AstraZeneca's Blockbuster Cancer Drug Imfinzi Flunks As Follow-Up In Type Of Early-Stage Lung Cancer, But Hits Primary Goal In Phase 3 Bladder Cancer Study

On Tuesday, AstraZeneca Plc AZN released topline data from the ADJUVANT BR.31 Phase 3 trial, sponsored by the Canadian Cancer Trials Group.

The data showed that Imfinzi (durvalumab) did not achieve statistical significance for the primary endpoint of disease-free survival versus placebo in early-stage non-small cell lung cancer (NSCLC) after complete tumor resection in patients whose tumors express PD-L1 on 25% or more tumor cells.

“We are disappointed in the ADJUVANT BR.31 results,” said Susan Galbraith, executive vice president of oncology research and development at AstraZeneca.

The safety profile for Imfinzi was consistent with its known safety profile, and no new safety concerns were reported.

Imfinzi is the only approved immunotherapy and the global standard of care in the curative-intent setting of unresectable, Stage III NSCLC patients whose disease has not progressed after chemoradiotherapy based on the PACIFIC Phase 3 trial.

Imfinzi 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).

In April, the European pharma giant shared data from the ADRIATIC Phase 3 trial. Imfinzi demonstrated a statistically significant and clinically meaningful improvement in the dual primary endpoints of overall survival and progression-free survival compared to placebo in limited-stage small-cell lung cancer patients.

AstraZeneca also shared high-level results from the NIAGARA Phase 3 trial showing Imfinzi in combination with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of event-free survival and the key secondary endpoint of overall survival versus neoadjuvant chemotherapy for muscle-invasive bladder cancer.

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

The addition of Imfinzi did not increase the discontinuation rate due to adverse events and did not compromise patients’ ability to complete surgery compared to neoadjuvant chemotherapy alone.

Concurrently, Japan approved AstraZeneca’s Tagrisso (osimertinib) with the addition of pemetrexed and platinum-based chemotherapy as the 1st-line treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated NSCLC whose tumors have exon 19 deletions or exon 21 mutations.

Price Action: At the last check on Tuesday, AZN shares were up 0.44% at $79.72.

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