- Merck's Keytruda is the first-ever FDA-approved PD-1 inhibitor.
- On September 5, Keytruda was approved for the secondary treatment of melanoma after patients have failed therapy with Bristol-Myers Squibb’s Yervoy (ilipimumab).
- Merck has released new data comparing the effect of chemotherapy treatment versus Keytruda in patients with ipilimumab-refractory advanced melanoma. Compared with chemotherapy, Keytruda significantly increases progression-free survival (PFS).
Once again, Keytruda is emerging as a treatment option for hard-to-treat cancers. At six months, the PFS rates for Keytruda were 34% at the 2 mg/kg dose and 38% at the 10 mg/kg dose, compared to 16% for chemotherapy.
The median duration of follow-up at the interim analysis was 10 months. Keytruda is already considered a powerhouse treatment option, with overall response rates in this study (the KEYNOTE-002 study) that were five to six times higher than chemotherapy. Merck continues to study the efficacy of Keytruda in various applications, although the company must remain vigilant about any safety or tolerability issues that may arise.