AstraZeneca's Imfinzi cleared in EU as first-line treatment for extensive-stage SCLC

AstraZeneca announced Tuesday that the European Commission approved Imfinzi (durvalumab) for the first-line treatment of adults with extensive-stage small-cell lung cancer (ES-SCLC) in combination with a choice of chemotherapies, etoposide plus either carboplatin or cisplatin. Dave Fredrickson, executive vice president of the company's oncology business unit, said "this is the first immunotherapy regimen to offer both a sustained survival benefit and an improved response rate, as well as a choice of chemotherapies and convenient dosing every four weeks during maintenance."

The decision follows a recommendation by the European Medicines Agency's Committee for Medicinal Products for Human Use in July, as well as recent approvals of the PD-L1 immunotherapy for the same indication by regulators in the US and Japan.

The European filing was backed by data from the Phase III CASPIAN trial, with Imfinzi plus chemotherapy achieving the primary endpoint by demonstrating a significant and clinically meaningful overall survival (OS) benefit for the first-line treatment of ES-SCLC. Specifically, Imfinzi plus chemotherapy reduced the risk of death by 27% versus chemotherapy alone, with median OS of 13 months versus 10.3 months, respectively. The results also showed that the respective confirmed objective response rates for the two groups were 68% versus 58%, while Imfinzi plus chemotherapy also delayed the time for disease symptoms to worsen.

Efficacy sustained two years out

Meanwhile, an updated analysis of outcomes after a median follow up of more than two years revealed sustained efficacy, with Imfinzi maintaining a 25% reduction in the risk of death versus chemotherapy alone. Specifically, median OS for Imfinzi-treated patients was 12.9 months, compared with 10.5 months for those only given chemotherapy. AstraZeneca also noted that no patients have tested positive for treatment-emergent anti-drug antibodies to Imfinzi.

Luis Paz-Ares, principal investigator in the CASPIAN trial, stated that "for the first time, patients with [ES-SCLC] in Europe will have the option of an immunotherapy combination with cisplatin, a preferred chemotherapy for many European physicians in this setting."

Imfinzi is also being tested following concurrent chemoradiation therapy in patients with limited-stage SCLC in the Phase III ADRIATIC trial, as part of a broader development programme as monotherapy and in combinations against multiple cancer types. The drug is already approved in the curative-intent setting of unresectable, Stage III non-small-cell lung cancer after chemoradiation therapy in Europe, as well as in the US, Japan, China and elsewhere.

To read more Top Story articles, click here.