Merck's Keytruda wins a double-header with new FDA approval in head-and-neck cancer

Editor's note: Corrects FDA filing status for Opdivo in head and neck cancer.

Merck & Co.’s immuno-oncology drug Keytruda’s fortunes took a significant upturn Friday, and not just because its head-to-head rival from Bristol-Myers Squibb failed a key lung cancer study. The PD-1 cancer-fighter picked up a new FDA approval, too.

Keytruda snagged an approval in head and neck cancer for patients with advanced disease who’ve failed on platinum-based chemotherapy. The approval is based on Merck’s KEYNOTE-012 study, in which the drug achieved a 16% response rate; 82% of those patients were still responding to the treatment at the 6-month mark.

The head-and-neck approval puts Keytruda ahead of the game in that cancer type, where Bristol-Myers’ Opdivo is still under FDA review. And in head-and-neck cancer, Keytruda patients won’t have to be screened with a PD-L1 diagnostic--a hurdle that has hindered use in relapsed non-small-cell lung cancer.

With 62,000 new cases expected in the U.S. this year, the head and neck cancer nod isn’t as significant as Keytruda’s new lead in previously untreated NSCLC, now that Opdivo has fallen short in its first-line lung cancer study, CHECKMATE-026. By contrast, the Merck drug topped chemotherapy in a first-line lung cancer trial earlier this year, by holding off cancer growth and extending patients’ lives to boot. The specifics on that trial won’t be public until it’s presented at a medical meeting later this year.

Bristol-Myers Squibb is scrambling to analyze data on various patient groups in the CHECKMATE-026 study, to see whether it can salvage the trial. Bristol-Myers had zeroed in on patients who tested positive for PD-L1 levels of 5% or more, and because responses tend to improve as PD-L1 levels rise, the researchers may be able to show Opdivo can prevail beyond a particular diagnostic threshold. Bristol-Myers is also on track with Opdivo-plus-Yervoy combo research in first-line lung cancer.

But Keytruda appears primed to press its advantage. “Without a doubt, Merck will be in the driver's seat for the next 12-18 months,” Leerink Partners analyst Seamus Fernandez said in a Sunday investor note. The firm raised its Keytruda sales estimates by more than $500 million in 2018 and almost $1 billion in 2021, bringing them to $3.7 billion and $7.2 billion.

Meanwhile, Merck continues to study Keytruda in head and neck cancer, alone and in combination with other drugs. Opdivo could come on strong with its own approval in that field soon enough; in the study data released in June, more than one-third of Opdivo patients were still alive after a year, compared with an average of 6 months for patients on any one of three standard treatment regimens. Roche’s new PD-L1 drug, Tecentriq, is also under study in the same cancer type, in early-stage combination trials.

First approved in 2014, both Keytruda and Opdivo are forecast by EvaluatePharma to be among the top 20 best-selling drugs in the world by 2020. The pharma research firm believes Opdivo could reach $8.4 billion in annual sales by 2020 sales while it forecasts Keytruda achieving $4.5 billion in annual sales. 

- see the Merck release

Special Report: Top 20 drugs by 2020 - Opdivo - Keytruda

Related Articles:
Bristol-Myers' Opdivo far outpaced Merck's Keytruda again in Q2. What gives?
Merck's Keytruda held back by docs who don't want to wait for diagnostics
Keytruda, Opdivo near new cancer uses where they won't butt heads--at least at first
Bristol-Myers to combo Opdivo, Yervoy with AbbVie's Rova-T in next-gen cancer cocktail trials
Merck's Keytruda tops chemo in first-line lung cancer trial
Bristol's Opdivo-Yervoy combo ups response rates in first-line lung cancer patients
Opdivo gives head and neck cancer patients a shot at 12-month survival