Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-80. A description of FDA expedited programs is in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics. CTRIAL-IE 18-21, MK3475-811 (KEYNOTE 811), Gastrointestinal, Industry. This application was granted priority review. This review used the Real-Time Oncology Review (RTOR) pilot program, which streamlined data submission prior to the filing of the entire clinical application, and the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment. View full prescribing information for Keytruda. The recommended pembrolizumab dose for adult patients with locally advanced unresectable or metastatic HER2 positive gastric or GEJ adenocarcinoma in combination with trastuzumab and chemotherapy is 200 mg every 3 weeks or 400 mg every 6 weeks. The adverse reaction profile observed in patients receiving pembrolizumab in Study KEYNOTE-811 is consistent with the known pembrolizumab safety profile. The median duration of response (DoR) was 10.6 months (range 1.1+, 16.5+) for patients treated with pembrolizumab and 9.5 months (range 1.4+, 15.4+) for those in the placebo arm. ![]() The ORR was 74% (95% CI 66, 82) in the pembrolizumab arm and 52% (95% CI 43, 61) in the placebo arm (one-sided p-value< 0.0001, statistically significant). The main efficacy measure for this analysis was overall response rate (ORR) assessed by blinded independent review committee. Patients were randomized (1:1) to receive pembrolizumab 200 mg or placebo every 3 weeks, in combination with trastuzumab and either fluorouracil plus cisplatin or capecitabine plus oxaliplatin. The accelerated approval comes less than a week after the FDA's Oncologic Drugs Advisory Committee voted 6 to 2 against maintaining accelerated approval for pembrolizumab in PD-L1-positive gastric or GEJ cancer.Īs a condition for accelerated approval, Merck may have to submit additional data confirming the benefit of this regimen in HER2-positive gastric cancer.On May 5, 2021, the Food and Drug Administration granted accelerated approval to pembrolizumab (Keytruda, Merck & Co.) in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma.Īpproval was based on the prespecified interim analysis of the first 264 patients of the ongoing KEYNOTE-811 (NCT03615326) trial, a multicenter, randomized, double‑blind, placebo‑controlled trial in patients with HER2‑positive advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma who had not previously received systemic therapy for metastatic disease. Patients enrolled in the clinical trial had tumors that were HER2-positive defined as either immunohistochemistry (IHC) 3+ or 2+, and HER2-positive according to in situ hybridization (ISH) or fluorescent in situ hybridization (FISH). The median duration of response was 10.6 months with the pembrolizumab-containing regimen versus 9.5 months in the placebo arm. The overall response rate among patients treated in the pembrolizumab arm was 74 percent, versus 52 percent for those in the placebo arm. KEYNOTE-811: ringing in IO-based therapy for HER2+ gastric cancer Previous phase II studies combining PD-1 antibody pembrolizumab with trastuzumab and chemotherapy have shown increased clinical. The agency based its approval on an interim analysis from the Phase III Keynote-811 trial, in which 264 patients with HER2-positive gastric or GEJ cancer were randomized to receive either the trastuzumab-chemotherapy combination plus pembrolizumab or the combination plus a placebo. NEW YORK – The US Food and Drug Administration on Wednesday granted accelerated approval to pembrolizumab (Merck's Keytruda) combined with trastuzumab (Genentech's Herceptin) and chemotherapy as a first-line treatment for patients with locally advanced or metastatic, HER2-positive gastric or gastroesophageal junction (GEJ) cancer.
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