Overall median survival was 21.4 months with the drug versus 14.3 months with best supportive care. That translated to one-year survival rates of 71.3% with avelumab and 58.4% without (P=0.001).
But the volunteers didn't go long without the tumor getting worse.
Median progression-free survival lasted only 3.7 months with the drug versus 2.0 months in the control group.
"Separation of the overall survival curves and the progression-free survival curves in favor of avelumab occurred early in the course of treatment and was maintained," said the team, led by Dr. Thomas Powles of Queen Mary University of London.
The avelumab group had nearly double the rate of adverse events of grade 3 or higher, although the rates for individual events were low.
Pfizer and Merck, which sell avelumab under the brand name Bavencio, financed the study. The findings were reported at the European Society for Medical Oncology (ESMO) Virtual Congress and published online by the New England Journal of Medicine.
Based on data supplied to the Pan-Canadian Oncology Drug Review, the cost of those extra seven months of life was roughly $200,000.
All of the 700 volunteers in the phase 3 test had unresectable local disease and had not experienced disease progression after first-line treatment with gemcitabine plus cisplatin or carboplatin given over four to six cycles.
The research team also found that the drug was effective against tumors that were positive for programmed cell death ligand 1. PD-L1-negative patients did not appear to benefit.
In the PD-L1-positive group, survival at 1 year was 79.1% with the drug and 60.4% without. Median progression-free survival was a bit longer than it was in the overall population of patients -- 5.7 months with avelumab and 2.1 months without.
The rate of grade 3 adverse events was 47.4% with the drug versus 25.2% in the control group.
The most common side effects of the treatment were fatigue (seen in 18%), pruritus, diarrhea and urinary tract infection (17%), and arthralgia, asthenia, constipation, back pain and nausea (16%). The highest rates of side effects of grade 3 or higher were for urinary tract infection and anemia (both at 4%).
Combination platinum-based chemotherapy typically controls the disease in 75% to 80% of patients, but most have disease progression within 9 months with a median overall survival time of 14 to 15 months when cisplatin-based regimens are used, the researchers said. The time is 9 to10 months with carboplatin-based regimens.
By Reuters Staff
SOURCE: https://bit.ly/35RI3NP The New England Journal of Medicine, online September 18, 2020.
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