The US Food and Drug Administration (FDA) has approved Merck & Co’s Keytruda plus chemotherapy as a first-line treatment for non-small cell lung cancer (NSCLC).
Following the results of a phase 3 trial, immunotherapy drug Keytruda (pembrolizumab) can be used in combination with carboplatin and either paclitaxel or nab-paclitaxel in patients with NSCLC.
The combination was shown to be more effective than treating patients with chemotherapy alone.
Keytruda is a type of programmed death-ligand 1 (PD-L1) inhibitor. Such drugs are immune checkpoint inhibitors that block PD-1 and PD-L1 proteins that stop the body’s immune system from attacking cancer cells. They essentially disrupt the cancer cells’ signals, exposing them to the body’s immune T-cells for attack.
In the pivotal phase 3 trial of patients, regardless of tumour PD-L1 expression status, Keytruda plus chemotherapy (carboplatin and either paclitaxel or nab-paclitaxel) significantly improved overall survival (OS), reducing the risk of death by 36% compared to chemotherapy alone.
Merck’s success marks the first time an anti-PD-1 treatment has been approved for first-line treatment of squamous NSCLC regardless of tumour PD-L1 expression status.
Dr Roger M Perlmutter, president, Merck Research Laboratories, said: “Today’s approval expands our current lung cancer indications to include combination treatment in patients with squamous cell carcinoma, a type of lung cancer that is particularly difficult to treat.
“Approval by the FDA has the potential to mean that Keytruda can be used to improve survival for more patients with this debilitating disease.”
The FDA’s approval comes on the back of Merck’s sales of the blockbuster Keytruda nearly doubling in the third quarter of this year, according to a report from Reuters.
The report also stated that sales of Keytruda rose 80.4% to $1.89 billion from a year earlier and topped estimates of $1.87 billion, according to six analysts polled by Refinitiv.
Sales of Keytruda also exceeded those of rival Bristol-Myers Squibb’s drug Opdivo (nivolumab) for the second straight quarter. Opdivo brought in sales of $1.79 billion for BMS in the third quarter.
Opdivo was the first PD-1 drug to hit the market after approval in December 2014 but the fact that Keytruda can be used as a first-line treatment has boosted its place in the market.