06 Aug Optune as Standard Treatment Option for Newly Diagnosed Glioblastoma
Novocure is the developer of Optune, which uses Tumor Treating Fields to treat cancer. Tumor Treating Fields, or TTFields, are low intensity, alternating electric fields within the intermediate frequency range. TTFields disrupt cell division through physical interactions with key molecules during mitosis. This non-invasive treatment targets solid tumors.
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: The National Comprehensive Cancer Network (NCCN) has recommended Optune as a standard treatment option for newly diagnosed glioblastoma (GBM) in its Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Central Nervous System Cancers. NCCN panel members designated Optune together with temozolomide as a category 2A treatment for newly diagnosed GBM for patients with good performance status, indicating uniform consensus among panel members to add Optune to the guidelines for newly diagnosed GBM. Optune has been included in the NCCN Guidelines as a category 2B treatment option for recurrent GBM since 2015. The recommendation follows the publication of Novocure’s EF-14 phase 3 pivotal trial data in The Journal of the American Medical Association (JAMA) in December, 2015. The EF-14 phase 3 pivotal trial demonstrated that adding TTFields to maintenance temozolomide chemotherapy significantly prolonged progression-free and overall survival in newly diagnosed GBM.
Glioblastoma, also called glioblastoma multiforme, or GBM, is a type of primary brain cancer. Approximately 12,500 GBM tumors, or tumors that may transform into GBM, are diagnosed in the U.S. each year. GBM is the most common type of primary brain cancer in adults. It is more likely to appear in older adults and to affect men than women. GBM is one of the deadliest forms of cancer, with patients typically not surviving beyond 15 months after diagnosis.
MedicalResearch.com: What is Optune? How does it work? What is temozolomide? How do they work in combination?
Response: Optune is Novocure’s first Tumor Treating Fields (TTFields) delivery system. TTFields are low intensity, alternating electric fields within the intermediate frequency range. TTFields disrupt cell division through physical interactions with key molecules during mitosis. This non-invasive treatment targets solid tumors. Novocure initially received U.S. FDA approval for Optune in 2011 for use as a monotherapy treatment for adult patients with GBM following confirmed recurrence after chemotherapy. We have built a commercial organization and launched Optune in the United States, Germany, Switzerland and Japan, which we refer to as our currently active markets. In November 2014, our phase 3 pivotal trial of Optune in combination with chemotherapy for patients with newly diagnosed GBM met its endpoints after a protocol pre-specified interim analysis showed significant improvements in both progression free and overall survival.
In October 2015, we received U.S. FDA approval to market and sell Optune for the treatment of adult patients with newly diagnosed glioblastoma in combination with temozolomide. We are actively marketing for that indication in the United States, Germany and Switzerland. In the same month, we also received CE mark for our newly designed second generation Optune system – which is half the weight and size of the original system – and have since made it available to all new patients in Europe. In December 2015, we submitted the registration dossier for premarketing approval of Optune to treat newly diagnosed GBM to the Japanese Pharmaceutical and Medical Device Agency (JPMDA). On July 13, 2016, the U.S. FDA approved our premarket approval (PMA) supplement application for our second generation Optune system. The new smaller, lighter Tumor Treating Fields (TTFields) delivery system is now available to glioblastoma (GBM) patients in the United States. We believe that TTFields will transform the standard of care for patients with GBM.
Temozolomide, brand names Temodar and Temodal and Temcad, is an oral chemotherapy drug. It is an alkylating agent used as a treatment of some brain cancers, e.g., as a second-line treatment for astrocytoma and a first-line treatment for glioblastoma. Optune with temozolomide is indicated for the treatment of adult patients with newly diagnosed, supratentorial glioblastoma following maximal debulking surgery and completion of radiation therapy together with concomitant standard of care chemotherapy. In the United States, for the treatment of recurrent GBM, Optune is indicated following histologically-or radiologically-confirmed recurrence in the supratentorial region of the brain after receiving chemotherapy.
MedicalResearch.com: Is there anything else you would like to add?
Response: Scientific evidence suggests TTFields therapy is broadly applicable to solid tumors; and our R&D team continues to make progress toward developing TTFields for additional tumor types. In the past three months, we enrolled the last patients in our PANOVA and INNOVATE phase 2 pilot trials in advanced pancreatic cancer and recurrent ovarian cancer, respectively, and received FDA approval of our IDE application to initiate our METIS phase 3 pivotal trial in brain metastases. Recent findings strengthen our belief that treatment with TTFields is compatible with both current standards of care and emerging novel therapies for a variety of solid tumors. We believe that TTFields, with the potential of superior outcomes and no systemic toxicity, will play a valuable role in the treatment of solid tumors.
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- NCCN Guidelines Now Recommend Optune as a Standard Treatment Option for Newly Diagnosed Glioblastoma
Sampson JH. Alternating Electric Fields for the Treatment of Glioblastoma. JAMA.2015;314(23):2511-2513. doi:10.1001/jama.2015.16701.
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