Ongoing Clinical Trials in Colorectal Cancer

Transcript:John Marshall, MD: I hear a lot from the folks on the other end of that camera that, “Okay, I did this and it said HER2-positive, or ALK, or something else and it suggests a trial. So, how am I going to get access to these drugs?” Tony, are there trials out there that can help support this?

Tanios Bekaii-Saab, MD: There are trials that are out there that do support this. Some of them are national trials, others are institutional trials. NCI-MATCH is one of them, and I understand it’s picking up steam and may be close to essentially getting to the target accrual. TAPER is an ASCO initiative that is mostly geared to community practices, essentially trying to match. So, if you have a molecular genetic finding on NGS platform, ASCO would actually help link to the company, and link patients and practices to the drug. There’s MyPathway through Genentech with select targets, but there are also others that are institutional network wide. So, there are a lot of opportunities to match those patients with a target.

John Marshall, MD: You’re an interesting group of panelists. We have strong Cooperative Group representation, a huge clinical network including all of Florida, basically, and 3 major centers around the country. You all have programs within your own systems to think about this problem of the ultimate basket studies that a doctor in the middle of Florida can get on a Sarah Cannon trial.

Johanna Bendell, MD: Yes, absolutely. I think the next step in clinical trial design is bringing the trial to the patient. There’s a lot of work that’s being done doing that now. There are also a lot of companies that are moving in clinical trial matching where, as a patient, you contact them and they work on trying to find the clinical trial nearest to you that makes sense. So, I think there are a lot of different options patients and physicians have right now.

John Marshall, MD: And a lot of us are thinking about this just in time. A doctor identifies, and they’re participating, and they get a quick IRB in a drug and data. What’s the Cooperative Group doing about all of this?

Alan P. Venook, MD: Well, the Cooperative Group, they were looking at a study called ASSIGN in colon cancer, and that has pretty much been abandoned. One of the problems from the MATCH trial is the hope was that this would give insight into colon cancer, for example. A minority of patients on MATCH have had colon cancer. I think, in fact, we don’t have enough drugs that hit the targets. So, there are studies looking at HER2 and a couple of other clear-cut things we can drug, but, otherwise, the Cooperative Groups are not active in this.

John Marshall, MD: Many of us have said that the phase III randomized trial is dead. We don’t need those anymore. Big phase III randomized studies, we don’t want to do them. Is it true?

Johanna Bendell, MD: Yes and no.

John Marshall, MD: You do small single arm, randomized trials?

Johanna Bendell, MD: I think for some tumor types where you have an unmet need or you have a specific mutation where you see an amazing result, getting those single arms, phase IIs good response rates the drug to approval fast, yes. But I also think there’s a lot of help in these large randomized phase III studies that provide us data sets, like Alan’s study, where we can glean so much information. Now we can potentially approve a drug, but we also can learn much more about the different tumor types and how we should treat certain subsets of patients.

John Marshall, MD: I’m thinking we talked earlier about MSI-high colon cancer patients now on compendia based on 2 phase I/II trials. I think the total number of patients is under 100.

Alan P. Venook, MD: It’s a little bit more than 100.

John Marshall, MD: It’s not much more than 100, and we’re now on a guideline based on that.

Alan P. Venook, MD: I’m the vice chair of the Colon Cancer guidelines with the NCCN, and I think this is part experiential. This is not a trivial difference in a way. As we look at the 1.4-month overall survival difference that may lead us to a drug approval, you see these amazing responses in patients. It’s much more compelling sometimes.

John Marshall, MD: Johanna, Tony, Alan, thank you so much for being here today and discussing this. I’d like to get some final thoughts from each of you. And Johanna, I’m going to let you go first. What are some of the key takeaways around colon cancer, precision medicine that our doctors need to know?

Johanna Bendell, MD: The future is bright. Get your patients profiled. Let’s learn as much about them as we can, both for their current treatment and for treatments to come, and for collating the data so we can learn more about what specific subsets of colon cancer patients should be treated now. And immunotherapy is coming, even for the microsatellite stable patients.

John Marshall, MD: Tony?

Tanios Bekaii-Saab, MD: I do think this is an exciting time in drug development and there are opportunities for our patients. I agree with Johanna. I think molecular testing should become a standard rather than the exception in the upfront setting, especially given the slew of opportunities that we have available through clinical trials, through platforms, and through incoming agents.

John Marshall, MD: Your thoughts?

Alan P. Venook, MD: The message, I think, is that colon cancer is a nuance disease, and, in fact, it’s not a one-size-fits-all treatment. I would encourage the community to really use their assets. There is a center with expertise in research, consider sending patients there. And it’s also a multidisciplinary disease. You need all the pieces in place to do right by patients.

John Marshall, MD: Thank you all for this, and, on behalf of our panel, we really thank you guys for joining us and we hope you found this Peer Exchange® discussion to be useful and informative.

Transcript Edited for Clarity