Immune checkpoint blockade has a predicted clinical benefit in patients with MSI-H/dMMR mCRC. These were the final results of the phase 3 KEYNOTE 177 trial. Pembrolizumab’s effectiveness when this mutation is present is well-recognized, and led to FDA’s first tissue-agnostic approval in May 2017.First-line treatment of patients with microsatellite instability-high/mismatch repair deficient (MSI-H/dMMR) metastatic colorectal cancer (mCRC) with pembrolizumab improved overall survival, but the prespecified threshold for significance was not reached. said in the statement that patients with colorectal cancer and the genetic mutations in the study have “historically faced poor outcomes, and until today, chemotherapy-containing regimens were the only FDA-approved first-line treatment options.”Ībout 5% of metastatic colorectal cancer patients have MSI-H/dMMR. Diaz, MD, head of the division of Solid Tumor Oncology, Memorial Sloan Kettering Cancer Center. Patients taking the PD-1 inhibitor may experience solid organ transplant rejection or complications from stem cell transplant.
KEYNOTE 177 COLORECTAL SKIN
Immune-related adverse events can include pneumonitis, colitis, hepatitis, skin reactions, renal dysfunction, and endocrinological abnormalities. “Our commitment to pursuing biomarker research continues to help us bring new treatments to patients,” he said, “particularly for those who have few available options.” “Today’s approval has the potential to change the treatment paradigm for the first-line treatment of patients with MSI-H colorectal cancer, based on the important findings from KEYNOTE-177 that showed Keytruda monotherapy demonstrated superior progression-free survival compared to standard of care chemotherapy,” Roy Baynes, MD, PhD, senior vice president and head of global clinical development, chief medical officer for Merck Research Laboratories, said in the statement.Īt ASCO, André trumpeted the value of biomarker-driven research, and Baynes did the same today. According to the Merck statement, the approval was reviewed under Project Orbis, an initiative of the FDA Oncology Center of Excellence that allows for concurrent submission and review of oncology drugs among its international partners-in this case, regulators in Australia, Canada, and Switzerland.
KEYNOTE 177 COLORECTAL LICENSE
The approval came less than a month after Merck submitted a supplemental Biologics License Application, which was handled through FDA’s Real-Time Oncology Review pilot program. From now on, he said, “It is critical that we test all colorectal cancer patients for mismatch repair or microsatellite status.” “No medical treatment has shown such an improvement,” André said.ĭiscussant Michael Overman, MD, of The University of Texas MD Anderson Cancer Center, agreed and said the tumors treated in the study were particularly good candidates for immunotherapy. Lead study author Thierry André MD, of the Sorbonne Université and Hôpital Saint Antoine in Paris, said at the time that the findings would change the standard of care. Results presented at ASCO showed that pembrolizumab doubled progression-free survival in these colorectal cancer patients, from 8.2 months to 16.5 months.
KEYNOTE 177 COLORECTAL TRIAL
The approval covers patients who have microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer and is based on results of KEYNOTE-177, a phase 3 trial of 307 patients that found the programmed cell death-1 (PD-1) inhibitor trimmed the risk of death of disease progression 40% compared with chemotherapy, which is the current standard of care (HR = 0.60, 95% CI: 0.45-0.80, P =. Merck, which makes pembrolizumab, sold as Keytruda, announced the approval in a statement.
FDA today approved pembrolizumab as a single-agent, first-line treatment for patients with unresectable or metastatic colorectal cancer and certain key genetic mutations, based on results that wowed virtual onlookers last month during the annual meeting of the American Society of Clinical Oncology (ASCO).
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