Over the past two days, the FDA gave us another illustration of the intense rivalry between Merck & Co.’s ($MRK) cancer immunotherapy Keytruda and Bristol-Myers Squibb’s ($BMY) Opdivo. The agency put Keytruda on the priority-review track for a new use in head and neck cancer--and it got to work on a priority review app for Opdivo in Hodgkin lymphoma.
Both would add significant numbers of new patients to each drug’s lineup of approvals to treat melanoma and lung cancer.
And with those approvals, each company would have the chance to market its immunotherapy without head-to-head competition from its rival, for awhile at least. That would be a new twist; the drugs have racked up similar indications almost simultaneously since their first approvals in melanoma back in 2014.
For Merck, the head and neck cancer approval would cover patients with squamous cell carcinomas of the head and neck that have recurred or spread, and progressed despite treatment with standard chemo. It’s a solo use, with Keytruda used on its own rather than alongside other meds.
Merck says 62,000 new cases of head and neck cancers are diagnosed every year in the U.S., about 560,000 worldwide. In the Keynote-012 trial, one-fourth of patients with these cancers responded to Keytruda, twice as many as with other approved meds, such as Eli Lilly’s ($LLY) Erbitux.
In a statement, Merck SVP Roger Dansey, who heads up late-stage oncology development at the company, called head and neck cancer “a difficult-to-treat and debilitating disease with very few treatment options. We are encouraged by the data emerging from our program in this type of cancer, and welcome today’s news as this is an important step toward making Keytruda available to these patients.”
For Bristol-Myers, a Hodgkin lymphoma approval lends access to fewer patients--only 8,500 new cases per year in the U.S. The non-Hodgkin form of the disease is much more common. Its approval application is based on the Checkpoint-205 trial, whose data is expected to be presented at a medical meeting later this year, the company said in a statement. “There is a significant burden on classical Hodgkin lymphoma patients who do not respond to initial treatment, and they need new treatment options that address the disease in a different way,” said Jean Viallet, Bristol-Myers’ global clinical research lead in oncology. “With the Agency’s acceptance of our application, Opdivo has the potential to be the first PD-1 inhibitor in hematology.”
Both meds are already delivering big sales to their companies, with Opdivo at $942 million for 2014 and Keytruda at $605 million. Both are predicted to be among the top 20 best-selling drugs in the world by 2020, according to EvaluatePharma research. Opdivo is still pegged as the leader in immuno-oncology, however, with $8.4 billion in 2020 sales, compared with Keytruda’s $4.5 billion.
- check out the Merck statement
- see the release from Bristol-Myers