Pembrolizumab hikes survival by 36% at 24-month mark in cervical cancer study

Reuters Health - 20/09/2021 - Treatment with the checkpoint inhibitor pembrolizumab (Merck's Keytruda) can increase overall survival by 36% in patients with persistent, recurrent or metastatic cervical cancer, a new study has concluded.

The test of 548 patients produced a 24-month survival rate of 53.0% with pembrolizumab versus 41.7% in the volunteers given a placebo (P<0.001).

The metric of disease progression or death was 35% lower when given the drug in the intention-to-treat population.

All of the patients also received platinum-based chemotherapy with or without bevacizumab.

Results of the study, known as KEYNOTE-826, are published online by the New England Journal of Medicine and were presented at this year's European Society for Medical Oncology Congress. Merck paid for the study.

Cervical cancer is diagnosed in nearly 14,500 U.S. women each year, producing almost 4,300 deaths. For patients diagnosed in the U.S. with cervical cancer that has spread to a distant part of the body, the five-year survival rate is estimated to be approximately 17%.

The test was done at 151 centers in 19 countries. Of all the patients, 56% had previously received chemoradiotherapy with or without surgery and 20% entered the trial with untreated metastatic disease. Squamous-cell carcinoma was the diagnosis in 72%.

The treatment was given every 3 weeks for up to 35 cycles.

In the other primary endpoint, progression-free survival was 10.4 months with pembrolizumab after a median follow-up of 22 months among patients with a PD-L1 combined positive score of at least 1. It was 8.2 months in the control group. When the PD-L1 score was 10 or higher, the times in the respective groups were almost identical (P<0.001).

A complete response was seen in 21.4% with pembrolizumab and 12.9% with placebo in the intention-to-treat population.

Duration of response was 18.0 months and 10.4 months respectively.

"Serious adverse events occurred in 49.8% of the patients in the pembrolizumab group and in 42.4% of those in the placebo group," said the team, led by Nicoletta Colombo of the European Institute of Oncology in Milan.

"The only serious adverse events that occurred in at least 5% of the patients were febrile neutropenia (6.8% and 4.2% respectively) and urinary tract infection (5.2% and 5.8% respectively), they wrote.

Pembrolizumab seemed to produce more hypothyroidism and decreased white-cell counts. There was also a greater chance of immune-mediated adverse events; encephalitis killed one pembrolizumab patient.

SOURCE: https://bit.ly/2Z84hd4 The New England Journal of Medicine, online September 18, 2021.

By Reuters Staff



Posted on 20 September, 202128 September, 2021