AstraZeneca and MedImmune, its global biologics research and development arm, have announced positive results for a trial of its lung cancer drug Imfinzi (durvalumab).
The phase III PACIFIC trial was a randomised, double-blinded, placebo-controlled multi-centre trial of Imfinzi as sequential treatment in patients with locally-advanced, unresectable (stage III) non-small cell lung cancer (NSCLC) who had not progressed following standard platinum-based chemotherapy concurrent with radiation therapy.
AstraZeneca and MedImmune said a planned interim analysis conducted by an independent data monitoring committee (IDMC) concluded that the trial has already met a primary endpoint by showing statistically-significant and clinically-meaningful PFS, as assessed by blinded independent central review, in patients receiving Imfinzi compared to placebo.
The results also demonstrated a favourable benefit/risk profile.
AstraZeneca and MedImmune said the trial would also evaluate overall survival (OS), the other primary endpoint, which would be assessed in due course as specified by the protocol.
AstraZeneca said it planned to submit the initial results from the PACIFIC trial for presentation at a forthcoming medical meeting.
AstraZeneca executive vice-president, global medicines development and chief medical officer, Sean Bohen, said: “These are highly encouraging results for patients with locally-advanced lung cancer for whom surgery is not an option. We look forward to working with regulatory authorities around the world to bring Imfinzi to lung cancer patients as soon as possible. Alongside this, we continue to explore Imfinzi’s full potential as monotherapy as well as in combination with tremelimumab and other medicines in areas of continued unmet need across multiple types of cancer.”