12:16 PM
Apr 26, 2019
 |  BioCentury  |  Product Development

For patients’ sake, collaborate already

How and where industry can collaborate on cancer immunotherapy platform trials

Cancer immunotherapy companies must stop squandering the most precious stakeholder, patients, and collaborate now on platform trials to test new combination regimens. A straightforward platform trial design that tests different combo partners with PD-1/PD-L1 agents could save companies time, money and get even greater advancements to patients faster.

Combination studies account for the largest portion of the thousands of ongoing PD-1/PD-L1 trials, as companies aim to gain a foothold in immuno-oncology or extend their franchise.

But with the huge degree of duplication across the trials, the calls are growing louder from some of the most influential voices for companies to collaborate.

The loudest thus far has come from head of FDA’s Oncology Center of Excellence Richard Pazdur, who devoted nearly his entire one-hour session at the American Association for Cancer Research (AACR) meeting to pushing the companies with the six marketed anti-PD-1/PD-L1 drugs to put an end to the wasteful redundancy of their trial strategies that are putting patients last, not first (see “Pazdur on Pandemonium: Calls for Collaboration, Competition on PD-1 Drugs”).

The goal of these combo trials is to unlock the benefits of PD-1/PD-L1 inhibition in patients who don’t respond to monotherapy, and extend them to tumor types where the drugs have shown limited efficacy.

Despite the feverish activity, we’re no closer to understanding in which patients these agents work best. The lack of a unified assay for PD-1 or PD-L1 means these trials could further complicate the biomarker picture rather than clear it up, because the results cannot be directly compared.

Platform trials, which use a single master protocol for all agents, could cut the number of patients needed by more than half, subject fewer of them to suboptimal treatment regimens and provide a tome of standardized biomarker data to identify the patients most likely to benefit.

So why won’t companies do what’s glaringly obvious and collaborate? The excuses range from internal structure and decision-making within biopharmas to the time it takes up front to get the protocol and statistical plan ironed out before the trial can be started.

But once started, a platform trial would avoid slow-downs in recruitment. And if done as a seamless Phase II/III design, or even as a controlled Phase II, it could save millions of dollars by avoiding large Phase III programs that fall flat because they are based on uncontrolled Phase Ib readouts (see “Lessons from the ECHO Chamber”).

This solution won’t be right for every indication or company, but it could go a long way towards providing a more efficient and more socially responsible way of investigating novel agents.

Figure: A Place to Start

A controlled platform trial for investigational agents combined with PD-1 or PD-L1 inhibitors could drastically reduce the massive duplication in the industry. In the end, patients would be spared exposure...

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