European Commission approves Keytruda + Alimta + platinum chemotherapy to treat nonsquamous NSCLC. Merck Inc

Merck Inc.,has announced that the European Commission has approved Keytruda,the company�s anti-PD-1 therapy, in combination with pemetrexed (ALIMTA ) and platinum chemotherapy for the first-line treatment of metastatic nonsquamous non-small cell lung cancer (NSCLC) in adults whose tumors have no EGFR or ALK positive mutations.

This approval, the first in Europe for an anti-PD-1 therapy in combination with chemotherapy, is based on data from the pivotal Phase III KEYNOTE-189 trial in patients with metastatic nonsquamous NSCLC regardless of PD-L1 tumor expression status, showed a significant survival benefit for the combination of Keytruda with chemotherapy as compared with standard-of-care chemotherapy alone.In KEYNOTE-189, there was a statistically significant improvement in OS and PFS for patients randomized to Keytruda in combination with pemetrexed and platinum chemotherapy compared with pemetrexed and platinum chemotherapy alone � with a reduction in the risk of death by 51 percent (HR=0.49 [95% CI, 0.38-0.64]; p<0.00001) and a 48 percent reduction in the risk of progression or death hr="0.52" 95 ci 0.43-0.64 p><0.00001). the orr was 48 percent 95 ci 43-53 for patients randomized to keytruda in combination with pemetrexed and platinum chemotherapy compared to 19 percent 95 ci 14-25 for patients randomized to pemetrexed and platinum chemotherapy alone p><0.0001). the median dor for patients randomized to receive keytruda in combination with pemetrexed and platinum chemotherapy was 11.2 months range 1.1 to 18.0 months compared to 7.8 months range 2.1 to 16.4 months for patients randomized to receive pemetrexed and platinum chemotherapy alone.>

Comment : Merck Inc., withdrew its European application to market the combination in October 2017. That filing was based on a cohort of the KEYNOTE-021 trial, which Merck Inc., considered showed significant improvements in overall response rate and progression-free survival for the Keytruda combination regimen compared to chemotherapy alone . However media reports at the time suggested that the European Medicines Agency�s Committee for Medicinal Products for Human Use (CHMP) was reluctant to back approval on that basis.

Comment: Keytruda is also approved in Europe as a monotherapy for the first-line treatment of metastatic squamous or nonsquamous 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 (KEYNOTE-024) 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 (KEYNOTE-010).