-- 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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