EU regulator approves combination of Merck & Co.'s Keytruda, chemotherapy in first-line non-squamous NSCLC

Merck & Co. announced Monday that the European Commission approved Keytruda (pembrolizumab), in combination with Eli Lilly's Alimta (pemetrexed) and platinum chemotherapy, for the first-line treatment of metastatic non-squamous non-small-cell lung cancer (NSCLC) in adults whose tumours have no EGFR or ALK positive mutations. The company noted that Keytruda is the first anti-PD-1 therapy approved in this indication in combination with chemotherapy in Europe.

The clearance was based on data from the Phase II KEYNOTE-189 trial, with results showing significant improvement in overall survival (OS) and progression-free survival for patients randomised to Keytruda in combination with Alimta and platinum chemotherapy compared with Alimta and platinum chemotherapy alone, with a reduction in the risk of death by 51 percent and a 48-percent reduction in the risk of progression or death. Further results demonstrated that the overall response rate was 48 percent for patients given Keytruda in combination with Alimta and platinum chemotherapy compared to 19 percent for those on Alimta and platinum chemotherapy alone.

While the FDA had granted accelerated approval last year to Keytruda in combination with Alimta and carboplatin, for use in previously untreated patients with metastatic non-squamous NSCLC irrespective of PD-L1 expression, Merck pulled a similar filing in Europe. The previous application in the EU was supported by data from Cohort G of the Phase II KEYNOTE-021 trial, with results showing an objective response rate of 56.7 percent after a median of 18.7 months of follow-up for patients given Keytruda plus Alimta and carboplatin, compared with 31.7 percent for Alimta and carboplatin alone.

At the time Merck withdrew its European submission last year, the company said it had amended the KEYNOTE-189 trial to include OS as a co-primary endpoint, with a new study completion date of February 2019. However, Merck also indicated that there would be opportunities to conduct interim analyses of the study.

Meanwhile, the FDA recently converted its accelerated approval of Keytruda plus chemotherapy for use in patients with previously untreated non-squamous NSCLC to a full approval using its Real Time Oncology Review.  

For related analysis, see ViewPoints: Merck versus Merck in lung cancer?

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