An independent data monitoring committee has reported encouraging data from the Phase III LUNAR trial.
Article published at Globes.co.il on April 13, 2021.
Drug Development company Novocure (Nasdaq: NVCR) today announced a positive update on its phase III pivotal LUNAR trial for treating lung cancer. The company said that an independent data monitoring committee (DMC), informed it that the pre-specified interim analysis for the LUNAR trial would be accelerated given the length of accrual and the number of events observed, and that the trial should continue with no evidence of increased systemic toxicity.
Novocure’s share price opened 48% higher on Nasdaq today at $195, giving a market cap of $20.034 billion. Prior to today, Novocure’s share price had risen 92% over the past year, and 440% in the past three years.
The primary endpoint of the LUNAR trial is superior overall survival when patients are treated with TTFields plus immune checkpoint inhibitors or docetaxel versus immune checkpoint inhibitors or docetaxel alone. The final analysis will also include an analysis of overall survival in the immune checkpoint inhibitor and docetaxel treatment subgroups.
Novocure CEO Asaf Danziger said, “The completion of the LUNAR interim analysis is an important milestone for Novocure. We are grateful to the DMC members for their diligence, guidance and support, and are looking forward to working closely with the FDA on amendments to the protocol given the DMC’s recommendations. Pending regulatory approval, the recommended protocol adjustments could accelerate trial completion by more than a year. We look forward to sharing final data from the LUNAR trial as quickly as possible.”
NovoCure’s technology is basically a completely new approach to treating cancer, developed by Prof. Yoram Palti, now aged 82, professor emeritus of physiology and biophysics at the Technion-Israel Institute of Technology. It consists of electric fields directed at the growth from several directions that disrupt the growth of the cancerous cells, without damaging other areas. The treatment is akin to radiation, but without the damage done by radiation to tissues that it encounters on the way to the growth. Now headquartered and registered in the US, Novocure has 200 employees in Israel.