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ORPHEUS: A study of the efficacy of immunotherapy for advanced cases of penile cancer

Dr. Alfonso Gómez de Liaño, oncologist at the Insular University Hospital of Gran Canaria and one of the principal investigators of our ORPHEUS Trial, had a conversation with a Spanish local radio ECCA Radio about the importance of early detection in penile cancer and his collaboration with MEDSIR. He details that while there is a vaccine and penile cancer is relatively rare, it can be deadly with current treatments being suboptimal. He and his hospital are participating in ORPHEUS, a multicenter phase II clinical trial led by MEDSIR, that aims to evaluate the efficacy and safety of Retifanlimab, a PD-1 inhibitor, for advanced penile squamous cell carcinoma. Dr. Gómez de Liaño hopes that this study will demonstrate the efficacy of immunotherapy in creating prolonged remission for penile cancer patients.

Read the full transcript of the interview below:

Victoria Caro (journalist): Alfonso Gómez de Liaño, good morning.

Dr. Alfonso Gómez de Liaño: Good morning.

Victoria C.: Well, to know the importance of this study, we are going to start. We will go by parts, talking about this type of cancer, what does it consist of? Why does it appear?

Dr. Gómez: Well, look, penile cancer is an orphan tumor that we say, is very rare in our country (Spain) and in developed countries in general, and the main cause of cancer is a virus, the human papillomavirus. This is important because, after all, this is a virus for which we already have vaccines and therefore one of its causes could be preventable.

Victoria C.: Sure, a vaccine that for now only women get, right?

Dr. Gómez: Well, there are already recommendations to apply it to men, starting at a young age, and although these recommendations are more lax in the United States than in Europe, we see that vaccination in men is more common in our country as well.

Victoria C.: How is it detected?

Dr. Gómez: Well, it is usually detected by self-examination. Usually there is a wound on the penis, and this wound does not heal, and it goes further.

Victoria C.: Are there ages more likely to suffer from it?

Dr. Gómez: Yes, usually this tumor, within the infrequency that it happens, is a tumor that occurs between 50 and 60 years of age more frequently.

Fran Villalba (journalist 2): It is, as you have said, a tumor that is linked to a virus, but we have also read a statistic that indicates that patients who smoke have four and a half times the risk of suffering from it.

Dr. Gómez: Indeed, there are several risk factors. I do not know very well what role tobacco plays with this tumor, but it also seems that these patients are at higher risk, although this is controversial data. There are also data, on the contrary, that suggest that, for example, circumcision could protect against penile cancer, perhaps due to the hygiene associated with it.

Victoria C.: Can it spread throughout the rest of the body?

Dr. Gómez: Indeed, unfortunately, although it is not very common, it can spread, metastasize and in fact the study that we are doing in the Hospital Insular, is a study that is carried out thanks to MEDSIR, a Spanish company that is the promoter, and is investigating an immunotherapy agent in patients in whom the cancer has spread and has no cure.

Victoria C.: What mortality does it represent?

Dr. Gómez: Well, unfortunately it is a tumor with a high mortality, at 5 years the survival estimate is less than 50%.

Victoria C.: It does have a high mortality rate, you are studying the efficacy of a drug for advanced cases of penile cancer, tell us a little about the objective and what this study consists of.

Dr. Gómez: Well, look, one of the big problems, as we have said, is that the treatments that we have for advanced stages are not very effective at the moment and they involve combination chemotherapies that are quite aggressive but with several chemotherapies together those therapies are very effective. The drug that we are investigating in the hospital is an immunotherapy that actually has a mechanism of action that has been developed for several years and that has given very good results in other tumors such as lung cancer and bladder cancer, and in fact is the mechanism that gave the Nobel Prize to Drs. James Allison and Tasuku Honjo, in 2018. This drug, roughly speaking, what it does is try to get our own lymphocytes, which are a part of our immune system, to recognize these cells of cancer as strangers and are able to attack it in such a way that our own body attacks the cancer instead of using aggressive external agents.

Victoria C.: I was saying that it can have a mortality that reaches 50%, what results do you expect from this drug? Can the percentage of deaths significantly decrease?

Dr. Gómez: Well, let's hope so, the objective of this study is to show that the drug works by controlling the disease, obtaining answers, and hopefully, this is what we have seen in other types of tumors, that there are patients who enter a prolonged remission, that is to say that the cancer is controlled, we are not talking about a cure yet but it is controlled, even in some cases it disappears and in some patients this effect can last for years, something that we are not used to seeing with chemotherapy.

Victoria C.: It is very normal to hear or hear about women's diseases, specifically their reproductive system, their breasts, ovaries, cervix, there is still a lot to do, because sometimes it gives the feeling that men get sick less. Are men also aware that they have to take care of their health, specifically, this time we are talking about the penis, the reproductive system?

Dr. Gómez: Well, it is a very good reflection. The truth is that indeed, I believe that tumors of the male reproductive system in general do not have as much visibility as those of women, in part because women have been able to organize and seek visibility, and in men this interest has not been the part of society, there are several factors that come together. I think that little by little that is beginning to change, and for example the prostate cancer Movember movement that is becoming more and more notorious every year. It is clear that we must continue, starting by giving information to the population, that they know about these diseases, that they are aware of them, and how to prevent them, above all. Because at the end of the day, in oncology we do treatments, and we hope to cure them or reach a remission, but the ideal would be to prevent that point from being reached and preventable cancers from developing, such as this type of tumor.

Victoria C.: How important is it for the Hospital Insular de Gran Canaria to participate in the study of this drug?

Dr. Gómez: Well, I think a lot, luckily in our hospital we have a very powerful clinical research unit. We have been investigating for years with these types of very innovative agents, and of course, being the only hospital in the Canary Islands and in the few in Spain that have this clinical trial, for us it is very important.

Victoria C.: Doctor Alfonso Gómez de Liaño, thank you very much for answering our call, and that the studies give the expected results, and that men who face advanced penile cancer have an effective treatment. Many thanks.

Dr. Gómez: Thanks to you, have a good day.

With the 5 years the survival for penile cancer estimated to be less than 50%, there is an unmet need for new treatments. Dr. Alfonso Gómez de Liaño sat down with ECCA Radio to discuss the latest in penile cancer and his involvement in the ORPHEUS clinical trial, led by MEDSIR. Penile cancer is rare but effects men in the 50s and 60s most frequently. While there is a vaccine against one of its causes, human papillomavirus, recommendations for it are weak, especially, in the United States. Current treatment for advance cases requires aggressive regimens of chemotherapy and are not very effective. The ORPHEUS trial aims to evaluate the efficacy of immunotherapy in harnessing the body’s immune system to treat penile cancer and will hopefully led to prolonged remission. While an oncologist’s job is treatment, Dr. Alfonso Gómez de Liaño stresses the importance of cancer awareness to not only catch cancer early but to also prevent it.

Click here to listen to the full interview (in Spanish) or contact us for more information.



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