Roche has reported more positive clinical data on its PD-L1 inhibitor atezolizumab, with a new study indicating it is effective in treating non-small cell lung cancer.
The phase II trial -called BIRCH – showed that atezolizumab (also known as MPDL3280A) was able to shrink tumours in NSCLC patients whose cancer cells expressed the PD-L1 protein, with the degree of response correlating with expression levels.
The drug was able to reduce the size of tumours even in patients who had previously been treated with several prior drug regimens, according to Roche‘s chief medical officer Sandra Horning, who said the data would be presented to regulators in order to “bring this medicine to patients as quickly as possible.”
The company has not yet released the objective response rate (ORR) data however, saying it would present the results at a forthcoming medical meeting.
The FDA has already granted atezolizumab breakthrough status for the treatment of PD-L1-positive NSCLC patients whose disease had progressed despite standard therapies such as platinum-based chemotherapy and targeted therapy for tumours expressing EGFR or ALK mutations.
This designation is designed to speed up the development and review of medicines intended to treat serious diseases with few treatment options.
The drug also has breakthrough status for bladder cancer patients whose tumours express PD-L1, and reported positive phase II data in this indication last month.
Both the NSCLC and bladder cancer trials have been described as pivotal, meaning they may be sufficient to secure approval in their own right.
Roche is playing catch-up in the PD-1/PD-L1 inhibitor class as competitors Bristol-Myers Squibb and Merck & Co have already gained approval for their PD-1 medicines Opdivo (nivolumab) and Keytruda (pembrolizumab) in skin cancer, with BMS also getting a green light to treat NSCLC in Europe.
The PD-1/PD-L1 inhibitors as a whole are expected to bring in sales of $35bn or more at peak thanks to their unprecedented efficacy across multiple tumour types, with a number of analysts suggesting BMS’ first-mover advantage will give it the largest share of that market.
Roche argues however that its candidate has a slightly different mechanism of action that could lead to higher efficacy rates and differentiate it in the marketplace.
The company says it has seven phase III studies evaluating atezolizumab alone or in combination with other medicines as a potential new treatment for people with early and advanced stages of lung cancer, with four other trials ongoing in kidney, breast and bladder cancer.