Tecentriq Prolongs Survival of Patients with Advanced Lung Cancer Beyond Chemo, Phase 3 Trial Shows

Tecentriq (atezolizumab) prolongs the lives of patients with advanced non-squamous and squamous non-small cell lung cancer (NSCLC) when administered as a first-line therapy, compared to chemotherapy, according to the interim analysis of a Phase 3 clinical trial.

That finding was presented in a late-breaking presentation titled, “IMpower110: Interim overall survival (OS) analysis of a Phase III study of atezolizumab (atezo) vs platinum-based chemotherapy (chemo) as first-line (1L) treatment (tx) in PD-L1–selected NSCLC,” at the European Society for Medical Oncology (ESMO) 2019 Congress, held Sept. 27 to Oct. 1 in Barcelona, Spain.

Tecentriq is an immune checkpoint inhibitor developed and marketed by Genentech that is approved by the U.S. Food and Drug Administration (FDA) and the European Commission to treat certain types of cancer, including bladder and metastatic NSCLC.

The randomized, open-label, IMpower110 Phase 3 trial (NCT02409342) is currently assessing the safety and effectiveness of Tecentriq when administered as a first-line therapy to patients with advanced forms of NSCLC, compared to standard platinum-based chemotherapy — cisplatin or carboplatin combined with either pemetrexed, for non-squamous disease, or gemcitabine, for squamous NSCLC.

The study enrolled 572 patients who were assigned randomly to receive either Tecentriq administered intravenously at a dose of 1,200 mg every three weeks, or platinum-based chemotherapy (four or six cycles), until disease progression, unacceptable toxicity, or death.

The trial’s primary outcome was to assess the overall survival of patients whose tumors contained different levels of the programmed death-ligand 1 (PD-L1, a protein that usually predicts responses to immunotherapies like Tecentriq).

Secondary outcomes included the time patients lived until disease progression or death due to any cause (termed progression-free survival), the percentage of patients who responded to treatment (the overall response rate) and the duration of response.

Findings from an interim analysis of IMpower110 presented at the ESMO Congress showed:

• The trial met its primary outcome, with Tecentriq extending the survival of patients whose tumors contained high levels of PD-L1 by 7.1 months, compared to chemotherapy alone (median overall survival of 20.2 versus 13.1 months);
• Tecentriq also prolonged the survival of patients whose tumors contained medium and low levels of PD-L1. However, these differences were insufficient to merit statistical significance;
• Tecentriq’s safety profile was consistent with previous reports in that no new safety concerns have been identified in this study.

“We are excited to share these positive data, showing that Tecentriq alone offers a significant survival benefit over chemotherapy as an initial treatment in people with squamous or non-squamous non-small cell lung cancer with high PD-L1 expression,” Sandra Horning, MD, chief medical officer and head of Global Product Development at Roche, said in a press release.

“The IMpower110 results demonstrate the potential of first-line Tecentriq monotherapy in certain types of advanced lung cancer, and could provide an additional treatment option for oncologists and the patients that they treat,” Horning said.

Genentech plans to submit data from IMpower110 to the FDA and the European Medicines Agency (EMA), and to discuss with health authorities the best way to make treatment available to patients as soon as possible.

Nine Phase 3 clinical trials assessing the safety and effectiveness of Tecentriq, either alone or in combination with other medications, are currently underway in patients with different types of lung cancer. Genentech also is exploring the therapeutic potential of Tecentriq in other types of cancers, including genitourinary, skin, breast, gastrointestinal, gynecological and head and neck cancers.