Roche wins first approval for subcutaneous PD-L1 immunotherapy

Pharma News: Roche has triumphed over its competitors by securing the registration of the first subcutaneous (SC) formulation of its PD-L1 immunotherapy, Tecentriq (atezolizumab). The new formulation boasts a shorter administration time, from 30-60 minutes for intravenous (IV) infusion to an average of just seven minutes for subcutaneous injection.

Tecentriq SC is indicated for resected early-stage non-small cell lung cancer, metastatic non-small cell lung cancer, extensive-stage small cell lung cancer, urothelial carcinoma, and metastatic hepatocellular carcinoma.

Associate Professor Thomas John, Medical Oncologist at the Peter MacCallum Cancer Centre, emphasised the importance of this advancement.“

“Efficacy and safety will always be key considerations for oncologists, but when efficacy and safety are combined with convenience, it is an appealing combination.” Associate Professor John explained.

He added “Subcutaneous PD-L1 immunotherapy offers potential time savings for busy oncology teams and hospitals, while freeing up patients from lengthy infusions. We can expect subcutaneous immunotherapy to become an attractive treatment option for many patients.”

The development of the SC formulation was made possible through Halozyme Therapeutics’ Enhanze drug delivery technology. It utilises the recombinant human hyaluronidase PH20 (rHuPH20) enzyme to stabilise the SC formulation. Notably, Tecentriq data from the Phase Ib/III (NCT03735121) trial demonstrated the non-inferiority of the SC formulation compared to intravenous administration. Furthermore, the safety profile of Tecentriq SC proved comparable to its intravenous counterpart.

Richard Woodfield, Country Medical Director at Roche, underscored the importance of this achievement, stating “The registration of Tecentriq SC is a critical step in making this first-in-class anti-PD-L1 formulation available for eligible patients.”

Roche is actively collaborating with the Pharmaceutical Benefits Advisory Committee (PBAC) and the Department of Health to secure a Pharmaceutical Benefits Scheme (PBS) listing for Tecentriq SC under the same conditions as the currently available IV infusion presentation.

Roche’s main competitors, MSD and Bristol Myers Squibb, are also in the race, developing subcutaneous formulations for their respective drugs, Keytruda (pembrolizumab) and Opdivo (nivolumab).

Reflecting on Roche’s legacy of innovation in cancer care, Dr Woodfield said “Roche has a long history of breaking new ground in cancer care. We are proud to pioneer the first subcutaneous PD-L1 immunotherapy and play our part in making cancer treatment less burdensome for patients, oncology teams, and hospitals.”

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