FDA Approves First Mesothelioma Treatment in 15 Years
It’s been 15 years since the Food and Drug Administration (FDA) approved a front-line treatment for patients with untreated, unresectable, locally advanced or metastatic malignant pleural mesothelioma (MPM). Just last week, the agency announced that it has approved another treatment for this population. NovoTTF-100L—a noninvasive, anti-mitotic cancer therapy that delivers Tumor Treating Fields (TTF) to the region of the tumor—has joined “Alimta plus Platinol” (pemetrexed plus cisplatin) as one of only two FDA-approved treatments for patients with unresectable MPM.
Prior to approval, this promising treatment had been studied in a number of clinical trials. The most recent study tipped the scales. Known as STELLAR, the decision-making clinical trial consisted of 80 patients. Median age was 67 (range 27-78), and 84% 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.
According to the study, published by the European Society for Medical Oncology (ESMO), among 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.
The development and commercialization of TTF’s to extend survival outcomes for some of the most aggressive cancers has been in the making for nearly 20 years. 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, there is hope. A number of innovative treatments are currently being studied for safety and effectiveness, bringing doctors and researchers closer to a cure.
Columbus, Gina. “NovoTTF-100L Plus Chemotherapy Approved by FDA for Malignant Pleural Mesothelioma.” Targeted Oncology. TargetedOnc, 23 May 2019. Web. 30 May 2019.
Columbus, Gina. “FDA Approves NovoTTF-100L Plus Chemo for Malignant Pleural Mesothelioma.” OncLive.com. OncLive, Intellisphere, LLC., 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.