The early-stage trial is assessing the safety and efficacy of the ipatasertib combination in patients with locally advanced or metastatic triple-negative breast cancer who previously did not receive chemotherapy in the advanced setting.
The chemotherapy used in the trial is paclitaxel or nab-paclitaxel (Abraxane [paclitaxel albumin-bound particles for injectable suspension]).
Roche said that the combination treatment showed a confirmed objective response rate (ORR) of 73%, irrespective of tumor biomarker status, according to the initial results of the clinical trial. This was as per the preliminary efficacy data recorded from the first 26 patients, of which 19 showed confirmed responses.
However, the median duration of follow-up was 6.1 months for the investigational combination therapy.
Roche chief medical officer and global product development head Sandra Horning said: “We are enthusiastic about the potential of this combination in triple-negative breast cancer, an aggressive type of breast cancer.
“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.”
Roche said that enrolment is in progress for the Phase 1b study. The Swiss drugmaker said that it plans to launch a randomized, double-blind Phase 3 trial later in 2019 to assess the combination of ipatasertib, atezolizumab and paclitaxel as first-line treatment for locally advanced/metastatic triple-negative breast cancer.
According to Roche, ipatasertib is designed to target and bind to all three isoforms of AKT, which inhibits the PI3K/AKT signaling pathway. The investigational drug could prevent the growth and survival of cancer cells, believes the Swiss pharma company.
The drug, which was discovered at Genentech in partnership with Array BioPharma, is being evaluated in tumors such as breast and prostate cancers that are often found to have activation of the PI3K/AKT pathway.
In March 2019, Roche secured approval from the US Food and Drug Administration (FDA) for Tecentriq in combination with carboplatin and etoposide (chemotherapy) for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC) in adults.