Eisai Lenvima combined with Keytruda for bladder cancer fails to prolong patient's life!

CompilationTom Lee

Although Merck and Eisai's oral multi-receptor tyrosine kinase inhibitor Lenvima has obtained a series of positive trial data over the years, the combination therapy still seems to face a difficult problem in the field of bladder cancer

Lenvima in combination with Merck's Keytruda did not significantly prolong the lives of patients with newly diagnosed advanced urothelial cancer compared with Keytruda alone, according to newly released trial results

The results of the Phase 3 LEAP-011 clinical trial were presented today at the American Society of Clinical Oncology Genitourinary System (ASCO GU) Cancer Symposium

Regarding the results of this trial, Scot Ebbinghaus, MD, head of Merck's advanced tumor clinical development therapeutic area, is optimistic that the results further consolidate the clinical application of Merck's Keytruda monotherapy in patients who are not eligible for platinum-based chemotherapy

After Merck's Keytruda previously failed to show a survival benefit in a phase 3 confirmatory trial called KEYNOTE-361, the FDA has restricted the drug's use to populations similar to those enrolled in the LEAP-011 trial

Additionally, as part of an update to the indication label, the indication was changed for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not candidates for any platinum-containing chemotherapy regimen

Notably, this isn't the first time the Keytruda and Lenvima combination has encountered development setbacks

However, in January this year, another pivotal Phase 3 clinical trial of Keytruda and Lenvima combination therapy achieved positive data

Currently, anti-nectin-4 drugs have been previously approved for the treatment of bladder cancer

Reference source: ASCO GU: Merck, Eisai's Lenvima fails to improve on Keytruda in bladder cancer as key Padcev readout nears