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• W4361953220 abstract "<div>AbstractPurpose:<p>The activating mutation <i>AKT1</i>^E17K occurs in approximately 7% of estrogen receptor–positive (ER⁺) metastatic breast cancer (MBC). We report, from a multipart, first-in-human, phase I study (NCT01226316), tolerability and activity of capivasertib, an oral AKT inhibitor, as monotherapy or combined with fulvestrant in expansion cohorts of patients with <i>AKT1</i>^E17K-mutant ER⁺ MBC.</p>Patients and Methods:<p>Patients with an <i>AKT1</i>^E17K mutation, detected by local (next-generation sequencing) or central (plasma-based BEAMing) testing, received capivasertib 480 mg twice daily, 4 days on, 3 days off, weekly or 400 mg twice daily combined with fulvestrant at the labeled dose. Study endpoints included safety, objective response rate (ORR; RECIST v1.1), progression-free survival (PFS), and clinical benefit rate at 24 weeks (CBR₂₄). Biomarker analyses were conducted in the combination cohort.</p>Results:<p>From October 2013 to August 2018, 63 heavily pretreated patients received capivasertib (20 monotherapy, 43 combination). ORR was 20% with monotherapy, and within the combination cohort was 36% in fulvestrant-pretreated and 20% in fulvestrant-naïve patients, although the latter group may have had more aggressive disease at baseline. <i>AKT1</i>^E17K mutations were detectable in plasma by BEAMing (95%, 41/43), droplet digital PCR (80%, 33/41), and next-generation sequencing (76%, 31/41). A ≥50% decrease in <i>AKT1</i>^E17K at cycle 2 day 1 was associated with improved PFS. Combination therapy appeared more tolerable than monotherapy [most frequent grade ≥3 adverse events: rash (9% vs. 20%), hyperglycemia (5% vs. 30%), diarrhea (5% vs. 10%)].</p>Conclusions:<p>Capivasertib demonstrated clinically meaningful activity in heavily pretreated patients with <i>AKT1</i>^E17K-mutant ER⁺ MBC, including those with prior disease progression on fulvestrant. Tolerability and activity appeared improved by the combination.</p></div>" @default.
• W4361953220 created "2023-04-05" @default.
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• W4361953220 date "2023-03-31" @default.
• W4361953220 modified "2023-10-18" @default.
• W4361953220 title "Data from Capivasertib, an AKT Kinase Inhibitor, as Monotherapy or in Combination with Fulvestrant in Patients with <i>AKT1</i>^E17K-Mutant, ER-Positive Metastatic Breast Cancer" @default.
• W4361953220 doi "https://doi.org/10.1158/1078-0432.c.6529365.v1" @default.
• W4361953220 hasPublicationYear "2023" @default.
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