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Checkpoint Frenzy
How innovations in the checkpoint inhibitor space are causing a glut in the global clinical research landscape
Jeff Hodge, Vice President, Medical Strategy Lead, Oncology Center of Excellence
Apr 11, 2022
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Checkpoint inhibitors have transformed the oncology landscape, bringing new hope to cancer patients across globe. Checkpoint inhibitors, which allow the immune system to attack cancer tumors, have been the catalyst for many recent clinical advances and overall development of immuno-oncology (IO) therapies.

But their extraordinary impact has also crowded the research environment with more trials than there may be patients to serve. As the PD-1/PD-L1 treatment modality continues to play a major role in IO, it is drawing a flood of new competitors into the research landscape.

A decade later

The US Food and Drug Administration (FDA) approved the first checkpoint inhibitor anti-CTLA4 to treat melanoma in 2012. Since then, they have become the backbone of the oncology treatment space, displacing chemotherapy for many indications.

While the response rate varies among populations, for those patients who do respond to these treatments, responses are durable with prolonged progression free survival and overall survial compared to chemotherapy. These findings have propelled checkpoint inhibitors from salvage therapy in the metastatic setting to front line treatments and into the neoadjuvant and adjuvant settings in many tumor types.

The progress has been amazing, especially given the short amount of time these treatments have been in the marketpace.

In the decade since the first approval, FDA has approved seven more PD-1/PD-L1 inhibitors; four anti-PD1s; and three anti-PD-L1 monoclonal antibodies (mAbs), including the recent accelerated approval of the anti-PD1 mAb, Dostarlimab, in April 2021.

These therapies are having a profound effect on patients’ lives, and generating significant revenue streams for their developers. The average treatment cost can exceed $150,000, while combination therapies can exceed $300,000 for some treatment options.

Within five years of the first approval, the checkpoint inhibitors marketplace exceeded $10.56 billion in annual revenues. By 2025, it is expected to reach $30 billion, with a CAGR of more than 20% per year. Much of this growth will come from emerging markets, where demand for innovative cancer treatments is growing.

Currently much of the excitement is about combination therapies and new formulations. Roughly 83% of the anti-PD1/L1 active studies are testing combination regimens, including IO therapies, targeted therapies, chemotherapies and radiotherapies. And more than a dozen PD-1/PD-L1 inhibitors are now being developed for oral delivery. This could be a significant gamechanger for patients, who can take these treatments at home rather than sitting for hours at a clinic getting an IV infusion.

Too much of a good thing?

All of this success is creating a frenzy in the research space, as developers race to bring the next best checkpoint inhibitor, or combination therapy to market. As of December 2021, IQVIA data shows that there are more than 4,897 clinical trials testing anti-PD1/L1 mAbs, 4,062 of which are currently active. This represents a 267% increase in the total number of clinical trials since 2017.

While innovation is essential to improve anti-PD-1/PD-L1 therapies, the volume of clinical trials, either novel combinations or “me-too” PD-1/PD-L1s, in this space has introduced challenges in finding patients who have not been previously exposed to checkpoint inhibitors. And many trials are testing immunotherapies that offer only nominal improvements over what is currently in the marketplace, so there are challenges generating clinician or patient enthusiasm for taking part.

The FDA’s top oncologists, Rick Pazdur and Julia Beaver have commented recently on the development landscape with these therapies. “Efforts to corral this enthusiasm should focus on increased international partnerships between sponsors of approved checkpoint inhibitors and those developing novel agents to be used with anti–PD-1 and anti–PD-L1 antibodies rather than developing ‘me too’ drugs,” Beaver and Pazdur wrote in the New England Journal of Medicine in December 2021.

They lamented the fact that the current landscape includes many companies hoping to take a familiar, albeit shorter path to accelerated approval (45% of indications in this class of PDL1s have taken the accelerated route), often via single-arm trials, and as confirmatory randomized clinical trials “designed to verify their benefits have shown inconsistent results.”

The FDA “now cautions sponsors developing checkpoint inhibitors against pursuing single-arm trials in patients with refractory disease for the purpose of drug approval,” Pazdur and Beaver wrote.

Sponsors seeking to claim they’re developing “a better” checkpoint inhibitor “should directly compare their agent with those that are already approved; unfortunately, there is no evidence that such randomized trials are under way,” they added.

For further discussion of trends in the PD-1/PD-L1 inhibitor space, please see recent publications by IQVIA experts, including this February 2022 article on Challenges and opportunities in the PD1/PDL1 inhibitor clinical trial landscape; and this 2020 piece on the rise in combination therapies for PD1/PDL1 inhibitor trials.

For more information about IQVIA’s oncology clinical research services,
please visit https://www.iqvia.com/solutions/therapeutics/oncology. 

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