#Keynote 811 trial
#Keynote 811 plus

#Keynote 811 trial

The trial is still recruiting ( NCT03615326) and aims to enroll about 692 patients, Dr. Two additional analyses are planned, including the final analysis. As expected, immune-mediated adverse events, notably pneumonitis and colitis, were more common in the pembrolizumab group, but the lack of new signals observed with this treatment combination was encouraging, Dr. The interim safety analysis, which was based on 433 participants and a median follow-up of 9.9 months, found that the rates of all-cause adverse events, most commonly diarrhea, nausea, and anemia, were similar between the two groups. Pembrolizumab also led to deeper responses, with 11% of patients in this arm achieving a complete response compared with 3% in the placebo arm. The study found that the ORR for the pembrolizumab arm was 74.4% compared with 51.9% for the placebo arm, which represented a statistically significant difference of 22.7% (95% CI p = 0.00006). Thirty percent of patients in both arms were in Asia, and the remainder were equally distributed between North America, Europe, Israel, Australia, and the rest of the world.

The first interim analysis was prespecified to occur when 260 participants were enrolled and the median follow-up was at least 8.5 months, but it ended up including 264 participants with a median follow-up of 12.0 months. The majority of patients are receiving capecitabine and oxaliplatin chemotherapy, although the study also permits 5-fluorouracil and cisplatin. HER2-positive status is defined as immunohistochemistry (IHC) 3+ or IHC 2+ and in situ hybridization positivity.

#Keynote 811 plus

KEYNOTE-811 is enrolling patients irrespective of PD-L1 status, although 88% and 85% of the patients in the pembrolizumab and placebo (trastuzumab plus chemotherapy alone) arms at the interim timepoint, respectively, had a PD-L1 combined positive score ≥ 1. It marks the first approval of a PD-1 checkpoint inhibitor as a first-line treatment for these cancer types, in combination with the anti-HER2 agent trastuzumab plus chemotherapy, which has been the standard of care in the first-line setting since 2010. Janjigian, MD, of Memorial Sloan Kettering Cancer Center, who presented the findings. The combination is a “very exciting possibility to offer to our patients in clinic,” said Yelena Y. Food and Drug Administration to grant accelerated approval on May 5 to pembrolizumab in combination with trastuzumab and fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or GEJ adenocarcinoma. “This is a practice-changing study,” said Nataliya Volodymyrivna Uboha, MD, PhD, of the University of Wisconsin Carbone Cancer Center, who was the discussant for the Poster Discussion Session in which the study was presented. These results were presented during the 2021 ASCO Annual Meeting. The addition of pembrolizumab to trastuzumab plus chemotherapy leads to superior overall response rate (ORR) compared with trastuzumab plus chemotherapy alone among patients with HER2-positive unresectable or metastatic gastric and gastroesophageal junction cancer (GEJ), according to the first interim analysis of the global, phase III KEYNOTE-811 trial ( Abstract 4013).

The interim results of KEYNOTE-811 led to the FDA granting accelerated approval for pembrolizumab in combination with trastuzumab plus chemotherapy, which is the standard of care for patients with HER2-positive unresectable or metastatic gastric and gastroesophageal junction cancer in the first-line setting.

The first interim analysis of KEYNOTE-811, an ongoing, global phase III trial, found that the addition of pembrolizumab to trastuzumab plus chemotherapy for first-line treatment in patients with HER2-positive unresectable or metastatic gastric and gastroesophageal junction cancer improves overall response rate and is safe.