The humanitarian use designation is the 1st step in winning a humanitarian device exemption, which would allow Novocure to makrket TTFields in combination with chemotherapy as a treatment for pleural mesothelioma. TTFields are low-intensity, intermediate frequency, alternating electric fields that are designed to inhibit cancer cell replication.
In March, Novocure enrolled the last patient in its Stellar Phase II pilot trial, evaluating TTFields in patients with pleural mesothelioma. The company plans to submit an HDE application after collecting data from the Stellar study in 2018.
“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,” chief science officer and head of R&D, Dr. Eilon Kirson, said in prepared remarks. “We are pleased that the FDA has recognized orphan status for mesothelioma and acknowledges the urgent demand for new treatment options.”
The ongoing, 80-patient Stellar trial aims to evaluate progression free survival, response rate and treatment-emergent toxicity of TTFields in patients with unresectable, previously treated malignant pleural mesothelioma. Interim results suggested improvements in progression free survival and 1-year survival rates when TTFields is administered in combination with standard chemotherapy.
Forty-two patients who received treatment with TTFields plus chemotherapy had a 12-month survival rate of nearly 80% and median progression free survival of 7.3 months.
“We believe that treatment with TTFIelds affects fundamental aspects of cell division and may have broad applicability across a variety of solid tumors,” CEO Asaf Danziger said. “We are pleased to receive HUD designation as it is a major step towards a second regulatory approval for TTFields in the United States.”
NVCR shares were trading at $12.35 apiece in mid-afternoon activity, up +4.7%.