529P - Post-marketing surveillance data from patients ≥70 years of age with central nervous system malignancies treated with Tumor Treating Fields (TTFields) therapy between 2011–2022

Background

Glioblastoma (GBM) is among the most aggressive central nervous system (CNS) malignancies. Furthermore, older age is associated with increased risk of treatment-related systemic toxicity. TTFields are electric fields that exert physical forces to disrupt cellular processes critical for cancer cell viability. TTFields therapy is approved for recurrent and newly diagnosed GBM, following the pivotal phase 3 EF-11 (TTFields 200 kHz) and EF-14 studies (TTFields 200 kHz + temozolomide), respectively, which demonstrated clinical benefit without additional systemic adverse events (AEs). We report safety data from patients (pts) ≥70 years of age with CNS malignancies receiving TTFields from a global post-marketing surveillance (PMS) analysis.

Methods

Unsolicited PMS data were collected from pts receiving TTFields globally (October 2011–March 2022). Data from pts ≥70 years old are reported here. AEs were categorized using MedDRA version 25.1.

Results

Overall, 25,898 pts from the US, Europe and Israel, and Japan were included. Of these, 4,071 (16%) were ≥70 years old. Overall, 75% of patients ≥70 years old experienced ≥1 AE, with 56% being related to TTFields, which is comparable to the overall population (73% and 56%, respectively). The most common TTFields-related AEs in the ≥70-year-old population were skin reaction (45%; overall population: 43%), heat (warmth) sensation (11%; overall population: 14%), and electric (tingling) sensation (10%; overall population: 14%). Serious AEs for the ≥70-year-old and overall group were 27% and 22%, respectively. No systemic toxicities were reported, regardless of age.

Conclusions

These long-term, real-world PMS data demonstrate that TTFields has a tolerable safety profile in pts ≥70 years old with CNS malignancies, with no new safety signals. Most AEs were localized skin reactions which can be easily managed. Real-world data of TTFields therapy in elderly subgroups provides clinicians with insights on adapting strategies to optimize treatment management.

Clinical trial identification

Editorial acknowledgement

Medical writing and editorial assistance was provided by Prime, UK, funded by Novocure.

Legal entity responsible for the study

Novocure.

Funding

Novocure.

Disclosure

W. Shi: Financial Interests, Personal, Research Grant: Novocure Inc, Brainlab AG, Regeneron Pharmaceuticals, Inc.; Financial Interests, Personal, Advisory Role: Novocure Inc, , Varian Medical Systems Inc, Brainlab AG & Dohme Corp; Financial Interests, Personal, Advisory Board: Vascular Biogenics Ltd (VBL), ViruCure Therapeutics; Financial Interests, Personal, Speaker’s Bureau: Takeda; Financial Interests, Speaker’s Bureau: AstraZeneca. M. Glas: Financial Interests, Personal, Advisory Role: Roche Pharma, Novartis, AbbVie Inc, Novocure Inc, Daiichi Sankyo; Financial Interests, Personal, Other, Honoraria: Novartis, UCB Inc, TEVA Pharmaceuticals, Bayer Corp, Merck Sharp & Dohme Corp, Kyowa Kirin Group; Financial Interests, Personal, Other, Honoraria, travel fees: Novocure Inc, Medac. M.M. Mrugala: Financial Interests, Personal, Advisory Role: Alexion, Biocept, Merck. F.M. Iwamoto: Financial Interests, Personal, Advisory Role: AbbVie, Alexion Pharmaceuticals, Gennao Bio, Guidepoint Global, Kiyatec, Massive Bio, Medtronic, Merck, MimiVax, Novocure, PPD, Regeneron Pharmaceuticals, Inc., Tocagen, Xcures; Financial Interests, Personal, Research Funding: Bristol Myers Squibb, Celldex, Forma Therapeutics, Merck, Northwest Biotherapeutics, Novocure, Sapience Therapeutics; Financial Interests, Personal, Research Grant: Tocagen; Financial Interests, Personal, Other, Travel and accommodation: Oncoceutics. R.V. Lukas: Financial Interests, Personal, Research Grant: NCI P50CA221747, BrainUp grant 2136, Bristol Myers Squibb (drug support only for IIT); Financial Interests, Personal, Advisory Board: Merck; Financial Interests, Personal, Speaker’s Bureau: Novocure Inc , Merck; Financial Interests, Personal, Other, Honoraria: MedLink Neurology, EBSCO Publishing, Clinical Care Options. J. Palmer: Financial Interests, Personal, Advisory Role: Varian Medical Systems, Novocure; Financial Interests, Personal, Research Funding: NIH, Genentech. J. Suh: Financial Interests, Personal, Advisory Role: Novocure, Philips; Financial Interests, Personal, Speaker, Consultant, Advisor: Neutron Therapeutics, EmpNia; Financial Interests, Other, Travel: Novocure Inc .