-- Tecentriq in combination with Avastin provides the longest overall 
      survival seen in a front-line Phase III study in unresectable 
      hepatocellular carcinoma (HCC) 
 
   -- Liver cancer is the 6th most common cancer and in 2020 was the third 
      leading cause of cancer deaths worldwide 
 
   -- Results to be presented at the 2021 Gastrointestinal Cancers Symposium 
      organised by the American Society of Clinical Oncology (ASCO), January 
      2021 
 
 
   Basel, 12 January 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) will present 
updated overall survival (OS) data from the Phase III IMbrave150 study 
evaluating Tecentriq(R) (atezolizumab) in combination with Avastin(R) 
(bevacizumab), compared with sorafenib, in people with unresectable 
hepatocellular carcinoma (HCC) who have not received prior systemic 
therapy. 
 
   After a median follow-up of 15.6 months, an updated analysis showed that 
Tecentriq in combination with Avastin reduced the risk of death (OS) by 
34%, with a median OS of 19.2 months, compared with 13.4 months for 
sorafenib (hazard ratio [HR]=0.66; 95% CI: 0.52--0.85). The updated OS, 
along with progression free survival (PFS) and objective response rate 
(ORR) results, were consistent with the primary analysis and support the 
use of the combination in HCC. Safety data for Tecentriq and Avastin 
were consistent with the known safety profiles of each individual drug, 
with no new safety signals identified. 
 
   "These results show that Tecentriq in combination with Avastin provides 
the longest survival that we've ever seen in a front-line Phase III 
study in unresectable HCC," said Levi Garraway, M.D., Ph.D., Roche's 
Chief Medical Officer and Head of Global Product Development. "The 
combination, which has now been approved in more than 60 countries 
around the world, represents a significant treatment advancement for 
patients with this challenging malignancy." 
 
   "After an additional year of follow-up, these data confirm the 
superiority of Tecentriq in combination with Avastin compared to 
sorafenib in patients with advanced HCC," said Dr Laura Kulik, Professor 
of Medicine, Interventional Radiology and Transplant, Feinberg School of 
Medicine, Northwestern University and member of the ASCO GI programme 
committee. "These results provide further confidence for physicians and 
patients in the use of this combination as first-line therapy." 
 
   These data will be presented in the Rapid Abstract Session: 
Hepatobiliary Cancer, Neuroendocrine/Carcinoid, Pancreatic Cancer, and 
Small Bowel Cancer at the Gastrointestinal Cancers Symposium on Sunday 
17 January at 15:30-16:15 ET. 
 
   Tecentriq in combination with Avastin is now approved around the world, 
including in the US, China, Japan and the EU, for people with 
unresectable HCC and is recommended in many clinical practice guidelines 
globally. 
 
   Roche is committed to tackling liver disease right across the disease 
journey, from the earliest stages through to advanced disease, with the 
ultimate goal of one day stopping chronic liver disease. 
 
   Roche has an extensive development programme for Tecentriq, including 
multiple ongoing and planned Phase III studies, across several types of 
lung, genitourinary, skin, breast, gastrointestinal, gynaecological, and 
head and neck cancers. This includes studies evaluating Tecentriq both 
alone and in combination with other medicines. 
 
 
 
 
 
 
 
 
Updated OS, PFS, response and duration of response data 
-------------------------------------------------------------------------- 
Global results 
-------------------------------------------------------------------------- 
                            Tecentriq + Avastin (n=336)  Sorafenib (n=165) 
--------------------------  ---------------------------  ----------------- 
                                       19.2                    13.4 
Median OS (95% CI), mo              (17.0--23.7)            (11.4--16.9) 
--------------------------  ---------------------------  ----------------- 
OS, HR                                           0.66 
 (95% CI), mo                                (0.52--0.85) 
--------------------------  ---------------------------------------------- 
                            Tecentriq + Avastin (n=336)  Sorafenib (n=165) 
--------------------------  ---------------------------  ----------------- 
Median PFS (95% CI),                    6.9                     4.3 
 mo                                  (5.7--8.6)              (4.0--5.6) 
--------------------------  ---------------------------  ----------------- 
PFS, HR                                          0.65 
 (95% CI), mo                                (0.53--0.81) 
--------------------------  ---------------------------------------------- 
                            Tecentriq + Avastin (n=326)  Sorafenib (n=159) 
--------------------------  ---------------------------  ----------------- 
Confirmed ORR (95% CI)                  30%                     11% 
 (%)                                  (25--35)                (7--17) 
--------------------------  ---------------------------  ----------------- 
     CR, n (%)                                  25 (8%)           1 (< 1%) 
--------------------------  ---------------------------  ----------------- 
     PR, n (%)                                 72 (22%)           17 (11%) 
--------------------------  ---------------------------  ----------------- 
     SD, n (%)                                144 (44%)           69 (43%) 
--------------------------  ---------------------------  ----------------- 
Ongoing response, n (%)                        54 (56%)            5 (28%) 
--------------------------  ---------------------------  ----------------- 
                            Tecentriq + Avastin (n=97)   Sorafenib (n=18) 
--------------------------  ---------------------------  ----------------- 
Median DOR (95% CI),                   18.1                    14.9 
 mo                                  (14.6, NE)             (4.9--17.0) 
--------------------------  ---------------------------  ----------------- 
Overall survival results in the Chinese subpopulation 
-------------------------------------------------------------------------- 
                            Tecentriq + Avastin (n=133)  Sorafenib (n=61) 
--------------------------  ---------------------------  ----------------- 
Median OS (95%CI), mo                  24.0                    11.4 
 -- Chinese subpopulation            (17.1, NE)             (6.7--16.1) 
--------------------------  ---------------------------  ----------------- 
OS, HR                                           0.53 
 (95% CI), mo                                (0.35--0.80) 
--------------------------  ---------------------------------------------- 
 
   PFS and all response data are reported by RECIST v1.1 assessed by an 
independent review facility. 
 
   Median follow-up: 15.6 months. 
 
   CR, complete response; DOR, duration of response; HR, hazard ratio; NE, 
not estimable; ORR, objective response rate; OS, overall survival; PFS, 
progression free response; PR, partial response; SD, stable disease. 
 
   See below for OS data from the primary analysis. 
 
 
 
 
 
   About the IMbrave150 study 
 
   IMbrave150 is a global Phase III, multicentre, open-label study of 501 
people with unresectable HCC who had not received prior systemic 
therapy. People were randomised 2:1 to receive the combination of 
Tecentriq and Avastin or sorafenib. Tecentriq was administered 
intravenously (IV), 1200 mg on day 1 of each 21-day cycle, and Avastin 
was administered IV, 15 mg/kg on day 1 of each 21-day cycle. Sorafenib 
was administered by mouth, 400 mg twice per day, on days 1-21 of each 
21-day cycle. People received the combination or the control arm 
treatment until disease progression or unacceptable toxicity. The two 
primary endpoints were OS and independent review facility (IRF)-assessed 
PFS per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 
v1.1). Additional study endpoints included IRF-assessed overall response 
rate (ORR) per RECIST v1.1 and HCC mRECIST. 
 
   The primary analysis from the IMbrave150 study showed that after 8.6 
months follow-up, Tecentriq in combination with Avastin reduced the risk 
of death (OS) by 42% (HR=0.58; 95% CI: 0.42--0.79; p=0.0006). 
 
   About hepatocellular carcinoma 
 
   HCC is an aggressive cancer with limited treatment options and is a 
major cause of cancer deaths worldwide.(1) Every year, more than 815,000 
people worldwide are diagnosed with HCC,(1,2) with the majority of cases 
in Asia and almost half of all cases in China.(2,3) In the US, the 
number of liver cancer cases have more than tripled since 1980 and HCC 
represents the fastest-rising cause of cancer-related death, while in 
Europe, liver cancer is also on the rise, accounting for more than 
87,000 diagnoses and approximately 78,000 deaths in 2020.(4-7) HCC 
develops predominantly in people with cirrhosis due to chronic hepatitis 
(B or C) or alcohol consumption, and typically presents at an advanced 
stage.(1) The prognosis for unresectable HCC remains poor, with few 
systemic therapeutic options and a 1-year survival rate of less than 50% 
following diagnosis.(8) 
 
   About the Tecentriq and Avastin combination 
 
   There is a strong scientific rationale to support the use of Tecentriq 
plus Avastin in combination. The Tecentriq and Avastin regimen may 
enhance the potential of the immune system to combat a broad range of 
cancers. Avastin, in addition to its established anti-angiogenic effects, 
may further enhance Tecentriq's ability to restore anti-cancer immunity, 
by inhibiting vascular endothelial growth factor (VEGF)-related 
immunosuppression, promoting T-cell tumour infiltration and enabling 
priming and activation of T-cell responses against tumour antigens. 
 
   About Tecentriq 
 
   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 

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January 12, 2021 01:00 ET (06:00 GMT)