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AstraZeneca Announces Results Of Updated Analysis Of Phase III CASPIAN Trial

AstraZeneca plc (AZN) announced Friday that detailed results from an updated analysis of the Phase III CASPIAN trial showed IMFINZI in combination with a choice of chemotherapies, etoposide plus either carboplatin or cisplatin, demonstrated a sustained, clinically meaningful overall survival (OS) benefit for adults with extensive-stage small cell lung cancer (ES-SCLC) treated in the 1st-line setting.

The CASPIAN trial met the primary endpoint of OS in June 2019, reducing the risk of death by 27% which formed the basis of the US FDA approval in March 2020.

After a median follow up of more than two years, the latest results for IMFINZI plus chemotherapy showed sustained efficacy, maintaining a 25% reduction in the risk of death versus chemotherapy alone. Updated median OS was 12.9 months versus 10.5 for chemotherapy.

IMFINZI, in combination with etoposide and either carboplatin or cisplatin, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).

CASPIAN is a randomized, open-label, multi-center, global, Phase III trial in the 1st-line treatment of 805 patients with ES-SCLC. The trial compared IMFINZI in combination with etoposide and either carboplatin or cisplatin chemotherapy, or IMFINZI and chemotherapy with the addition of a second immunotherapy, tremelimumab, versus chemotherapy alone.

IMFINZI is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumor's immune-evading tactics and releasing the inhibition of immune responses.

Lung cancer is the leading cause of cancer death among both men and women and accounts for about one-quarter of all cancer deaths in the United States: more than breast, prostate and colorectal cancers combined

The second experimental arm in the CASPIAN trial testing tremelimumab, an anti-CTLA4 monoclonal antibody, added to IMFINZI and chemotherapy showed a trend towards OS, but did not reach statistical significance compared to chemotherapy alone.

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