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Association details:
| Biomarker: | HR positive |
|---|---|
| Cancer: | HER2 Negative Breast Cancer |
| Drug: | tenalisib (RP6530) (PI3K inhibitor, PI3Kδ inhibitor, PI3Kγ inhibitor, SIK3 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Efficacy and safety of tenalisib, a PI3K δ/γ and SIK3 inhibitor, in patients with locally advanced or metastatic breast cancer: Updated results from an on-going phase II study.
Published date:
05/25/2023
Excerpt:
The CBR was 57.5% while the DCR was 67.5%. The median duration of response in PR pts and median duration of clinical benefit were 9.36 and 7.46 months respectively. The progression free survival (PFS) was 5.6 months (range: 0.93 to 15.26+ months)….Based on the data from the ongoing study, tenalisib shows encouraging efficacy as a single agent in pts with relapsed/refractory HR+ HER2- difficult to treat MBC patients.
DOI:
10.1200/JCO.2023.41.16_suppl.1064
Trial ID:
Source:
Title:
Efficacy and safety of tenalisib, a PI3K δ/γ and SIK3 inhibitor in patients with locally advanced or metastatic breast cancer: Initial results from a phase II study
Published date:
05/26/2022
Excerpt:
The aim of this phase II study was to investigate the efficacy and safety of single-agent tenalisib in patients (pts) with HR+ HER2- locally advanced or metastatic breast cancer (MBC). Of the 28, 2 pts had a PR (7%), 17 pts had SD (61%) and 6 pts had PD (21%) at the first efficacy assessment after completion of 2 cycles. The CBR was 68%. Tenalisib showed encouraging preliminary efficacy as a single agent in patients with advanced MBC.
DOI:
10.1200/JCO.2022.40.16_suppl.1059
Trial ID:
Source:
Title:
183P Efficacy and safety of tenalisib, a PI3K δ/γ and SIK3 inhibitor in patients with locally advanced or metastatic breast cancer: Initial results from a phase II study
Published date:
05/01/2022
Excerpt:
This randomized, open-label study was designed to evaluate 2 doses (800 mg BID and 1200 mg BID) of tenalisib in HR+/HER2- locally advanced or MBC patients ...Of the 28, 2 pts had a PR (7%), 17 had SD (61%) and 6 showed PD (21%) at the first efficacy assessment after completion of 2 cycles….The CBR was 68%....Based on the data from the ongoing study, Tenalisib showed encouraging preliminary efficacy as a single agent in patients with advanced MBC.
DOI:
https://doi.org/10.1016/j.annonc.2022.03.202
