Roche ($RHHBY) released two more batches of promising outcomes for cancer patients taking its keenly followed PD-L1 checkpoint inhibitor atezolizumab, setting the stage for an accelerated approval campaign on both sides of the Atlantic as one expert in the field touts the pharma giant's chances of realigning the way lung cancer is treated.
Appearing at the 2015 European Cancer Congress, investigators for Roche reported that atezo was linked with a 7.7-month survival advantage over chemo among lung cancer patients defined by a significant expression of PD-L1. Twenty-seven percent of the same type of patient saw tumors shrink while in another mid-stage trial an equal percentage of bladder cancer patients with high levels of PD-L1 expression also responded.
"These results may represent the first major treatment advancement in advanced bladder cancer in nearly 30 years," said Sandra Horning, Roche's chief of global product development, who also touted the company's lung cancer results. "We are encouraged that responses to atezolizumab were ongoing in the large majority of people when the study results were assessed."
Atezolizumab's success is central to Roche's pipeline story. The pharma giant has been largely sitting out the deal game in biotech this year, put off by the high valuations that clinical stage assets are fetching these days. While Merck ($MRK) and Bristol-Myers Squibb ($BMY) seized the first two pioneering approvals for PD-1 drugs, Roche was mounting a major assault on the PD-L1 side of the equation, looking for pivotal data from 11 late-stage studies that it's drug could be a superior choice for patients whose tumors express high levels of PD-L1.
Investigators have found that by breaking a biologic link that tumor cells use to escape detection by the immune system, they can unleash a new attack on a wide range of cancers. And Roche has been pursuing its own combination approach to provethat it can leap frog the pioneers in the market--provided it earns an accelerated approval.
If Roche succeeds in gaining quick approvals, look for the pharma giant to distinguish itself by carving out the PD-L1 expression group. Roche enjoys nothing more than defining patient groups most likely to respond to one of its drugs, and in this case that business practice will be key to carving out a significant share of a business that could one day bring in $100 billion a year.
Atezolizumab's data on refractory lung cancer also earned an endorsement over the weekend from Martin Reck, chief oncology physician at Germany's Hospital Grosshansdorf.
"Atezolizumab is the second checkpoint inhibitor to show a superior efficacy and better tolerability compared to standard second-line chemotherapy in patients with pre-treated non-small cell lung cancer (NSCLC)," says Reck. "Therefore it is to be expected that atezolizumab, like other PD-1 and PD-L1 antibodies, will substantially change treatment strategies of patients with refractory lung cancer."