Nivolumab plus RT and Temozolomide Tolerated in Glioblastoma
First-line nivolumab plus radiotherapy with or without temozolomide was tolerated by patients with glioblastoma.
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First-line nivolumab plus radiotherapy (RT) with or without temozolomide was tolerated by patients with glioblastoma, thus warranting continued development, according to updated safety results from the CheckMate 143 trial presented at the European Society of Medical Oncology (ESMO) 2017 Congress in Spain.1
The prognosis of glioblastoma is poor, with most patients experiencing recurrence despite treatment. The aim of the exploratory cohorts 1c and 1d of the CheckMate 143 trial was to evaluate the safety of nivolumab plus RT with or without temozolomide in the first-line setting among patients with newly diagnosed glioblastoma with or without methylated MGMT.
In cohort 1c, patients received 3 mg/kg every 2 weeks plus standard RT and concurrent temozolomide followed by adjuvant temozolomide for at least 6 cycles. Only patients with methylated MGMT were initially enrolled, but a second arm of patients with unmethylated MGMT was added.
Patients with unmethylated MGMT in cohort 1d received 3 mg/kg of nivolumab every 2 weeks plus standard RT. All patients continued nivolumab until progression or unacceptable toxicity.
Treatment was discontinued by 67% (both arms) and 83% of patients in cohorts 1c and 1d, respectively, primarily due to radiographic progression of disease. Discontinuations due to drug toxicity occurred in 8%, 9%, and 10% of patients in cohorts 1c (methylated and unmethylated disease) and 1d, respectively.
The rate of neurologic adverse events (AEs) was similar to that observed with other treatments for glioblastoma. The most common neurologic AEs were headache and seizure. Other common AEs included fatigue, nausea, constipation, and alopecia.
There were no deaths due to drug toxicity.
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The investigators stated that the nivolumab combination was well-tolerated, and these data support the ongoing CheckMate 498 and 548 trials.
Read more of Cancer Therapy Advisor's coverage of the European Society of Medical Oncology (ESMO) 2017 Congress by visiting the conference page.
- Lim M, Omuro A, Vlahovic G, et al. Nivolumab (nivo) incombination with radiotherapy (RT) ± temozolomide (TMZ): updated safety results from CheckMate 143 in pts with methylated or unmethylated newly diagnosed glioblastoma (GBM). Presented at: ESMO 2017 Congress; Madrid, Spain: September 8-12, 2017. Abstract 325O.