Application duralumin in combination with standard chemotherapy (CT) etoposide and carboplatin or cisplatin (a drug combination of platinum and etoposide) approved in US as first-line therapy in adult patients with advanced small cell lung cancer (rmrl).
The basis for the approval of the Administration for control over food and drugs was the positive results of the study phase III of the CASPIAN, which showed that the use of duralumin in combination with the chemotherapy drug combination of platinum and etoposide provided statistically and clinically significant increase in overall survival (OS) compared to using only HT. The application was approved in an accelerated mode and duralumin received the status of orphan drug for this indication.
SCLC is a highly aggressive lung cancer, which typically recurs and progresses rapidly, despite the high initial sensitivity to chemotherapy.
In the study phase III CASPIAN had two primary endpoints for comparison of experimental groups with the group HT. Under duralube in combination with chemotherapy the risk of death was decreased by 27% (corresponding to a hazard ratio of 0.73; 95% confidence interval of 0.59–0,91; p=0,0047), and median OS made up of 13.0 months compared with 10.3 months in the HT group only. The results of the study also showed an increase in the frequency of confirmed objective response in the group duralube in combination with chemotherapy (68% compared with 58% when using only HT). Safety and tolerability of combination duralumin with HT is consistent with known data on the safety of these drugs. These studies CASPIAN on the application of duralumin in combination with chemotherapy was published in the journal The Lancet.
Statistical analysis of data of the second experimental group with the addition of tremelimumab to duralumin and HT was recently completed, however, the primary endpoint in this group was not achieved. Detailed results will be presented at a future medical conference.
In the study of the CASPIAN duralumin was used at a fixed dose (1500 mg) once every 3 weeks for 4 cycles in combination with chemotherapy and then every 4 weeks until disease progression. In an extensive programme of development application duralumin also evaluated after simultaneous chemoradiotherapy in patients with localized SCLC in the study phase III ADRIATIC, the results of which are expected in 2021
Duralumin was first approved for the treatment of patients with rnrl on the basis of the results of the study phase III CASPIAN in February 2020 in Singapore. The possibility of using duralumin in combination with etoposide and carboplatin or cisplatin as first-line therapy rmrl on the basis of research results of phase III of the CASPIAN is currently being evaluated by the authorized regulatory authorities, the EU and Japan.