KEYNOTE 177 COLORECTAL CODE
KEYNOTE 177 COLORECTAL FREE

“Before the KEYNOTE-177 trial, conventional chemotherapy with targeted therapy was the standard of care for patients with metastatic colorectal cancer who have tumours that are MSI-H/dMMR,” explained Dr Thierry Andre, professor of medical oncology at Sorbonne University and head of the medical oncology department at St. The treatment also more than doubled median progression-free survival (PFS) compared with chemotherapy (16.5 months versus 8.2 months). In addition, there was a lower incidence of Grade 3 or higher treatment-related adverse events (TRAEs) with KEYTRUDA compared with chemotherapy (22 percent versus 66 percent), and no new toxicities were observed. The approval is based on results from the Phase III KEYNOTE-177 trial, in which KEYTRUDA monotherapy significantly reduced the risk of disease progression or death by 40 percent, compared with chemotherapy. This approval marks the first gastrointestinal indication for KEYTRUDA in Europe and makes it the first anti-PD-1/L1 therapy approved in Europe for these patients. Whether the US FDA gives the green light without waiting for an OS analysis is now the main question.The European Commission (EC) has approved KEYTRUDA, Merck/MSD’s anti-PD-1 therapy, as a monotherapy for the first-line treatment of adult patients with metastatic microsatellite instability-high (MSI-H), or mismatch repair deficient (dMMR), colorectal cancer.

KEYNOTE 177 COLORECTAL CODE

Last month Merck had said it would move to share the Keynote-177 data with regulators, which tends to be code for a filing. The difference might be slight: MSI-high/MMRd tumours mainly comprise colorectal cancer, accounting for 15% of early metastatic and 4% of stage IV disease.īristol is running a phase III trial, Checkmate-8HW, in MSI-high/MMRd colorectal cancer that includes front-line subjects, but apart from this there do not appear to be any significant immediate challengers to Keytruda in this space. Shortly after Keytruda’s second-line tumour-agnostic approval Opdivo, as monotherapy or combined with Yervoy, secured a second-line label specifically in colorectal cancer that was MSI-high/MMRd. MSI (miscrosatellite instability) high and MMRd (mismatch repair-deficient) cancer has turned into something of a battleground between Merck and Bristol Myers Squibb. In the absence of OS data, another key factor in Keytruda’s favour is safety: grade 3 or higher treatment-related adverse events were seen in only 22% of Keytruda subjects, versus 66% in those on chemo control. Keynote-177 will continue to final analysis, at which point OS will be evaluated. Another peculiar feature of the PFS curves is that they cross over early on, suggesting that disease in some Keytruda patients initially progresses faster than with chemo, though this could be down to pseudoprogression.

KEYNOTE 177 COLORECTAL FREE

This bold statement is backed up by the fact that an astonishing 40% of Keytruda recipients appear still to be free of disease at over 40 months. some patients were cured of metastatic disease.” “In the past no medical treatment has shown such a difference in terms of improvement of PFS in metastatic colorectal cancer. “The study met one of the two primary endpoints, and is definitively a positive trial,” Dr André told an Asco press briefing. Indeed, the widening PFS curves with time shows that there likely have not been enough deaths to derive much meaning from an OS analysis. However, nothing has been revealed about Keytruda’s effect on Keynote-177’s second co-primary measure, OS, presumably because the data are insufficiently mature. Accordingly, the reduction in risk of progression across all subjects was 40% (p=0.0002), said Keynote-177’s lead author, Dr Thierry André of Hôpital Saint Antoine in Paris. Importantly, some subjects derived an especially strong PFS benefit, resulting in continued separation of the survival curves after the median was reached.

Keynote 177 colorectal