The U.S. Food and Drug Administration has officially approved the use of Pembrolizumab (Keytruda) plus Pemetrexed and platinum chemotherapy as the frontline treatment for patients diagnosed with unresectable advanced or metastatic malignant pleural mesothelioma. The decision was based on data from a study that showed the combination provided significant improvement in overall survival versus chemotherapy alone, with median overall survival improving from 16.1 months to 17.3 months.
Keynote-483 Study Revealed Significant Improvement in Mesothelioma Outcomes
The Keynote-483 study is a randomized, open-label trial that included 440 mesothelioma patients randomized to receive either a combination of pembrolizumab with pemetrexed and cisplatin or pemetrexed plus cisplatin alone. Carboplatin substitution for cisplatin was also permitted. In addition to extended overall survival, the combination treatment improved the objective response rate from 29% to 52%. There was no difference in median progression-free survival between the two groups; in both cases, it was 7.1 months.
The mesothelioma patients enrolled in the study had either unresectable advanced or metastatic malignant pleural mesothelioma. To be admitted to the study, patients needed measurable disease, an ECOG performance status of 0 or 1, and acceptable hematological, liver, and renal function. They also could not have previously received systemic therapy in the advanced setting, could not have any other active malignancy, and could not have any known central nervous system metastases unless treated and stable.
FDA Approval of Treatment Recognizes Improved Median Overall Survival for Mesothelioma
Among the notable findings that impacted the FDA decision were the difference in median overall survival with and without the combination (19.8 months vs. 18.2 months, respectively) and the difference in three-year overall survival rates, with 26% of those receiving the combination treatment living three years vs. 20% among those who only received the chemotherapy treatment.
In mesothelioma patients with non-epithelioid disease, median overall survival with the combination treatment was 12.3 months as compared to 8.2 months for those receiving chemotherapy alone. The difference in median three-year overall survival is even starker; 23% of non-epithelioid patients receiving the combination treatment survived three years versus only 7% of those receiving chemotherapy alone.
If you or someone you love has been diagnosed with malignant mesothelioma, new treatment protocols offer reason for hope. If you need information or resources, the Patient Advocates at Mesothelioma.net are here to help. Contact us today at 1-800-692-8608 to learn more.
