Merck Inc., provides update on phase III trial KEYNOTE-789 in combination with pemetrexed plus platinum-based chemotherapy for metastatic nonsquamous non-small cell lung cancer.
Merck Inc,. announced that the Phase III KEYNOTE-789 trial evaluating Keytruda in combination with pemetrexed plus platinum-based chemotherapy did not meet its dual primary endpoint of OS for the treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with epidermal growth factor receptor (EGFR)-genomic tumor mutations, who have previously progressed on a tyrosine kinase inhibitor (TKI), including osimertinib
At the final analysis of the study, there was an improvement in OS for patients who received Keytruda plus pemetrexed with platinum-based chemotherapy compared to pemetrexed with platinum-based chemotherapy; however, these results did not meet statistical significance per the pre-specified statistical plan. At an earlier interim analysis, the trial’s other dual primary endpoint, progression-free survival (PFS) was tested and showed an improvement in the Keytruda arm compared to chemotherapy alone, but these results did not reach statistical significance.
In KEYNOTE-641 and KEYNOTE-789, the safety profile of Keytruda was consistent with that observed in previously reported studies and no new safety signals were identified. In KEYNOTE-641, the combination was associated with a higher incidence of Grade 3-5 adverse events and serious adverse events compared to the control arm. Results will be shared at future scientific congresses.
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