Merck’s Keytruda Opens Door, But Combination Trials Could Unlock Efficacy
FDA’s approval of Merck’s anti-PD-1 drug pembrolizumab in melanoma marks a major milestone for oncology and industry’s immune checkpoint efforts. But with an overall response rate in labeling of 24%, there’s still room for improvement with combinations and use in earlier lines of therapy.
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KEYNOTE-001 started as a small, Phase I trial in melanoma but morphed into a 1,200-patient registrational study for two indications and a companion diagnostic.
With Keytruda, Merck has shown it has the wherewithal to compete in immuno-oncology against more experienced rivals. Now, as management outlined at ASCO, the company is digging its heels into the field, studying Keytruda in 30 tumor types and evaluating other early stage assets.
Merck’s sBLA for Keytruda in lung cancer has been accepted by FDA and granted an Oct. 2 action date, the firm announced. The company also revealed several new research collaborations to study Keytruda in more combination trials at ASCO.