Phase III IMscin001 study of subcutaneous Tecentriq meets primary endpoint in NSCLC

The study showed non-inferior levels of Tecentriq in the blood (pharmacokinetics), when injected subcutaneously, compared with intravenous (IV) infusion, in cancer immunotherapy-naïve patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) for whom prior platinum therapy has failed. The safety profile of the subcutaneous formulation was consistent with that of IV Tecentriq. Administering Tecentriq subcutaneously (injecting the medicine under the skin) reduces the treatment time to 3-8 minutes per injection, compared with 30-60 minutes for standard IV infusion. Multiple oncology studies suggest that the majority of cancer patients generally prefer to receive treatment subcutaneously due to reduced pain and discomfort, ease of administration and shorter duration of treatment, compared to IV infusion. Genentech will share detailed findings of the IMscin001 study at an upcoming medical meeting and submit them for regulatory approval to health authorities globally, including the FDA and EMA.

IMscin001 is a Phase Ib/III, global, multicenter, randomized study evaluating the pharmacokinetics, safety and efficacy of the subcutaneous formulation of Tecentriq, compared with IV Tecentriq, in patients with previously treated locally advanced or metastatic NSCLC for whom prior platinum therapy has failed. The study enrolled 371 patients. The co-primary endpoints of the study are minimum levels of Tecentriq in the blood during a given dosing interval on the basis of established pharmacokinetic measurements; observed serum Ctrough and model-predicted area under the curve. Secondary endpoints include safety, immunogenicity, patient-reported outcomes and efficacy.