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Primary IPATunity130 Results Show No Extra PFS Benefit With Ipatasertib

Adding ipatasertib to paclitaxel does not improve progression-free survival in advanced triple-negative breast cancer with alterations to PIK3CA, AKT1 or PTEN
16 Dec 2020
Anticancer Agents;  Breast Cancer

Author: By Lynda Williams, Senior medwireNews Reporter 


medwireNews: The addition of the AKT inhibitor ipatasertib to first-line paclitaxel does not improve progression-free survival (PFS) for patients with inoperable locally advanced or metastatic triple-negative breast cancer (TNBC) with a PIK3CA, AKT1 or PTEN alteration, research indicates. 

The results of the IPATunity130 trial were presented during the 2020 San Antonio Breast Cancer Symposium by Rebecca Dent from the National Cancer Centre Singapore. 

Investigator-assessed PFS after a median 8.3 months of follow-up was a median of 7.4 months for the 168 patients who were randomly assigned to receive oral ipatasertib 400 mg/day on days 1–21 of a 28-day cycle plus paclitaxel 80 mg/m2 on days 1, 8 and 15. 

This did not significantly differ from the median 6.1 months for the 87 patients who instead were given placebo plus paclitaxel, and further analysis did not identify any patient subgroups who significantly benefited from the AKT inhibitor. 

The ipatasertib and control arms also had comparable rates of overall response (39 vs 35%) and clinical benefit (47 vs 45%). 

At the time of analysis, 33% of patients given ipatasertib plus paclitaxel were continuing with treatment, as were 32% of those given placebo plus paclitaxel, and OS follow-up is ongoing, the presenter commented. 

“Safety was consistent with previously reported results for this combination”, said Rebecca Dent. 

Adverse events (AE) led to ipatasertib discontinuation in 10% of patients in the combination arm and placebo discontinuation in 6% of the controls, with paclitaxel being discontinued in 11% and 15%, respectively, and dose reductions of any agent required by 35% and 14%, respectively. 

Serious AEs were reported in 19% of patients given ipatasertib plus paclitaxel and 21% of controls. The most common AE in the combination arm was diarrhoea, followed by alopecia and other gastrointestinal side effects, while alopecia and gastrointestinal complaints were the most commonly reported AEs for patients given placebo plus paclitaxel. 

“Results from this trial differ from findings in both randomised phase II trials of AKT inhibition in [advanced] TNBC”, said Rebecca Dent, explaining that both the LOTUS trial of ipatasertib plus paclitaxel and the PAKT trial of capivasertib plus paclitaxel had shown a survival benefit compared with chemotherapy alone. 

“Further analyses of IPATunity130 cohort A are ongoing to explore the potential biomarkers of benefit from ipatasertib”, she concluded. 


Abstract GS3-04. Dent RA, Kim S-B, Oliveria M, et al. Double-blind placebo (PBO)-controlled randomized phase III trial evaluating first-line ipatasertib (IPAT) combined with paclitaxel (PAC) for PIK3CA/AKT1/PTEN-altered locally advanced unresectable or metastatic triple-negative breast cancer (aTNBC): Primary results from IPATunity130 cohort A. 2020 San Antonio Breast Cancer Symposium; 8–11 December. 

medwireNews (www.medwireNews.com) is an independent medical news service provided by Springer Healthcare. © 2020 Springer Healthcare part of the Springer Nature group

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