Merck and Eisai’s combo of Keytruda and Lenvima has missed the mark yet again, rounding out a year of multiple trial flops for the pairing. This time, the duo chalked up a flop in a specific group of patients with endometrial carcinoma.
In a phase 3 study of patients with advanced or recurrent endometrial carcinoma whose disease is classified as mismatch repair proficient, not microsatellite instability-high or mismatch repair deficient, the combo as a first-line treatment couldn’t demonstrate an improvement in overall survival or progression-free survival over a platinum-based chemotherapy regimen. Therefore, the trial missed both its primary endpoints.
Merck “remains confident” in the benefits of the combo in the patient group and will “continue to research the Keytruda plus Lenvima combination in patients with other types of difficult-to-treat cancers,” vice president of global clinical development at Merck Research Laboratories, Dr. Gregory Lubiniecki, said in a press release.
Lubiniecki acknowledged the company’s “disappointment” in the results, while Eisai’s oncology global clinical development lead, Dr. Corina Dutcus, noted that the results “underscore the challenges” of treating patients with the disease.
A full evaluation of the data remains “ongoing”, the companies added in the release.
Despite the combo’s two approved uses to treat certain types of advanced endometrial carcinoma and advanced renal cell carcinoma, the duo has posted multiple trial fails just this year.
In September, the companies disclosed dual primary endpoint misses in the first-line treatment of certain patients with metastatic, nonsquamous non-small cell lung cancer (NSCLC). The combo also failed a study as a second-line therapy for patients with metastatic NSCLC whose disease worsened on a combo of platinum-containing chemotherapy and a PD-1/L1 immunotherapy.
In August, the partners shut down a phase 3 trial in newly diagnosed recurrent or metastatic PD-L1-positive head and neck squamous cell carcinoma. The combo did delay the progression of cancer, but it couldn’t significantly extend patients’ lives, leading Merck and Eisai to figure that the study wouldn’t be likely to meet statistical significance for overall survival.
The two similarly ended another phase 3 study in April, with that study testing the regimen as an initial treatment for unresectable or metastatic melanoma.
Meanwhile, the combination is also being studied across various tumor types including hepatocellular carcinoma, renal cell carcinoma, head and neck cancer, gastric cancer and esophageal cancer, among other cancers, the companies said.