KEYTRUDA® receives new approval from European Commission

KEYTRUDA® receives new approval from European Commission
September 11, 2018 Sofie Svendsen
In News

On September 10, 2018, Keytruda® (pembrolizumab) received yet another approval. This time, the immunotherapy, in combination with Alimta® (pemetrexed) and platinum chemotherapy, was approved by the European Commission for the first-line treatment of metastatic non-squamous non-small cell lung cancer (NSCLC) in adults whose tumors have no EGFR or ALK positive mutations.

This newest approval marks another “first” for the anti-PD-1 therapy, as it is now the first immunotherapy to be approved by the European Commission for the treatment of NSCLC in combination with chemotherapy.

What was this new approval of Keytruda® based upon?

This new approval from the European Commission was based on data from the KEYNOTE-189 trial. The trial compared Keytruda® in combination with Alimta® and chemotherapy to treatment with Alimta® and chemotherapy alone.

In the trial, the primary efficacy outcome measures were overall survival and progression-free survival. In terms of both of these measures, Keytruda® showed significant improvements. The data from these measures showed a reduction in the risk of death of 51% and a 48% reduction in risk of progression or death for the Keytruda® combination compared to Alimta® and chemotherapy alone.

Secondary efficacy outcome measures were overall response rate and duration of response. The overall response rate was 48% for the Keytruda® combination compared to 19% for Alimta® and chemotherapy alone. As for duration of response, the data showed 11.2 months versus 7.8 months respectively.

One of many indications

Keytruda® already has other indications approved in Europe in the lung cancer-setting. It is approved as a monotherapy for the first-line treatment of metastatic squamous or non-squamous NSCLC in patients whose tumors have high PD-L1 expression (tumor proportion score [TPS] of 50 percent or more) with no EGFR or ALK positive tumor mutations, and for previously-treated patients with locally advanced or metastatic NSCLC whose tumors express PD-L1 (TPS of 1 percent or more) and who have received at least one prior chemotherapy regimen.

Moreover, Keytruda® has approved indications in many other cancer settings such as, but not limited to, head and neck cancer, gastric cancer, cervical cancer and classical Hodgkin lymphoma.

 

If you have any questions concerning pembrolizumab, please contact us at hello@aposave.com or through our contact formula here 

 

Keytruda® (pembrolizumab) is a registered trademark of Merck (MSD outside of the US)

 

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