US nod for Alimta/Keytruda lung cancer combo
US regulators have approved a combination of Eli Lilly’s Alimta and MSD’s Keytruda as first-line treatment for patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), irrespective of PD-L1 expression status.
The combination was approved via the US Food and Drug Administration’s accelerated approval pathway based on Phase II tumour response rate and progression-free survival (PFS) data observed in a cohort of Merck's KEYNOTE-021 study, and so its clinical benefit may still need to be verified in confirmatory trials.
In the trial, the combination of Alimta (pemetrexed), carboplatin and Keytruda (pembrolizumab) showed a statistically significant improvement in objective response rate (ORR) versus Alimta plus carboplatin alone (55 percent vs 29 percent), while median progression free survival came in at 13.0 months and 8.9 months, respectively.
Read more: http://www.pharmatimes.com/news/us_nod_for_alimtakeytruda_lung_cancer_combo_1238721
The combination was approved via the US Food and Drug Administration’s accelerated approval pathway based on Phase II tumour response rate and progression-free survival (PFS) data observed in a cohort of Merck's KEYNOTE-021 study, and so its clinical benefit may still need to be verified in confirmatory trials.
In the trial, the combination of Alimta (pemetrexed), carboplatin and Keytruda (pembrolizumab) showed a statistically significant improvement in objective response rate (ORR) versus Alimta plus carboplatin alone (55 percent vs 29 percent), while median progression free survival came in at 13.0 months and 8.9 months, respectively.
Read more: http://www.pharmatimes.com/news/us_nod_for_alimtakeytruda_lung_cancer_combo_1238721