Roche Secures FDA Approval for Subcutaneous Tecentriq, Surpassing Merck's PD-1

Roche's Tecentriq Hybreza, a combination of Tecentriq and Halozyme Therapeutics’ Enhanze drug delivery technology, has been heralded as the first and only subcutaneous anti-PD-(L)1 cancer immunotherapy. The FDA has recently approved the subcutaneous formulation of Tecentriq, branded as Tecentriq Hybriza (atezolizumab and hyaluronidase-tqjs), for treating various cancers. This marks a significant step as Tecentriq Hybriza is the first PD-(L)1 blocker approved for subcutaneous use in the U.S., addressing all the cancer types covered by its intravenous counterpart, including several forms of skin, liver, lung, and soft-tissue cancers.

Levi Garraway, Roche’s Chief Medical Officer, emphasized that the approval of Tecentriq Hybriza builds on the well-established safety and efficacy of intravenous Tecentriq. He highlighted that the new subcutaneous formulation could treat patients faster and in more accessible settings, offering greater flexibility and choice in treatment administration for patients and their physicians.

The innovation in Tecentriq Hybriza comes from Halozyme Therapeutics’ Enhanze technology, which employs the patented recombinant hyaluronidase PH20 enzyme. This enzyme digests hyaluronan proteins beneath the skin, enhancing fluid flow in the subcutaneous space and allowing large volumes of fluids to be injected under the skin, thereby improving their dispersion and absorption. This technology significantly reduces the administration time of Tecentriq Hybriza to approximately seven minutes, compared to the 30 to 60 minutes required for intravenous infusions of Tecentriq.

In clinical trials, specifically the Phase Ib/III IMscin001 study, the subcutaneous injection of Tecentriq was found to achieve similar drug levels in the blood as its intravenous form, maintaining comparable safety and efficacy profiles. Additionally, data from the Phase II IMscin002 study showed that 71% of patients preferred the Hybriza formulation over the intravenous version. The main reasons for this preference were the convenience of less time spent in the clinic, increased comfort, and reduced emotional distress.

The approval of Tecentriq Hybriza positions Roche to carve out a unique niche for its PD-1 inhibitor in a market largely dominated by Merck’s Keytruda (pembrolizumab). In 2023, Tecentriq generated approximately $4.45 billion, while Keytruda led the market with over $25 billion in revenue. Despite Roche's efforts, it has faced challenges in keeping up with Keytruda, particularly highlighted by a late-stage trial defeat in July 2024. Results from the Phase II/III SKYSCRAPER-06 study showed that Tecentriq combined with an investigational anti-TIGIT antibody, tiragolumab, had reduced efficacy in progression-free survival compared to Keytruda plus chemotherapy. Consequently, this trial for the first-line treatment of non-small cell lung cancer was discontinued.

Meanwhile, Merck is moving forward with its subcutaneous formulation of Keytruda, currently in a Phase III study set to be completed by late 2026. As the competition intensifies, both companies continue to innovate and seek new ways to enhance cancer treatment options.