Commercial-stage global oncology company Novocure Ltd. (NVCR:NASDAQ) today announced "an update regarding its phase 3 pivotal LUNAR trial of Tumor Treating Fields (TTFields) in stage 4 non-small cell lung cancer (NSCLC) following platinum failure."
Novocure advised that after a pre-planned interim analysis review, the independent data monitoring committee (DMC) overseeing its Phase 3 LUNAR trial, determined that the trial should be accelerated given the length of accrual and the number of events observed in the clinical study and that no evidence of increased systemic toxicity has been observed. The analysis was based upon data gathered through February 2021 from 210 patients enrolled in the LUNAR trial.
The DMC recommended that the number of patients in the control group be reduced to 276 from 534 and that the follow-up time also be reduced to 12 months from 18 months as it believes those parameters will be sufficient to evaluate the primary and secondary endpoints and will also address some ethical concerns regarding the effects of the size of the patient pool and length of the trial on the control arm.
The firm stated that it has contacted the U.S. Food and Drug Administration (FDA) regarding the recommendations from the DMC and notified the agency of its plans to submit an Investigational Device Exemption (IDE) supplement taking into account the protocol adjustment recommendations.
Novocure's Executive Chairman William Doyle remarked, "We are very pleased with the DMC recommendations, which we believe support the potential for TTFields to make a significant difference in treatment outcomes for patients with non-small cell lung cancer, whether used together with immune checkpoint inhibitors or docetaxel...The accelerated interim analysis with an encouraging outcome adds to the accumulating evidence of Tumor Treating Fields' broad potential across a range of hard-to-treat cancers."
"Combination therapy is a cornerstone of cancer care, and we believe using TTFields together with other cancer treatments, including immunotherapies, may lead to better outcomes for some patients...We are very encouraged that, consistent with our expectations, the DMC concluded that TTFields exhibited no systemic toxicity. We will continue to develop TTFields as a limited toxicity backbone therapy upon which other standard-of-care and emerging cancer treatments can be added," Chairman Doyle added.
The company explained that "lung cancer is the most common cause of cancer-related death worldwide, and NSCLC accounts for approximately 85% of all lung cancers."
Novocure's CEO Asaf Danziger commented, "The completion of the LUNAR interim analysis is an important milestone for Novocure...Pending regulatory approval, the recommended protocol adjustments could accelerate trial completion by more than a year. We look forward to sharing final data from the LUNAR trial as quickly as possible."
The firm stated that the Phase 3 LUNAR clinical study was designed to test the effectiveness of TTFields used either together with immune checkpoint inhibitors or docetaxel compared to treatment of immune checkpoint inhibitors or docetaxel alone in patients with stage 4 NSCLC. The trial's primary endpoint is superior overall survival of patients across the different treatment cohorts.
The firm advised that TTFields are electric fields that have a unique frequency range of between 100 to 500 kHz, that disrupt cancer cell division. The company indicated that "when cancer develops, rapid and uncontrolled division of unhealthy cells occurs." The TTFields can be programmed to specifically target cancer cells while leaving healthy cells largely unaffected. Novocure noted that TTFields is intended primarily to be utilized in combination with other current standard-of-care cancer treatments such as radiation, chemotherapy and some immunotherapies.
The firm pointed out that scientific research studying TTFields has existed for many years and in preclinical research has displayed a consistent anti-mitotic effect. The company added that "the TTFields global development program includes a broad range of clinical trials across all phases, included four phase 3 pivotal trials in a variety of tumor types and that to date more than 18,000 patients have been treated with TTFields."
Novocure is a global oncology company headquartered in St. Helier, Jersey (U.K.) with additional operations in the U.S., Germany, Switzerland, Japan and Israel. The firm is focused on the development, application and commercialization of TTFields to improve and extend survival rated in highly aggressive forms of cancer. The company indicated that it has commercial products that have been approved in treating adult glioblastoma patients and for malignant pleural mesothelioma. In addition, Novocure noted that it is presently conducting several clinical trials in order to evaluate the beneficial effects of TTFields in the areas of brain metastases, glioblastoma, gastric, liver, ovarian, pancreatic and non-small cell lung cancers.
Novocure started the day with a market capitalization of around $13.5 billion with approximately 102.4 million shares outstanding and a short interest of about 4.6%. NVCR shares opened 50% higher today at $198.01 (+66.13, +50.14%) over yesterday's $131.88 closing price and reached a new 52-week high price this morning of $218.09. The stock has traded today between $179.88 and $218.09 per share and is currently trading at $199.05 (+$67.17, +51.04%).
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1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
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