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Merck reports outcomes of several clinical trials for Keytruda® (pembrolizumab)

Aug 15, 2022

Merck’s PD-1 receptor blocker Keytruda is approved in the US and Europe for the treatment of a range of tumours, including melanoma, non-small cell lung cancer, head and neck squamous cell cancer, classical Hodgkin Lymphoma, urothelial carcinoma, oesophageal cancer, cervical cancer, renal cell carcinoma and triple negative breast cancer.  Merck has now reported updates on several clinical trials, in which treatment with Keytruda® did not reach its primary endpoints:

  • Phase 3 LEAP-002 trial investigating Keytruda® plus Eisai’s Lenvima® (lenvatinib), compared to Lenvima® monotherapy as a first-line treatment for patients with unresectable hepatocellular carcinoma (uHCC). See the Merck update of 3 August here.
  • Phase 3 KEYNOTE-921 trial evaluating Keytruda® in combination with chemotherapy (docetaxel) compared to chemotherapy alone for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). See the Merck update of 3 August here
  • Phase 3 KEYNOTE-412 trial evaluating Keytruda®with concurrent chemoradiation therapy (CRT) followed by Keytruda® as maintenance therapy for the treatment of patients with unresected locally advanced head and neck squamous cell carcinoma (HNSCC). See the Merck update of 20 July here

In each trial clinical improvements were shown but they did not meet pre-specified statistical significance.  The safety profile from each trial was consistent with earlier studies.