- The Food and Drug Administration approved Merck & Co.’s cancer immunotherapy Keytruda for use before surgery to shrink lung tumors and then prevent their return after the operation, the company said Monday. Keytruda is the first PD1-blocking drug to gain approval both before and after lung cancer surgery.
- The OK was based on results from a clinical study called KEYNOTE-671, which found a Keytruda-based regimen reduced the risk of cancer’s return and death when compared to a regimen of chemotherapy before surgery and no treatment afterward. Merck announced last week that Keytruda improved study participants’ survival, detailed data of which are set to be presented at a medical meeting Friday.
- Bristol Myers Squibb and AstraZeneca have also been testing their respective immunotherapies Opdivo and Imfinzi in people whose lung tumors are small enough to be removed with surgery and haven’t seen their disease spread widely.
This is the sixth FDA approval for Keytruda in non-small cell lung cancer, including its clearance in combination with chemo for newly diagnosed people whose cancer has spread throughout their bodies.
In the “perioperative” setting — its latest approval — Keytruda is combined with chemo before surgery and then used as a monotherapy after. Keytruda in March hit an early study goal of improving “event-free survival,” a measure of progression, treatment discontinuation or death. Merck followed up last week with the survival data.
The results show Keytruda reduced the risk of lung-cancer related events by 42% and of death by 28%. More than half of people who received the Keytruda regimen were still alive and hadn’t experienced an event, so median survival couldn’t yet be calculated. Patients given the pre-surgical chemotherapy, meanwhile, went a median of 17 months before experiencing a disease-related event and 52 months before dying.
Last month, Bristol Myers announced Opdivo showed a statistically significant benefit on event-free survival, and will continue its trial until investigators are able to complete a overall survival calculation. AstraZeneca, meanwhile, had positive event-free survival data from Imfinzi in the perioperative setting in March, finding treatment reduced the risk of disease-related events by 32%.
The three drugs turn the body’s immune system against cancer by disrupting PD-1, a pathway that regulates the response of T and B cells to human tissue. Besides those three drugs, Roche’s Tecentriq and Regeneron’s Libtayo have won approval in some lung cancer settings.