Clinical Research: Phase 1 - Phase 4

Boosting Immuno-Oncology’s Effectiveness Against Cancer

Immuno-oncology continues to be an exciting frontier in the fight against cancer. Researchers continue to develop drugs that allow the body to weaponize its own immune system against the growth of new tumors. Most uses of immunotherapies have been limited to cancers, like those in the lungs or pancreas, that produce a strong immune response.

In his article “Maximizing Immuno-Oncology Clinical Trial Success,” Luke Gill, head of oncology at Premier, takes a look at how improvements in the methods used for immuno-oncology drug trials could benefit both researchers and patients.

Rethinking How We Measure Success

The current limitations on the use of immunotherapy drugs could be swept away thanks to the development of immune checkpoint inhibitors. They block disruptive proteins that limit the body’s natural immune response and stop T-Cells from destroying cancer cells. Some of the biggest factors stopping the more widespread use of these drugs are the limitations of current standards in effectively measuring how well they work.

The Traditional Method
The success of most cancer drugs is measured by a set of documented rules that judge the immediacy of a tumor’s response. Known as RECIST (Response Evaluation Criteria in Solid Tumors), they take into account factors like how quickly the drug starts shrinking tumors and its success in fighting the emergence of new tumors.

Most immunotherapy drugs follow patterns that differ from those that RECIST encounters in trials for standard cancer drugs. That makes it difficult to give an accurate assessment of whether a drug is actually effective, leaving open the possibility of a promising therapy being abandoned.

That’s why researchers are pushing for the adoption of new standards that measure the unique responses immuno-oncology agents exhibit when battling cancer. Developed by a number of professionals including industry insiders, medical providers, and academics, these updated rules, known as iRECIST, account for those varying patterns.

Researchers currently use iRECIST mainly as a secondary method to RECIST standards during late-stage clinical trials and the exploratory phase of new studies. Any medical providers looking to use iRECIST standards for their trials need to be well trained in their usage. Stakeholders should understand the differences in how immunotherapies function in trials versus traditional cancer drugs.

Verifying New Biomarkers

Another barrier limiting the widespread use of immunotherapy is the difficulty in determining how patients will respond to them. Developing new biomarkers—substances that provide information on how an organism functions—to pinpoint effective therapies for individual patients would improve response rates for drugs and reduce the chances of a patient responding badly to a treatment. The complexity of how immunotherapy drugs interact with different cancers makes this difficult.

Combining Old and New Therapies

Numerous clinical trials are underway to determine the usefulness of combining traditional cancer drugs with newer immuno-oncology agents. One drawback emerging from trials is the level of toxicity to which patients are exposed. That makes flexibility in dosing extremely important in preventing combinations from causing long-term damage.

Being Observant and Open
The best way to do this is for doctors to remain vigilant in monitoring the effects of these combinations and knowing when to pull back. Any combination therapy should undergo rigorous testing and be conducted by professionals willing to alter standard administration schedules to find the most effective dosage intervals and limits.

What Comes Next

Increasing our knowledge about cancer’s response to different therapies widens the pool of patients who could benefit from drugs being developed in the immuno-oncology field. Effective clinical trials are the key to getting things right and improving the chances of cancer patients in need of every weapon we’re capable of providing. Take a deeper look at these observations by reading the entire article in Applied Clinical Trials.