A new form of the Roche cancer drug Tecentriq met its goals in a Phase 3 trial, the first in a series of studies the Swiss company and its peers could use to extend the patent lives of their lucrative immunotherapies.
Roche said Tuesday that, in a study of 371 patients with metastatic, non-small cell lung cancer, an under-the-skin injection of Tecentriq produced similar levels of active drug in the blood as the intravenous version that’s been approved since 2016. Safety was “consistent” with what’s been reported in other clinical tests, the company added.
Roche didn’t disclose results on additional secondary measures, such as efficacy and certain patient-reported outcomes. But it will share the findings at a future medical meeting and submit them for approvals in the U.S., Europe and elsewhere.
The results could position Roche’s drug to be the first subcutaneous version of a checkpoint inhibitor, a widely used type of cancer immunotherapy, to reach the market.
Tecentriq, Merck & Co.’s Keytruda and Bristol Myers Squibb’s Opdivo have become blockbuster medicines over the last decade and are now standard treatments for dozens of tumor types. Each are currently administered via infusion, with Tecentriq given over 30 to 60 minutes.
All three will also lose patent protection by the end of this decade, leaving Roche, Merck and Bristol Myers searching for ways to replace the lost revenue. Tecentriq generated about $3.5 billion in sales last year. Keytruda recorded more than $17 billion and is one of the world’s top-selling pharmaceutical products.
Drugmakers use several tools to prepare for upcoming patent expirations, from acquiring new drugs through deals to extending the lives of old ones through other means. If Merck’s rumored acquisition of Seagen comes to fruition, for instance, the pharmaceutical company would acquire components of a drug combination with the potential to stretch Keytruda’s exclusivity. Bristol Myers bought MyoKardia for a heart drug that’s meant to help offset patent losses later this decade for Opdivo and a few other key medicines.
Merck, Roche and Bristol Myers are also focusing on bringing new versions of their immunotherapies to market, too. Merck is testing a subcutaneous form of Keytruda in a late-stage trial in lung cancer, and in earlier tests in other tumors. Bristol Myers is running two Phase 3 studies of an Opdivo alternative in skin and kidney tumors.
Results for those studies are expected next year, according to a federal clinical trials database. In the meantime, Roche now has results for an injected form of Tecentriq that takes between 3 to 8 minutes to adminster. The treatment involves drug delivery technology developed by Halozyme, which is also working with Bristol Myers on updating Opdivo.
Roche cited multiple studies showing cancer patients “generally prefer” subcutaneous treatments over infusions, as they’re shorter and cause less discomfort. The new formulation “could help save time for patients and healthcare systems,” said Roche chief medical officer Levi Garraway, in a statement.
