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Roche files Tecentriq/Avastin combo in liver cancer

First treatment in over a decade to improve overall survival

Roche

Just days after it reported a fail in a phase 3 study of Tecentriq in bladder cancer, Roche has filed a Tecentriq and Avastin combination therapy in liver cancer. 

Roche has filed Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) as a first-line treatment for unresectable hepatocellular carcinoma (HCC) – the most common form of liver cancer.

The filing is based on results from the IMbrave150 study in HCC, which involved patients who could not be treated with surgery but who had not been treated with any other systemic therapy. Patients received PD-L1 inhibitor Tecentriq plus anti-VEGF antibody Avastin or Bayer’s Nexavar (sorafenib) – a standard first-line therapy for HCC.

If Roche wins approval, the Tecentriq/Avastin regimen would be the first therapy to extend survival in first-line HCC treatment for more than a decade, according to Roche’s chief medical officer Levi Garraway (pictured below).

Levi Garraway

Levi Garraway

“Liver cancer is the most rapidly increasing cause of cancer-related death in the US. In the IMbrave150 study, Tecentriq in combination with Avastin became the first treatment in more than a decade to improve overall survival compared with the current standard of care,” said Levi Garraway, Roche’s chief medical officer and head of global product development.

The filing in liver cancer is an important milestone in Roche’s plans for Tecentriq, which is a latecomer to the checkpoint inhibitor category. Its combination with Avastin is viewed as a central part of its strategy to gain ground on the leaders in the category, such as Merck & Co/MSD’s Keytruda (pembrolizumab) and Bristol-Myers Squibb’s Opdivo (nivolumab).

Although the combination is carving out market share in some therapy areas, Roche has continued to test Tecentriq as a monotherapy in certain indications, but has faced setbacks.

This includes a fail in a recent trial readout of the IMvigor010 study, which evaluated Tecentriq in muscle-invasive urotherial cancer (MIUC) – the most common type of bladder cancer.

Tecentriq has carved out a nice for itself in indications including triple-negative breast cancer and extensive-stage small cell lung cancer, where it isn’t facing direct competition from other checkpoint inhibitors.

A positive result in bladder cancer would have been significant for Roche – while the treatment of MIUC is being transformed by checkpoint inhibitors, a mix of surgery, chemotherapy and radiotherapy remains the standard option for these patients, with a lot of opportunity remaining in this therapy area.

The Swiss pharma also had to withdraw a filing in Europe for Tecentriq/Avastin in renal cell carcinoma – a common form of kidney cancer – on the grounds that the data behind it wasn’t strong enough.

Despite the setbacks, Roche has grown Tecentriq into a blockbuster drug, generating sales of more than $500m in third quarter alone.

Article by
Lucy Parsons

27th January 2020

From: Regulatory

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