AstraZeneca has reported that a mixture of its drug Imfinzi (durvalumab) with chemotherapy enhanced progression-cost-free survival (PFS) in the ongoing Phase III POSEIDON clinical trial involving remedy-naïve individuals with stage IV non-smaller cell lung cancer (NSCLC).
Imfinzi is a human monoclonal antibody developed to inhibit the interaction of PD-L1 with PD-1 and CD80. It has regulatory approval to treat unresectable, stage III NSCLC.
The drug is also indicated in 11 nations for previously treated sophisticated bladder cancer individuals.
In the open-label, randomised, multi-centre POSEIDON trial, Imfinzi is becoming tested in mixture with platinum-primarily based chemotherapy, as properly as with tremelimumab plus chemotherapy as a initially-line remedy.
The trial is becoming carried out at 153 web-sites in 18 nations and compared the mixture therapy to chemotherapy alone. Its major endpoints for the Imfinzi and chemotherapy mixture are PFS and all round survival (OS).
Crucial secondary endpoints contain PFS and OS for the triple mixture.
The major endpoint has been met with statistically substantial and clinically meaningful improvement in PFS when treated with Imfinzi plus a option of 5 platinum-primarily based chemotherapies versus chemotherapy alone.
Related improvements have been observed with the Imfinzi plus tremelimumab and chemotherapy mixture.
The security and tolerability of AstraZeneca’s drug have been constant with its recognized security profile.
The triple mixture also demonstrated a security profile related to that of the Imfinzi and chemotherapy mixture, with no any improve in remedy discontinuation.
AstraZeneca Oncology R&D executive vice-president José Baselga mentioned: “Clinical advantage was observed in a trial population that integrated a higher proportion of individuals with squamous illness and many possibilities of chemotherapy regimens.
“Additionally, the prospective to add tremelimumab to Imfinzi and chemotherapy may perhaps present an essential remedy strategy in this difficult setting, specifically taking into consideration the favourable security profile.”
The trial will additional evaluate the further major endpoint of OS and information is anticipated subsequent year.
AstraZeneca’s drug is also undergoing a separate Phase III trial, PEARL, as monotherapy in stage IV NSCLC individuals.