Roche have announced positive data from the Phase III IMpower110 study evaluating Tecentriq® (atezolizumab) as a first-line (initial) monotherapy compared with cisplatin or carboplatin and pemetrexed or gemcitabine (chemotherapy) in advanced non-squamous and squamous non-small cell lung cancer (NSCLC) without ALK or EGFR mutations (wild-type; WT).
Phase III IMpower110 study showed Tecentriq monotherapy helped people with advanced non-small cell lung cancer (NSCLC) with high PD-L1 expression live longer compared with chemotherapy alone. Data will be shared with health authorities globally, including the US Food and Drug Administration (FDA) and European Medicines Agency (EMA).
The study met its primary endpoint in an interim analysis showing that Tecentriq monotherapy improved overall survival (OS) by 7.1 months compared with chemotherapy alone in people with high PD-L1 expression (TC3/IC3-WT). Encouraging OS was also observed in people with medium levels of PD-L1 expression (TC2/3 or IC 2/3-WT), however these data did not reach statistical significance at this interim analysis. The study will continue to final analysis for patients with lower levels of PD-L1 expression. Safety for Tecentriq appeared to be consistent with its known safety profile and no new safety signals were identified.
“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,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “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.”
These data was presented at the European Society for Medical Oncology (ESMO) 2019 Congress on Friday the 27th of September.
Roche will submit the data to global health authorities, including the US Food and Drug Administration (FDA) and European Medicines Agency (EMA), and will discuss how best to bring this option to patients as quickly as possible.
The Tecentriq lung programme currently consists of nine Phase III lung cancer studies as either monotherapy or in combination with other medicines across different types of lung cancer. Roche has an extensive development programme for Tecentriq, including multiple ongoing and planned Phase III studies, across lung, genitourinary, skin, breast, gastrointestinal, gynaecological and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines.
About the IMpower110 study
IMpower110 is a Phase III, randomised, open-label study to evaluate the efficacy and safety of Tecentriq monotherapy compared with cisplatin or carboplatin and pemetrexed or gemcitabine (chemotherapy) in programmed death-ligand 1 (PD-L1)-selected, chemotherapy-naive participants with advanced non-squamous or squamous NSCLC without ALK or EGFR mutations (wild-type; WT).
A total of 572 people (555 WT) were enrolled and were randomised 1:1 to receive:
The primary efficacy endpoint is OS by PD-L1 subgroup (TC3/IC3-WT; TC2/3/ IC2/3-WT; and TC1,2,3/IC1,2,3-WT), as determined by the SP142 assay test. Key secondary endpoints include investigator-assessed progression-free survival (PFS), objective response rate (ORR) and duration of response (DoR).
An overview of the key OS results is below:
|Arm A (Tecentriq)||Arm B (chemo)||HRa 95% Cl||P Value|
|TC3 or IC3-WT||107||20.2||98||13.1||0.595 (0.398, 0.890)||0.0106|
|TC2/3 or IC2/3-WT*||166||18.2||162||14.9||0.717 (0.520,0.989)||0.0416|
|TC1/2/3 or IC1/2/3-WT**||277||17.5||277||14.1||0.832 (0.649,1.067)||0.1481b|
TC, tumour cell; IC, tumour-infiltrating immune cells. PD-L1 expression was centrally evaluated with the VENTANA SP142 IHC assay. TC3 or IC3 = TC ≥ 50% or IC ≥ 10% PD-L1+; TC1/2/3 or IC1/2/3 = TC ≥ 1% or IC ≥ 1% PD-L1+; TC2/3 or IC2/3 = TC ≥ 5% or IC ≥ 5% PD-L1+. a Stratified. b Only for descriptive purpose.
*TC2/3 or IC2/3-WT did not cross the pre-specified boundary for statistical significance
**TC1/2/3 or IC1/2/3-WT was not formally tested and did not meet statistical significance
The safety population comprised 286 patients in Arm A and 263 in Arm B. Treatment-related AEs (TRAEs) and Grade 3-4 TRAEs occurred in 60.5% (Arm A) and 85.2% (Arm B), and 12.9% (Arm A) and 44.1% (Arm B), respectively.
Lung cancer is the leading cause of cancer death globally. Each year 1.76 million people die as a result of the disease; this translates into more than 4,800 deaths worldwide every day. Lung cancer can be broadly divided into two major types: NSCLC and small cell lung cancer. NSCLC is the most prevalent type, accounting for around 85% of all cases. NSCLC comprises non-squamous and squamous-cell lung cancer, the squamous form of which is characterised by flat cells covering the airway surface when viewed under a microscope.
About Tecentriq (atezolizumab)
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1, which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T cells. Tecentriq is a cancer immunotherapy (CIT) that has the potential to be used as a foundational combination partner with other immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers. The development of Tecentriq and its clinical programme is based on our greater understanding of how the immune system interacts with tumours and how harnessing a person’s immune system combats cancer
Tecentriq is approved in the US, EU and countries around the world, either alone or in combination with targeted therapies and/or chemotherapies in various forms of non-small cell and small cell lung cancer, certain types of metastatic urothelial cancer, and in PD-L1-positive metastatic triple-negative breast cancer.
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