Educational content on VJOncology is intended for healthcare professionals only. By visiting this website and accessing this information you confirm that you are a healthcare professional.

Share this video  

WCLC 2021 | Challenges in targeted drug development and treatment in lung cancer

Bruce Johnson, MD, Dana-Farber Cancer Institute, Boston, MA, discusses the challenges in development of targeted agents for use in lung cancer. Efforts to comprehensively genotype lung cancers and identify efficacious targeted therapies are ongoing. There are currently 7 different genomic changes with approved agents for use in clinical practice. However, there are difficulties associated with drug development and deployment. Firstly, thorough biomarker testing of lung patients is required to identify those with genomic changes that are eligible for targeting, yet surveys show many patients are not being tested. Additionally, there are significant costs associated with the trials needed for drug approval. Since the treatments are only beneficial to a small subset of patients, balancing these costs with the expected revenue from a small target market is a challenge. This interview took place during the IASLC World Conference on Lung Cancer (WCLC) virtual meeting 2021.

Transcript (edited for clarity)

And now there are seven different genomic changes for which one can have effective and regulatory agency-approved drugs, and these have moved into clinical treatment. In order to be able to deploy these agents, one needs to undergo a rather comprehensive biomarker testing for these genomic changes for which there’s effective targeted agents. And one of the things that I speak about is the proportion of people who get tested...

And now there are seven different genomic changes for which one can have effective and regulatory agency-approved drugs, and these have moved into clinical treatment. In order to be able to deploy these agents, one needs to undergo a rather comprehensive biomarker testing for these genomic changes for which there’s effective targeted agents. And one of the things that I speak about is the proportion of people who get tested.

We took a look at what was going on in the United States with Dr Kehl and it was only about 10-25% in the US in 2016-18. We’ve also had some information from the members of the International Association for the Study of Lung Cancer, where people who ordered the testing, and most of the people said they get it non-squamous non-small cell lung cancer, but it’s not really the real evidence of who actually get the test. It’s just saying how many people say they ordered the test, and it was from people who responded to the IASLC questionnaire, so it’s a biased group. Not enough people are getting tested, and we have broad efforts in the United States to try to deploy this.

One of the other things that’s a problem about the drug development is the costs and what it costs to be able to deliver this care. And for part of this drug development, I took a look at how much it costs per month in the United States. And this just comes off of a drugs.com website, and the cost of the agent per month varies from $11-34,000. And then I also multiplied this by the progression-free survival, so you assume that they’re getting treated for this, and the costs end up being per course between $200,000 to over $900,000.

This isn’t likely what the patients have to pay, but both for the societal costs, as well as for our third-party payers, this is going to be a challenge to be able to maintain this. The second part of this challenge with going after the subsets, with each of our mutations, depending on where you are in the world, is 15-30% of the lung cancer patients, and with ALK, it’s 3-5%, but all the ones that I talked about there about 1% of the patients or less. And when you take a look at the numbers of people with lung cancer in the US, there’s about 150,000 deaths, and if you assume two thirds of those would be eligible for treatment, that leaves about a thousand people in our country. And if the costs are on the low end of those that I showed you, is about 200,000 a year. So the total revenue, assuming everybody gets paid for all these things, is about 200 million. And that may be okay, but that’s under the most optimistic scenarios, and these drugs are very expensive to develop, and is that enough to sustain it, A, and B, are our regulatory groups going to be able to sustain this?

The other piece of this, one of the things that’s very exciting about this is that our pharma companies are carrying out this drug development at a very rapid pace and are willing to go after these rare subsets despite the challenges to the companies, which is a good thing. One of the things that, if you take home any message today, is that these patients need to have comprehensive biomarker testing. This is not being deployed in enough people to be able to get access to these drugs. It’s important both for the patient’s outcome, as well as the ability for this to reach as many people as possible. And the other part that we’ll be having some discussions is whether our worldwide health systems are going to be able to cover the costs of supplying these drugs. And how are we going to be able to do this with these costly drugs that people are taking for, we hope, years, and will our third-party payers and governments be able to sustain this?

Read more...