Roche said that a phase 3 study evaluating the Tecentriq (atezolizumab) and chemotherapy combination as a first-line treatment for triple negative breast cancer met its co-primary endpoint of progression-free survival (PFS).
The chemotherapy used in combination with Tecentriq is Abraxane [albumin-bound paclitaxel; nab-paclitaxel]).
The late-stage trial dubbed IMpassion130 was found to have reduced the risk of disease worsening or death or PFS to a significant extent in the intention-to treat and PD-L1 positive population with metastatic or unresectable locally advanced triple negative breast cancer (TNBC).
Roche said that interim analysis so far have shown overall survival (OS), the other primary endpoint of the trial to be encouraging in the PD-L1 positive population with follow up to continue until the next planned analysis.
IMpassion130 is being held in 902 patients to evaluate Tecentriq and nab-paclitaxel in comparison to placebo in combination with nab-paclitaxel in patients with locally advanced or metastatic TNBC who did not get any prior systemic therapy for metastatic breast cancer (mBC).
Roche chief medical officer and global product development head Sandra Horning said: “IMpassion130 is the first positive Phase III immunotherapy study in triple negative breast cancer, an aggressive disease with limited treatment options.
“Highly encouraged by these results, we plan to submit to health authorities globally with the aim of bringing this combination to people with triple negative breast cancer as soon as possible.”
Overall, IMpassion130 is the third positive phase 3 study involving Tecentriq and nab-paclitaxel as part of a treatment regimen, said Roche.
Currently, the Swiss drugmaker is assessing Tecentriq in TNBC across seven ongoing phase 3 trials.
Tecentriq, a cancer immunotherapy is a monoclonal antibody which blocks the PD-L1 protein expressed on tumour cells and tumour-infiltrating immune cells.
The drug had been approved in the US, the European Union, and more than 70 countries for patients with previously treated metastatic non-squamous non-small cell lung cancer (NSCLC) and for certain forms of untreated or previously treated metastatic urothelial carcinoma (mUC).