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Roche’s Tecentriq in combination with Avastin shows encouraging results in Phase Ib study of people with unresectable hepatocellular carcinoma

2019-09-27 14:20:09
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Data from the non-randomised Tecentriq and Avastin cohort (Arm A) showed clinically meaningful and durable responses after a median follow-up of 12.4 months, with a confirmed objective response rate (ORR) of 36% (95% CI 26–46) by central review per RECIST v1.1. The data also showed that 12% of people had a complete response to treatment and a median duration of response (DOR) was not yet reached, wie die Roche ausführt.

Median progression-free survival (PFS), by central review per RECIST v1.1, a secondary efficacy endpoint in the study, was 7.3 months (95% CI 5.4–9.9).2 Safety for the combination of Tecentriq and Avastin appeared to be consistent with the known safety profile of the individual medicines. No new safety signals were identified.For the randomised portion of the study (Arm F), evaluating the combination approach with Tecentriq and Avastin versus Tecentriq alone, the primary efficacy endpoint of PFS as assessed by central review per RECIST v1.1 was met, with the combination reducing the risk of disease worsening or death by 45% compared with Tecentriq monotherapy.

After a median follow-up of 6.6 months, the results demonstrate the superiority of the combination of Tecentriq and Avastin over Tecentriq monotherapy (hazard ratio =0.55, 80% CI 0.40–0.74, p=0.0108). Median PFS in the Tecentriq and Avastin arm was 5.6 months (95% CI 3.6–7.4) compared with 3.4 months (95% CI 1.9–5.2) in the Tecentriq monotherapy arm.2 Additional secondary endpoints of Arm F are being evaluated and at this time the data remain immature.

Safety for both cohorts in Arm F appeared to be consistent with the known safety profile of the individual medicines. No new safety signals were identified.GO30140 is an open-label, multicentre Phase Ib study evaluating the safety and efficacy of Tecentriq (anti-PD-L1 antibody) administered in combination with Avastin and/or other treatments in people with solid tumours, including HCC.

In Arms A and F of the study, people with unresectable HCC who had not received prior systemic therapy were eligible for enrolment. All patients in Arm A received Tecentriq and Avastin.

Patients in Arm F were randomised 1:1 to receive Tecentriq and Avastin or Tecentriq monotherapy. Patients on the combination received Tecentriq (1200 mg) and Avastin (15 mg/kg) intravenously every 3 weeks, while those in the monotherapy cohort received Tecentriq (1200 mg) intravenously every 3 weeks.

In all cohorts, treatment continued until unacceptable toxicity or loss of clinical benefit. Primary endpoints were ORR (Arm A) and PFS (Arm F) by central review per RECIST v1.1, and safety (both arms).IMbrave150 is a global Phase III, multicentre, open-label study of 480 people with unresectable HCC who have not received prior systemic therapy.

People are randomised 2:1 to receive the combination of Tecentriq and Avastin or sorafenib. Tecentriq is administered intravenously, 1200 mg on day 1 of each 21-day cycle, and Avastin is administered intravenously, 15 mg/kg on day 1 of each 21-day cycle.

Sorafenib is administered by mouth, 400 mg twice per day, on days 1–21 of each 21-day cycle. People receive the combination or the control arm treatment until unacceptable toxicity or loss of clinical benefit as determined by the investigator.

Co-primary endpoints are overall survival (OS) and PFS by central review per RECIST v1.1. Secondary endpoints include ORR, PFS, time to progression (TTP) and DOR all assessed by the investigator per RECIST v1.1 and HCC mRECIST, as well as ORR, TTP and DOR by central review per RECIST v1.1, along with time to deterioration (TTD) in patient-reported global health status/quality of life (GHS/QoL).There is a strong scientific rationale to support the use of Tecentriq and 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.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 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.Avastin is a prescription-only medicine that is a solution for intravenous infusion.

It is a biologic antibody designed to specifically bind to a protein called VEGF that plays an important role throughout the lifecycle of the tumour to develop and maintain blood vessels, a process known as angiogenesis. Avastin is designed to interfere with the tumour blood supply by directly binding to the VEGF protein to prevent interactions with receptors on blood vessel cells.

The tumour blood supply is thought to be critical to a tumour’s ability to grow and spread in the body (metastasize).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 eleventh consecutive year, Roche has been recognised as one of the most sustainable companies 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..

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Roche’s Tecentriq combination Avastin shows encouraging results Phase Ib study people unresectable hepatocellular carcinoma