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