Add another failed trial to the list of setbacks for Merck and Eisai’s combination of Keytruda and Lenvima.
The two companies have decided to shut down a phase 3 trial testing the PD-1/TKI combo in newly diagnosed recurrent or metastatic, PD-L1-positive head and neck squamous cell carcinoma, they said Friday.
Although Lenvima helped Keytruda trigger more tumor responses and delayed the progression of cancer, the combo failed to significantly extend patients’ lives in the LEAP-010 trial. After analyzing the data at the second analysis, Merck and Eisai figured the study will likely never hit statistical significance for overall survival.
The companies are now running a full evaluation of the data. Lessons from the trial will help continue advancing research of this combination, Gregory Lubiniecki, M.D., VP of global clinical development at Merck Research Laboratories, said in a statement.
The combo’s failure in the front-line setting won’t affect another Keytruda-Lenvima study in previously treated patients, the two companies said. The phase 2 LEAP-009 trial is testing the two-drug regimen against either standard chemotherapy or Lenvima monotherapy in patients who have progressed on or after initial anti-PD1/L1 treatment.
LEAP-010 joins a long list of failures by the Keytruda-Lenvima pairing. Last year, the combo surprisingly—and narrowly—missed its goal in newly diagnosed liver cancer after Lenvima monotherapy outperformed its past record.
Then in April, Merck and Eisai cut the LEAP-003 first-line melanoma trial short. Similar to LEAP-010, the combo showed a tumor progression benefit that failed to translate into an overall survival advantage over Keytruda alone.
The pairing has also separately missed the mark in colorectal, bladder and PD-L1-positive non-small cell lung cancers (NSCLC).
Meanwhile, several phase 3 trials remain ongoing for the combo. The LEAP-006 trial adds Lenvima to the standard Keytruda-chemo regimen in first-line nonsquamous NSCLC. The trial’s estimated primary completion date was Monday, according to clinicaltrials.gov. The LEAP-015 trial is testing the combo in first-line gastroesophageal adenocarcinoma, as well.