Clinical Progress and Coverage Policies in Immuno-Oncology - Episode 2
Benjamin P. Levy, MD: I think immunotherapy has really changed the way that we think about lung cancer; the way that we treat lung cancer. It’s also altered our perception of how cancer behaves. So, there’s a lot of things that are unique about immunotherapy. One is its mechanism of action. These drugs harness the patient’s own immune system to turn against the cancer, the way the immune system would turn against the virus or bacteria. And this is a concept and a strategy that’s been looked at for over 30, 40 years. We’ve finally started to iron out that we can give drugs that harness the patient’s own immune system to turn against the cancer.
And what we now know is that when we compare these drugs to single-agent chemotherapy for advanced-stage lung cancer patients that are chemorefractory, meaning that the chemotherapy no longer works, these drugs outperform chemotherapy. So, we need to now look at them in the first-line space for stage 4 patients. But, I think what’s unique about them truly is their mechanism of action, their superiority over chemotherapy in some settings, as well as their adverse event profile—a very unique set of adverse events that we don’t see with chemotherapy. It’s a win for doctors, but it’s a win for patients most importantly.
What we’ve seen in the data, and what I can tell you I’ve seen in my practice, are very similar. And that is, these drugs are much better tolerated than chemotherapy, exceptionally well-tolerated agents that don’t have the traditional chemotherapy side effects. There’s no hair loss. There is some fatigue, but certainly not as pronounced as it is with chemotherapy. There’s very little neuropathy or numbness and tingling in the hands and feet that we see with chemotherapy. There’s very little nausea. Those side effects that we traditionally link with chemotherapy, we don’t see with these drugs. The side effects that we do see are quite interesting. It turns out if you are giving drugs that tell the immune system to turn against the cancer, they may also turn against normal host tissue, as well.
So, there is an incidence, very low, of pneumonitis, or inflammation of the lung; colitis, inflammation of the colon; and hepatitis, inflammation of the liver. This biologically makes sense. You’re turning the immune system against the cancer, but you’re also turning it against other organs. I would tell you that the rate of those adverse events are very, very low. And the rate of grade 3/4 adverse events, at least in the studies, is less than 10%. We generally think of grade 3/4, and that’s how we grade adverse events, as clinically meaningful for the patient, or experienced by the patient. And that’s less than 10% in these trials.
These drugs not only provide survival advantages, but also are better tolerated. And in fact, data that we have, and had seen here at ASCO this year, showed better quality of life. There’s been formal quality of life analysis for patients who have received immunotherapy versus those who have received chemotherapy. Not surprisingly, formal quality of life analysis is that patients have better quality of life on these drugs.