The interim analysis of the phase III IMpower132 study has demonstrated that Tecentriq and chemotherapy reduced the risk of disease worsening or death (progression-free survival (PFS)) by 40% compared against chemotherapy alone.
Tecentriq is a monoclonal antibody designed to bind with PD-L1 protein expressed on tumour cells and tumour-infiltrating immune cells, enabling to block its interactions with both PD-1 and B7.1 receptors.
Tecentriq is expected to enable the activation of T cells by inhibiting PD-L1.
The interim analysis has not achieved statistical significance, even though had a numerical improvement of 4.5 months for the co-primary endpoint of overall survival (OS).
Roche will continue the study as planned, and intends to present final OS results next year.
IMpower132 is an open-label and randomised study designed to assess the efficacy and safety of Tecentriq plus chemotherapy versus chemotherapy alone in chemotherapy-naïve patients with NSCLC.
The company randomized 578 patients in 1:1 ratio to secure Tecentriq in combination with cisplatin or carboplatin and pemetrexed or Cisplatin or carboplatin and pemetrexed.
Roche chief medical officer and global product development head Dr Sandra Horning said: “This is our third Phase III trial in non-squamous non-small cell lung cancer demonstrating that a Tecentriq -based regimen can help reduce the risk of disease progression for people living with this disease.”
Separately, Roche’s investigational medicine entrectinib has demonstrated a durable response of more than two years in people with a specific type of lung cancer.
The integrated analysis of the pivotal phase II STARTRK-2, phase I STARTRK-1 and phase I ALKA trials have demonstrated that entrectinib shrank tumours in 77.4% of people with locally advanced or metastatic ROS1-positive NSCLC.
Entrectinib is an investigational and oral medicine under development to treat locally advanced or metastatic solid tumours that harbour NTRK1/2/3 or ROS1 gene fusions.
Entrectinib is a selective and CNS-active tyrosine kinase inhibitor designed to prohibit the kinase activity of the TRKA/B/C and ROS1 proteins, whose activating fusions drive proliferation in certain types of cancer.