On September 17, 2024, the Food and Drug Administration (FDA) approved Keytruda (pembrolizumab), in combination with pemetrexed and platinum-based chemotherapy, as a first-line treatment for unresectable advanced or metastatic malignant pleural mesothelioma (MPM). Keytruda is an immunotherapy drug that helps the immune system recognize and kill cancer cells by blocking proteins in immune cells, making them more effective at detecting and destroying cancer. This is especially promising for those affected by malignant pleural mesothelioma, the most common form of the disease, accounting for 75% of cases.
This comes as encouraging news, as treatment for mesothelioma is often challenging due to the risk of nearby nerves and blood vessels in the lungs’ lining. In combination with pemetrexed and platinum chemotherapy, Keytruda offers a multi-faceted approach to improving progression-free survival rates to treat those suffering from pleural mesothelioma. In this article, we will break down how this news could affect one’s mesothelioma prognosis and how you can find out more about talking to a doctor about receiving treatment.
According to the ASCO Post, Keytruda’s effectiveness was evaluated in the KEYNOTE-483 trial, which focused on overall survival (OS), progression-free survival (PFS), overall response rate (ORR), and the duration of response (DOR). The trial involved 440 patients with advanced malignant pleural mesothelioma that couldn’t be surgically removed. Those who received Keytruda with chemotherapy had an average OS of 17.3 months, compared to 16.1 months for patients on chemotherapy alone, marking a significant improvement.
The trial showed a 21% lower risk of death for Keytruda and chemotherapy compared to chemotherapy alone and a higher ORR (52% for Keytruda with chemotherapy versus 29% with chemotherapy alone), highlighting the potential of Keytruda to provide better outcomes for patients with few treatment options. This marks a new standard of treatment care for mesothelioma, offering hope to those affected by this aggressive cancer.
Immune checkpoint inhibitors, such as Keytruda (pembrolizumab), target the PD-1/PD-L1 pathway to instruct the immune system on how to detect and destroy cancer cells. For those suffering from mesothelioma, Keytruda functions as an “immune checkpoint inhibitor,” boosting the immune system’s ability to effectively combat the disease. PD-1 is a receptor on T cells, and when it binds with PD-L1 receptors on cancer cells, the immune system’s response is weakened. As a result, the immune system cannot attack tumor cells effectively. Keytruda blocks this interaction and leverages participants’ immune systems to identify and combat mesothelioma cells.
Doctors and researchers determined patients should receive 200 mg of Keytruda every 3 weeks or 400 mg every 6 weeks. The duration of treatment depends on how the individual responds to the medication, tolerability, and the progression of the tumor. Treatment is usually conducted over 2 years, with the flexibility to personalize care plans as needed. Healthcare providers can take an individualized approach to every patient’s case, adapting to their specific needs while maintaining the drug’s benefits.
Although the benefits of Keytruda (pembrolizumab) are helpful in the fight against mesothelioma, recipients should also be aware of the very real potential for side effects. During clinical trials, researchers noted side effects that occurred in 20% or more of patients. Mild side effects included nausea, fatigue, diarrhea, and skin rashes. In some cases, participants reported experiencing immune-related events, such as inflammation of the lungs (pneumonitis), liver, and other organs. Recipients should notify their healthcare providers if they experience any side effects so their providers can make adjustments to their treatment plan if necessary.
The FDA recognizes that cancer is a worldwide fight, so the Oncology Center of Excellence created Project Orbis to expedite the development of oncology research and medical products. At times, drug approvals are denied because of differing standards in other nations, slowing the development of anticancer products and potentially affecting clinical trial results.
Project Orbis allows the FDA to collaborate with other countries so we can further serve the global community suffering from devastating diseases. For the development of Keytruda (pembrolizumab), the FDA collaborated with the Australian Therapeutic Goods Administration and Health Canada to streamline the FDA approval of Keytruda as a mesothelioma drug internationally without undue delay. As a result, Keytruda was reviewed faster so patients could access this evidence-based, effective treatment quickly.
Keytruda’s FDA approval is a breakthrough for patients and families battling this aggressive cancer. As mesothelioma primarily affects the lining of the lungs, treating it has always been complex due to the proximity of vital organs and tissues. This approval gives healthcare providers another powerful tool to improve treatment for mesothelioma patients, offering a much-needed option for those who have been fighting against the odds.
People interested in this treatment should speak with their healthcare provider to fully understand if Keytruda (pembrolizumab) is right for them. Mesothelioma Hub can connect you with the best healthcare providers and facilities in the nation to further explore your options and discuss potential side effects. Contact us today to connect with a healthcare professional in your area to see if Keytruda can fit into your cancer treatment plan.
Scott Haley belongs to the patient advocate team and maintains a strong passion for helping patients and families in the lung cancer and mesothelioma community.
Dr. Andrew Proulx is a medical reviewer and author dedicated to ensuring the accuracy and credibility of our health content. With years of experience in clinical medicine and medical education, Dr. Proulx brings a physician’s perspective to every article he reviews. His work helps ensure that readers receive trustworthy, evidence-based information about mesothelioma, asbestos exposure, and related health topics. Mesothelioma Hub prioritizes accuracy and compassion, values that Dr. Proulx exemplifies in his commitment to clear, medically sound communication.
KEYTRUDA® (pembrolizumab) – Official Site, https://keytruda.com/. Accessed 15 October 2024.
The ASCO Post Staff. “FDA Approves Pembrolizumab With Chemotherapy for Unresectable Advanced or Metastatic Malignant Pleural Mesothelioma.” The ASCO Post, 18 September 2024, https://ascopost.com/news/september-2024/fda-approves-pembrolizumab-with-chemotherapy-for-unresectable-advanced-or-metastatic-malignant-pleural-mesothelioma/. Accessed 15 October 2024.
Conroy, Russ. “FDA Approves Pembrolizumab/Chemo in Unresectable Pleural Mesothelioma.” Cancer Network, 17 September 2024, https://cancernetwork.com/view/fda-approves-pembrolizumab-chemo-in-unresectable-pleural-mesothelioma. Accessed 15 October 2024.
The FDA. “FDA approves pembrolizumab with chemotherapy for unresectable advanced.” FDA, 17 September 2024, https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-chemotherapy-unresectable-advanced-or-metastatic-malignant-pleural. Accessed 15 October 2024.
Gerlach, Alexandra. “FDA Approves Pembrolizumab Plus Pemetrexed and Platinum Chemotherapy for Malignant Pleural Mesothelioma.” Pharmacy Times, 18 September 2024, https://pharmacytimes.com/view/fda-approves-pembrolizumab-plus-pemetrexed-and-platinum-chemotherapy-for-malignant-pleural-mesothelioma. Accessed 15 October 2024.
Merck & Co. “FDA Grants Priority Review to Merck’s Application for KEYTRUDA® (pembrolizumab) Plus Chemotherapy as First-Line Treatment of Patients With Unresectable Advanced or Metastatic Malignant Pleural Mesothelioma.” Merck.com, 29 May 2024, https://merck.com/news/fda-grants-priority-review-to-mercks-application-for-keytruda-pembrolizumab-plus-chemotherapy-as-first-line-treatment-of-patients-with-unresectable-advanced-or-metastatic-malignant-pl/. Accessed 15 October 2024.
Merck & Co. “Five-Year Data for Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy Showed Sustained Survival Benefit Versus Chemotherapy Alone in Two Studies for Metastatic Non-Small Cell Lung Cancer (NSCLC).” Merck.com, https://merck.com/news/five-year-data-for-mercks-keytruda-pembrolizumab-plus-chemotherapy-showed-sustained-survival-benefit-versus-chemotherapy-alone-in-two-studies-for-metastatic-non-small-cell-lung-cancer-nsclc/. Accessed 15 October 2024.