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Keynote 177 colorectal8/11/2023 ![]() Two years of pembrolizumab therapy, for chemo, like pembrolizumab, and we stopped in the case of toxicity or in the case of progressive disease. The design of the trial was very simple, it was a randomisation, one to one, pembrolizumab 200mg every three weeks versus chemo – FOLFOX or FOLFIRI plus or minus cetuximab and bevacizumab. It was necessary to have a phase III to have labelling in first line, to have labelling in Europe and KEYNOTE-177 is this trial. We have a lot of trials with pembrolizumab, with nivolumab, with nivolumab and ipilimumab, with good efficacy in MSI high but refractory patients. The story began now five years ago with the first paper by the John Hopkins in the US with the incredible New England Journal of Medicine and after we have a lot of data. It’s clear that it’s a very particular tumour with a lot of neoantigens and a very high mutation tumour burden, that’s the reason. It’s also a rationale to use immuno-oncology and anti-PD1 because MSI has a lot of mutation, a lot of infiltration with lymphocytes. We know that MSI metastatic colorectal cancers are a little bit particular because the prognosis and the chemo sensibility is a little bit less compared to the microsatellite stable disease. 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 80.įor assistance with single-patient oncology investigational new drug applications, contact OCE’s Project Facilitate at 24 or email. A description of FDA expedited programs is in the Guidance for Industry-Expedited Programs for Serious Conditions-Drugs and Biologics. The application was granted priority review. FDA approved the application five months ahead of its goal date. ![]() The review used the Real Time Oncology Review pilot program Assessment Aid, a voluntary submission from the applicant to facilitate FDA’s assessment and Summary Level Review, which relied on qualified data summaries to support approval of a supplemental application. The review is ongoing for these three agencies. FDA is collaborating with Australia’s Therapeutic Goods Administration, Health Canada, and Swissmedic. For this application, a modified Project Orbis was undertaken because of the timing of submission to other regulatory agencies. Project Orbis provides a framework for concurrent submission and review of oncology drugs among international partners. įDA conducted the review under Project Orbis, an initiative of the FDA Oncology Center of Excellence. View full prescribing information for pembrolizumab. The recommended pembrolizumab dose for MSI-H/dMMR colorectal cancer is 200 mg every three weeks or 400 mg every six weeks. The most common adverse reactions (≥ 20%) were fatigue, musculoskeletal pain, decreased appetite, pruritus, diarrhea, nausea, rash, pyrexia, cough, dyspnea, constipation, pain, and abdominal pain. At the time of PFS analysis, OS data were not mature. The main efficacy outcome measures were progression-free survival (PFS) and overall survival (OS). Patients randomized to chemotherapy were offered pembrolizumab at the time of disease progression. Patients were randomized to receive pembrolizumab 200 mg via IV every three weeks or investigator’s choice of mFOLFOX6/FOLFIRI with or without bevacizumab or cetuximab via IV every two weeks. Investigators determined MSI or MMR tumor status locally using polymerase chain reaction or immunohistochemistry, respectively. Approval was based on a multicenter, international, open-label, active-controlled, randomized (1:1) trial (KEYNOTE ‑ 177 NCT02563002) that enrolled 307 patients with previously untreated unresectable or metastatic MSI-H or dMMR colorectal cancer.
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