NOVARTIS
Kisqali demonstrated prolonged PFS in the first-line setting in patients with HR+/HER2-metastatic breast cancer versus chemotherapy.
Novartis announced the Phase 2 RIGHT Choice trial, evaluating Kisqali (ribociclib) plus endocrine therapy (ET) in patients with pre- and perimenopausal patients with hormone receptor-positive, human epidermal growth factor receptor-2 negative (HR+/HER2−) metastatic breast cancer in the first-line setting. The drug is under evaluation in patients with aggressive breast cancer.
Chemotherapy was the preferred first-line option in patients with visceral crises and progressing diseases. Compared to chemotherapy, Kisqali plus endocrine therapy (ET) showed a progression-free survival benefit of one year.
RIGHT Choice Phase II trial is the first trail evaluating CDK4/6 inhibitor plus ET versus chemotherapy in HR+/HER2-negative breast cancer. The trial included 222 patients, with more than 50% of patients with the visceral crisis. The median time for treatment failure in patients on Kisqali plus ET was 18.6 months versus 8.5 months in patients on chemotherapy.
Kisqali is the CDK4/6 inhibitor, and the National Comprehensive Cancer Network (NCCN) guidelines recognized that Kisqali is the only CDK4/6 inhibitor that showed overall survival benefit.
ELI LILLY
Eli Lilly's CDK4/6 inhibitor, Verzenio, showed sustained benefit in early breast cancer.
Eli Lilly presented the updated data of the Phase 3 monarchE trial, demonstrating the efficacy of Verzenio (abemaciclib) in combination with endocrine therapy for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, high-risk early breast cancer (EBC).
The trial included 5,637 patients with HR+, HER2-, and node-positive EBC at high risk of disease recurrence.
At four years of treatment, there was improvement in invasive disease-free survival (IDFS) and distance relapse-free survival (DRFS) rates by 6.4% and 5.9%, respectively. Eli Lilly announced that the overall survival data were immature; fewer deaths were reported in Verzenio plus ET arm (5.6%) versus ET monotherapy (6.1%).
No new safety signals were raised, and is consistent with the existing safety profile.
GILEAD
Trodelvy demonstrated new data from Phase 3 TROPiCS-02 study, demonstrating efficacy across different Trop-2 expression levels.
Gilead presented the new data of the Phase 3 TROPiCS-02 study, demonstrating the efficacy in breast cancer patients with different Trop-2 expression levels.
Trop-2 levels are expressed in 90% of breast cancers. There was a significant improvement in the progression-free survival (PFS), overall survival (OS), and objective response rate (ORR) versus the physician's choice of therapy.
Gilead announced that Trodelvy is under Priority Review in the US for pre-treated HR+/HER2-metastatic breast cancer.
ASTRAZENECA
Enhertu showed significant improvement in overall survival versus Genentech's Kadcyla.
AstraZeneca and Daiichi Sankyo's presented the Phase 3 Enhertu DESTINY-Breast03 trial in patients with HER2-positive metastatic breast cancer. Enhertu also demonstrated significant improvement in overall survival versus T-DM1.
Enhertu is a HER2-directed antibody-drug conjugate (ADC), which AstraZeneca and Daiichi Sankyo develop.
In the DESTINY-Breast03 trial, Enhertu reduced the risk of death by 36% versus trastuzumab emtansine (T-DM1). In both arms, median overall survival was not achieved. 77.4% of patients were alive after two years on the Enhertu arm versus 69.9% on T-DM1. The median PFS was 28.8 months in patients on Enhertu versus 6.8 months in patients on T-DM1.
The safety profile was consistent with the existing safety profile.
Capivasertib plus Faslodex reduced the risk of death by 40% in HR-positive breast cancer.
AstraZeneca announced the CAPItello-291 Phase III trial, demonstrating clinically meaningful progression-free survival of Capivasertib plus Faslodex in patients with hormone receptor (HR)-positive, HER2-low or negative breast cancer, which had a recurrence following endocrine therapy.
Capivasertib is the first-in-class AKT inhibitor, in combination with Faslodex, reduced the risk of death by 40% versus Faslodex monotherapy. In the AKT pathway biomarker-altered population, the risk of death was reduced by 50% versus placebo plus Faslodex. The overall response rate was 22.9% in the capivasertib plus Faslodex combination versus 12.2% in patients on placebo plus Faslodex.
AstraZeneca’s selective estrogen receptor degrader camizestrant showed significant improvement in PFS versus Faslodex in ER-positive breast cancer.
AstraZeneca announced the SERENA-2 Phase II trial of camizestrant, demonstrating significant improvement in progression-free survival versus Faslodex in patients with estrogen receptor (ER)-positive locally advanced or metastatic breast cancer.
Two doses of 75 and 150 mg of camizestrant were evaluated. The median PFS was 7.2 months in patients on Camizestrant (75mg), 7.7 months in patients on Camizestrant (150 mg), versus 3.7 months in patients on Faslodex (500mg).
Datopotamab deruxtecan demonstrated durable efficacy in heavily pretreated HR+/HER2-low or negative breast cancer.
AstraZeneca presented the Phase 1 results of datopotamab deruxtecan, a TROP2-directed DXd antibody-drug conjugate (ADC) in patients with hormone receptor (HR)-positive, HER2-low or negative breast cancer.
In TROPION-PanTumor01 (n=41), datopotamab deruxtecan demonstrated an objective response rate of 27% in heavily pretreated HR+/HER2-low or negative breast cancer. After a median follow-up of 13.5 months, 59% of patients were alive, and the median duration of response and overall survival was not reached.
In the TROPION-PanTumor01 trial, the patients were heavily pretreated and were treated with at least five previous therapies, including CDK4/6 inhibitors, capecitabine, taxanes, anthracyclines, neoadjuvant chemotherapy, mTOR inhibitors, and PI3KCA inhibitors.