AstraZeneca’s oncology immunotherapy Imfinzi (durvalumab) has been granted orphan drug designation (ODD) for the treatment of small cell lung cancer (SCLC).
Last month, a phase 3 trial called CASPIAN met its primary endpoint with Imfinzi by delivering a statistically-significant and clinically-meaningful improvement in overall survival for patients suffering from extensive-stage small cell lung cancer.
The CASPIAN trial evaluated Imfinzi in combination with standard-of-care etoposide and platinum-based chemotherapy against chemotherapy alone. The drug is also being evaluated in limited-stage small cell lung cancer after concurrent chemoradiation therapy in a phase 3 trial, called ADRIATIC.
AstraZeneca R&D Oncology executive vice president José Baselga said: “This Orphan Drug Designation comes on the heels of positive results from the Phase III CASPIAN trial, which is the first trial to offer the flexibility of combining immunotherapy with different platinum-based regimens in small cell lung cancer.
“We are eager to expand treatment options for patients facing such a devastating diagnosis and look forward to working with regulatory authorities to bring forward new options as soon as possible.”
Currently, Imfinzi is approved for the treatment of unresectable, stage III non-small cell lung cancer (NSCLC) following chemotherapy and radiation therapy in more than 45 countries including the US, European Union, and Japan. The approval was based on the data from the phase 3 PACIFIC trial.
Imfinzi is a human monoclonal antibody, which has been designed to target the PD-1/PD-L1 pathway. The drug prevents the interaction of PD-L1 with PD-1 and CD80 proteins and through this action, works against the immune-evading tactics of the tumour and releases the inhibition of immune responses.
The oncology immunotherapy is also approved for the treatment of patients with locally-advanced or metastatic urothelial carcinoma in the US, Canada, Israel, Brazil, India and Hong Kong.
Imfinzi, as part of a larger development programme, is also being assessed as a monotherapy and in combination with anti-CTLA4 monoclonal antibody tremelimumab as a treatment for patients with NSCLC, SCLC, bladder cancer, head and neck cancer, biliary tract cancer, liver cancer, cervical cancer, and other solid tumours.