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On Friday, Merck (NYSE:MRK) and Eisai (OTCPK:ESALF) (OTCPK:ESAIY) made the announcement that they will stop two late-stage combination trials for the cancer medication Keytruda in melanoma and colorectal cancer. This decision was made since the studies needed to meet their primary aims.
In individuals diagnosed with melanoma or colorectal cancer, the anti-PD-1 therapy combined with Eisai’s (OTCPK:ESALF) tyrosine kinase inhibitor Lenvima was the subject of two clinical trials, LEAP-003 and LEAP-017. The purpose of these studies was to determine whether or not the combination was an effective first-line or second-line treatment option.
A conclusion has been reached after considering an interim study by an impartial Data Monitoring Committee.
The panel concluded that LEAP-003 did not enhance overall survival (OS), which was one of the study’s dual main goals when compared to Keytruda by itself. Additionally, LEAP-017 did not meet the primary endpoint, OS, compared to regorafenib or TAS-102.
Nevertheless, an earlier analysis of LEAP-003 found that Keytruda and Lenvima met the trial’s second dual main goal, progression-free survival (PFS), with a statistically significant improvement relative to Keytruda plus placebo. This finding was based on the comparison of the two treatment groups.
In critical secondary goals of progression-free survival (PFS), including objective response rate (ORR) and duration of response (DOR), LEAP-017 showed benefits without reaching statistical significance.
Both trials found no new safety signals for the treatment combination, already licensed in countries including the United States and Japan for advanced renal cell carcinoma (RCC) and specific forms of advanced endometrial carcinoma. [C] areas in which the combination is used include renal cell carcinoma (RCC) and endometrial carcinoma.
Featured Image: Megapixl © Andreistanescu
Author Shariq Khan 
