Following positive results from its research to treat malignancies, NovoCure Limited (NASDAQ: NVCR) shares jumped 67.57% to $118.19 on Thursday morning.
Which NVCR study had fruitful outcomes?
The LUNAR study showed a statistically significant and clinically significant increase in overall survival above conventional therapy alone, according to Novocure’s (NVCR) announcement today that the research fulfilled its primary goal.
Novocure has been evaluating the safety and efficacy of Tumor Treating Fields (TTFields) in combination with conventional therapies for stage 4 non-small cell lung cancer (NSCLC) following progression during or after treatment with platinum-based therapy in the pivotal, open-label, randomized LUNAR study. In addition, patients who received TTFields and immune checkpoint inhibitors (ICI) had a statistically significant and clinically significant improvement in overall survival compared to patients who received immune checkpoint inhibitors alone.
There was also a trend toward improvement in overall survival when patients received TTFields and docetaxel as opposed to docetaxel alone, according to NVCR’s LUNAR study. The proportion of patients in the ICI and docetaxel strata of the experimental and placebo arms were evenly distributed, and the performance of the control arms was consistent with that of other trials. Patients who participated in the experimental portion of the trial tolerated TTFields treatment well.
The LUNAR study’s encouraging results led to NVCR’s support. The fact that LUNAR was the first phase 3 study in six years to significantly increase overall survival in late-stage, platinum-resistant non-small cell lung cancer highlights how tough it is to treat this condition. Based on the remarkable results of the TTFields in conjunction with immunotherapy, NVCR believes it has the potential to significatively increase patient survival beyond what was previously feasible.
What further plans does NVCR have?
The complete LUNAR research findings will be made public by Novocure (NVCR) at a later medical meeting. In the second half of 2023, NVCR intends to submit a Premarket Approval application to the U.S. Food and Drug Administration (FDA). In addition to the FDA submission, Novocure anticipates filing for a CE Mark in the European Union at the same time.