TIGER Study Reports New TTFields Therapy Survival Results for Newly Diagnosed Glioblastoma Patients in Germany

Rhea-AI Summary

Novocure (NASDAQ: NVCR) has announced results from the TIGER study, which investigated the use of Tumor Treating Fields (TTFields) therapy for newly diagnosed glioblastoma (GBM) in Germany. The study, conducted from August 2017 to November 2019, included 429 patients and is the largest prospective, non-interventional study of TTFields therapy to date. Key findings indicate a median overall survival of 19.6 months and a median progression-free survival of 10.2 months. The therapy was well tolerated with no increase in systemic toxicity. One-year, two-year, three-year, and four-year survival rates were 79.2%, 42.4%, 31.5%, and 27.7%, respectively. These results align with previous phase 3 EF-14 clinical trial outcomes. The data will be presented at the 2024 American Society of Clinical Oncology Annual Meeting.

Positive

• Largest prospective, non-interventional study of TTFields therapy in newly diagnosed GBM with 429 patients.
• Median overall survival was 19.6 months (95% CI, 17.9-22.4).
• Median progression-free survival was 10.2 months (95% CI, 9.4-11.4).
• One-year, two-year, three-year, and four-year survival rates were 79.2%, 42.4%, 31.5%, and 27.7%, respectively.
• TTFields therapy was well tolerated with no increase in systemic toxicity.
• Study results are consistent with previous phase 3 EF-14 clinical trial outcomes.

Negative

• The median overall survival of 19.6 months, while positive, may still be seen as insufficient for long-term expectations.
• Despite promising survival rates, the majority of patients still do not survive beyond four years.
• The study does not address potential long-term side effects beyond the median follow-up of 56.2 months.

Oncology Doctor

The TIGER study results provide promising news for patients with newly diagnosed glioblastoma (GBM). The reported median overall survival of 19.6 months and median progression-free survival of 10.2 months are notable statistics that can offer hope to GBM patients, a group historically associated with poor prognosis. For context, traditional treatment methods for GBM—typically surgery, radiation and chemotherapy—often yield median overall survival times around 12-15 months. The study’s long follow-up period of over 56 months and the consistent survival rates over one to four years further reinforce the potential efficacy of TTFields therapy in not only extending life but also maintaining quality of life due to its well-tolerated nature. This data supports the argument for TTFields therapy becoming a standard care consideration for newly diagnosed GBM patients.

Medical Research Analyst

The significance of the TIGER study extends beyond individual patient outcomes. It represents a substantial contribution to existing literature, corroborating earlier phase 3 clinical trial results with real-world data. Such large-scale, prospective, non-interventional studies are critical in validating the efficacy and safety of new therapies in routine clinical practice. The lack of increased systemic toxicity is a key finding, as it indicates that TTFields therapy does not add to the burden of side effects that patients typically endure with conventional treatments. The results suggest that TTFields could be a complementary therapy, potentially integrated into current treatment regimens without exacerbating side effects. This expands the attractiveness of TTFields therapy from a clinical and patient-reception standpoint.

Financial Analyst

Novocure’s release of the TIGER study results could have a positive impact on the company’s stock performance. The data showcases the effectiveness of TTFields therapy in a real-world clinical setting, potentially increasing physician adoption and payer support. Investors should note the consistency of these findings with earlier trials, which could bolster confidence in the therapy’s market viability. Moreover, the presentation of this data at a prominent conference such as the American Society of Clinical Oncology Annual Meeting will likely boost visibility and credibility within the medical community. In the short-term, this might drive positive sentiment and stock price appreciation. In the long-term, the potential for increased market penetration and expanded indications for TTFields therapy could provide sustained financial growth for Novocure.

Durable survival effect observed in the largest prospective, non-interventional study completed examining TTFields therapy use in newly diagnosed GBM

Topline data to be presented Saturday, June 1, 2024 at the 2024 American Society of Clinical Oncology Annual Meeting in Chicago

ROOT, Switzerland--(BUSINESS WIRE)-- Novocure (NASDAQ: NVCR) today released topline efficacy and safety data from the TIGER study investigating the use of Tumor Treating Fields (TTFields) therapy in routine clinical care in the treatment of patients with newly diagnosed glioblastoma (GBM) in Germany. The TIGER study enrolled 429 patients who used TTFields therapy between August 2017 and November 2019 and is the largest prospective, non-interventional study of the use of TTFields therapy in routine clinical care completed to date.

Median overall survival for patients treated with TTFields therapy was 19.6 months (95% CI, 17.9-22.4). Median progression-free survival was 10.2 months (95% CI, 9.4-11.4). TTFields therapy use was not associated with an increase in systemic toxicity and was well tolerated. The outcomes observed in the TIGER study are consistent with the survival and safety results from Novocure’s phase 3 EF-14 clinical trial.

Patients were followed for a median duration of 56.2 months. One-, two-, three-, and four- year survival rates were 79.2%, 42.4%, 31.5%, and 27.7%, respectively.

“As TTFields therapy use becomes more prevalent around the globe, it is exciting to see large, prospective studies like TIGER corroborate the survival benefits provided by using TTFields therapy to treat newly diagnosed GBM,” said Oliver Bähr, MD, Department of Neurology, General Hospital Aschaffenburg-Alzenau. “The outcomes observed, particularly long-term survival rates, are promising and make a compelling case that TTFields therapy should be presented to all eligible GBM patients.”

“TIGER is the largest prospective, non-interventional study analyzing TTFields therapy use in newly diagnosed GBM completed to date,” said Nicolas Leupin, MD, Novocure’s Chief Medical Officer. “The observations from TIGER contribute to the multitude of data validating the use of TTFields therapy, and we are eager to continue exploring the benefits of our therapy in both the clinical and real-world settings.”

The TIGER data (abstract #2036) will be presented at 9:00 a.m. CDT on Saturday, June 1, 2024 in Hall A during the Central Nervous System Tumors session at the 2024 American Society of Clinical Oncology Annual Meeting in Chicago.

About TIGER

TIGER (NCT03258021) is a prospective, non-interventional, multicenter, medical device post-authorization study designed to obtain real life data on the use of Tumor Treating Fields (TTFields) therapy in patients with newly diagnosed glioblastoma in routine clinical care in Germany. 710 patients with histologically confirmed newly diagnosed glioblastoma, who had clinical indication for TTFields therapy and were within the first 3 cycles of maintenance chemotherapy treatment were enrolled in the study from August 2017 to November 2019, across 81 participating centers in Germany. 583 patients opted to use TTFields therapy, and 429 received treatment. Endpoints of the study included overall survival, progression-free survival, safety and quality of life.

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 targeted therapies 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 and malignant 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.

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 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 22, 2024, 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/20240522936209/en/

INVESTORS AND MEDIA:

Ingrid Goldberg

investorinfo@novocure.com

media@novocure.com

Source: Novocure

FAQ

What are the survival rates for patients using TTFields therapy in the TIGER study?

The one-year, two-year, three-year, and four-year survival rates were 79.2%, 42.4%, 31.5%, and 27.7%, respectively.

What is the median overall survival for newly diagnosed GBM patients treated with TTFields therapy according to the TIGER study?

The median overall survival was 19.6 months.

When and where will the TIGER study data be presented?

The data will be presented on Saturday, June 1, 2024, at the 2024 American Society of Clinical Oncology Annual Meeting in Chicago.

Was TTFields therapy associated with an increase in systemic toxicity in the TIGER study?

No, TTFields therapy was well tolerated and did not show an increase in systemic toxicity.

How many patients were enrolled in the TIGER study for TTFields therapy?

The study enrolled 429 patients.

What is the significance of the TIGER study for TTFields therapy?

The TIGER study is the largest prospective, non-interventional study of TTFields therapy in routine clinical care, corroborating its survival benefits for newly diagnosed GBM.