HONG KONG – Shanghai-based Zai Lab Ltd. has won an approval for the first innovative treatment for glioblastoma approved by China in more than 15 years, with the National Medical Products Administration’s (NMPA) nod for Optune in combination with temozolomide for use in patients with newly diagnosed glioblastoma (GBM), and also as a monotherapy for the treatment of patients with recurrent GBM.
Optune is a noninvasive, antimitotic treatment for GBM. Zai Lab combines its patch transductor with Novocure Ltd.’s platform therapy called Tumor Treating Fields.
According to Novocure, Tumor Treating Fields use electric fields tuned to specific frequencies to disrupt cell division. It does not stimulate or heat tissue and targets dividing cancer cells of a specific size. Thus, the treatment only causes minimal damage to healthy cells with mild to moderate skin irritation being the most common side effect reported.
Optune works by delivering the Tumor Treating Fields therapy to the region of the tumor.
"Optune was previously granted an innovative medical device designation, which highlights the differentiation and importance of this novel treatment for GBM patients,” said Samantha Du, the founder, chairperson and CEO of Zai Lab.
“We appreciate the NMPA for their partnership through this rapid and thorough assessment of the Optune application, and for recognizing the high unmet medical need it serves,” she added. “We look forward to working with Novocure to bring Tumor Treating Fields to GBM and other difficult to treat cancer indications.”
The company said that more than 15,000 GBM patients have been treated with Optune worldwide to date. Its global phase III pivotal study in newly diagnosed patients showed that adding Optune to chemotherapy more than doubled the five-year overall survival rate.
“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,” said Jiang Tao, the head of the Beijing Neurosurgical Institute, the founder of Chinese Glioma Genome Atlas and a professor of Beijing Tiantan Hospital.
“Optune was recommended by 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.”
GBM is the most common form of primary brain cancer, but not much progress has been made in its treatment. Though Zai Lab’s approval has broken the 15-year standstill in China, it could soon see competition from Sydney-based Kazia Therapeutics Ltd., which has a promising candidate in the works.
"The approval of Optune in China is an important step forward for glioblastoma patients, and we look forward to seeing the therapeutic toolkit expand further with new drug treatments such as Kazias's paxalisib," James Garner, Kazia CEO, told BioWorld.
The company recently reported very encouraging interim survival data from an ongoing phase II study with “very positive survival signals.” Final data from the trial are expected in early 2021.
The interim data showed a median overall survival (OS) of 17.7 months with paxalisib, compared to the 12.7 months associated with temozolomide, which is the existing drug treatment that is being paired with Zai Lab’s Optune.
However, temozolomide is ineffective in two-thirds of patients. And Kazia is hoping to fill in the gap.
“Meanwhile, an international pivotal study is being set up, and we expect to begin the recruitment of patients in the second half of 2020. Further data from ongoing studies in other forms of brain cancer will also be reported during the second half of the year," said Garner.
Novocure’s Tumor Treating Fields has also been approved for the treatment of malignant pleural mesothelioma (MPM) by the U.S. FDA under the humanitarian device exemption pathway. The companies expect that to be the next indication filed for NMPA approval.
Besides GBM and MPM, Tumor Treating Fields is being evaluated in global phase III pivotal trials for the treatment of brain metastases, non-small-cell lung cancer, pancreatic cancer and ovarian cancer, and in phase II pilot trials for liver cancer and gastric cancer.
That could be another big opportunity for the company, as approximately 1.5 million patients a year in China are diagnosed with non-small-cell lung cancer, pancreatic cancer, ovarian cancer and gastric cancer, collectively.
The GMB green light is Zai Lab’s second product approval in six months.