The side effect profile in patients treated with Keytruda was consistent with what has already been established with this particular drug, according to the release. In addition, Patients in the Keytruda group had a longer median duration of response compared with those in the placebo group (10.6 months versus 9.5 months. Some Isac assets are in very early monotherapy development, while others are in studies in combination with anti-PD-(L)1 antibodies. Fuchs, Shukui Qin, Taroh Satoh, Kohei Shitara . What Keynote-811 shows is that Her2 antagonism and immune system activation has legs, but crucially perhaps only if also combined with chemotherapy in a triple approach. Yelena Yuriy Janjigian, Yung-Jue Bang, Charles S.
#Keynote 811 plus#
The overall response rate (or the percentage of patients with partial or complete response to a therapy) was 74% in patients assigned Keytruda compared with 52% in those assigned placebo. KEYNOTE-811 pembrolizumab plus trastuzumab and chemotherapy for HER2+ metastatic gastric or gastroesophageal junction cancer (mG/GEJC): A double-blind, randomized, placebo-controlled phase 3 study. Both groups also received trastuzumab and either Xeloda (capecitabine) plus Eloxatin (oxaliplatin) or fluorouracil plus cisplatin. Patients were assigned either 200 milligrams of Keytruda or placebo every three weeks.
#Keynote 811 trial#
In this trial, patients were not previously treated with systemic therapy for metastatic disease. The KEYNOTE-811 trial (NCT03615326) built on the promising findings of the mEGA study and is an ongoing Phase III study of HER2+, metastatic or unresectable gastric or GEJ adenocarcinoma evaluating. This accelerated approval was based on an analysis of 264 patients with HER2-positive advanced gastric or GEJ adenocarcinoma from the ongoing KEYNOTE-811 trial, according to a release from the FDA.
Clinical trial registration: NCT03615326 ( Food and Drug Administration (FDA) approved Keytruda (pembrolizumab) for use with trastuzumab, fluoropyrimidine-and platinum-containing chemotherapy for first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma.
Here we aimed to describe the design of and rationale for the randomized, double-blind, placebo-controlled Phase III KEYNOTE-811 study, which will evaluate the efficacy and safety of pembrolizumab or placebo in combination with trastuzumab and chemotherapy as first-line treatment for patients with advanced HER2-positive gastric or gastroesophageal junction adenocarcinoma. Combining pembrolizumab with trastuzumab and chemotherapy may therefore provide a benefit for patients with advanced HER2-positive gastric cancer. Pembrolizumab has demonstrated promising antitumor activity in patients with advanced gastric or gastroesophageal junction adenocarcinoma as monotherapy, in combination with chemotherapy and in combination with trastuzumab. Clinical trial registration: NCT03615326 (.ĪB - Treatment options for patients with HER2-positive advanced gastric cancer are limited, and the prognosis for these patients is poor. N2 - Treatment options for patients with HER2-positive advanced gastric cancer are limited, and the prognosis for these patients is poor. T1 - First-line pembrolizumab/placebo plus trastuzumab and chemotherapy in HER2-positive advanced gastric cancer
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