Merck fleshes out Keytruda win in first-line cervical cancer, adding more firepower to its early cancer push
Merck has worked hard to bring its I/O blockbuster Keytruda into earlier and earlier lines of therapy, and now the wonder drug appears poised to make a quick entry into early advanced cervical cancer.
A combination of Keytruda and chemotherapy with or without Roche’s Avastin cut the risk of death by 33% over chemo with or without Avastin (p=<0.001) in first-line patients with persistent, recurrent or metastatic cervical cancer, according to full data from the Phase III KEYNOTE-826 study presented Saturday at #ESMO21.
The Keytruda arm posted a median OS of 24.4 months compared with 16.5 months for the chemo arm, Merck said. Meanwhile, the Keytruda arm also posted a median progression-free survival of 10.4 months compared with 8.2 months in the chemo arm (p=<0.001). Patients in the Keytruda arm posted a response rate of 65.9% compared with 50.8% in the chemo arm, and a median duration of response of 18 months compared with 10.4 months.
Merck toplined these results back in June, which the drugmaker called a first-time clinical outcomes win for immunotherapy in first-line cervical cancer regardless of patients’ PD-L1 status. The 826 study served a double purpose as the confirmatory trial for Keytruda’s approval in second-line cervical cancer, which the FDA granted an accelerated approval back in June 2018.
The KEYNOTE-158 study on which that approval was based showed an ORR of 14.3% at an 11.7-month follow-up with 2.6% of patients posting complete responses and 11.7% posting partial responses.
There are nearly 14,500 new cases of invasive cervical cancer diagnosed each year in the US with nearly 4,300 deaths in the US in 2021, Merck said. Five-year survival rate for advanced cervical cancer is estimated at about 17% with most patients diagnosed between the ages of 35 and 44.
Like Keytruda’s other recent wins in early lines of therapy, the KN-826 win represents the megablockbuster’s arrival in another first-line indication, potentially offering early intervention in a disease that is the second-largest cancer killer in women worldwide.
The results are also a quiet slapdown for Avastin, the widely used standard of care across multiple women’s cancer indications since the survival results were mostly consistent regardless of whether the older drug was included in treatment.