*According to the information listed in the SmPC (Summary of Product Characteristics) LENVIMA plus KEYTRUDA is now 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 advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum-containing therapy in any setting and who are not candidates for curative surgery or radiation. This approval allows marketing of LENVIMA plus KEYTRUDA in all 27 EU member states plus Iceland, Liechtenstein, Norway and Northern Ireland. In the CLEAR/KEYNOTE-581 trial, the most common adverse reactions (≥30%) for LENVIMA plus KEYTRUDA* were diarrhoea (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 participation of many patients, families and healthcare providers made this approval possible, for which we are very grateful.” “We remain committed to continuing to explore this combination therapy with the goal of improving care for people living with cancer. “Renal cell carcinoma is the most common type of kidney cancer in both men and women, marking the significance of the European approval for the LENVIMA plus KEYTRUDA combination,” said Corina Dutcus, M.D., Vice President, Clinical Research, Oncology Business Group at Eisai Inc. ![]() “Today’s approval of KEYTRUDA plus LENVIMA brings a new treatment option to patients with advanced renal cell carcinoma in Europe, and further validates our efforts to research this promising combination of an immunotherapy and tyrosine kinase inhibitor for some of the most difficult-to-treat cancers.” Gregory Lubiniecki, Vice President, Clinical Research, Merck & Co., Inc., Kenilworth, N.J., U.S.A. “A key focus of our collaboration with Eisai is to advance our clinical development program to evaluate the potential of KEYTRUDA plus LENVIMA to improve responses across different types of cancer, including renal cell carcinoma,” said Dr. Patients treated with LENVIMA plus KEYTRUDA achieved a complete response (CR) rate of 16% and partial response (PR) rate of 55% versus a CR rate of 4% and a PR rate of 32% for patients treated with sunitinib. The objective response rate (ORR) was 71% (95% CI: 66-76) for patients treated with LENVIMA plus KEYTRUDA (n=355) versus 36% (95% CI: 31-41) for patients treated with sunitinib (n=357 p<0.0001). Median OS was not reached at the time of analysis in either study arm. The approval for advanced RCC is based on results from the pivotal Phase 3 CLEAR (Study 307)/KEYNOTE-581 trial, in which LENVIMA plus KEYTRUDA demonstrated statistically significant improvements versus sunitinib in the efficacy outcome measures of progression-free survival (PFS), reducing the risk of disease progression or death by 61% (HR=0.39 p<0.0001) with a median PFS of 23.9 months versus 9.2 months for sunitinib, and overall survival (OS), reducing the risk of death by 34% (HR=0.66 p=0.0049) versus sunitinib. ![]() (known as MSD outside the United States and Canada) today announced that the European Commission has approved the combination of LENVIMA (KISPLYX ® in the European Union for the treatment of advanced renal cell carcinoma ), the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, plus, KEYTRUDA, the anti-PD-1 therapy from Merck & Co., Inc., Kenilworth, N.J., U.S.A., for the first-line treatment of adult patients with advanced RCC. 29, 2021 – Eisai (Headquarters: Tokyo, CEO: Haruo Naito) and Merck & Co., Inc., Kenilworth, N.J., U.S.A.
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