Novocure Initiates Phase 3 Pivotal Trial in Recurrent Ovarian Cancer.
M2 PHARMA-March 25, 2019-Novocure Initiates Phase 3 Pivotal Trial in Recurrent Ovarian Cancer
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- Jersey-based oncology company Novocure (NASDAQ: NVCR) has initiated INNOVATE-3, a phase 3 pivotal trial testing the efficacy of Tumor Treating Fields combined with paclitaxel in patients with recurrent, platinum-resistant ovarian cancer.
INNOVATE-3 is Novocure's fourth phase 3 pivotal trial initiated to study solid tumors beyond glioblastoma.
INNOVATE-3, a prospective, open-label study, will include 540 patients with recurrent, platinum-resistant ovarian cancer.
Patients will be randomised to receive either weekly paclitaxel alone or weekly paclitaxel in combination with Tumor Treating Fields tuned to 200 kHz until progression.
The primary endpoint is overall survival.
Secondary endpoints include progression free survival, objective response rate, severity and frequency of adverse events, time to undisputable deterioration in health-related quality of life or death, and quality of life.
Patients may have had a maximum of two prior lines of systemic therapy following diagnosis of platinum-resistance.
Novocure developed the trial design for INNOVATE-3 after learning the results of its phase 2 pilot trial of Tumor Treating Fields in combination with weekly paclitaxel, the INNOVATE trial.
In 31 evaluable patients, the INNOVATE trial suggested a more than doubling of progression free survival and an improvement in overall survival among patients who received Optune with paclitaxel compared to paclitaxel alone.
In the United States, ovarian cancer ranks fifth in cancer deaths among women, accounting for more deaths than any other cancer of the female reproductive system.
Ovarian cancer incidence increases with age, and the median age at time of diagnosis is 63 years old.
The incidence of ovarian cancer is approximately 22,500 new cases annually in the United States, approximately 68,000 new cases annually in Europe, and approximately 10,000 new cases annually in Japan.
Tumor Treating Fields is not approved for the treatment of ovarian cancer by the US Food and Drug Administration.
The safety and effectiveness of Tumor Treating Fields for ovarian cancer has not been established.
Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer by developing and commercialising its innovative therapy, Tumor Treating Fields. Tumor Treating Fields is a cancer therapy that uses electric fields tuned to specific frequencies to disrupt solid tumor cancer cell division.
Novocure's commercialised product is approved for the treatment of adult patients with glioblastoma. Novocure has ongoing or completed clinical trials investigating Tumor Treating Fields in mesothelioma, brain metastases, non-small cell lung cancer, pancreatic cancer, ovarian cancer and liver cancer.
Headquartered in Jersey, Novocure has US operations in Portsmouth, New Hampshire, Malvern, Pennsylvania and New York City.
Additionally, the company has offices in Germany, Switzerland, Japan and Israel.
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|Date:||Mar 25, 2019|
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