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NMPA approves Optune for glioblastoma
SHANGHAI & ST. HELIER, Jersey—Zai Lab Ltd. and Novocure recently announced that the China National Medical Products Administration (NMPA) has approved the Marketing Authorization Application (MAA) for Optune in combination with temozolomide for the treatment of patients with newly diagnosed glioblastoma multiforme (GBM) and as a monotherapy for the treatment of patients with recurrent GBM.
Novocure is an oncology company with a proprietary platform therapy called Tumor Treating Fields. Zai Lab is a research-based, commercial stage biopharmaceutical company based in China and the United States that is focused on bringing transformative medicines for cancer, autoimmune and infectious diseases to patients in China and around the world.
“The NMPA’s approval of Optune is a significant treatment advance for GBM patients in China and another important milestone for Zai. Optune was previously granted the Innovative Medical Device designation, which highlights the differentiation and importance of this novel treatment for GBM patients,” said Dr. Samantha Du, co-founder, chairperson and CEO of Zai Lab. “We look forward to working with Novocure to bring Tumor Treating Fields to GBM and other difficult to treat cancer indications.”
“Optune is a noninvasive, antimitotic cancer treatment for glioblastoma multiforme. Optune delivers Tumor Treating Fields (TTFields) to the region of the brain containing the tumor. TTFields are a novel cancer therapy that uses electric fields tuned to specific frequencies to disrupt cell division, leading to inhibition of tumor growth [and] death of tumor cells,” Du tells DDN. “TTFields do not stimulate or heat tissue, and target dividing cancer cells of a specific size. TTFields cause minimal damage to healthy cells, with mild-to-moderate skin irritation being the most common side effect reported. The therapy shows promise in multiple solid tumor types, including some of the most aggressive forms of cancer.”
Globally, more than 15,000 GBM patients have been treated with Optune to date. The TTFields technology is also approved by the U.S. Food and Drug Administration (FDA) under the Humanitarian Device Exemption pathway for the treatment of malignant pleural mesothelioma (MPM), which is anticipated to be the next MAA filed with the NMPA.
“The TTFields treatment modality is the brainchild of Prof. Yoram Palti, M.D, Ph.D., who hypothesized that alternating electric fields in the intermediate frequency range could disrupt cancer cell division and cause cancer cell death. TTFields are ... offering an alternative to surgery, radiotherapy, chemotherapy, targeted therapy and immunotherapy. GBM is the most common and deadliest type of primary brain cancer and Optune is the first FDA-approved treatment in more than a decade for newly diagnosed GBM,” Du notes.
“For patients with newly diagnosed GBM, Optune has proven to extend survival and maintain quality of life. A large clinical trial showed that the survival rate with Optune plus TMZ vs. TMZ alone was significantly higher at the two-year landmark analysis (43 percent vs. 31 percent), and remained higher at five years (13 percent vs. 5 percent),” she continues. “TTFields do not enter the bloodstream like a drug, so they did not significantly increase chemotherapy-related side effects.”
In addition to GBM and MPM, the TTFields technology is under evaluation in global Phase 3 pivotal trials for the treatment of brain metastases, non-small cell lung cancer (NSCLC), pancreatic cancer and ovarian cancer. TTFields technology is also in Phase 2 pilot trials for liver cancer and gastric cancer.
“We see significant market potential with TTFields due to their broad applicability in different cancers,” says Du. “When all the late stage/approved indications are taken together, the total addressable patient base could be as large as 1.5 million [or more] in China. GBM and MPM together contribute about 50,000 patients. The largest opportunity comes from NSCLC and gastric cancer, with more than 670,000 addressable patients, respectively.”
“Preliminary data from pilot trials show potential clinical benefit of TTFields as a complementary therapy in 2L+ NSCLC, 1L pancreatic cancer, and 2L+ ovarian cancer when compared to chemo-alone historical controls,” she adds. “Zai Lab will continue testing TTFields combined with chemotherapy in multiple other indications with our partner.”
“TTFields have been shown to exert their antimitotic effects in numerous clinical/preclinical models of solid tumors through the same mechanisms of action. For the same reason, we will collaborate with Novocure in other development activities for TTFields in multiple solid tumor indications in addition to GBM. We are working closely with our partner on several late-stage indications (four Phase 3 pivotal trials on-going for NSCLC, brain-metastases from NSCLC, pancreatic and ovarian),” explains Du. “We are focusing on NSCLC, pancreatic and brain-met, and joining global trials in [the second half of] 2020 for these three indications.”
SVB Leerink analysts wrote that “Optune represents a significant market opportunity for [Zai Lab] and we currently model sales of $339M in 2028 across both newly diagnosed and recurrent GBM. We also assign value for other indications where Optune is currently approved by the FDA (mesothelioma, 100% POS [probability of success]), or in Phase 3 development (65% POS for all), including non-small cell lung cancer (NSCLC, LUNAR trial), NSCLC with brain metastases (METIS trial), platinum-resistant ovarian cancer (prOC, INNOVATE-3 trial), and pancreatic cancer (PANOVA-3 trial).”
“In China, there are more than 45,000 patients diagnosed with GBM each year and this approval marks the first new treatment option for these patients in over 15 years,” stated Dr. Jiang Tao, head of the Beijing Neurosurgical Institute, founder of the Chinese Glioma Genome Atlas and a professor at Beijing Tiantan Hospital. “Optune was recommended with Level 1 evidence as a treatment for newly diagnosed GBM patients in China’s Glioma Treatment Guideline in 2018, and we are excited to now have Optune available as part of the standard of care for GBM patients in China.”
“Novocure is working to extend survival in some of the most aggressive cancers through the development and commercialization of Tumor Treating Fields,” concluded William Doyle, executive chairman of Novocure. “Approval of Optune for GBM in Greater China extends the promise of Tumor Treating Fields therapy to patients in the world’s largest market. We thank Zai Lab for their commitment and hard work and congratulate them on their second product approval in six months.”