AstraZeneca’s Imfinzi misses target in Phase III head and neck cancer trial

pharmafile | February 5, 2021 | News story | Medical Communications AstraZeneca, Cancer 

AstraZeneca’s Imfinzi (durvalumab) has failed to improve overall survival (OS) for patients with recurrent or metastatic head and neck cancer in its Phase III trial.

The KESTREL Phase III trial for the drug did not meet the primary endpoint of improving OS versus the EXTREME treatment regimen (chemotherapy plus cetuximab), a standard of care, in the first-line treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma whose tumours expressed high levels of PD-L1.

Additionally, survival rates did not improve using a combination of Imfinzi plus tremelimumab in ‘all-comer’ patients, a secondary endpoint.

The trial was conducted in more than 200 centres across 23 countries, including centres in the US, Europe, South America, and Asia. The safety and tolerability profiles for the treatment as a monotherapy and in combination with tremelimumab were consistent with previous trials, and the company says the data will be shared in due course.

Imfinzi is approved in the curative-intent setting of unresectable, stage III non-small cell lung cancer (NSCLC) after chemoradiation therapy in the EU, US, Japan, China, and many other countries, based on the PACIFIC Phase III trial. It is also approved in the EU, US, Japan, and other countries for the treatment of extensive-stage small cell lung cancer (SCLC) based on the CASPIAN Phase III trial. In addition, the drug has received approval for previously treated patients with advanced bladder cancer in the US and several other countries.

Dave Fredrickson, Executive Vice President of AstraZeneca’s Oncology Business Unit, said: “Metastatic head and neck cancer is a complex and challenging disease with a poor prognosis. While we are disappointed by these results, insights from the KESTREL Phase III trial will advance our understanding and application of immunotherapy across our clinical development programme.

“We will continue to build on the established benefits of Imfinzi in early lung cancer and small cell lung cancer, to bring immunotherapy treatment options to all patients who may benefit.”

As part of a broad development programme, Imfinzi is being tested as a monotherapy and in combination with other anti-cancer treatments for patients with NSCLC, SCLC, bladder cancer, hepatocellular carcinoma, biliary tract cancer, oesophageal cancer, gastric and gastroesophageal cancer, cervical cancer, ovarian cancer, endometrial cancer, and other solid tumours. 

Darcy Jimenez

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