MSD said Tuesday that the combined use of its cancer immunotherapy Keytruda (ingredient: pembrolizumab) and Eisai’s multi-kinase inhibitor Lenvima (ingredient: lenvatinib) has received approval as having an indication for progressive endometrial cancer.
Keytruda won the nod for the indication on May 21, and Lenvima, on May 11.
|MSD’s cancer immunotherapy Keytruda (right) and Eisai’s multi-kinase inhibitor Lenvima|
The Ministry of Food and Drug Safety granted its approval based on results from the phase 1b/2 “KEYNOTE-146/Study 111” trial, which evaluated the combination therapy in treating progressive endometrial cancer patients.
The patients were without Microsatellite Instability-High (MSI-H) or deoxyribonucleic acid Mismatch Repair Deficient (dMMR), and their disease progression was confirmed after systemic therapy but could not receive surgical or radiation therapy.
Researchers conducted the study on 108 endometrial cancer patients who had experienced systemic therapy. Among the patients, 94 had no MSI-H or dMMR corresponding to the approved indications.
The researchers intravenously administered 200 milligrams of Keytruda every three weeks and gave 20 milligrams of Lenvima daily.
Among the 94 patients, Keytruda and Lenvima combination therapy showed a 36.2 percent objective response rate at week 24 based on Immune-related Response Evaluation Criteria in Solid Tumors, which is the primary endpoint for patients without MSI-H or dMMR. The rate of complete remission was 2.1 percent, and partial remission was 34 percent. The median follow-up period was 18.7 months, which has not reached the median duration of response.
Hypertension, diarrhea, and fatigue, which are moderate to severe adverse events of grade three or higher, occurred in 69.4 percent of the patients.
Early uterine corpus cancer, including endometrial cancer, has a good five-year relative survival rate of 95 percent or higher. However, if the tumor spread far from the origin, the survival rate drops sharply to about one-third of 95 percent.
About 70 to 80 percent of the patients with recurrent endometrial cancer did not have MSI-H or dMMR, and they are likely to benefit from combination therapy.
“The permit has significance as it is the first case of Keytruda and Lenvima combination therapy and Keytruda’s female cancer indication,” MSD’s Oncology Business Unit Director Choi Jae-yoon said.
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