AstraZeneca's immunotherapy Imfinzi granted orphan drug status by FDA for small-cell lung cancer

AstraZeneca said Friday that the FDA has granted an orphan drug designation to the PD-L1 inhibitor Imfinzi (durvalumab) for the treatment of small-cell lung cancer (SCLC). José Baselga, head of R&D Oncology at the company, said the 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 SCLC." 

In the study, first-line treatment with Imfinzi plus standard-of-care etoposide and platinum-based chemotherapy led to significant and clinically-meaningful improvement in overall survival (OS), versus chemotherapy alone, in patients with extensive-stage SCLC. AstraZeneca said the CASPIAN results will be unveiled at an upcoming research conference. Meanwhile, Imfinzi is also being evaluated following concurrent chemoradiation therapy in patients with limited-stage SCLC in the Phase III ADRIATIC trial. 

Shore Capital analysts suggested the US market for SCLC is worth up to $2 billion based on their estimate of 34,500 new cases of SCLC in the country every year. Roche's Tecentriq was approved as a first-line treatment for extensive-stage SCLC in March after Phase III data from the IMpower133 study showed that the PD-L1 inhibitor plus chemotherapy significantly extended OS compared to chemotherapy alone.

"We will have to wait and see the full data from CASPIAN, but note [AstraZeneca's] use of 'clinically-meaningful' in the description of its results," Shore Capital analysts stated. However, they noted that "Imfinzi's extensive use in the Stage III non-small-cell lung cancer (NSCLC) setting would be a competitive advantage given its brand equity and awareness amongst physicians." The immunotherapy is approved in several markets for use in NSCLC, including the US, EU and Canada.

Sales of Imfinzi climbed 376% in the first quarter to $295 million.

For related analysis, see ViewPoints: AstraZeneca sets up key readout for Imfinzi in SCLC later this year.  

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