Carboxyamidotriazole Orotate Shows Promising Activity in Brain Cancers

Excerpt:

“Carboxyamidotriazole orotate (CTO) in combination with temozolomide (Temodar), with or without radiotherapy, produced positive safety and efficacy results in a phase Ib study of patients with glioblastoma (GBM) or anaplastic gliomas.

“Forty-two patients were divided into 2 cohorts and received treatment. Cohort 1 included 27 patients with recurrent, temozolomide-refractory anaplastic gliomas or GBM. Twenty-one patients were assigned to a regimen of 219 to 812.5 mg/m2 of once-daily CTO in escalating doses and 6 were assigned to a fixed daily dose of 600 mg of CTO. All 27 patients received 150 mg/m2 of temozolomide on days 1 to 5 of each 28-day cycle.”

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NCCN Guidelines Recommend Optune in Combination with Temozolomide as a Category 1 Treatment for Newly Diagnosed Glioblastoma

Excerpt:

“NovoCure (NASDAQ: NVCR) announced today that the National Comprehensive Cancer Network (NCCN) has updated its clinical practice guidelines to recommend Optune® in combination with temozolomide as a category 1 treatment for newly diagnosed glioblastoma (GBM) in its globally recognized Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Central Nervous System Cancers.

“NCCN panel members designated alternating electric field therapy, or Optune, as a Category 1 treatment recommendation for patients with newly diagnosed GBM in conjunction with temozolomide after maximal safe resection and completion of radiation therapy in patients with newly diagnosed GBM.”

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Monoclonal Antibody Treatment in Newly Diagnosed Pediatric High-Grade Glioma

Excerpt:

“In a phase II study reported in the Journal of Clinical Oncology, Grill et al found that the addition of bevacizumab (Avastin) to radiotherapy plus temozolomide (RT + TMZ) did not improve event-free survival in pediatric patients with newly diagnosed high-grade glioma.

“In the international open-label study, 121 patients aged 3 to 18 years with localized nonbrainstem disease from 51 sites in 14 countries were randomized between October 2011 and February 2015 to receive RT + TMZ with (n = 62) or without (n = 59) bevacizumab 10 mg/kg every 2 weeks. RT + TMZ consisted of RT at 1.8 Gy 5 days per week and TMZ at 75 mg/m2 per day for 6 weeks followed by a 4 weeks off, then up to twelve 28-day cycles at 150 mg/m2 per day on days 1 to 5 in cycle 1 and 200 mg/m2 per day on days 1 to 5 in cycles 2 to 12. The primary endpoint was event-free survival on blinded central radiology review. Results are reported as of 12 months after the enrollment of the last patient.”

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Tumor-Treating Fields for Glioblastoma Do Not Negatively Impact Quality of Life

Excerpt:

“The addition of tumor-treated fields to standard therapy with temozolomide prolonged deterioration-free survival without negatively influencing health-related quality of life among patients with glioblastoma, according to a secondary analysis of a phase 3 clinical trial published in JAMA Oncology.

“However, tumor-treating fields, or TTFields (Optune, Novocure) — alternating electrical fields delivered via four transducer arrays at an intermediate frequency of 200 MHz (1-3 V/cm) placed on the shaved scalp of patients and connected to a portable medical device — also caused skin irritation in more than half of patients.”

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Electric Fields Therapy Improved Survival for Glioblastoma

Excerpt:

“The addition of tumor-treating fields to maintenance temozolomide chemotherapy significantly delayed progression and improved overall survival in patients with glioblastoma who had received standard radiochemotherapy compared with maintenance temozolomide alone, according to final results of a trial published in JAMA.

“Tumor-treating fields use low-intensity, alternating electric fields delivered via transducer arrays applied to the scalp. Patients treated with combined tumor-treating fields and temozolomide had a 37% improvement in progression-free and overall survival.”

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Electric Fields Therapy Improved Survival for Glioblastoma

Excerpt:

“The addition of tumor-treating fields to maintenance temozolomide chemotherapy significantly delayed progression and improved overall survival in patients with glioblastoma who had received standard radiochemotherapy compared with maintenance temozolomide alone, according to final results of a trial published in JAMA.

“Tumor-treating fields use low-intensity, alternating electric fields delivered via transducer arrays applied to the scalp. Patients treated with combined tumor-treating fields and temozolomide had a 37% improvement in progression-free and overall survival.”

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Cancer Drug Starts Clinical Trials in Human Brain-Cancer Patients

Excerpt:

“A drug that spurs cancer cells to self-destruct has been cleared for use in a clinical trial of patients with anaplastic astrocytoma, a rare malignant brain tumor, and glioblastoma multiforme, an aggressive late-stage cancer of the brain. This phase Ib trial will determine if the experimental drug PAC-1 can be used safely in combination with a standard brain-cancer chemotherapy drug, temozolomide.

“The trial is approved for patients who have seen their cancer progress after first-line therapy. This is an extension of an ongoing human phase I clinical trial of PAC-1 alone in patients with various late-stage cancers. Phase I  are designed to test the safety of new drugs in human patients.”

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Combination of Optune® with Temozolomide Demonstrates Unprecedented Five-Year Survival for Newly Diagnosed Glioblastoma Patients

Excerpt:

“Novocure (NVCR) announced today results from its phase 3 pivotal EF-14 trial adding Optune to temozolomide for the treatment of newly diagnosed glioblastoma (GBM), including results from health-related quality of life analyses, were presented at the American Society for Radiation Oncology’s (ASTRO) 2017 Annual Meeting in San Diego. This marks the first presentation of EF-14 five-year survival and quality of life data at a radiation oncology conference.

“A late-breaking oral presentation focused on Novocure’s EF-14 phase 3 pivotal trial, which demonstrated unprecedented five-year survival results in newly diagnosed GBM. Patients treated with Optune in combination with temozolomide experienced a significant extension of overall survival without added toxicity compared to patients treated with temozolomide alone. The data also showed that Optune-treated patients were able to maintain quality of life for longer compared to patients treated with temozolomide alone.”

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ACT IV: Rindopepimut Not Effective for Glioblastoma

Excerpt:

“The phase 3 study ACT IV showed that rindopepimut, an investigational vaccine against EGFRvIII, did not improve outcomes when added onto temozolomide (Temodar, Merck), the current standard of care. The combination of rindopepimut plus temozolomide provided a median survival of 20.0 months compared with 20.1 months for temozolomide alone in patients with newly diagnosed EGFRvIII glioblastoma and minimal residual disease (MRD) after surgical resection and adjuvant chemoradiation.

“The announcement that the trial results were negative was made some time ago, but full details of those results were published online August 22 in Lancet Oncology.”

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