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Merck and Eisai receive positive EU CHMP opinions for Keytruda plus Lenvima in advanced renal cell carcinoma and endometrial carcinoma.

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Last updated:17th Oct 2021
Published:17th Oct 2021
Merck Inc., and Eisai announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted positive opinions recommending approval of the combination of Keytruda, Merck’s anti-PD-1 therapy, plus Lenvima (marketed as Kisplyx in the European Union [EU]) for the treatment of advanced renal cell carcinoma [RCC]), the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, for two different indications.

One positive opinion is for the first-line treatment of adult patients with advanced RCC, and the other is for the treatment of adult patients with advanced or recurrent endometrial carcinoma (EC) who have disease progression on or following prior treatment with a platinum-containing therapy in any setting and are not candidates for curative surgery or radiation.

Decisions on the CHMP’s recommendations will be given by the European Commission for marketing authorization in the EU, and are expected in the fourth quarter of 2021. If approved, this would be the first combination of an anti-PD-1 therapy with a tyrosine kinase inhibitor approved for the treatment of two different types of cancer in the EU.

The positive CHMP opinions are based on data from two pivotal Phase III trials: CLEAR (Study 307)/KEYNOTE-581 evaluating the combination in adult patients with advanced RCC and KEYNOTE-775/Study 309 evaluating the combination in certain patients with advanced EC.

In CLEAR/KEYNOTE-581 , Keytruda plus Lenvima demonstrated statistically significant improvements versus sunitinib in the efficacy outcome measures of overall survival (OS), reducing the risk of death by 34% (HR=0.66 [95% CI, 0.49-0.88]; p=0.0049) versus sunitinib, and progression-free survival (PFS), reducing the risk of disease progression or death by 61% (HR=0.39 [95% CI, 0.32-0.49]; p<0.0001) with a median pfs of 23.9 months versus 9.2 months for sunitinib. additionally, the confirmed objective response rate was 71% (95% ci: 66-76) (n="252)" for patients who received keytruda plus lenvima versus 36% with sunitinib (95% ci: 31-41) (n="129)."></0.0001)>

In KEYNOTE-775/Study 309 , Keytruda plus Lemvima demonstrated statistically significant improvements in the study’s dual efficacy outcome measures of OS, reducing the risk of death by 38% (HR=0.62 [95% CI, 0.51-0.75]; p<0.0001) with a median os of 18.3 months versus 11.4 months for chemotherapy (investigator’s choice of doxorubicin or paclitaxel), and pfs, reducing the risk of disease progression or death by 44% (hr="0.56" [95% ci, 0.47-0.66]; p><0.0001), with a median pfs of 7.2 months versus 3.8 months for chemotherapy (investigator’s choice of doxorubicin or paclitaxel).></0.0001),></0.0001)>

Condition: Renal Cell Carcinoma
Type: drug

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