Exploratory subgroup analysis from INNOVATE-3 finds that pegylated liposomal doxorubicin (PLD) -naïve patients randomized to receive TTFields therapy and paclitaxel had a median overall survival of 16.0 months compared to 11.7 months in PLD-naïve patients treated with paclitaxel alone
Novocure (NASDAQ: NVCR) today announced a late breaking abstract which reviews the results of an exploratory subgroup analysis of the phase 3 ENGOT-ov50 GOG-3029 INNOVATE-3 (INNOVATE-3) clinical trial has been selected for presentation at the "Best Oral Session Late Breaking Abstracts" on Sunday, March 10, 2024 at the European Society on Gynaecological Oncology (ESGO) 2024 Congress in Barcelona.
The randomized, phase 3 INNOVATE-3 clinical trial evaluated the use of Tumor Treating Fields (TTFields) therapy together with paclitaxel in platinum-resistant ovarian cancer (PROC) in patients with a maximum of five total prior lines of systemic therapy. While the INNOVATE-3 study did not meet its primary endpoint of overall survival in the intent-to-treat population, an exploratory analysis of a subgroup from the trial concluded that PLD-naïve patients treated with TTFields therapy and paclitaxel saw a significant improvement in overall survival compared to PLD-naïve patients treated with paclitaxel alone. Of the 558 total patients enrolled in the INNOVATE-3 clinical trial, 201 patients (36%) were PLD-naïve. Overall survival in PLD-naïve patients randomized to receive TTFields therapy and paclitaxel was 16.0 months (n=113), compared to 11.7 months in PLD-naïve patients randomized to receive paclitaxel alone (n=88). In the PLD-naïve subgroup, baseline demographics were similar across both cohorts. Novocure is further exploring the effect of doxorubicin on tumor tissue alteration and the potential consequences for TTFields dose. The findings from this post-hoc analysis may help explain the potential survival benefit observed in INNOVATE-3 patients who received only one prior line of therapy, as previously reported. TTFields therapy was well-tolerated, and no additive systemic toxicity or safety signals were observed.
"We are extremely pleased to share these data with our colleagues at ESGO and humbled by the selection for a best oral presentation session," said primary investigator Professor Ignace Vergote, MD, PhD, Professor at the Catholic University of Leuven, Belgium. "There is an immense clinical need for safe, effective and less toxic therapies for PROC patients and I look forward to continued exploration of TTFields therapy in gynecological cancers."
"The presentation of these data is an exciting achievement for the INNOVATE-3 investigators, as well as the Novocure team, reflecting exceptional work, collaboration and dedication," said Nicolas Leupin, MD, PhD, Novocure's Chief Medical Officer. "I would like to thank our collaborators, ENGOT and The GOG Foundation, for their partnership designing and conducting the INNOVATE-3 trial. These findings provide valuable new insights, and we are eager to continue exploring the capabilities of TTFields therapy in the treatment of solid tumors."
The exploratory analysis from the INNOVATE-3 data will be presented on Sunday, March 10, 2024 at 11:50 a.m. UTC+1 by Professor Vergote, and has been selected for inclusion in the "Best Oral Session Late Breaking Abstracts" as part of the European Society on Gynaecological Oncology (ESGO) annual congress.
About ENGOT-ov50 GOG-3029 INNOVATE-3
The ENGOT-ov50 GOG-3029 INNOVATE-3 clinical trial was designed to evaluate the safety and effectiveness of TTFields together with paclitaxel in patients with platinum-resistant ovarian cancer and a maximum of five total prior lines of systemic therapy. The primary endpoint of INNOVATE-3 was 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. Enrollment in the trial closed in October 2021 with 558 patients enrolled, beginning the minimum 18-month follow-up period. In 2023, Novocure announced the trial did not meet its primary endpoint. Together with investigators, the company will continue to analyze the data from the INNOVATE-3 trial.
The European Network for Gynaecological Oncological Trial groups ("ENGOT") and The GOG Foundation, Inc. ("GOG"), third-party clinical trial networks, collaborated with Novocure on the trial. Both ENGOT and GOG were involved in the development and facilitation of the trial at leading cancer centers in Europe and the United States.
About Ovarian Cancer
In the U.S., ovarian cancer ranks fifth in cancer deaths among women, with approximately 24,000 women diagnosed each year. Ovarian cancer incidence increases with age, and the median age at time of diagnosis is 63 years old.
Physicians use different combinations of surgery and pharmacological therapies to treat ovarian cancer, depending on the stage of the disease. Surgery is usually used in early stages of the disease and is usually combined with chemotherapy, including paclitaxel and platinum-based chemotherapy. Unfortunately, the majority of patients are diagnosed at an advanced stage when the cancer has spread outside of the ovaries to include regional tissue involvement and/or metastases. Platinum-based chemotherapy remains part of the standard of care in advanced ovarian cancer, but most patients with advanced ovarian cancer will have tumor progression or, more commonly, recurrence. Almost all patients with recurrent disease ultimately develop platinum resistance, and the prognosis for this population remains poor.
About Tumor Treating Fields Therapy
Tumor Treating Fields (TTFields) are electric fields that exert physical forces to kill cancer cells via a variety of mechanisms. TTFields do not significantly affect healthy cells because they have different properties (including division rate, morphology, and electrical properties) than cancer cells. The multiple, distinct mechanisms of TTFields therapy work together to selectively target and kill cancer cells. Due to its multimechanistic actions, TTFields therapy can be added to cancer treatment modalities in approved indications and demonstrates enhanced effects across solid tumor types when used with chemotherapy, radiotherapy, immune checkpoint inhibition, or PARP inhibition in preclinical models. TTFields therapy provides clinical versatility that has the potential to help address treatment challenges across a range of solid tumors. To learn more about Tumor Treating Fields therapy and its multifaceted effect on cancer cells, visit tumortreatingfields.com.
About Novocure
Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer through the development and commercialization of its innovative therapy, Tumor Treating Fields. Novocure's commercialized products are approved in certain countries for the treatment of adult patients with glioblastoma, malignant pleural mesothelioma and pleural mesothelioma. Novocure has ongoing or completed clinical studies investigating Tumor Treating Fields in brain metastases, gastric cancer, glioblastoma, liver cancer, non-small cell lung cancer, pancreatic cancer and ovarian cancer.
Headquartered in Root, Switzerland and with a growing global footprint, Novocure has regional operating centers in Portsmouth, New Hampshire and Tokyo, as well as a research center in Haifa, Israel. For additional information about the company, please visit Novocure.com and follow @Novocure on LinkedIn and Twitter.
About ENGOT and BGOG (https://engot.esgo.org and www.bgog.eu)
The European Network of Gynaecological Oncology Trial groups (ENGOT) is a platform that guarantees that the European spirit and culture is incorporated into the medical progress in gynaecological oncology, and that all European patients and countries can participate in an active way in clinical research and progress. The ultimate goal is to bring the best treatment to gynecological cancer patients through the best science and enabling every patient in every European country to access a clinical trial. The Belgium and Luxembourg Gynaecological Oncology Group (BGOG) is one of the founding study groups of ENGOT.
About The GOG Foundation, Inc. (GOG-F) (www.gog.org)
The GOG Foundation, Inc. is a not-for-profit organization with the purpose of promoting excellence in the quality and integrity of clinical and translational scientific research in the field of gynecologic malignancies. The GOG Foundation is committed to maintaining the highest standards in clinical trials development, execution, analysis, and distribution of results. The GOG Foundation is the only clinical trialist group in the United States that focuses its research on patients with pelvic malignancies, such as cancer of the ovary (including surface peritoneal malignancies), uterus (including endometrium, soft tissue sarcoma, and gestational trophoblastic neoplasia), cervix, and vulva. The GOG Foundation is multi-disciplinary in its approach to clinical trials, and includes gynecologic oncologists, medical oncologists, pathologists, radiation oncologists, oncology nurses, biostatisticians (including those with expertise in bioinformatics), basic scientists, quality of life experts, data managers, and administrative personnel.
About GOG Partners Program
Supported by industry, GOG Partners is structured to work directly with pharmaceutical organizations and operate clinical trials outside the National Cancer Institute (NCI) framework. The GOG Partners Program shares the same mission of the GOG Foundation dedicated to transforming the care in Gynecologic Oncology. By providing an alternative venue for patient accrual and site infrastructure support, GOG Partners has helped provide additional trials and opportunities for patients outside the national gynecologic clinical trials network.
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