The FINANCIAL — Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the China National Medical Products Administration (NMPA) has approved Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab) for the treatment of people with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy.
“Today’s approval of Tecentriq in combination with Avastin for unresectable hepatocellular carcinoma means that people in China now have a cancer immunotherapy option which is changing the treatment landscape for this aggressive disease”, said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “With almost half of the world’s hepatocellular carcinoma cases diagnosed in China, this approval marks a major advance for Chinese patients.”
“In China, primary liver cancer ranks as the fourth most common malignancy and is the second leading cause of cancer death. With most patients diagnosed at the intermediate and advanced stages where surgery or other locoregional therapies are not an option, there is an urgent need for effective treatments for unresectable HCC”, said Prof. Shukui Qin, Leading Principal Investigator of the IMbrave150 study in China and Chairman of the Liver Cancer Expert Committee of the Chinese Society of Clinical Oncology (CSCO). “The IMbrave150 study demonstrated that the combination of Tecentriq and Avastin in this setting can significantly improve outcomes for patients. It is truly gratifying news that the combination is now approved in China and gives a new option to Chinese liver cancer patients.”
Liver cancer is one of the most common cancers in China, accounting for nearly 400,000 diagnoses and approximately 368,000 deaths every year, equivalent to over 1,000 per day.1 Only 20% of people with HCC in China are diagnosed in the early stages, when curative treatments are still an option.2 The average 5-year survival rate for people in China with liver cancer is only approximately 15%.3 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.
The approval was based on results of the Phase III IMbrave150 study, which included analyses of a cohort of Chinese patients (n=194) from the same study. Data from this cohort were consistent with the global results. Among Chinese patients, Tecentriq in combination with Avastin reduced the risk of death (overall survival; OS) by 56% (hazard ratio [HR]=0.44; 95% CI: 0.25–0.76) and reduced the risk of disease worsening or death (progression-free survival; PFS) by 40% (HR=0.60; 95% CI: 0.40–0.90), compared with sorafenib. Tecentriq and Avastin were generally well-tolerated with manageable toxicities, and the safety profile was consistent with the known safety profiles of the individual medicines and with the underlying disease.
Global results from the IMbrave150 study demonstrated that 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) and reduced the risk of disease worsening or death (PFS) by 41% (HR=0.59; 95% CI: 0.47–0.76; p<0.0001), compared with sorafenib. IMbrave150 is the first Phase III cancer immunotherapy study to show an improvement in OS and PFS in people with unresectable or metastatic HCC compared with sorafenib. Grade 3–4 adverse events occurred in 57% of people receiving Tecentriq and Avastin and 55% of people receiving sorafenib. The most frequent serious adverse reactions (≥2%) were bleeding in the gastrointestinal tract and fever. These results were published in the New England Journal of Medicine on 14 May 2020.4
In May 2020, the US Food and Drug Administration approved Tecentriq in combination with Avastin for the treatment of people with unresectable or metastatic HCC who have not received prior systemic therapy. In addition, in September, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the approval of Tecentriq in combination with Avastin for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy. Tecentriq in combination with Avastin was also recently recommended as a preferred option by the CSCO for the treatment of unresectable HCC, as well as by many clinical practice guidelines globally.
Earlier this year, the China NMPA also approved Tecentriq in combination with chemotherapy (carboplatin and etoposide) for the first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC), an area of major unmet need and one that has seen limited advances in treatment until now. The submission was based on the results from the positive Phase III IMpower133 study and was the first cancer immunotherapy available in China for the initial treatment of ES-SCLC.
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.