An update from the phase 3 IMpower010 study shows that the study has met its primary end point of improvement in disease-free survival with atezolizumab versus use of best supportive care as treatment of patients with non–small cell lung cancer.
Treatment with atezolizumab (Tecentriq) demonstrated improvement in disease-free survival (DFS) compared with best supportive care (BSC) when given as adjuvant therapy following surgery and chemotherapy to patients with stage II-IIIA non–small cell lung cancer (NSCLC), meeting the primary end point of the phase 3 IMpower010 clinical trial.1
Genentech, developer of atezolizumab announced the findings in a press release and noted that the DFS benefit was most profound for the subgroup of patients with PD-L1–positive NSCLC.
“With these landmark results, Tecentriq has become the first cancer immunotherapy to help many people with resectable early lung cancer live longer without their cancer returning," said Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development, in a statement. “We’re excited by the clinical benefit adjuvant Tecentriq may bring to lung cancer patients, particularly in the PD-L1–positive population. We will submit these data to regulatory authorities as soon as possible.”
IMpower010 is a global, multicenter, open-label, randomized trial (NCT02486718), which is comparing the safety and efficacy of atezolizumab and BSC in the adjuvant setting of NSCLC. The secondary efficacy end point of the study is overall survival, and the study is also investigating the percentage of patients with adverse events (AEs) as a secondary safety end point. The exploratory end points of the study were PD-L1 status, immune- and tumor-related biomarkers before, during, and after treatment with atezolizumab and at radiographic disease recurrence, or at confirmation of a new primary NSCLC.
A total of 1005 patients with stage II-IIIA NSCLC enrolled in IMpower010 were randomized 1:1 to receive 16 cycles of atezolizumab intravenously (IV) at 1200 mg every 2 weeks for up to 21 days. As chemotherapy administered prior to adjuvant atezolizumab, patients received either IV cisplatin 75 mg/m2 on day 1 of up to 4 21-day cycles, IV vinorelbine 30 mg/m2 given on days 1 and 8, IV docetaxel 75 mg/m2 administered on day 1, IV gemcitabine 1250 mg/m2 given on days 1 and 8, and IV pemetrexed 500 mg/m2 administered on day 1. The same chemotherapy agents, dosages, and dosing schedules were utilized as BSC in the study.
Eligible patients were those with stage IB to IIIA disease and an ECOG performance status of 0 or 1 who had a complete tumor resection 4-12 weeks prior to enrollment and have adequately recovered from the surgery. Patients were required to also be eligible to received cisplatin-based chemotherapy in the adjuvant setting. The presence of other malignancies, use of hormonal cancer or radiation therapy within 5 years, prior chemotherapy, exposure to prior immunotherapy, and autoimmune disease were grounds for exclusion from the trial.2
The planned analyses of DFS and overall survival in the overall intent-to-treat (ITT) population of IMpower010 will continue with patient follow-up to retrieve data that were immature at the time of the interim analysis. The safety analysis of atezolizumab versus BSC was completed and showed consistency with prior with the known safety profile. No new safety signals were observed in the study. Genentech plans to share the results from the study IMpower010 study in a presentation at an upcoming medical meeting in addition to submitting the data to regulatory health authorities around the world.
Results from IMpower010 could add to the growing list of United States (US) indications for atezolizumab, 4 of which are for NSCLC either as a single-agent or in combination with targeted therapies or chemotherapy. Atezolizumab also has approval from the FDA as the first approved cancer immunotherapy for the front-line treatment of adults with extensive-stage small-cell lung cancer in combination with carboplatin and etoposide. There are 3 approved dosing options of atezolizumab in the United States, which include use every 2, 3, or 4 weeks. Outside of lung cancer, atezolizumab is being developed for the treatment of genitourinary, skin, breast, gastrointestinal, gynecological, and head and neck cancers.
1. Pivotal phase III study shows Genentech’s Tecentriq helped people with early lung cancer live longer without their disease returning. News release. March 22, 2021. Accessed March 23, 2021. https://bit.ly/2OQNxCp
2. Zhou C, Altorki N, Valliéres E , et al. IMpower010: A Phase III trial investigating atezolizumab (atezo) vs best supportive care (BSC) after adjuvant chemotherapy (chemo) in patients (pts) with completely resected NSCLC. Ann Oncol. 2016;26 (suppl 9): ix134-ix135. doi: 10.1093/annonc/mdw592