Nivolumab and Ipilimumab as a Treatment for Malignant Pleural Mesothelioma

Based on new data, the European Medicines Agency’s Committee for Medicinal Products for Human Use has designated nivolumab and ipilimumab as the frontline treatment for malignant pleural mesothelioma (MPM) in adult patients with unresectable disease. There have been very few advances in the treatment for this cancer in the past years, so this development is very exciting for medical professionals and patients alike.

About Malignant Pleural Mesothelioma

MPM is the most common form of mesothelioma, accounting for about three-quarters of all cases. It is a type of lung cancer, growing in the pleura. MPM is the result of the inhalation of asbestos; the fibers get stuck in the lungs’ soft tissue, causing inflammation and irritation. The asbestos then moves to the pleura, where it eventually causes changes in the DNA of the cells, leading to MPM. This results in symptoms such as fever, weight loss, fatigue, shortness of breath, difficulty swallowing, chest pain, coughing up blood, night sweats, pain when breathing, pain in the lower back and ribs, lumps under the skin on the chest, and swelling in the face and/or arms. Chemotherapy is most often used to treat this cancer, although surgery is an option if it is caught early enough. Clinical trials and radiation therapy act as other treatment options.

New Treatment for MPM

It was the Phase 3 CheckMate-743 trial that led the EU to recommend nivolumab and ipilimumab as the frontline treatment for MPM. This study enrolled 605 patients with MPM and randomized them 1:1. The first group received 3 mg/kg of nivolumab every two weeks along with 1 mg/kg of ipilimumab every six weeks. The other group received the current standard of care: chemotherapy in combination with either carboplatin or cisplatin alongside pemetrexed every three weeks. The researchers continued the treatment until disease progression, intolerable adverse effects or toxicities, or until two years had passed.

They focused on the primary endpoint of overall survival, with secondary endpoints of progression-free survival, objective response rate, PD-L1 expression, and disease control rate. Results include:

  • 26% reduction in the risk of death in the nivolumab/ipilimumab group
  • Median overall survival in the nivolumab/ipilimumab group was 18.1 months as compared to 14.1 months in the chemotherapy group
  • The two-year overall survival rates were 41% in the first group vs. 27% in the second
  • The median progression-free survival was higher in the chemotherapy group at 7.2 months, compared to 6.8 months in the nivolumab/ipilimumab group
    • This changed with the one and two-year progression-free survival rates. The nivolumab/ipilimumab group saw 30% progression-free survival after one year, and 24% after two years. The chemotherapy group saw 16% and 7% respectively
  • The objective response rate was 40% in the nivolumab/ipilimumab group and 43% in the chemotherapy group
  • The disease control rate was 77% in the nivolumab/ipilimumab group and 85% in the other group
  • The median time to response in the nivolumab/ipilimumab group was 2.7 months, which led to a median duration of response of 11 months. The chemotherapy group saw 2.5 months until response and a median duration of response of 6.7 months

In terms of safety, this new treatment regimen demonstrated a favorable safety profile when compared to chemotherapy. Adverse effects falling within grade 3 or 4 occurred in 30% of patients in the first group, compared to 32% in the second. Serious adverse events happened in 21% vs. 8% of patients respectively as well. The most common events were severe itching and diarrhea.

Looking Forward

Currently, most MPM patients live for about a year after their diagnosis. Despite this disheartening statistic, there have been few advances in the treatment for this aggressive cancer. The approval and recommendation of nivolumab/ipilimumab marks a positive change for patients and doctors.

Find the source article here.

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