-- Tecentriq significantly improved overall survival in people with high 
      PD-L1 expression, compared with chemotherapy in a Phase III study 
 
   -- Tecentriq approval offers an alternative to chemotherapy for all eligible 
      patients 
 
   -- This approval marks Tecentriq's fourth indication in metastatic non-small 
      cell lung cancer and fifth indication in lung cancer overall in the EU 
 
 
   Basel, 5 May 2021 -- Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced 
that the European Commission has approved Tecentriq(R) (atezolizumab) as 
a first-line (initial) treatment for adults with metastatic non-small 
cell lung cancer (NSCLC) whose tumours have high PD-L1 expression*, with 
no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase 
(ALK) genomic tumour aberrations. 
 
   "We are delighted to bring Tecentriq to people in the EU with this 
specific type of lung cancer," said Levi Garraway, M.D., Ph.D., Roche's 
Chief Medical Officer and Head of Global Product Development. "Tecentriq 
monotherapy has been shown to improve overall survival in people with 
high PD-L1 expression, when compared to chemotherapy, and therefore 
represents a new treatment option for people living with this 
difficult-to-treat disease." 
 
   Tecentriq is now the first and only single-agent cancer immunotherapy 
with three dosing options, allowing administration every two, three or 
four weeks, giving physicians and patients greater flexibility on how 
they manage their treatment. 
 
   This approval is based on data from the Phase III IMpower110 study, 
which showed that Tecentriq monotherapy improved overall survival (OS) 
by 7.1 months compared with chemotherapy (median OS=20.2 versus 13.1 
months; hazard ratio [HR]=0.59, 95% CI: 0.40--0.89; p=0.0106) in people 
with high PD-L1 expression (TC3 or IC3-wild-type [WT]).(1) Safety for 
Tecentriq was consistent with its known safety profile, with no new 
safety signals identified. Grade 3--4 treatment-related adverse events 
were reported in 12.9% of people receiving Tecentriq, compared with 
44.1% of people receiving chemotherapy.(2) 
 
   Tecentriq has shown clinically meaningful benefit in various types of 
lung cancer, with five currently approved indications in markets around 
the world. In Europe, Tecentriq now has four approved indications in 
NSCLC, including as a single agent or in combination with targeted 
therapies and/or chemotherapies. It was also the first approved cancer 
immunotherapy for the first-line treatment of adults with 
extensive-stage small cell lung cancer (SCLC) in combination with 
carboplatin and etoposide (chemotherapy). 
 
   Roche has an extensive development programme for Tecentriq, including 
multiple ongoing and planned Phase III studies across different settings 
in lung, genitourinary, skin, breast, gastrointestinal, gynaecological, 
and head and neck cancers. This includes studies evaluating Tecentriq 
both alone and in combination with other medicines, as well as studies 
in metastatic, adjuvant and neoadjuvant settings across various tumour 
types. 
 
   About the IMpower110 study 
 
   IMpower110 is a Phase III, randomised, open-label study evaluating the 
efficacy and safety of Tecentriq monotherapy compared with cisplatin or 
carboplatin and pemetrexed or gemcitabine (chemotherapy) in 
PD-L1-selected, chemotherapy-naïve participants with Stage IV 
non-squamous or squamous NSCLC. The study enrolled 572 people, of whom 
554 were in the intention-to-treat WT population, which excluded people 
with EGFR or ALK genomic tumour aberrations, and were randomised 1:1 to 
receive: 
 
 
   -- Tecentriq monotherapy, until disease progression (or loss of clinical 
      benefit, as assessed by the investigator), unacceptable toxicity or 
      death; or 
 
   -- Cisplatin or carboplatin (per investigator discretion) combined with 
      either pemetrexed (non-squamous) or gemcitabine (squamous), followed by 
      maintenance therapy with pemetrexed alone (non-squamous) or best 
      supportive care (squamous) until disease progression, unacceptable 
      toxicity or death. 
 
 
   The primary efficacy endpoint was 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 included investigator-assessed 
progression-free survival, objective response rate and duration of 
response. 
 
   At the World Conference on Lung Cancer 2020 (January 2021), an updated, 
exploratory OS analysis in the PD-L1 high (TC3 or IC3)-WT population 
showed a continued OS benefit at a median follow-up of 31.3 months 
(HR=0.76, 95% CI: 0.54--1.09). Median OS in the Tecentriq arm was the 
same as observed at the previous analysis (20.2 months); in the 
chemotherapy arm, median OS was 14.7 months.(3) Data from this 
exploratory OS analysis were also submitted to the European Commission. 
 
   PD-L1 is a protein expressed on tumour cells and tumour-infiltrating 
cells, which suppresses the immune response and enables tumour cells to 
avoid detection by binding to proteins on the surface of immune cells. 
Immunotherapies such as Tecentriq block PD-L1 from binding to immune 
cells, allowing the immune system to detect and destroy tumour cells. In 
IMpower110, patients were classified as PD-L1 high if they had PD-L1 on 
at least 50% of tumour cells or if PD-L1 expressing tumour-infiltrating 
cells were covering at least 10% of the tumour area. 
 
   About NSCLC 
 
   Lung cancer is the one of the leading causes of cancer death 
globally.(4) Each year 1.8 million people die as a result of the 
disease; this translates into more than 4,900 deaths worldwide every 
day.(4) Lung cancer can be broadly divided into two major types: NSCLC 
and SCLC. NSCLC is the most prevalent type, accounting for around 85% of 
all cases.(5) 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.(5) 
 
   About Tecentriq 
 
   Tecentriq is a monoclonal antibody designed to bind with a protein 
called Programmed Death Ligand-1 (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 
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 more effectively. 
 
   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 NSCLC, SCLC, certain types of 
metastatic urothelial cancer, in PD-L1-positive metastatic 
triple-negative breast cancer and for hepatocellular carcinoma. In the 
US, Tecentriq is also approved in combination with Cotellic(R) 
(cobimetinib) and Zelboraf(R) (vemurafenib) for the treatment of people 
with BRAF V600 mutation-positive advanced melanoma. 
 
   About Roche in cancer immunotherapy 
 
   Roche's rigorous pursuit of groundbreaking science has contributed to 
major therapeutic and diagnostic advances in oncology over the last 50 
years, and today, realising the full potential of cancer immunotherapy 
is a major area of focus. With over 20 molecules in development, Roche 
is investigating the potential benefits of immunotherapy alone, and in 
combination with chemotherapy, targeted therapies or other 
immunotherapies with the goal of providing each person with a treatment 
tailored to harness their own unique immune system to attack their 
cancer. Our scientific expertise, coupled with innovative pipeline and 
extensive partnerships, gives us the confidence to continue pursuing the 
vision of finding a cure for cancer by ensuring the right treatment for 
the right patient at the right time. 
 
   In addition to Roche's approved PD-L1 checkpoint inhibitor, Tecentriq(R) 
(atezolizumab), Roche's broad cancer immunotherapy pipeline includes 
other checkpoint inhibitors, such as tiragolumab, a novel cancer 
immunotherapy designed to bind to TIGIT, individualised neoantigen 
therapies and T-cell bispecific antibodies. 
 
   To learn more about Roche's scientific-led approach to cancer 
immunotherapy, please follow this link: 
 
   http://www.roche.com/research_and_development/what_we_are_working_on/oncology/cancer-immunotherapy.htm 
 
 
   About Roche 
 
   Roche is a global pioneer in pharmaceuticals and diagnostics focused on 
advancing science to improve people's lives. The combined strengths of 
pharmaceuticals and diagnostics under one roof have made Roche the 
leader in personalised healthcare -- a strategy that aims to fit the 
right treatment to each patient in the best way possible. 
 
   Roche is the world's largest biotech company, with truly differentiated 
medicines in oncology, immunology, infectious diseases, ophthalmology 
and diseases of the central nervous system. Roche is also the world 
leader in in vitro diagnostics and tissue-based cancer diagnostics, and 
a frontrunner in diabetes management. 
 
   Founded in 1896, Roche continues to search for better ways to prevent, 
diagnose and treat diseases and make a sustainable contribution to 
society. The company also aims to improve patient access to medical 
innovations by working with all relevant stakeholders. More than thirty 
medicines developed by Roche are included in the World Health 
Organization Model Lists of Essential Medicines, among them life-saving 
antibiotics, antimalarials and cancer medicines. Moreover, for the 
twelfth consecutive year, Roche has been recognised as one of the most 
sustainable companies in the Pharmaceuticals Industry by the Dow Jones 
Sustainability Indices (DJSI).

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May 05, 2021 01:00 ET (05:00 GMT)