Roche has shared the data that it hopes will secure approval for a subcutaneous formulation of its PD-L1 checkpoint inhibitor Tecentriq. Having revealed the top-line success in August, the Swiss drugmaker will use the ESMO Immuno-Oncology Congress 2022 to show off the figures behind the co-primary endpoint hits.
The second part of the clinical trial, IMscin001, randomized 371 adults with previously treated locally advanced or metastatic non-small cell lung cancer to receive subcutaneous or intravenous Tecentriq. Two-thirds of the participants received the subcutaneous formulation, which is designed to reduce the burden of treatment and increase convenience without sacrificing safety or efficacy.
Roche’s co-primary pharmacokinetic endpoints looked at drug concentration just before administration of the next dose and model-predicted total exposure to a drug. Subcutaneous Tecentriq was noninferior to the approved formulation against both endpoints. Dosing took around seven minutes, compared to 30 to 60 minutes for the intravenous infusion.
Success on the pharmacokinetic endpoints translated into similar clinical outcomes across the two arms. Median progression-free survival in the subcutaneous and intravenous arms was 2.8 months and 2.9 months, respectively. The objective response rates clocked in at 11.8% in the subcutaneous group and 9.7% in the intravenous cohort. Safety and immunogenicity were comparable between the arms.
Roche thinks the data set is strong enough to support approval of the subcutaneous formulation, leading it to submit the results to health authorities globally. If approved, Roche plans to roll out the formulation across multiple tumor types.
The subcutaneous launch may give Roche a point of differentiation in the congested checkpoint inhibitor space. While Chinese authorities approved a locally developed subcutaneous checkpoint inhibitor last year, Roche is leading the charge in the West. Merck’s phase 3 trial of subcutaneous Keytruda is on track to reach primary completion early next year, while Bristol Myers Squibb is targeting late 2023 and Pfizer is looking at a 2024 end date.
Roche claimed its spot at the front of the race with the support of Halozyme Therapeutics’ Enhanze drug delivery technology. The approach uses a recombinant enzyme to temporarily degrade hyaluronan in the subcutaneous space, thereby increasing permeability and enabling the drug to enter the bloodstream quickly.