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Merck’s Keytruda beats chemo in first-line colorectal cancer

Achieved “clinically meaningful” improvement in progression-free survival

Merck Keytruda

Merck & Co/MSD has new data for its checkpoint inhibitor Keytruda that could see the drug move into first-line use for highly mutated forms of colorectal cancer.

PD-1 inhibitor Keytruda has been approved as a second-line therapy after chemo for any tumour with microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) mutations – regardless of where it originates in the body – since 2017.

Now, data from the phase 3 KeyNote-177 study backs the efficacy of the drug compared to standard chemotherapy as a front-line therapy for MSI-H- or dMMR-positive colorectal cancer that had either spread to other parts of the body or couldn’t be surgically removed.

It’s the first single-agent therapy to improve on chemo in patients with this type of cancer, according to Merck, which says it intends to talk to regulators about a regulatory filing based on the results in the coming months.

Based on the top-line results, Keytruda achieved “clinically meaningful” improvement in progression-free survival (PFS) compared to standard therapy based on either the mFOLFOX6 or FOLFIRI chemo regimens, with or without Roche’s Avastin (bevacizumab) or Eli Lilly’s Erbitux (cetuximab).

The ongoing trial also includes overall survival as a second primary endpoint, but that data isn’t mature yet.

MSI-H and dMMR mutations are seen a cross a wide range of tumour types, but are most commonly seen in colorectal, endometrial and gastrointestinal cancers, occurring in around 10-15% of all colorectal tumours.

If Merck succeeds in getting approval for first-line MS-H/dMMR-mutated colorectal cancer it will steal a march yet again on Bristol-Myers Squibb, whose rival PD-1 drug Opdivo (nivolumab) was approved by the FDA in 2017 as a second-line therapy for metastatic colorectal cancer with MSI-H mutations.

The narrower approval in colorectal cancer only already put Opdivo at a disadvantage given Keytruda’s green light across any tumour location.

In an attempt to fight back, the company is testing the combination of Opdivo and its CTLA4 inhibitor Yervoy (ipilimumab) as a first-line therapy for MSI-H/dMMR-positive metastatic colon cancer in the phase 2 CheckMate-142 trial.

Data reported in 2018 showed that the combination had an overall response rate of 60%, including 7% complete responses. The trial is due to generate final results in 2022, according to the clinicaltrials.gov database.

Article by
Phil Taylor

3rd April 2020

From: Research

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