The regulator authorized MSD’s anti-PD-1 immunotherapy Keytruda (pembrolizumab) in combination with Eisai’s oral multiple receptor tyrosine kinase inhibitor Lenvima (lenvatinib) as the first-line treatment of renal cell carcinoma (RCC).
It also confirmed the combination therapy’s indication for endometrial carcinoma through a phase 3 confirmatory clinical trial.
The Ministry of Food and Drug Safety said on Tuesday that it allowed the combo of Keytruda and Lenvima to be used to treat RCC as first-line therapy and endometrial carcinoma.
The approval for the first-line treatment of RCC was based on data from the phase 3 CLEAR trial.
The CLEAR study showed that Keytruda+Lenvima proved statistically meaningful improvement in progression-free survival (PFS) and overall survival (OS) compared to the existing therapy of sunitinib.
The combination therapy reduced the risk of disease progression or mortality by 61 percent, and the risk of death, 34 percent, compared to sunitinib.
Keytruda+Lenvima also improved the objective response rate (ORR) compared to sunitinib (71 percent versus 36 percent). The complete response was 16 percent versus 4 percent, and the partial response, 55 percent versus 32 percent.
The most frequently observed adverse reactions in patients receiving Keytruda+Lenvima were diarrhea and hypertension.
Also, the Keytruda+Lenvima combo confirmed the existing indications for endometrial cancer treatment based on the results of the KEYNOTE-775/Study 309 study, a phase 3 trial. In addition, the combination therapy received incomplete approval from the MFDS in May 2020 based on the results of phase 2 KEYNOTE-146/Study 111 trial.
In the study, the Keytruda+Lenvima combo reduced the risk of death by 32 percent compared to chemotherapy (doxorubicin or paclitaxel). In addition, it lowered the risk of disease progression or death by 40 percent, statistically significant in both OS and PFS.
The median OS was 17.4 months in the Keytruda+Lenvima group vs. 12 months in the chemotherapy group. The median PFS was 6.6 months and 3.8 months, respectively.
Serious adverse reactions occurred in 50 percent of the Keytruda+Lenvima group, and the most common adverse events were hypertension (4.4 percent) and urinary tract infection (3.2 percent).