Keytruda failed to meet the primary endpoints in mCRPC and 1L uHCC | iParmaCenter

Merck has announced the results of two Phase 3 trials of Keytruda - in combination with Lenvima in unresectable hepatocellular carcinoma (uHCC) as first-line therapy and patients with metastatic castration-resistant prostate cancer in combination with chemotherapy.

In the Phase 3 KEYNOTE-921 trial, Keytruda was evaluated in combination with chemotherapy in patients with metastatic castration-resistant prostate cancer (mCRPC). Keytruda failed to meet the primary endpoint of overall survival (OS) and radiographic progression-free survival (rPFS). Further, Merck announced that the safety profile is consistent with the previously reported studies.

Merck is evaluating the efficacy of Keytruda in patients with prostate cancer in different trials. In KEYNOTE-641, it is under evaluation in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer. In KEYNOTE-991, Keytruda is under evaluation in combination with enzalutamide and Androgen Deprivation Therapy (ADT) versus placebo in prostate cancer patients.



Merck also announced the Phase 3 LEAP-002 trial, evaluating the combination of Keytruda plus Lenvima (lenvatinib) versus Lenvima in patients with unresectable hepatocellular carcinoma (uHCC). Keytruda has not met the endpoints of overall survival (OS) and progression-free survival (PFS).

Lenvima monotherapy was previously approved as first-line therapy in patients with unresectable hepatocellular carcinoma (uHCC) in Europe, the US, China, and in patients with uHCC in Japan.

Merck and Eisai announced that they are evaluating the efficacy of the Keytruda plus Lenvima combination in more than ten different tumors.

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