Roche’s ipatasertib in combination with Tecentriq and chemotherapy shows promising anti-tumour activity in triple-negative breast cancer in early phase trial
- Data from Phase Ib study to be presented at American Association for Cancer Research (AACR) 2019 annual congress
- 73% overall response rate (ORR) irrespective of PD-L1 status or PI3KCA/AKT1/PTEN alteration status
Roche (SIX: RO, ROG; OTCQX: RHHBY) will today present the initial results from a Phase Ib study evaluating the efficacy and safety for the combination of ipatasertib, Tecentriq® (atezolizumab) and chemotherapy (paclitaxel or nab-paclitaxel (Abraxane® [paclitaxel albumin-bound particles for injectable suspension]) as a first-line treatment option for people with advanced triple-negative breast cancer (TNBC). Combination treatment demonstrated a confirmed objective response rate (ORR) of 73% (95% CI 53-88%), irrespective of tumour biomarker status. The median duration of follow-up was 6.1 months (range 3.1-10.6). Grade ≥3 adverse events occurred in 14 people (54%); the most common all-grade adverse events were diarrhea (88%; grade ≥3 19%) and rash (69%; grade ≥3 27%).
‘We are enthusiastic about the potential of this combination in triple-negative breast cancer, an aggressive type of breast cancer,’ said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. ‘These early results support the contribution of ipatasertib to our combination treatment approach in TNBC and reinforce our vision to develop medicines that may benefit patients with this challenging disease.’
Trial enrolment for the Phase 1b study is ongoing. Later this year, Roche will initiate a pivotal multi-center, randomised, double-blind Phase III study investigating the combination of ipatasertib, atezolizumab and paclitaxel as first-line therapy for locally advanced/metastatic triple-negative breast cancer.
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