Αρχική World News Immunotherapy Drug Cemiplimab Approved for Advanced Squamous Cell Skin Cancer

Immunotherapy Drug Cemiplimab Approved for Advanced Squamous Cell Skin Cancer

October 19, 2018, by NCI Staff

Squamous cell carcinoma cells in a state of uncontrolled growth.

Credit: National Cancer Institute

The Food and Drug Administration (FDA) has approved the drug cemiplimab (Libtayo) for patients with an advanced form of cutaneous squamous cell carcinoma (SCC), a common type of skin cancer. This is the first agent to be approved by FDA specifically for advanced SCC.

Cemiplimab belongs to a class of agents known as immune checkpoint inhibitors, which work by strengthening the body’s immune response to tumors.

FDA’s approval covers patients with metastatic or locally advanced SCC who are not candidates for surgery or radiation therapy.

“Cemiplimab is certainly a meaningful step forward in the treatment of this relatively rare disease,” said Larissa A. Korde, M.D., of NCI’s Cancer Therapy Evaluation Program (CTEP).

Approval Based on Results of Two Clinical Trials

Although squamous cell carcinoma of the skin is common, it is rare for the cancer to spread, or metastasize, to distant parts of the body. Surgery can cure earlier stages of SCC in more than 95% of patients.

SCC begins in cells that form the outer layer of the skin, usually in areas that have been exposed to natural or artificial sunlight, such as from tanning beds, over long periods of time. Advanced SCC may cause disfigurement and may become life-threatening if it spreads to other parts of the body.

FDA’s approval of cemiplimab was based on the results of two early-phase clinical trials involving 108 patients (75 with metastatic disease and 33 with locally advanced disease). In one of the trials, 13 of 26 patients responded to cemiplimab.

In the second trial, 28 of 59 patients with metastatic disease who were treated with cemiplimab had their tumors shrink or disappear.

Among the 28 patients with metastatic disease who had a response, 16 had responses that lasted longer than 6 months, and 13 of these continued to have a response and to receive cemiplimab when the analysis ended.

By comparison, only about 15%–25% of patients with advanced SCC respond to the chemotherapy regimens or targeted therapies that are sometimes used to treat the disease, and many experience debilitating side effects from these treatments, explained Michael Migden, M.D., of the University of Texas MD Anderson Cancer Center, who led the clinical trials.

Dr. Migden and his colleagues reported their results in the New England Journal of Medicine (NEJM) in July. Given the need for new treatments for SCC, the results “led to a lot of excitement in the field,” said Dr. Korde.

The trial was funded by Regeneron Pharmaceuticals, which invented cemiplimab, and Sanofi, which will help to market the drug. Patients with advanced SCC were the first to receive cemiplimab.

Other checkpoint inhibitors are now being evaluated in patients with this rare cancer, and cemiplimab is being tested for patients with other types of cancer, according to Dr. Korde.

Common side effects of cemiplimab include fatigue, rash, and diarrhea. The drug can also cause the immune system to attack normal organs and tissues in the body. In some cases, these reactions can be severe and may be life threatening.

“As with any other immunotherapy drug on the market, there can be significant side effects from treatment with cemiplimab,” said Dr. Korde. “Any treatment decision should be made by physicians and patients working together.”

Testing an Immunotherapy Drug

The researchers decided to test a checkpoint inhibitor in advanced SCC for two reasons. First, these cancers tend to have a high number of genetic mutations (i.e., they are hypermutated), likely because of the exposure to ultraviolet radiation. Known as a high tumor mutational burden, this condition has been associated with a response to immunotherapy in some other types of cancer.

In addition, the risk of SCC is much higher in individuals whose immune system and ability to fight infections and other diseases have been suppressed as a result of illness or treatment for disease than in people whose immune systems function normally. This observation suggested to the researchers that strengthening the body’s immune response against tumor cells might be an effective strategy for treating the disease.

More research is needed to identify the best treatment for patients with advanced SCC, noted Dr. Korde. “But the current study is moving in the right direction, and we are hopeful that future studies will lead to the discovery of additional treatments for this disease.”

Source

NEWSLETTER

Συμπληρώστε το email σας για να λαμβάνετε τις σημαντικότερες ειδήσεις από το ogkologos.com

Βρείτε μας

2,449ΥποστηρικτέςΚάντε Like
57ΑκόλουθοιΑκολουθήστε

Διαβαστε Επίσης

ΕΞΕΛΙΞΕΙΣ ΣΤΗ ΘΕΡΑΠΕΙΑ ΤΟΥ ΜΗ-ΜΙΚΡΟΚΥΤΤΑΡΙΚΟΥ ΚΑΡΚΙΝΟΥ ΤΟΥ ΠΝΕΥΜΟΝΑ (ΜΜΚΠ)

ΕΞΕΛΙΞΕΙΣ ΣΤΗ ΘΕΡΑΠΕΙΑ ΤΟΥ ΜΗ-ΜΙΚΡΟΚΥΤΤΑΡΙΚΟΥ ΚΑΡΚΙΝΟΥ ΤΟΥ ΠΝΕΥΜΟΝΑ (ΜΜΚΠ) Γράφει ο Δρ Παπαδούρης Σάββας, Παθόλογος-Ογκολόγος   Ο ΜΜΚΠ βρίσκεται αναλογικά στο 80% και πλέον του συνολικού...

Διατρέχουν όντως οι καρκινοπαθείς μεγαλύτερο κίνδυνο λόγω κοροναϊού;

Σε πρακτικό επίπεδο, τα δεδομένα των σχετικών μελετών υποδηλώνουν ότι η χημειοθεραπεία ή οι άλλες αντι-νεοπλασματικές θεραπείες δεν αυξάνουν σημαντικά τον κίνδυνο θνησιμότητας από...

FDA: Η ακτινοβολία των smartphones δεν προκαλεί καρκίνο

Σε μια νέα έκθεσή της, η Υπηρεσία Τροφίμων και Φαρμάκων (FDA) των ΗΠΑ αναφέρει ότι επανεξέτασε τις σχετικές επιστημονικές έρευνες που δημοσιεύθηκαν τα τελευταία...

Νέα ανακάλυψη, νέα ελπίδα για τον καρκίνο

Ένα νεοανακαλυφθέν τμήμα του ανοσοποιητικού μας συστήματος θα μπορούσε να αξιοποιηθεί για την αντιμετώπιση όλων των ειδών καρκίνου, σύμφωνα με επιστήμονες του πανεπιστημίου Cardiff...

Καρκίνος: Ευεργετική για τους καρκινοπαθείς η άσκηση

Σημαντικά ωφέλη προσφέρει η άσκηση, ακόμη και σε ασθενείς με καρκίνο. Οι περισσότεροι ασθενείς αγνοούν τα οφέλη που μπορεί να έχει γι’ αυτούς η συχνή...

Prostate Cancer

The article is provided by Scientific Communications Officer of NIPD Genetics, Ms Marina Charitou (MSc) Prostate Cancer Awareness Prostate cancer is the second most common cancer...
- Advertisment -

Ροή Ειδήσεων

Targeted Therapy Based on Molecular Profiling of Malignant Mesothelioma Tumours Is Feasible

Targeted therapy recommendations can be made based on the molecular profiles of tumour samples from patients with metastatic malignant mesothelioma (MM) according to findings...

News digest – targeted radiation beam, precision medicine and our early detection roadmap

<img width="620" height="348" src="https://zniup3zx6m0ydqfpv9y6sgtf-wpengine.netdna-ssl.com/wp-content/uploads/2020/10/Radiation_hero-1.jpg" class="attachment-hero size-hero" alt srcset="https://zniup3zx6m0ydqfpv9y6sgtf-wpengine.netdna-ssl.com/wp-content/uploads/2020/10/Radiation_hero-1.jpg 620w, https://zniup3zx6m0ydqfpv9y6sgtf-wpengine.netdna-ssl.com/wp-content/uploads/2020/10/Radiation_hero-1-300x168.jpg 300w, https://zniup3zx6m0ydqfpv9y6sgtf-wpengine.netdna-ssl.com/wp-content/uploads/2020/10/Radiation_hero-1-220x123.jpg 220w, https://zniup3zx6m0ydqfpv9y6sgtf-wpengine.netdna-ssl.com/wp-content/uploads/2020/10/Radiation_hero-1-150x84.jpg 150w" sizes="(max-width: 620px) 100vw, 620px" data-attachment-id="18059" data-permalink="https://scienceblog.cancerresearchuk.org/2020/10/17/news-digest-targeted-radiation-beam-precision-medicine-and-our-early-detection-roadmap/radiation_hero-3/" data-orig-file="https://scienceblog.cancerresearchuk.org/wp-content/uploads/2020/10/Radiation_hero-1.jpg" data-orig-size="620,348" data-comments-opened="1"...

A Pet Pug Helped Two Sisters Realize They Both Had Breast Cancer

Sisters Amanda Tasca and Amy Niosi are grateful for one very perceptive pug. Amanda’s dog Daisy, a gift from her husband Steve and one...

Woman with Breast Cancer May Have Saved Her Twin’s Life by Revealing Her Lumpectomy Scar

When Meagan McCallum was diagnosed with breast cancer, she had no idea that her experience might actually save her sister’s life. Meagan underwent a...

Lo que debe saber sobre el cáncer de pulmón

La Dra. Jyoti D. Patel es profesora de Medicina y directora de Oncología Torácica de la Universidad de Chicago y es editora asociada para...

Alternatives for Outdoor Foods

Autumn has arrived, but that doesn’t mean outdoor dining has to end! You might be wondering what foods you could prepare that are healthy...