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Merck's Keytruda rides breast cancer hot streak to frontline chemo-combo win

Merck & Co.'s Keytruda has now come up positive in two straight TNBC studies. (Merck)

Merck & Co.’s Keytruda may have stumbled early in its candidacy as a triple-negative breast cancer treatment, but those days seem to be behind it.

The immuno-oncology star, in tandem with chemo, topped solo chemo at staving off disease progression in patients with certain levels of biomarker PD-L1—specifically, those with a combined positive score of 10 or greater.

Full results from the trial, called Keynote-355, won’t be available until a future medical meeting—RBC Capital Markets analyst Randall Stanicky has his money on ASCO, he wrote in a Wednesday morning note to clients—but in the meantime, the New Jersey drugmaker intends to discuss them with regulators. The trial will also continue, to see whether Keytruda can hit its other primary endpoint by showing it can lengthen patients’ lives.

The results extend a positive streak for Keytruda in TNBC, an aggressive, tough-to-treat form of breast cancer. Back in September, the pharma giant revealed that among pre-surgery patients, a Keytruda-chemo combo beat chemo alone at clearing all signs of cancer from breast and lymph node tissue by the time of surgery, doing so in 64.8% of patients.

And the way Stanicky sees it, Merck’s Wednesday update “should de-risk” that neoadjuvant study, called Keynote-522, he wrote.

But things didn’t start out so well for Keytruda in the TNBC arena. Last May, study results showed the drug had failed to extend the lives of previously treated patients.

Of course, there were some key differences between that trial and the two that have now read out positively: It tested the drug solo, instead of with chemo, and in a later line of treatment. It also used only overall survival as a primary endpoint.

While things may be looking up, though, Merck will have to contend with Roche if it can snag a frontline okay. The Swiss drugmaker was the first immuno-oncology company to score a TNBC nod: Its checkpoint inhibitor Tecentriq has been approved for PD-L1 positive patients since last March, and industry watchers will be waiting eagerly to compare its data set with Merck’s.

Written by: Carly Helfand

Published on: Feb 12, 2020 10:54am



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