Federal agency okays new line of treatment of asbestos-related cancer.
The Food and Drug Administration (FDA) has approved combination nivolumab (Opdivo, Bristol-Myers Squibb) and ipilimumab (Yervoy, Bristol-Myers Squibb) to be used as a first-line treatment in adults who have unresectable malignant pleural mesothelioma, a form of cancer caused by inhaled asbestos. It forms in the lungs, abdomen or heart and symptoms can include shortness of breath and chest pain. The life expectancy for most mesothelioma patients has been approximately one year.
People most at risk of developing mesothelioma are those who have had direct exposure to asbestos for a prolonged period of time, most commonly as part of their occupation. Secondhand exposure is also common, especially among family members in direct contact with people who worked with asbestos. It can be found in the installation of older buildings and today, if needed, is typically removed and these buildings remediated in order to bring them up to code. Schools and places of work have taken measures to eliminate these toxins as much as possible so as not to exposure students, faculty and employees. Many, however, continue to have asbestos contained within the walls, and as long as direct exposure is not expected, it is left alone.
“Today’s approval of nivolumab plus ipilimumab provides a new treatment that has demonstrated an improvement in overall survival for patients with malignant pleural mesothelioma,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, said. He added, “In 2004, FDA approved pemetrexed in combination with cisplatin for this indication, and now patients have an important, additional treatment option after more than a decade with only one FDA-approved drug regimen.”
The approval was based on efficacy results from the CheckMate 743 trial. The study results were presented during the presidential symposium of the World Congress on Lung Cancer 2020. The combined immunotherapy produced a “26% improvement in overall survival. At 2 years, 41% of patients in the immunotherapy arm were still alive vs 27% in the chemotherapy group.”
The most common side effects, according to the study, were fatigue, musculoskeletal pain, rash, diarrhea, dyspnea, nausea, decreased appetite, cough, and pruritus.
The recommended doses for unresectable malignant pleural mesothelioma are “nivolumab 360 mg every 3 weeks and ipilimumab 1 mg/kg every 6 weeks until disease progression or unacceptable toxicity, or up to 2 years in patients without disease progression,” according to the study authors.
The FDA review was performed under Project Orbis, an initiative of the FDA Oncology Center of Excellence. The FDA worked alongside the Australian Therapeutic Goods Administration (TGA), the Brazilian Health Regulatory Agency (ANVISA), Health Canada, and Switzerland’s Swissmedic to determine whether to implement the treatment combination.
“The trial met its primary endpoint of statistically improving overall survival for the experimental arm vs chemotherapy in a prespecified interim analysis,” reported study author Paul Baas, MD, PhD, Netherlands Cancer Institute, Amsterdam, The Netherlands, at the time of the presentation. He recommended it “be considered as a new standard of care.”