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The approval based on the results of the CLEAR/KEYNOTE-581 trial proved that LENVIMA plus KEYTRUDA significantly reduced the risk of disease progression or death by 61%. The median progression-free survival was nearly two years, compared with nine months for sunitinib
KENILWORTH, Tokyo and New Jersey, November 29, 2021-(JCN Newswire)-Eisai and Merck (known as MSD outside the US and Canada) of Kenilworth, New Jersey, USA today announced that the European Commission has approved LENVIMA (EU KISPLYX) combination [EU] For the treatment of advanced renal cell carcinoma [RCC]), an oral multi-receptor tyrosine kinase inhibitor discovered by Eisai, plus KEYTRUDA, an anti-PD-1 therapy from Kenilworth Merck, New Jersey, USA, is used for the first-line treatment of advanced RCC in adult patients.
The approval of advanced RCC is based on the results of the key Phase 3 CLEAR (Study 307)/KEYNOTE-581 trial. In this trial, LENVIMA plus KEYTRUDA was shown to be comparable to sunitinib in the outcome indicators of progression-free survival (PFS). Compared with a statistically significant improvement, it reduces the risk of disease progression or death by 61% (HR=0.39 [95% CI, 0.32- 0.49]; p<0.0001), the median PFS of sunitinib was 23.9 months, while that of sunitinib was 9.2 months, overall survival (OS) reduced the risk of death by 34% (HR=0.66 [95% CI, 0.49-0.88]; p=0.0049) compared with sunitinib. None of the study groups reached the median OS at the time of analysis. The objective response rate (ORR) of patients treated with LENVIMA plus KEYTRUDA (n=355) was 71% (95% CI: 66-76), while patients treated with sunitinib (n=355) were 36% ( 95% CI: 31-41) =357; p<0.0001). Patients receiving LENVIMA plus KEYTRUDA achieved a complete remission (CR) rate of 16% and a partial remission (PR) rate of 55%, while patients receiving sunitinib had a CR rate of 4% and a PR rate of 32% .
“A focus of our collaboration with Eisai is to advance our clinical development plan to evaluate the potential of KEYTRUDA plus LENVIMA to improve the response of different types of cancer, including renal cell carcinoma,” said Dr. Gregory Lubiniecki, vice president of clinical research, Merck & Co. , Inc., Kenilworth Research Laboratory, New Jersey, USA. “Today’s approval of KEYTRUDA plus LENVIMA brings a new treatment option for patients with advanced renal cell carcinoma in Europe, and further validates our research on this promising immunotherapy and tyrosine kinase inhibition for some of the most difficult-to-treat cancers. Efforts of the combination of agents.”
“Renal cell carcinoma is the most common type of kidney cancer in men and women. This signifies the importance of the European approval of the LENVIMA plus KEYTRUDA combination,” said Corina Dutcus, MD, Vice President of Clinical Research, Eisai Oncology Group Inc. “We remain committed Yu continues to explore this combination therapy to improve the care of cancer patients. The participation of many patients, families, and healthcare providers has made this approval possible, for which we are very grateful.”
In the CLEAR/KEYNOTE-581 trial, the most common adverse reactions (≥30%) of LENVIMA plus KEYTRUDA* were diarrhea (61.8%), hypertension (51.5%), fatigue (47.1%), hypothyroidism (45.1%) , Decreased appetite (42.1%), nausea (39.6%), stomatitis (36.6%), proteinuria (33.0%), dysphonia (32.8%) and arthralgia (32.4%).
The approval allows the sale of LENVIMA and KEYTRUDA in all 27 EU member states as well as Iceland, Liechtenstein, Norway and Northern Ireland. LENVIMA plus KEYTRUDA has now been approved by the European Commission for two different types of cancer: for the first-line treatment of adult patients with advanced renal cell carcinoma, and for adult advanced or recurrent endometrial cancer that has progressed during or after previous treatment First-line treatment. In any case, platinum-containing therapy is not suitable for curative surgery or radiotherapy. *Based on the information listed in SmPC (Summary of Product Characteristics)
About CLEAR/KEYNOTE-581 Trial
The approval is based on data from the CLEAR (study 307)/KEYNOTE-581 trial (ClinicalTrials.gov, NCT02811861), a phase 3, multicenter, open-label, randomized trial in 1,069 patients with advanced RCC with clear cell components This is done in the middle, including other histological features such as sarcoma and papillary in the first-line setting. Regardless of the PD-L1 tumor expression status, patients were included in the study. The study excluded patients with active autoimmune diseases or medical conditions requiring immunosuppression. Randomization was stratified by geographic region (North America and Western Europe and the “rest of the world”) and Memorial Sloan Kettering Cancer Center (MSKCC) prognosis group (favorable vs. moderate vs. poor). The main efficacy outcome measure is based on blinded Independent Central Review (BICR) PFS, using RECIST 1.1, and the PFS results are consistent between pre-specified subgroups, MSKCC prognostic groups, and PD-L1 tumor expression status. The key secondary efficacy indicators are OS and ORR.
Patients were randomized at a ratio of 1:1:1 to receive LENVIMA (20 mg orally once a day) plus KEYTRUDA (200 mg intravenously every three weeks for up to 24 months), or LENVIMA (18 mg orally once a day) plus Ever Moss (5 mg orally once a day), or sunitinib (50 mg orally once a day for 4 weeks, then stop the drug for 2 weeks). Treatment continues until unacceptable toxicity or disease…
The full story can be found on Benzinga.com
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