Novocure Announces Last Patient Enrolled in Phase 3 TRIDENT Trial in Newly Diagnosed Glioblastoma

Rhea-AI Summary

Novocure (NVCR) completes enrollment in TRIDENT trial, evaluating Optune Gio for newly diagnosed glioblastoma patients. Final data expected in 2026.

Medical Research Analyst

The TRIDENT clinical trial's exploration into the efficacy of TTFields therapy, combined with radiation therapy and temozolomide, has significant implications for the treatment of glioblastoma, a particularly aggressive type of brain cancer. The potential to enhance patient survival by introducing TTFields earlier in the treatment process could represent a major advancement in oncology. The comprehensive set of endpoints, including overall survival and progression-free survival, will provide a robust dataset for evaluating the treatment's impact. Additionally, the assessment of quality of life and neurological function reflects a holistic approach to understanding the therapy's benefits and limitations.

From a research perspective, the trial's design and scale are noteworthy. As the largest trial conducted by Novocure to date, it encompasses a substantial patient population, which will contribute to the statistical power and generalizability of the findings. The inclusion of secondary endpoints like radiological response and pathological changes offers a multi-faceted view of TTFields therapy's effectiveness, potentially informing future treatment protocols and guidelines.

Oncology Doctor

TTFields therapy, which utilizes electric fields to disrupt cancer cell division, has already been integrated into the treatment regimen for glioblastoma. The TRIDENT trial's initiative to combine TTFields with concurrent radiation therapy and temozolomide from the outset of treatment could potentially enhance the cytotoxic effect against tumor cells. This approach is based on preclinical evidence suggesting a synergistic effect when these therapies are applied in tandem.

Understanding the implications for patient management, the trial's focus on not just survival metrics but also on the quality of life is crucial. Glioblastoma treatments can be physically and cognitively taxing and the integration of TTFields has to be evaluated not only for its potential survival benefit but also for how it affects patients' day-to-day lives. The neurological assessments using the NANO scale will be particularly telling in this regard. The trial's results could lead to a shift in the standard of care for glioblastoma patients, emphasizing the importance of early and aggressive intervention.

Market Research Analyst

For stakeholders in Novocure and the broader oncology market, the TRIDENT trial represents a critical milestone that could influence the company's market position and valuation. The anticipation of final data in 2026 suggests a long-term investment horizon for those tracking the company's progress. The successful demonstration of improved efficacy in treating glioblastoma could lead to expanded indications for TTFields therapy, potentially increasing Novocure's addressable market and revenue prospects.

However, it is important to consider the competitive landscape and reimbursement challenges that could affect the adoption of TTFields therapy, even with positive trial results. The cost of therapy, insurance coverage and healthcare providers' willingness to adopt new treatments are all factors that will play a role in the commercial success of this treatment modality. Additionally, the impact on Novocure's stock will depend on the trial outcomes relative to investor expectations and the performance of competing therapies in the market.

Final data from the TRIDENT trial anticipated in 2026

ROOT, Switzerland--(BUSINESS WIRE)-- Novocure (NASDAQ: NVCR) today announced that the final patient has been enrolled in the global phase 3 TRIDENT clinical trial evaluating the safety and efficacy of initiating Optune Gio^® (formerly known as Optune^®) concurrent with radiation therapy and temozolomide (TMZ) for the treatment of adult patients with newly diagnosed glioblastoma (GBM).

“TTFields therapy has played a critical role in the treatment of newly diagnosed glioblastoma for nearly a decade, and the TRIDENT trial represents the potential evolution of this treatment paradigm by introducing TTFields earlier, at the same time as radiation therapy and temozolomide,” said Asaf Danziger, Novocure’s Chief Executive Officer. “Preclinical research has shown that the application of TTFields together with radiation therapy leads to a more pronounced cytotoxic effect in glioma cell lines as compared to TTFields after administration of radiation therapy. The TRIDENT study could unlock our ability to reach patients earlier in their treatment journey, further extending patient survival. We remain committed to exploring opportunities to further extend the survival horizon for patients diagnosed with glioblastoma.”

Optune Gio^® is currently approved for use together with maintenance TMZ for the treatment of newly diagnosed GBM following maximal debulking surgery and the completion of radiation therapy.

The TRIDENT clinical trial is a randomized, open-label study designed to enroll 950 adult patients with newly diagnosed GBM. Following maximal debulking surgery, patients enrolled in TRIDENT were randomized to receive either TTFields therapy, concomitant with TMZ and radiation therapy, or TMZ and radiation therapy for six weeks. Following the initial six-week period, all patients receive the current standard of care – TTFields therapy together with maintenance TMZ for a period of 24 months or until a second disease progression is experienced. TRIDENT began enrolling patients in December 2020 and is the largest trial Novocure has conducted to date.

Final data from the TRIDENT trial is anticipated in 2026. The trial’s primary endpoint is overall survival. Secondary endpoints are progression-free survival, one-year and two-year survival rate, overall radiological response, next progression-free survival, progression-free survival at six and 12 months, severity and frequency of adverse events, pathological changes in resected GBM tumors following study treatments, quality of life, dependence of overall survival on TTFields dose at the tumor, and neurological assessment using the NANO scale.

About Optune Gio

Optune Gio delivers Tumor Treating Fields (TTFields) therapy to the region of the tumor. Optune Gio, previously known as Optune, is a noninvasive, antimitotic cancer treatment for glioblastoma (GBM).

TTFields therapy uses electric fields to physically disrupt cell division. TTFields therapy does not stimulate or heat tissue and targets dividing cancer cells of a specific size. TTFields therapy takes advantage of the special characteristics and geometrical shape of dividing cells, which make them susceptible to the effects of the alternating electric fields. TTFields therapy causes minimal damage to healthy cells. Mild to moderate skin irritation is the most common side effect reported. TTFields therapy is approved in certain countries for the treatment of adults with glioblastoma, malignant pleural mesothelioma and pleural mesothelioma, some of the most difficult cancer types to treat.

Important Safety Information

Contraindications

Do not use Optune Gio in patients with an active implanted medical device, a skull defect (such as, missing bone with no replacement), or bullet fragments. Use of Optune Gio together with implanted electronic devices has not been tested and may theoretically lead to malfunctioning of the implanted device. Use of Optune Gio together with skull defects or bullet fragments has not been tested and may possibly lead to tissue damage or render Optune Gio ineffective.

Do not use Optune Gio in patients that are known to be sensitive to conductive hydrogels. In this case, skin contact with the gel used with Optune Gio may commonly cause increased redness and itching, and rarely may even lead to severe allergic reactions such as shock and respiratory failure.

Warnings and Precautions

Do not prescribe Optune Gio for patients that are pregnant, you think might be pregnant or are trying to get pregnant, as the safety and effectiveness of Optune Gio in these populations have not been established.

The most common (≥10%) adverse events involving Optune Gio in combination with temozolomide were thrombocytopenia, nausea, constipation, vomiting, fatigue, medical device site reaction, headache, convulsions, and depression.

The most common (≥10%) adverse events seen with Optune Gio monotherapy were medical device site reaction and headache.

The following adverse reactions were considered related to Optune Gio when used as monotherapy: medical device site reaction, headache, malaise, muscle twitching, fall and skin ulcer.

Use of Optune Gio in patients with an inactive implanted medical device in the brain has not been studied for safety and effectiveness, and use of Optune Gio in these patients could lead to tissue damage or lower the chance of Optune Gio being effective.

If the patient has an underlying serious skin condition on the scalp, evaluate whether this may prevent or temporarily interfere with Optune Gio treatment.

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 trials 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.

Forward-Looking Statements

In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Novocure’s current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, clinical study progress, development of potential products, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, coverage, collections from third-party payers and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe” or other words and terms of similar meaning. Novocure’s performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, environmental, regulatory and political conditions as well as issues arising from the COVID-19 pandemic and other more specific risks and uncertainties facing Novocure such as those set forth in its Annual Report on Form 10-K filed on February 23, 2023, and subsequent filings with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Novocure does not intend to update publicly any forward-looking statement, except as required by law. Any forward-looking statements herein speak only as of the date hereof. The Private Securities Litigation Reform Act of 1995 permits this discussion.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240109397768/en/

Investors & Media:

Ingrid Goldberg

610-723-7427

investorinfo@novocure.com

media@novocure.com

Source: Novocure

FAQ

What is the TRIDENT trial conducted by Novocure (NVCR)?

The TRIDENT trial is a global phase 3 clinical trial evaluating the safety and efficacy of initiating Optune Gio concurrent with radiation therapy and temozolomide for the treatment of adult patients with newly diagnosed glioblastoma.

When is the final data from the TRIDENT trial expected?

The final data from the TRIDENT trial is anticipated in 2026.

What is the current approval status of Optune Gio for glioblastoma treatment?

Optune Gio is currently approved for use together with maintenance TMZ for the treatment of newly diagnosed GBM following maximal debulking surgery and the completion of radiation therapy.

How many patients are enrolled in the TRIDENT trial?

The TRIDENT trial is designed to enroll 950 adult patients with newly diagnosed GBM.

What are the primary and secondary endpoints of the TRIDENT trial?

The primary endpoint is overall survival, and secondary endpoints include progression-free survival, one-year and two-year survival rate, overall radiological response, and more.