On February 4, 2004, the Food and Drug Administration (FDA) approved pemetrexed in combination with cisplatin for the treatment of patients with malignant pleural mesothelioma (MPM) whose disease is unresectable or who are otherwise not candidates for curative surgery. Now, some 15 years later, NovoTTF-100L—a noninvasive, anti-mitotic cancer therapy that delivers Tumor Treating Fields (TTF) to the region of the tumor—has joined pemetrexed plus cisplatin as one of only two FDA-approved treatments for patients with unresectable MPM.
In a decision-making study, known as STELLAR, the treatment was administered to 80 patients, median age 67 (range 27-78). Eight-four percent of the patients were male and 56% were smokers. Thirteen patients (16%) had metastatic disease and 35 patients (44%) had an ECOG (Eastern Cooperative Oncology Group) performance status (ECOG PS) of one. Fifty-three patients (66%) had epithelioid histology. Compliance with TTFields was 16.3 hours/day (68%) during the first three months of therapy. All patients had a minimum follow up of 12 months.
In the study, published by the European Society for Medical Oncology (ESMO) and others, researchers were able to meet the primary endpoint of significant extension of survival for previously untreated mesothelioma patients. Median overall survival (OS) was 18.2 months (95% Confidence Interval-CI 12.1-25.8) compared to 12.1 months in historical controls.
Median progression-free survival (PFS) was 7.6 months (95% CI 6.7-8.6) compared to 5.7 months in historical controls. Partial responses (PR) were seen in 40.3% of patients and clinical benefit (PR+SD - Stable Disease) was seen in 97.2% of patients. No device-related serious adverse events (AEs) were reported. Expected TTFields-related dermatitis was reported in 46% (37 patients). Only four patients (5%) had Grade 3 dermatitis.
In a Targeted Oncology report, Bill Doyle, Executive Chairman of Novocure (the developer of NovoTTF-100L) said, “since 2000, we have been developing and commercializing Tumor Treating Fields to extend survivals in some of the most aggressive forms of cancer. FDA approval of NovoTTF-100L provides patients with the first FDA-approved treatment for MPM in more than 15 years and, as our first FDA-approved torso cancer indication, marks a major milestone for Novocure. We are thankful for the patients, caregivers and health care providers who partnered with us to make this possible.”
If you have been diagnosed with mesothelioma, consider participating in a clinical trial such as STELLAR. A new or experimental treatment could be effective in treating your specific type of mesothelioma. Talk to your doctor about participating in a clinical trial today.
Columbus, Gina. “FDA Approves NovoTTF-100L Plus Chemo for Malignant Pleural Mesothelioma.” OncLive.com. OncLive, Intellisphere, LLC., 23 May. 2019. Web. 30 May 2019.
Columbus, Gina. “NovoTTF-100L Plus Chemotherapy Approved by FDA for Malignant Pleural Mesothelioma.” Targeted Oncology. TargetedOnc, 23 May 2019. Web. 30 May 2019.
Grosso, Federica. “STELLAR – Final results of a phase 2 trial of TTFields with chemotherapy for first line treatment of pleural mesothelioma.” Oncology Pro. European Society for Medical Oncology (ESMO), 20 Oct. 2018. Web. 30 May 2019.
- Hazarika, RM White, JR Johnson, and R. Pazdur. “FDA drug approval summaries: pemetrexed (Alimta).” National Center for Biotechnology Information (NCBI), U.S. National Library of Medicine. National Institutes of Health (NIH), 2004. Web. 31 May 2019.