Source: Fierce Pharma
Date: February 11, 2019
Author: Carly Helfand

Merck & Co.’s Keytruda is duking it out with Bristol-Myers Squibb’s Opdivo in the head and neck cancer marketplace, but Keytruda just took one step toward a green light that would give it a big edge.

The FDA has tagged Merck’s approval application for the immuno-oncology superstar—alone or in tandem with chemo—with its priority review designation in previously untreated patients with head and neck cancer. The move, which Merck announced Monday, sets Keytruda up for a quick trip down the regulatory pathway; the agency expects to have a decision by June 10, Merck said.

FDA staffers based their decision on data Merck trotted out at last year’s European Society for Medical Oncology (ESMO) meeting in October. Results showed that solo Keytruda, when pitted against a standard-of-care regimen dubbed by doctors as “Extreme,” could cut the risk of death by 22% in patients testing positive for the biomarker PD-L1. In patients with high levels of PD-L1 in their tumors, that figure shot up to 39%.

And when paired with chemo, Keytruda pared down the risk of death by 23% regardless of patients’ PD-L1 status.

Based on “the limited interaction we’ve had with key opinion leaders, I think this is seen as practice-changing,” Roy Baynes, Merck SVP and head of global clinical development, said when the data were released. And in addition to shaping opinions on clinical practice, the results also confirmed Keytruda’s place in the second-line setting, where it had previously suffered a narrow trial miss.

If Merck can snag a go-ahead in new patients, it’ll be an option for the more than 65,000 patients diagnosed each year in the U.S., according to the company. It’ll also mean a major leg up on BMS, whose Opdivo only bears a second-line OK. And with untreated patients in line to get Keytruda, the number of patients eligible for Opdivo—because those who used Keytruda first wouldn’t be in line for a second round of PD-1 therapy—will presumably dwindle.

The two drugs have been battling it out in different tumor types since the early days of immuno-oncology, when both started off with FDA nods in melanoma. While Opdivo has held market leads in important areas including kidney cancer, it’s Keytruda that has the No. 1 position, thanks to its dominant status in lung cancer, the biggest arena for the medicines.