Roche hustles its PD-L1 'breakthrough' star into 11 late-stage trials

Roche Global Medical Affairs Chief Niko Andre

Every time there's a major breakthrough in drug R&D, the biopharma industry is almost guaranteed to see a group of major league industry players thunder down the late-stage pipeline angling for a leading position in the market they're tackling. With the immune checkpoint inhibitors, that race has been been clearly called out, showing Bristol-Myers Squibb ($BMY) out in front with the biggest and fastest effort, a comeback Merck ($MRK) in hot pursuit and Roche/Genentech ($RHHBY) and AstraZeneca ($AZN) following but still in the front of the pack.

With revenue forecasts circulating in the $30 billion-plus arena for the checkpoint crowd, the pack has been growing quickly.

AstraZeneca, which has been badly bruised over the years, has taken particular pride in its frontrunner status. But of all the leaders, Roche has been less eager to tout the full range of its activities. So when Niko Andre, the head of Roche's global medical affairs, outlined plans to have the PD-L1 drug MPDL3280A in 11 late-stage studies by the end of the year, Reuters quickly headlined the news.

Cathi Ahearn, another executive for the global pharma giant, added that their PD-L1 drug would be filed for lung and bladder cancer in the "year to come," Reuters added. And that's where the FDA has been keeping an open door for Roche investigators looking to hurry along this new drug.

Regulators clearly believe that coming in behind Bristol-Myers and Merck still leaves plenty of room for major new additions to the field. Just two months ago MPDL3280A picked up the FDA's second "breakthrough" therapy designation for non-small cell lung cancer after the disease has progressed during or after platinum-based chemotherapy (and an appropriate targeted therapy for those with an EGFR mutation-positive or ALK-positive tumor). And that follows the 2014 BTD for bladder cancer.

By hitting PD-L1, there's significant clinical evidence that a drug can rev up a T cell attack on cancer. That kind of strategy has broad applicability in oncology, setting up a long lineup of potential targets and combinations. In the past, Genentech execs have always been clear that an abundance of internal cancer drug candidates gives it a chance to do a lot of mixing and matching without needing to go outside the company to find many more. But a string of recent deals at Genentech has underscored R&D's interest in beefing up its pipeline, while Roche CEO Severin Schwan has flagged a big appetite for new collaborations.

"Partnering is absolutely fundamental," he recently told reporters.

The way Roche/Genentech is approaching the field in a runner-up position, there's apparently still plenty of market potential that warrants making this drug a top priority. 

- here's the Reuters piece

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