US FDA grants breakthrough therapy designation to Imfinzi for patients with locally-advanced unresectable NSCLCRead Now
AstraZeneca and MedImmune, its global biologics research and development arm, announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for Imfinzi (durvalumab) for the treatment of patients with locally-advanced, unresectable non-small cell lung cancer (NSCLC) whose disease has not progressed following platinum-based chemoradiation therapy.
Sean Bohen, executive vice president, global medicines development and chief medical officer at AstraZeneca, said: “For patients who have not progressed following chemoradiation therapy the only current option is active monitoring. Unfortunately, for the majority of patients, their cancer will progress to metastatic disease, typically within 12 months. Imfinzi is the first immuno-oncology medicine to show a clinically-significant benefit in this earlier, non-metastatic setting, so following the Breakthrough Designation we hope to bring it to patients as soon as possible.”
The Breakthrough Therapy Designation is designed to expedite the development and regulatory review of new medicines that are intended to treat a serious condition and that have shown encouraging early clinical results, which demonstrate substantial improvement on a clinically-significant endpoint over available medicines and when there is significant unmet medical need.
The Breakthrough Therapy Designation for Imfinzi was granted on the basis of interim results from the Phase III PACIFIC trial, a randomised, double-blinded, placebo-controlled multi-centre trial of Imfinzi as sequential treatment in patients with locally-advanced, unresectable (Stage III) NSCLC who had not progressed following standard platinum-based chemotherapy concurrent with radiation therapy. This achievement follows the recent accelerated approval from the US FDA for Imfinzi in previously-treated patients with advanced bladder cancer, and is the fourth Breakthrough Therapy Designation AstraZeneca has received from the FDA for a New Oncology cancer medicine over the past three years, the second for Imfinzi.
Data from the PACIFIC trial have been submitted for presentation at a forthcoming medical meeting.
Imfinzi is also being tested in the adjuvant NSCLC setting in the ADJUVANT phase III trial. In the Stage IV 1st-line setting for patients with advanced NSCLC, Imfinzi as monotherapy and in combination with tremelimumab, an anti-CTLA4, is being tested in the MYSTIC, NEPTUNE, and PEARL phase III trials. The POSEIDON trial is evaluating Imfinzi with and without tremelimumab in combination with chemotherapy.
The PACIFIC trial is a randomised, double-blinded, placebo-controlled multi-centre trial of Imfinzi as sequential treatment in unselected patients with locally-advanced, unresectable (Stage III) NSCLC who have not progressed following platinum-based chemotherapy concurrent with radiation therapy.
The trial is being conducted in 235 centres across 26 countries, including the US, Canada, Europe, South and Central America, Japan, Korea, Taiwan, South Africa and Australia. The primary endpoints of the trial are PFS and OS, and secondary endpoints include landmark PFS and OS, objective response rate and duration of response.
Imfinzi (durvalumab), a human monoclonal antibody directed against PD-L1, blocks PD-L1 interaction with PD-1 and CD80 on T cells, countering the tumour's immune-evading tactics and inducing an immune response.
Imfinzi continues to be studied in multiple monotherapy trials and combination trials with tremelimumab and other potential new medicines in immuno-oncology. Imfinzi is being assessed in Phase III trials as a monotherapy in various stages of NSCLC, in small-cell lung cancer (SCLC), in metastatic urothelial cancer (mUC) and in head and neck squamous cell carcinoma (HNSCC). The combination of Imfinzi and tremelimumab is being assessed in Phase III trials in NSCLC, SCLC, mUC and HNSCC and in Phase I/II trials in hepatocellular carcinoma (HCC) and haematological malignancies.