Merck carves out path in first-line advanced cervical cancer with new FDA win for Keytruda juggernaut
Merck’s PD-(L)1 blockbuster Keytruda has held a steady march into earlier lines of therapy, with cervical cancer next up on its checklist. After flashing winning data as part of a chemo combo last month, Keytruda now has the FDA’s green light in first-line patients.
The FDA on Wednesday approved a combination of Keytruda plus chemotherapy with or without bevacizumab to treat first-line persistent, recurrent or metastatic cervical cancer, making it the first PD-(L)1 checkpoint inhibitor approved in that setting.
The agency based its review on data from the KEYNOTE-826 study, which showed the Keytruda-chemo combo cut the risk of death by 33% over chemo alone (p=<0.001), according to data unfurled at September’s ESMO conference.
The Keytruda arm posted a median OS of 24.4 months compared with 16.5 months for the chemo arm, Merck said. Meanwhile, Keytruda also posted a median progression-free survival of 10.4 months compared with 8.2 months for chemo (p=<0.001). Patients in the Keytruda cohort posted a response rate of 65.9% compared with 50.8% for chemo alone, and a median duration of response of 18 months compared with 10.4 months, respectively.
KEYNOTE-826 served a dual purpose for Merck as both the grounds for Keytruda’s move into first-line advanced cervical cancer, a disease with about 14,500 new diagnoses each year in the US, and a confirmatory study for the drug’s previous approval in the second line.
Establishing itself as standard of care in early lines of metastatic disease has become par for the course for Keytruda, but cervical cancer remains a hard nut to crack and the second leading cancer killer of women worldwide. Meanwhile, Merck has aspirations for bringing Keytruda into the adjuvant/neoadjuvant setting before a patient’s disease ever progresses.
Also at ESMO this year, Merck rolled out new Phase III data showing Keytruda cut the risk of relapse or death by 35% over placebo (p=0.00658) in high-risk, stage II melanoma patients who had previously undergone surgery to remove their tumors. In August, Merck earned the FDA’s nod for a regimen of Keytruda plus chemo in the neoadjuvant setting followed by adjuvant Keytruda solo in patients with high-risk triple-negative breast cancer. The drugmaker has also flashed winning data in early kidney cancer.