Novocure (NASDAQ: NVCR) recently announced the FDA approval of Optune Pax® for the treatment of adult patients with locally advanced pancreatic cancer concomitant with gemcitabine and nab-paclitaxel. Optune Pax is a wearable medical device that delivers tumor-treating fields (TTFields), alternating electric fields that disrupt cancer cell replication to cause cell death, providing a new treatment approach for pancreatic tumors.
The FDA approval of Optune Pax is significant because it marks the first new treatment in decades for people living with locally advanced pancreatic cancer. The Panova-3 trial, a phase 3 clinical trial designed to evaluate the use of Optune Pax concomitantly with gemcitabine and nab-paclitaxel as a first-line treatment for locally advanced pancreatic cancer, demonstrated a statistically significant improvement in median overall survival (MOS) for patients treated with Optune Pax.
In the intent-to-treat population (ITT), patients treated with Optune Pax concomitantly with gem/nab-pac had an MOS of 16.2 months compared to 14.2 months for patients treated with gem/nab-pac alone. In the modified per protocol (MPP) population, patients treated with Optune Pax had an MOS of 18.3 months compared to 15.1 months in those treated with gem/nab-pac alone. These results show a statistically significant improvement in overall survival with the use of Optune Pax.
The one-year survival rate in the ITT population showed a significant improvement in the Optune Pax concomitant with gem/nab-pac treated group with 68.1% compared to 60.2% for those who received gem/nab-pac alone. In the MPP population, the one-year survival rate showed a significant improvement in the Optune Pax concomitant with gem/nab-pac treated group with 75.2% compared to 65.9% in patients who received gem/nab-pac alone.
Furthermore, time to pain progression was significantly extended for patients treated with Optune Pax concomitant with gem/nab-pac, with a median time to pain progression of 15.2 months compared to 9.1 months in the group treated with gem/nab-pac alone, representing a 6.1-month extension in time to pain progression.
Quality of life (QOL) was also measured, and treatment with Optune Pax concomitant with gem/nab-pac resulted in longer deterioration-free survival in global health status, pain, pancreatic pain, and most of the digestive problems.
It's worth noting that Optune Pax was well-tolerated and did not exacerbate gem/nab-pac-related systemic toxicity. Most Optune Pax-treated patients experienced the expected device-related skin adverse events, with the majority being mild to moderate.
The results from the phase 3 Panova-3 trial were published in the Journal of Clinical Oncology.
Pancreatic cancer is one of the most lethal cancers and is the third most frequent cause of death from cancer in the U.S. The FDA approval of Optune Pax represents a significant milestone for the pancreatic cancer community, providing a new treatment option for patients with locally advanced pancreatic cancer. As a result of these announcements, the company's shares have moved -1.16% on the market, and are now trading at a price of $13.64. For the full picture, make sure to review NovoCure Ltd's 8-K report.
