Monday, July 15, 2024

Lung Cancer Setback as Imfinzi Fails to Achieve Primary Endpoint in Phase III Trial

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High-level results from the ADJUVANT BR.31 Phase III trial, sponsored by the Canadian Cancer Trials Group (CCTG), showed that Imfinzi (durvalumab) 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 tumor resection in patients whose tumors express PD-L1 on 25% or more tumor cells. This outcome was disappointing for AstraZeneca, as Imfinzi has shown promise in multiple other trials for earlier stages of lung cancer.

Despite this setback, the company remains committed to advancing its development program and exploring new therapeutic options for lung cancer patients. The data from this trial will be further analyzed and discussed at upcoming medical meetings to gather more insights and plan future strategies.

Susan Galbraith, Executive Vice President, of Oncology R&D at AstraZeneca, expressed disappointment over the ADJUVANT BR.31 results but reaffirmed the company’s commitment to addressing unmet needs in lung cancer through a broad development program. She emphasized the importance of continuing to explore and develop innovative treatments for patients who have limited options. The safety profile for Imfinzi was consistent with its known profile, with no new safety concerns reported, which is reassuring for ongoing and future trials. The detailed data will be shared at an upcoming medical meeting to provide a comprehensive understanding of the trial results and their implications.

Imfinzi remains the only approved immunotherapy for unresectable, Stage III NSCLC in patients whose disease has not progressed after chemoradiotherapy, based on the PACIFIC Phase III trial. This approval has established Imfinzi as a critical option in the treatment landscape for this particular group of lung cancer patients. It is also being investigated in various other early-stage lung cancer settings, including the PACIFIC-4, 5, 8, and 9 trials, which aim to expand its use and provide more treatment options across different stages of lung cancer. The ongoing research underscores the potential of Imfinzi in improving patient outcomes in various settings.

Lung Cancer Remains Leading Cause of Death as Imfinzi Faces Setbacks in Phase III Trial

Lung cancer is the leading cause of cancer-related deaths worldwide, with an estimated 2.4 million diagnoses annually. NSCLC accounts for 80-85% of these cases, highlighting the significant impact of this disease. Despite complete tumor resection and adjuvant chemotherapy, many patients with resectable disease experience recurrence, which poses a major challenge in treatment. Survival rates decrease significantly with more advanced stages of the disease, reflecting the urgent need for effective treatments that can improve long-term outcomes and reduce recurrence rates.

The ADJUVANT BR.31 trial evaluated Imfinzi in the adjuvant treatment of 1,415 patients with Stage IB, II, or IIIA NSCLC following complete tumor resection, with or without adjuvant chemotherapy. Sponsored by CCTG, the trial involved 269 centers across 19 countries, including Canada, the US, Australia, Europe, and Asia. This wide geographical coverage ensures diverse patient demographics and robust data. The primary endpoint was DFS in patients with high PD-L1 expression and no common EGFR mutations or ALK rearrangements, which are key biomarkers in lung cancer prognosis and treatment response.

The Canadian Cancer Trials Group (CCTG) is an academic cooperative that runs Phase I-III trials to test anti-cancer and supportive therapies at over 85 hospitals and cancer centers across Canada. Their extensive network and experience in conducting large-scale clinical trials contribute significantly to advancing cancer treatment. CCTG’s mission is to improve survival and quality of life for people with cancer, supporting over 600 trials globally since its inception. Their work is pivotal in bringing new treatments from the research stage to clinical practice.

Lung Cancer


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Enhancing Lung Cancer Treatment and AstraZeneca’s Commitment to Innovative Oncology

Imfinzi, a human monoclonal antibody, works by binding to the PD-L1 protein, blocking its interaction with PD-1 and CD80 proteins, and thereby countering the tumor’s immune evasion tactics. This mechanism allows the immune system to recognize and attack cancer cells more effectively. It is approved for various indications, including extensive-stage small-cell lung cancer (SCLC) and unresectable hepatocellular carcinoma (HCC). These approvals demonstrate Imfinzi’s broad applicability and effectiveness across different cancer types.

AstraZeneca is committed to improving lung cancer outcomes through early detection and innovative treatments. Their comprehensive lung cancer portfolio includes leading medicines such as Tagrisso, Iressa, Imfinzi, and Imjudo, as well as a pipeline of potential new medicines. The company is also a founding member of the Lung Ambition Alliance, aiming to accelerate innovation in lung cancer care and improve patient outcomes through collaborative efforts. This alliance brings together various stakeholders to tackle the challenges in lung cancer treatment collectively.

In the broader field of oncology, AstraZeneca is pioneering immunotherapy and aims to transform cancer care with a diverse portfolio of treatments. Their innovative approach includes next-generation immunotherapies like bispecific antibodies and cell therapies, which aim to overcome resistance and drive longer-lasting immune responses. These therapies are designed to harness different aspects of the immune system to target cancer more effectively.


Resource: AstraZeneca, June 25, 2024

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