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Dalpiciclib or placebo plus fulvestrant in hormone receptor-positive and HER2-negative advanced breast cancer: a
Binghe Xu1, Qingyuan Zhang2, Pin Zhang3
1Department of Medical Oncology and Clinical Trial Center, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. bhxu@hotmail.com.
Abstract:
Blockade of the cyclin-dependent kinase 4 and 6 pathway has been shown to be effective in the treatment of hormone receptor-positive advanced breast cancer (ABC). We report the interim results of DAWNA-1 ( NCT03927456 ), a double-blind, randomized, phase 3 trial of dalpiciclib (a new cyclin-dependent kinase 4 and 6 inhibitor) plus fulvestrant in hormone receptor-positive, HER2-negative ABC with disease progression after endocrine therapy. A total of 361 patients were randomized 2:1 to receive dalpiciclib plus fulvestrant or placebo plus fulvestrant. The study met the primary end point, showing significantly prolonged investigator-assessed progression-free survival with dalpiciclib plus fulvestrant versus placebo plus fulvestrant (median = 15.7, 95% confidence interval (CI) = 11.1-not reached versus 7.2, 95% CI = 5.6-9.2 months; hazard ratio = 0.42, 95% CI = 0.31-0.58; one-sided P < 0.0001 (boundary was P ≤ 0.008)). The most common grade 3 or 4 adverse events with dalpiciclib plus fulvestrant were neutropenia (84.2%) and leukopenia (62.1%). The incidence of serious adverse events was 5.8% with dalpiciclib plus fulvestrant versus 6.7% with placebo plus fulvestrant. Our findings support dalpiciclib plus fulvestrant as a new treatment option for pretreated hormone receptor-positive, HER2-negative ABC.
Insights
Dalpiciclib combined with fulvestrant significantly improves progression-free survival in advanced hormone receptor-positive breast cancer. This combination offers a new treatment option for patients who have progressed after endocrine therapy.
Area of Science:
- Oncology
- Pharmacology
Background:
- Cyclin-dependent kinase 4 and 6 (CDK4/6) pathway blockade is effective for hormone receptor-positive advanced breast cancer (HR+ ABC).
- Endocrine therapy resistance is a challenge in HR+ ABC treatment.
Purpose of the Study:
- To evaluate the efficacy and safety of dalpiciclib plus fulvestrant versus placebo plus fulvestrant in patients with HR+, HER2-negative ABC who progressed after endocrine therapy.
Main Methods:
- DAWNA-1 is a randomized, double-blind, phase 3 trial (NCT03927456).
- 361 patients were randomized 2:1 to receive dalpiciclib plus fulvestrant or placebo plus fulvestrant.
- The primary endpoint was investigator-assessed progression-free survival (PFS).
Main Results:
- The study met its primary endpoint, demonstrating significantly prolonged PFS with dalpiciclib plus fulvestrant (15.7 months) compared to placebo plus fulvestrant (7.2 months).
- The hazard ratio for progression was 0.42 (95% CI: 0.31-0.58; P < 0.0001).
- Common Grade 3/4 adverse events included neutropenia (84.2%) and leukopenia (62.1%); serious adverse events were similar between arms (5.8% vs 6.7%).
Conclusions:
- Dalpiciclib plus fulvestrant represents a new and effective treatment option for pretreated HR+, HER2-negative advanced breast cancer.
- The findings support the use of CDK4/6 inhibitors in combination with endocrine therapy for this patient population.
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