The juggernaut of immuno-oncology drug research around the world continues to rapidly gain speed and mass, offering patients with virtually every cancer type the prospect of new combinations or monotherapies that may bend the course of their disease, according to a new study mapping the global landscape of I/O. But it also raises fresh concerns about commoditization and patient recruitment as the number of PD-1/L1s on the market continues to multiply, with hundreds more coming from behind in the pipeline.
A team at the Cancer Research Institute has been studying the field for the past 2 years, tracking trial activity around the globe as I/O continues to attract blockbuster-sized investments in pursuit of new standards of cancer medicine. And the numbers at the end of 2018 have swelled significantly in most categories.
Some of the highlights from their report — which was published in Nature Reviews Drug Discovery — include:
— Worldwide the number of I/O drugs in 6 key classes has hit 3,394 — up 67% in one year. Those drugs involved 417 targets like CD19, at the top of the list, followed by PD-1, PD-L1 and HER2. A year ago they were tracking 2,031 drugs involving 273 targets.
— The group counted 2,250 clinical trials underway for PD-1/L1 agents, an increase of 748 from a year ago. And there are 1,176 combination studies underway, with a total of 240 different targets.
— With a handful of cell therapies approved, CRI tracked 448 in preclinical development. Nine are in Phase III and 227 are in Phase II. The spike in cell therapy work has pushed it into the lead among all 6 categories tracked, well ahead of cancer vaccines and leaving oncolytic viruses behind — though that field is still growing as well.
The US easily remains the leader in the geography of I/O research, but China has been coming on strong as the number 2 country engaged in new research involving I/O. And a number of home grown PD-1/L1 drugs are nearing approval in China, with implications for the rest of the world.
Particularly exciting, says Vanessa Hubbard-Lucey, director of the CRI Clinical Accelerator, is that “almost all cancer types are being studied with PD-1/L1 therapies in clinical trials, including many rare cancers.”
But while all the numbers continue to steam ahead, there has been a significant decline in one key category: patient recruitment has slowed 70% in 4 years, they say. And that underscores a dramatic need to expand the number of patients who can be recruited for current and upcoming drug trials.
One of the reasons why I/O is so popular is due to the mega-blockbuster checkpoint successes at Merck and Bristol-Myers Squibb. But while the leaders continue to do well, everyone else looking to score gains of their own in a field like PD-1/L1 will be facing a myriad of rivals being advanced for every conceivable target. And a crush of competitors could well end up commoditizing the field, which is one reason why you’re seeing so many combo studies underway.
The leaders want to maintain their lead, and the biopharmas coming from behind want to find a way to break in with something new.
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