ASCO 2026 | Future directions in metastatic anal cancer treatment and research

Anal cancer is a rare GI cancer, but there’s a rising incidence in the United States. Every year, more people are being diagnosed with advanced disease. At the time of their initial diagnosis, more and more people are dying from this disease, despite the availability of preventative HPV vaccines. So this continues to be a growing problem in the United States and across the world, even though it is a rare cancer. Two years ago, we had the first positive phase three clinical trial for patients with metastatic anal cancer. That was the PODIUM 303 trial. And it showed that there was a benefit of adding immunotherapy with anti-PD-1 retifanlimab to chemotherapy with carboplatin and paclitaxel. This is definitely a win for our patients because now we have the ability of giving these patients immunotherapy in the front line. I also want to mention there’s another trial in parallel, the EA-2176 clinical trial that’s looking at the benefit of adding nivolumab to carboplatin and paclitaxel in the frontline setting as well to really validate. We’re looking forward to those results. So this is a win for our patients. The challenge is that after progression on this therapy, there really aren’t any effective therapies for these patients. So you can imagine how difficult this is for patients and their families. I’ve been diagnosed with stage four anal cancer. I’ve gotten the frontline therapy. It’s no longer working. And my doctor is telling me I have no treatment options left. So our group at MD Anderson and researchers and colleagues all over the world are really working on digging into the biology of anal cancer. Unlike colorectal cancer, where we know the mutational landscape and have the availability of targeted therapies to treat these, in an HPV-associated cancer like anal cancer, we don’t see actual mutations arising out of the DNA. So this creates a much bigger challenge. Our group is really interested in looking at immunotherapy combinations to improve further upon outcomes. There’s a lot of promising data of combining TGF-beta targeted therapies with PD-1 antibodies in this disease, as well as a lot of interesting early signal out of combinations for therapeutic DNA vaccines with immunotherapy. We’re also presenting data at ASCO this weekend from some RNA profiling. So our question at MD Anderson was, if the DNA is not informative and helping guide treatment directions for these patients, can we look at the RNA? And one of the initial really interesting signals that’s coming out of work in this rare cancer is that we’re seeing that RNA is highlighting various ADC targets, which may show promise, antibody drug conjugate targets, which may show promise as future possible treatments for anal cancer. Dr. Mira Lim at MD Anderson has researched this weekend showing that TROP2 is overexpressed in the majority of patients with metastatic anal cancer. And we have a subsequent clinical trial looking at the anti-TROP2 antibody, sacituzumab govitecan. They’ll be coming shortly to MD Anderson for patients with the disease. So I think just one example of, you know, the need for more research, more clinical trials, and really our team’s passion to match good science with the best shots on goal to help patients with this rare cancer.

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