Results from the phase 3 IMscin001 trial indicated that atezolizumab given subcutaneously vs intravenously yielded non-inferior pharmacokinetics for patients with immunotherapy-naïve locally advanced or metastatic non–small cell lung cancer.
Patients receiving atezolizumab (Tecentriq) subcutaneously had non-inferior levels of the immunotherapy agent in their blood compared with intravenous administration for patients with immunotherapy-naïve locally advanced or metastatic non–small cell lung cancer (NSCLC) for whom their first-line therapy failed, according to results from the phase 3 IMscin001 trial (NCT03735121), published in a press release from Roche.1
Patients who received atezolizumab subcutaneously had a reduction in treatment time to approximately 3 to 8 minutes compared with 30 to 60 minutes for a standard intravenous infusion. Notably, the safety of the subcutaneous agent was comparable with the intravenous infusion. The results will be shared at an upcoming meeting, and then be submitted to the FDA and European Medicines Agency for regulatory approval.
“By reducing the administration time, this new atezolizumab formulation could help save time for patients and healthcare systems,” Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development at Roche, said in the press release. “We are excited by the potential of bringing a subcutaneous cancer immunotherapy to patients globally, delivering on our commitment to improving the treatment experience for patients.”
A total of 371 patients enrolled on the global, multicenter, randomized trial. The study’s primary end points were minimum levels of atezolizumab in the blood during dosing intervals and observed serum Ctrough and model predicted under the curve. Secondary end points included safety, immunogenicity, patient-reported outcomes, and efficacy.
To be included in the study, patients were required to have cytologically documented locally advanced or metastatic NSCLC, received prior platinum-containing regimens or have disease recurrence within 6 months since platinum-based therapies, and have measurable disease. Additional criteria included having a life expectancy of 12 weeks or more, an ECOG performance status of 0 or 1, and adequate hematologic and end-organ function.
Exclusion criteria included having symptomatic, untreated, or actively progressing central nervous system metastases; uncontrolled or symptomatic hypercalcemia; and those who were pregnant and breastfeeding. Patients must also not have an active history of autoimmune disease or immune deficiency, a severe infection within the last 4 weeks, or treatment with therapeutic oral or intravenous antibiotics within 2 weeks prior to the study treatment. In addition, patients were not able to have significant cardiovascular disease, prior allogeneic stem cell or solid organ transplant, or treatment of a live attenuated vaccine within the last 4 weeks.
Atezolizumab has previously been approved by the FDA in combination with chemotherapy and bevacizumab (Avastin) as a first-line treatment for metastatic non-squamous NSCLC.2 Atezolizumab monotherapy was also approved by the FDA in conjunction with the VENTANA PD-L1 assay for adjuvant treatment following resection and platinum-based chemotherapy with stage II to IIIA NSCLC who have PD-L1 expression of 1% or more.3