Roche has revealed promising trial data from two lung cancer treatments with one improving survival and the other shrinking tumours.
Its experimental immunotherapy MPDL3280A has been shown to double the likelihood of survival compared with chemotherapy in people with a specific type of lung cancer.
It is in a new drug class that is designed to help the body’s immune system fight cancer by stopping a protein known as Programmed Death receptor (PD-1), or a related target known as PD-L1.
Phase II results from the trial of 287 patients with previously treated non-small cell lung cancer (NSCLC), showed that the immunotherapy reduced the risk of death by more than half in those with the highest levels of the biomarker – compared with those treated by chemotherapy.
“In our study of MPDL3280A in previously treated lung cancer, the amount of PD-L1 expressed by a person’s cancer correlated with improvement in survival,” says Sandra Horning, chief medical officer and head of Roche’s product development.
Roche says MPDL3280A – that has been granted a breakthrough therapy status by the FDA – is being studied for treatment in a range of different cancer types.
“The goal of PD-L1 as a biomarker is to identify people most likely to experience improved overall survival with MPDL3280A alone and which people may be appropriate candidates for a combination of medicines.”
Meanwhile the Swiss firm will be celebrating that in trials its oral ALK inhibitor alectinib has been shown to shrink tumours in patients with advanced lung cancer (with a specific gene mutation) who had stopped responding to Xalkori (crizotinib) – another drug in the same class.
Currently Pfizer’s Xalkori is approved for patients with advanced NSCLC with a mutation of the ALK gene, which is found in around 4% of NSCLC cases.
Roche says its alectinib is able to cross the blood-brain barrier – an important benefit for lung cancer, which often spreads to the brain. It also carries the FDA breakthrough therapy status.
“Cancer spreads to the brain in about half of people with ALK-positive lung cancer, and these studies suggest that alectinib can shrink tumours in people with this difficult-to-treat disease,” says Horning.
“We plan to submit these data to the FDA this year to support alectinib as a potential new option for people whose advanced ALK-positive lung cancer progressed on crizotinib.”