Positive results against bladder cancer; fails NSCLC trial (Il Sole 24 Ore Radiocor) - London, 25 Jun - Anglo-Swedish drug maker AstraZeneca announced mixed results from recent Phase III trials of Imfinzi that recorded positive results against bladder cancer while not achieving statistical significance of disease free survival for early-stage (IB-IIIA) non-small cell lung cancer (NSCLC).

The company announced positive high-level results from the NIAGARA Phase III trial that showed that Imfinzi (durvalumab) in combination with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of event-free survival (EFS) and the key secondary endpoint of overall survival (OS) versus neoadjuvant chemotherapy for patients with muscle-invasive bladder cancer (MIBC).

Patients were treated with Imfinzi in combination with neoadjuvant chemotherapy before the surgery to remove the bladder followed by Imfinzi as adjuvant monotherapy.

However, high-level results from the ADJUVANT BR.31 Phase III trial, sponsored by the Canadian Cancer Trials Group (CCTG), showed Imfinzi did not achieve statistical significance for the primary endpoint of disease-free survival (DFS) versus placebo in early-stage (IB-IIIA) non-small cell lung cancer (NSCLC) after complete tumour resection.

Imfinzi is the only approved immunotherapy and the global standard of care in the curative-intent setting of unresectable, Stage III NSCLC in patients whose disease has not progressed after chemoradiotherapy based on the PACIFIC Phase III trial.

It is also being investigated as monotherapy and in combinations in several other early-stage lung cancer settings, including in medically inoperable or unresected Stage I-II NSCLC (PACIFIC-4) and unresectable, Stage III NSCLC (PACIFIC-5, 8 and 9).

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(RADIOCOR) 25-06-24 10:47:19 (0238) 5 NNNN