Merck to Seek Another FDA Indication for Keytruda in Treating Lung Cancer


Ahead of June’s annual American Society of Clinical Oncology meeting Merck said this morning that its Phase III lung cancer trial met a pre-specified secondary endpoint of overall response rate (ORR) in an early cohort of participants at an interim analysis.

With the looming annual meeting in Chicago coming, Merck said it likely release an additional interim analysis of KEYNOTE-407, which is studying its blockbuster checkpoint inhibitor, Keytruda, as a first-line treatment for metastatic squamous non-small cell lung cancer (sNSCLC). In the trial, Keytruda is being investigated in combination with chemotherapy treatments carboplatin-paclitaxel or nab-paclitaxel. Merck said additional data may be available for its oral presentation at ASCO.

The company recently submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for the potential approval of Keytruda in this indication, the company announced this morning.

Squamous cell lung cancer accounts for about 30 percent of all lung cancers. This type of lung cancer tends to be found in the middle of the lungs.

Merck’s KEYNOTE-407 is testing the combination of the PD-1 inhibitor and chemo combination against chemotherapy along in 560 untreated patients with metastatic squamous NSCLC. Patients in the trial were required to have no previous systemic therapy for advanced disease. The dual primary endpoints were overall survival (OS) and progression-free survival (PFS). Secondary endpoints include ORR and duration of response (DOR).

The clinical successes of Keytruda continue to show why the checkpoint inhibitor is a key lynchpin in Merck’s pipeline. Only days ago the company announced that it was filing for FDA approval of Keytruda in combination with Eli Lilly’s Alimta and platinum chemotherapy a first-line choice for patients with metastatic nonsquamous non-small cell lung cancer (NSCLC). That filing was based on Phase III results of another trial, KEYNOTE-189. Data from the Phase III trial showed that the addition of Keytruda, Alimta and platinum chemotherapy significantly improved overall survival (OS) in the NSCLC patients and reduced the risk of death by half when compared with chemotherapy alone. An OS benefit was observed regardless of PD-L1 expression in the three PD-L1 categories that were evaluated, Merck said at the time the Phase III results were released.

NSCLC is the most common type of lung cancer. It accounts for about 85 percent of all cases. The five-year survival rate for patients diagnosed in the United States with any stage of lung cancer is estimated to be 18 percent, according to data shared by Merck. If Merck is able to secure approval for Keytruda for this lung cancer indication it will open up a larger market share for the company. Sales of Keytruda generated more than $3.8 billion for Merck in 2017.

Subscription JPEG

Back to news