May 15, 2017
Novocure (NASDAQ:NVCR) announced today that United States Food and Drug Administration (FDA) has designated it’s Tumor Treating Fields (TTFields) delivery system as a Humanitarian Use Device (HUD) for the treatment of pleural mesothelioma.
Novocure states the HUD designation covers devices that treat rare, orphan diseases or conditions. The HUD designation is the first step in obtaining a Humanitarian Device Exemption (HDE) for the treatment of pleural mesothelioma with TTFields. Novocure enrolled the last patient in its STELLAR trial, a phase 2 pilot trial in pleural mesothelioma, in March 2017 and, with final data collection in 2018, is evaluating its options to file an HDE application with the STELLAR data. An approved HDE would allow Novocure to market TTFields in combination with standard of care chemotherapy as a treatment for pleural mesothelioma in the United States.
“Due to the clinical and pathological course of mesothelioma, standard treatment methods rarely lead to a complete cure and new effective treatments are desperately needed. Our interim data from the STELLAR trial give us hope that TTFields used in combination with standard of care chemotherapies may increase survival for patients with mesothelioma without significantly increasing side effects,” said Dr. Eilon Kirson, Novocure’s Chief Science Officer and Head of Research and Development. “We are pleased that the FDA has recognized orphan status for mesothelioma and acknowledges the urgent demand for new treatment options.”
Novocure’s ongoing STELLAR trial includes 80 patients with unresectable, previously untreated malignant pleural mesothelioma. STELLAR’s primary endpoint is overall survival and secondary endpoints are progression free survival, response rate, and treatment-emergent toxicity. Interim results presented in December 2016 at the International Association for the Study of Lung Cancer (IASLC) 17th World Conference on Lung Cancer suggest improvements in progression free survival and one-year survival rates when TTFields is added to standard chemotherapy.
Forty-two STELLAR patients who received treatment with TTFields plus pemetrexed and cisplatin or carboplatin experienced a 12-month survival rate of 79.7 percent and median progression free survival of 7.3 months. Median survival had not been reached at the time of presentation due to limited follow-up time, with an average follow-up time of 11.5 months. No device-related serious adverse events were reported.
“We believe that treatment with TTFIelds affects fundamental aspects of cell division and may have broad applicability across a variety of solid tumors,” said Asaf Danziger, Chief Executive Officer of Novocure. “We are pleased to receive HUD designation as it is a major step towards a second regulatory approval for TTFields in the United States.”
Treatment with TTFields is not approved for the treatment of mesothelioma by the U.S. Food and Drug Administration. The safety and effectiveness of TTFields therapy for mesothelioma has not been established.