamab Deruxtecan Demonstrates Significant Progression-Free Survival Benefit in HR-Positive, HER2-Low or Negative Breast Cancer: TROPION-Breast01 Phase III Trial Results
AstraZeneca and Daiichi Sankyo have reported positive outcomes from the pivotal TROPION-Breast01 Phase III trial, showcasing the effectiveness of datopotamab deruxtecan (Dato-DXd) in extending progression-free survival (PFS) significantly when compared to chemotherapy. The trial included patients with inoperable or metastatic hormone receptor (HR)-positive, HER2-low or negative breast cancer. The drug is tested in patients who were previously treated with endocrine-based therapy and at least one systemic therapy.
Datopotamab deruxtecan, a TROP2-directed DXd antibody-drug conjugate (ADC), jointly developed by AstraZeneca and Daiichi Sankyo, demonstrated a substantial reduction in the risk of disease progression or death by 37% as compared to chemotherapy.
Median PFS for patients treated with datopotamab deruxtecan was 6.9 months, surpassing the 4.9 months observed with chemotherapy. Importantly, this PFS benefit was consistently observed across different patient subgroups. Furthermore, datopotamab deruxtecan exhibited a confirmed objective response rate (ORR) of 36.4%, whereas chemotherapy achieved an ORR of 22.9%.
Datopotamab deruxtecan maintained a favorable safety profile in comparison to chemotherapy.