- Merck & Co.’s Keytruda helped people with lung cancer live longer than those taking a placebo when used before and after surgical removal of tumors, the company said Tuesday, a finding that could give it an edge on Bristol Myers Squibb’s rival drug Opdivo.
- Keytruda can now be used in patients following surgery and chemotherapy to prevent the return of lung cancer, but Merck is now seeking Food and Drug Administration approval in a pre- and post-surgical regimen designed to improve the operation’s effectiveness and then prevent recurrence afterward. The FDA’s decision deadline is Oct. 16.
- Last month, Bristol Myers released data showing Opdivo improved “event-free survival” when compared to placebo in the same setting, a hurdle Keytruda passed in March along with AstraZeneca’s Imfinzi. Overall survival remains a gold standard measure for regulators and doctors, which should help Merck further expand Keytruda use should the FDA approve it first for these patients.
In the trial, called KEYNOTE-671, patients received Keytruda and chemotherapy before surgery and Keytruda afterward. The regimen was compared to placebo and chemotherapy pre-surgery and placebo alone after.
Patients receiving the Keytruda-based regimen had a 42% reduced risk of progression, recurrence or death two years after entering the trial when compared to placebo. AstraZeneca’s similar trial of Imfinzi yielded a 32% reduction in risk of progression, recurrence or death, although cross-trial comparisons should be treated with caution.
Merck didn’t release detailed overall survival numbers, but noted that at a planned interim analysis the Keytruda regimen “demonstrated a statistically significant and clinically meaningful improvement.” The overall survival data are scheduled to be revealed in a presentation at the European Society for Medical Oncology later this month, Merck said Tuesday.
Keytruda has won many of the important competitive battles in lung cancer, most importantly in treatment of newly diagnosed patients with metastatic disease. Opdivo famously missed in one of the first pivotal trials in these patients, as a single agent compared with chemotherapy, opening the door for Merck to prevail using a strategy of treating patients with a Keytruda-chemo combination.
In this latest “perioperative” setting, Merck is the first to deliver overall survival data and looks on track to be the first to get FDA approval.
The three drugs work by turning the body’s immune response against tumors, utilizing a pathway called PD-1 that regulates the response of T and B cells to cells of the human body. Two other PD-1 drugs, Roche’s Tecentriq and Regeneron’s Libtayo, also have won approval in some lung cancer settings.