Roche : to present results of the largest safety study of its kind with Tecentriq (atezolizumab) in patients with metastatic bladder cancer

Basel, 18 March 2019

Roche to present results of the largest safety study of its kind with Tecentriq (atezolizumab) in patients with metastatic bladder cancer

• The SAUL study evaluated the safety of Tecentriq in approximately 1000 patients with locally advanced or metastatic urothelial carcinoma
• Data to be presented at the European Association of Urology (EAU)

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced first results from SAUL, a Phase IIIb study evaluating the safety of Tecentriq® in approximately 1000 patients with locally advanced or metastatic urothelial carcinoma (mUC) including several clinically relevant populations reflective of real-world clinical practice (patients with renal impairment, poor performance status (ECOG PS 2), treated asymptomatic CNS metastases, stable controlled autoimmune disease).^[1] Data from the study showed that both safety and efficacy, a secondary endpoint, were consistent with previous studies in both the overall population and a subgroup of patients corresponding to the patient population of the pivotal Phase III study, IMvigor211 ('IMvigor211-like'^[2]). The SAUL study is ongoing and further subgroup analyses will also be presented at future medical meetings.

'SAUL is the largest prospective safety study of a cancer immunotherapy in metastatic urothelial carcinoma and provides clinicians with valuable information about Tecentriq in a real-world setting' said Sandra Horning, M.D., Chief Medical Officer and Head of Global Product Development. 'We remain committed to improving outcomes for people living with this devastating illness and we look forward to sharing data in the future from our ongoing Phase III studies in early and metastatic disease'.

The data presented at EAU show that the safety of the Tecentriq monotherapy treatment was consistent with the known safety profile of the medicine. Grade 3-4 adverse events (AEs) occurred in 43% of the patients, and treatment-related grade ≥3 AEs occurred in 13% of the patients, with most common reported side effects being fatigue, asthenia, colitis and hypertension (each in 1%). AEs leading to treatment discontinuation happened in 6% of the patients. Additionally, the efficacy results, secondary endpoints of the study, showed an overall survival of 10 months (95% CI 8.8-11.9 months) in the IMvigor211-like population. In the overall population, median OS was 8.7 months (95% CI 7.8-9.9). The median duration of follow up was 12.7 months.

These data are being presented today at the annual EAU Congress Breaking News Session at 7:30am CET.

About the SAUL study

The SAUL study is a Phase IIIb, prospective, open label, single arm, multicentre study designed to assess the safety of Tecentriq as a second- to fourth-line treatment for people with locally advanced or metastatic urothelial carcinoma (95%) or non-urothelial carcinoma (5%) of the urinary tract. In addition, the study evaluates the efficacy of Tecentriq and potential tumour biomarkers associated with Tecentriq. It enrolled 1004 people globally, 997 of whom received Tecentriq. IMvigor211-like patients and patients with renal impairment, poor performance status (ECOG PS 2), treated asymptomatic CNS metastases or stable controlled autoimmune disease were eligible. The primary endpoint was safety; secondary endpoints included overall survival (OS), progression-free survival (PFS), overall response rate (ORR) and duration of response (DoR).

A summary of the data is included below:

Tecentriq in genitourinary cancers

Roche has five Tecentriq Phase III studies investigating Tecentriq in different settings and diseases of genitourinary cancers including two Phase III studies in early bladder cancer (IMvigor010) and metastatic bladder cancer (IMvigor130), a Phase III study in metastatic castrate resistant prostate cancer (IMbassador250) and two Phase III studies in renal cell carcinoma (IMmotion151 and IMmotion010). Tecentriq is already approved as a monotherapy for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma: after prior platinum‐containing chemotherapy, or who are considered cisplatin ineligible and whose tumours have a PD-L1 expression ≥5%. The FDA also approved Tecentriq in patients with locally advanced or mUC and ineligible for any platinum-based chemotherapy, irrespective of PD-L1 status.

About Tecentriq

Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1 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 has the potential to be used as a foundational combination partner with cancer immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers.

In the United States Tecentriq in combination with nab-paclitaxel is approved for treatment of PD-L1-positive metastatic triple-negative breast cancer; and in combination with Avastin and chemotherapy for the initial treatment of people with metastatic non-squamous NSCLC. In the Europe Union, the non-squamous NSCLC indication includes people with EGFR mutant or ALK genomic tumour aberrations after failure of appropriate targeted therapies. Tecentriq is also approved in the European Union, United States and more than 85 countries for people with previously treated metastatic non-small cell lung cancer (NSCLC) and for certain types of untreated or previously treated metastatic urothelial carcinoma who are not eligible for cisplatin chemotherapy, or who have had disease progression during or following platinum-containing therapy.

About bladder cancer

Bladder cancer is the tenth most common cancer worldwide, with almost 555,000 new cases diagnosed in 2018. ^[3] It is the sixth most common cancer in men and the 17th most common cancer in women,^[3] and the disease is three times more common in developed countries than in less developed countries.^[4] There are three types of bladder cancer: transitional cell carcinoma (which begins in cells in the innermost tissue layer), squamous cell carcinoma (which begins in squamous cells) and adenocarcinoma (which begins in glandular cells in the lining of the bladder). Most cancers that form in the bladder are transitional cell carcinomas.^[5]

About Roche in cancer immunotherapy

For more than 50 years, Roche has been developing medicines with the goal to redefine treatment in oncology. Today, we're investing more than ever in our effort to bring innovative treatment options that help a person's own immune system fight cancer.
By applying our seminal research in immune tumour profiling within the framework of the Roche-devised cancer immunity cycle, we are accelerating and expanding the transformative benefits with Tecentriq to a greater number of people living with cancer. Our cancer immunotherapy development programme takes a comprehensive approach in pursuing the goal of restoring cancer immunity to improve outcomes for patients.

To learn more about the Roche 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. 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 tenth consecutive year, Roche has been recognised as the most sustainable company in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2018 employed about 94,000 people worldwide. In 2018, Roche invested CHF 11 billion in R&D and posted sales of CHF 56.8 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.