Roche scores phase 3 win for subcutaneous Tecentriq, eyes filings

Roche's Tecentriq could become the first drug in the PD-1/PD-L1 inhibitor class to be approved in a subcutaneous formulation, after the new version matched the original intravenous formulation in a phase 3 trial.

The results of the IMscin001 study found that an injection of Tecentriq under the skin taking just a few minutes was non-inferior to a 30 to 60-minute infusion with the IV version in terms of pharmacokinetics – how the active ingredient behaves in the body after administration.

The trial involved cancer immunotherapy-naïve patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) patients who were getting treatment with Tecentriq second-line after earlier platinum-based chemotherapy failed.

The current crop of approved PD-1/PD-L1 inhibitors headed by Merck & Co's Keytruda (pembrolizumab) and Bristol-Myers Squibb's Opdivo (nivolumab) are all given IV , and have mainly jostled for market share based on their clinical indications.

Now, Roche has an opportunity to add ease of administration to the competitive profile of Tecentriq, reducing the time patients have to spend in clinics and potentially reducing the cost of treatment.

The switch to an injectable version of the drug could also help to extend the commercial lifespan for Tecentriq and reduce the impact when biosimilars of the IV version reach eventually reach the market – assuming of course Roche can persuade clinicians to switch.

Roche isn't the only pharma company looking at subcutaneous checkpoint inhibitors, but the phase 3 readout and a plan to submit the data for approval with regulators including the FDA and EMA puts it among the leaders in the category.

Also coming through is Pfizer, which partners with Germany's Merck KGaA on latecomer PD-L1 drug Bavencio (avelumab). The company started talking about its own subcutaneous PD-1 inhibitor sasanlimab last year, which is also in phase 3 for NSCLC and other cancers, but as a brand new drug could take longer to navigate the regulatory pathway to market.

Merck meanwhile is running phase 3 trials of a subcutaneous formulation of Keytruda, with one eye on the possible loss of patent protection for the $17 billion blockbuster in 2028. Results from a trial in first-line NSCLC are due in early 2023. And BMS is also running late-stage trials of injectable Opdivo, so the race is on.

Roche's subcutaneous project has been flying largely under the radar until now, but now looks like it could beat its rivals to the market.

It is debatable whether the new formulation alone will be enough to make meaningful inroads into territory held by Keytruda and Opdivo where indications overlap. For patients however, the promise of greater convenience is a bright spot on the horizon.