NEW YORK (Reuters Health) – In patients with advanced gastric or gastro-esophageal cancer progressing after second-line treatment, monotherapy with pembrolizumab offers a “promising new treatment option,” according to research from Merck, which sells the drug as Keytruda.
“There is a critical need for new therapies for patients with gastric cancer. Our study demonstrates that pembrolizumab offers a real benefit for patients,” said lead author Dr. Charles S. Fuchs of Yale School of Medicine, in New Haven, Connecticut, who has consulted for the drugmaker.
Dr. Fuchs and colleagues, whose findings appeared online March 15 in JAMA Oncology, enrolled 259 patients from 16 countries in an open-label, single-arm study. Three-quarters of the patients were men. They were given pembrolizumab 200 mg intravenously every three weeks until disease progression, investigator or patient decision to withdraw, or unacceptable toxicity.
The median follow-up was 5.8 months and the median number of treatments was 4.0. Thirty of the patients (11.6%) showed an objective response and six (2.3%) had a complete response.
In addition, 95 patients (42.4%) had a reduction in measurable tumor size. The median duration of response was 8.4 months. However, the range extended beyond 17 months with no progressive disease being seen at the last assessment.
Forty-six patients had grade 3 to 5 treatment-related adverse events; two discontinued treatment and two died from treatment-related causes.
The researchers concede that the single-arm nature of the trial “limits our ability to compare the findings directly with available therapies for this patient population.”
However, Dr. Fuchs concluded, “we look forward to ongoing and future studies combining pembrolizumab with other therapies to further expand and enhance benefit.”
Dr. Axel Grothey, professor of oncology at the Mayo Clinic in Rochester, Minnesota, told Reuters Health by email that the trial “clearly demonstrated the efficacy of pembrolizumab as a single agent in advanced gastric and gastro-esophageal adenocarcinoma.”
“While the overall response and disease control rates might not be that impressive, the durability of response is astounding since it approached 2 years in select patients,” said Dr. Grothey, who was not involved with the study.
The work was funded by Merck Sharp & Dohme Corp, a subsidiary of Merck & Co, Inc, which was involved in all aspects of the study.
SOURCE: https://bit.ly/2IML9V9
JAMA Oncol 2018.
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