In the CLEAR/KEYNOTE-581 trial, Keytruda plus Lenvima significantly reduced the risk of disease progression or death by 61%, compared to sunitinib
Merck Research Laboratories in South San Francisco, California. (Credit: Coolcaesar/Wikipedia.)
Merck and its partner Eisai have received Japan’s Ministry of Health, Labour and Welfare (MHLW) approval for their Keytruda plus Lenvima combination to treat metastatic renal cell carcinoma (RCC).
Keytruda is Merck’s anti-PD-1 therapy, used in cancer treatment. Lenvima is the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai.
The Keytruda plus Lenvima combination was previously approved in the US and Europe as the first-line treatment for advanced RCC in adults.
The current approval marks the combination’s second approval in Japan, following unresectable, advanced or recurrent endometrial carcinoma, granted in December last year.
Eisai Japan president and Eisai senior vice president Terushige Iike said: “Today’s milestone for KEYTRUDA plus LENVIMA as a treatment for radically unresectable or metastatic renal cell carcinoma is particularly exciting as it marks the second approval for the combination in Japan.
“We are thrilled to be able to provide Japanese patients with a new treatment option, illustrating our shared commitment with Merck to develop therapies with the aim of addressing the unmet needs of those living with difficult-to-treat cancers.”
The MHLW approval is based on results from the Phase 3 CLEAR/KEYNOTE-581 trial in 1,069 patients with advanced RCC in the first-line setting.
In the study, Keytruda plus Lenvima combination showed a statistically significant improvement in the primary efficacy outcome of progression-free survival (PFS).
The combination therapy reduced the risk of disease progression or death by 61%, with a median PFS of 23.9 months compared to 9.2 months for sunitinib.
The most common adverse reactions include diarrhoea, hypertension, hypothyroidism, decreased appetite, fatigue, stomatitis, proteinuria, nausea, dysphonia and asthenia.
Merck Research Laboratories oncology clinical research vice president Gregory Lubiniecki said: “Nearly one in three cases of renal cell carcinoma are diagnosed at an advanced stage, and patients are in need of new treatment options that may improve survival outcomes.
“In the CLEAR/KEYNOTE-581 trial, KEYTRUDA plus LENVIMA reduced the risk of disease progression or death by 61% versus sunitinib, a current standard of care.
“We are encouraged that patients with certain types of advanced renal cell carcinoma may have the opportunity to benefit from this combination.”