Keytruda scores big as a first-line monotherapy in NSCLC patients with any level of PD-L1 expression

pharmafile | April 10, 2018 | News story | Manufacturing and Production, Research and Development Cancer, MSD, NSCLC, keytruda, lung cancer, pharma 

Closely following the news that Keytruda (pembrolizumab) had failed in the treatment of unresectable or metastatic melanoma as a combination therapy with Incyte’s epacadostat, MSD announced that its blockbuster immunotherapy drug hit its primary endpoint as a monotherapy in the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in patients expressing any level of PD-L1.

In an interim analysis conducted by the Data Monitoring Committee, it was found that Keytruda produced “significantly longer” overall survival in patients with a PD-L1 tumour proportion score of at least 1%, compared to platinum-based chemotherapy.

“Improvement in overall survival is the ultimate objective in the treatment of advanced lung cancer. KEYNOTE-042 is the first randomised Phase 3 study of a single-agent immunotherapy using overall survival as the primary endpoint that has demonstrated significant benefit as first-line therapy in NSCLC patients who tested positive for PD-L1 at 1 percent or higher,” commented Dr Tony Mok, Professor in the Department of Clinical Oncology at the Chinese University of Hong Kong.

Keytruda is currently the only anti-PD-1 drug authorised as a monotherapy for the first-line treatment of NSCLC, but it is only approved for use in patients with a tumour proportion score of greater than 50%, so this new data could be instrumental in widening its potential applications for patients. The trial is due to continue in order to evaluate its secondary endpoint of progression-free survival.

“With KEYNOTE-042, Keytruda has now shown a significant survival benefit compared with chemotherapy for patients with locally advanced or metastatic nonsquamous or squamous NSCLC expressing PD-L1 at 1% or higher by tumour proportion score,” remarked MSD President Dr Roger M Perlmutter. “Keytruda is a foundational treatment for NSCLC and has consistently demonstrated a survival benefit as monotherapy, or in combination with chemotherapy, in the treatment of metastatic lung cancer. We sincerely thank the patients and clinical investigators for their participation in this important study.”

Matt Fellows

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