Dr Neil Gross on Potential Impact of Future Novel Treatments for cSCC

Currently, there is no treatment approved for resectable cutaneous squamous cell carcinoma (cSCC), nor do we have biomarkers to predict treatment response. There is room for improvement, noted Neil D. Gross, MD, FACS, head and neck surgeon and director of clinical research in the Department of Head and Neck Surgery at The University of Texas MD Anderson Cancer Center

Transcript

What must future treatments for cSCC address for adverse effects beyond the physical?

There’s no systemic therapy approved for cutaneous squamous cell carcinoma in the resectable setting. Immunotherapy is approved for patients with unresectable, or metastatic, disease, and it can improve survival for these patients; there can be durable disease control in that setting. This study was designed to push it earlier into treatment, 1, to see if importantly we could improve quality of life, if we could spare patients functionally devastating surgery and potentially avoid radiation.

But it also has the opportunity to improve outcomes for patients as well. I think that is yet to be determined. And this will need to be compared to a standard-of-care approach in a phase 3 setting, I think, to be definitive evidence. But I’m confident that there is room for improvement in how we’re currently doing things and that this approach has a very good chance of beating the alternative.

Is there potential for biomarkers in the space?

We don’t know currently which patients will respond to neoadjuvant treatment and which ones will not. We don’t have a biomarker currently. We looked in this study at tumor mutational burden, we looked at PD-L1 status; we’ve collected circulating tumor DNA, and that is being analyzed. But as of yet, we don’t have predictors of response to treatment. But that’s going to be critical moving forward. I think if we can identify biomarkers of response and really select our patients better for treatment, then it’ll be a win-win for everyone.

One thing that’s really nice about this approach, the neoadjuvant approach, is that you can see the responses almost in real time. Patients will tell you that it’s improving. Patients have even told me that they’ve seen other skin cancers or skin lesions fall off during the neoadjuvant treatment or that their tumor itself, they felt it shrink or have seen it shrink. And we’ve seen this on imaging as well. So, you can measure the responses and see how it’s working. And if it’s working, great, you can continue. And if it’s not, you can shift gears and you can always go to a standard approach of surgery and radiation for advanced cancer.