NovoCure Ltd. (NASDAQ: NVCR) saw its shares skyrocket early on Monday after the firm provided an update for its late-stage cancer trial. The company announced its final results from its Phase 3 pivotal EF-14 trial adding Optune to standard temozolomide chemotherapy for the treatment of newly diagnosed glioblastoma (GBM). Ultimately the results were incredibly positive and investors responded accordingly.
Landmark analyses show a consistent and maintained improvement in overall survival at two, three, four and five years. The final results include data from all 695 patients included in the EF-14 trial with a median follow-up of 40 months. The overall survival benefit was seen across all patient subgroups.
The two-year survival rate increased from 30% to 43% for patients treated with Optune together with temozolomide, while the five-year survival rate increased from 5% to 13%. These are the best results reported for newly diagnosed GBM patients in a Phase 3 trial to date and represent clinically meaningful increases in landmark survival rates.
The median overall survival for patients with newly diagnosed GBM was roughly 15 months. Combining Optune with temozolomide resulted in a statistically significant extension of median overall survival to 21 months.
Keep in mind that GBM is the most common form of primary brain cancer, with an estimated 12,500 people diagnosed in the U.S. annually.
Principal Investigator Roger Stupp, M.D., Associate Director for Strategic Initiatives at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University, commented:
When I started treating patients with GBM 20 years ago, the majority of patients died within less than one year and long-term survival was nearly absent. Now, we see a meaningful improvement in survival at two years and beyond. With the combination of Optune and temozolomide, one out of seven patients is living longer than five years.
This is the first positive phase 3 trial in newly diagnosed GBM since we demonstrated the efficacy of temozolomide in 2005, establishing it as a standard first-line therapy. Beyond GBM, I believe this trial establishes an entirely different approach to cancer treatment with minimal toxicity which may be well suited for combination with conventional treatments for many other cancer types.
Shares of NovoCure closed Friday at $8.10, with a consensus analyst price target of $19.50 and a 52-week trading range of $5.95 to $17.00. Following the announcement, the stock was up roughly 63% at $13.25 in early trading indications Monday.