FDA approves Keytruda + either paclitaxel or nab-paclitaxel, for the first-line treatment of patients with metastatic squamous NSCLC- Merck Inc.

Merck Inc., has announced that the FDA has approved Keytruda, Merck�s anti-PD-1 therapy, in combination with carboplatin and either paclitaxel or nab-paclitaxel, for the first-line treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC) based on results from the KEYNOTE-407 trial.

In the pivotal Phase III trial of patients regardless of tumor PD-L1 expression status, Keytruda in combination with chemotherapy (carboplatin and either paclitaxel or nab-paclitaxel) significantly improved overall survival (OS), reducing the risk of death by 36 percent compared to chemotherapy alone (HR=0.64 [95% CI, 0.49, 0.85]; p=0.0017). This approval marks the first time an anti-PD-1 regimen has been approved for the first-line treatment of squamous NSCLC regardless of tumor PD-L1 expression status.

Immune-mediated adverse reactions, which may be severe or fatal, can occur with Keytruda including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, severe skin reactions, solid organ transplant rejection, and complications of allogeneic hematopoietic stem cell transplantation (HSCT). Based on the severity of the adverse reaction,

Comment: Keytruda is the first PD-1 inhibitor to receive an approval in first-line squamous NSCLC �strengthening its position against competing BMS with Opdivo and Roche witb Tecentriq. Squamous NSCLC is a harder-to-treat and more aggressive tumor type, estimated to account for about a quarter of lung cancer cases. Merck has previously secured first-line approvals for Keytruda monotherapy and in combination for first-line non-squamous NSCLC.