Roche’s cancer immunotherapy, Tecentriq (atezolizumab), has achieved a notable milestone with the introduction of subcutaneous injection administration. Recently approved by the European Commission (EC), Tecentriq stands as the first subcutaneous PD-(L)1 cancer immunotherapy to gain approval within the European Union.
Initially approved in Great Britain in August 2023, Tecentriq has demonstrated a significant reduction in treatment duration, reducing the process by approximately 80 percent. These findings emerged from a Phase III study comparing subcutaneous and intravenous delivery, with results presented at the European Society for Medical Oncology (ESMO) in October 2023.
Traditionally administered through a 30-60 minute intravenous infusion, Tecentriq’s subcutaneous injection method has streamlined the process to an average of seven minutes, with individual injections taking between four and eight minutes, as reported at ESMO 2023.
Functioning by binding to the programmed death ligand-1 (PD-L1) protein, Tecentriq disrupts its interactions with PD-1 and B7.1 receptors. This inhibition of PD-L1 potentially facilitates T-cell activation, a point highlighted by Roche. Dr. Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development notes that this administration approach provides enhanced flexibility for patients and plays a role in mitigating resource constraints in healthcare systems.
Tecentriq’s intravenous infusion previously pioneered cancer immunotherapy approval for specific early-stage cancers, including (adjuvant) non-small cell lung cancers (NSCLCs), small cell lung cancer (SCLC), and hepatocellular carcinoma (HCC).
The EC’s marketing authorization for this indication is based on pivotal data from the Phase IB/III IMscin001 study, focusing on patients with locally advanced or metastatic NSCLC who had undergone unsuccessful platinum therapy. The study demonstrated comparable levels of Tecentriq in the bloodstream for subcutaneous and intravenous administration, maintaining a safety and efficacy profile congruent with the intravenous formulation.
Roche’s phase 3 trial SKYSCRAPER-08, encompassing 461 esophageal cancer patients across five Asian countries, exhibited prolonged overall survival and progression-free survival through the combination of Roche’s TIGIT candidate tiragolumab, PD-L1 drug Tecentriq, and chemotherapy, compared to the control group.
Despite statistical significance, inquiries arise due to the unconventional choice of the comparator arm, lacking checkpoint inhibitor treatment, the contemporary standard of care for advanced esophageal squamous cell carcinoma.
Roche’s ongoing esophageal cancer study, SKYSCRAPER-07, aims to elucidate uncertainties and assess tiragolumab and Tecentriq in patients who have not progressed following definitive concurrent chemoradiotherapy. This study, set to continue until 2027, is part of Roche’s comprehensive initiative involving seven phase 3 trials initiated in 2020 to scrutinize tiragolumab across various settings.
Simultaneously, industry players like Gilead and Merck & Co. are conducting phase 3 trials on rival anti-TIGIT antibodies. Despite setbacks, the commitment of frontrunners signals an effort to unravel the potential impact of TIGIT blockade on cancer.
