Saturday, July 13, 2024

Tagrisso and Chemotherapy Approved for Lung Cancer in the European Union

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AstraZeneca’s Tagrisso (osimertinib) combined with pemetrexed and platinum-based chemotherapy has been approved in the European Union (EU) for the first-line treatment of adult patients with advanced EGFR-mutated non-small cell lung cancer (NSCLC). This approval is based on results from the FLAURA2 Phase III trial, which demonstrated significant improvements in median progression-free survival (PFS) compared to standard care.

The FLAURA2 trial results, published in The New England Journal of Medicine, showed that Tagrisso plus chemotherapy reduced the risk of disease progression or death by 38% compared to Tagrisso monotherapy, the current first-line global standard of care. The median PFS was 25.5 months for patients treated with the combination therapy, an 8.8-month improvement over Tagrisso monotherapy.

Results from the blinded independent central review (BICR) were consistent, showing a median PFS of 29.4 months with Tagrisso plus chemotherapy, a 9.5-month improvement over Tagrisso alone. Additionally, a prespecified exploratory analysis of patients with brain metastases at baseline indicated that Tagrisso plus chemotherapy reduced the risk of CNS disease progression or death by 42% compared to Tagrisso monotherapy.

While overall survival (OS) results are still maturing, a trend toward an OS benefit with Tagrisso plus chemotherapy versus monotherapy was observed. The trial continues to assess OS as a key secondary endpoint. David Planchard, MD, PhD, Thoracic Oncologist at Gustave Roussy Institute, emphasized the significance of this new first-line treatment option, highlighting a meaningful nine-month improvement in PFS.

Reinforcing Tagrisso’s Role in Lung Cancer Treatment

Dave Fredrickson, Executive Vice President of AstraZeneca’s Oncology Business Unit, noted that this approval reinforces Tagrisso as a foundational therapy for EGFR-mutated lung cancer, either alone or in combination with chemotherapy. This is particularly important for patients with aggressive disease, including those with brain metastases and L858R mutations.

The safety profile of Tagrisso plus chemotherapy was consistent with the individual medicines’ established profiles, with higher adverse event rates in the combination arm due to chemotherapy-related effects. Tagrisso is already approved as monotherapy in over 110 countries, including the US, EU, China, and Japan, for various stages of EGFR-mutated NSCLC. The combination with chemotherapy is also approved in multiple regions, and ongoing reviews by global regulatory authorities continue for additional indications.

Lung cancer remains the leading cause of cancer death globally, accounting for about one-fifth of all cancer deaths. Non-small cell lung cancer is the most common form, with a significant percentage of patients having EGFR mutations. These patients are particularly responsive to EGFR-tyrosine kinase inhibitors (TKIs) like Tagrisso, which block cell-signaling pathways driving tumor growth.

FLAURA2 is a global Phase III trial assessing the first-line treatment of advanced EGFR-mutated non-small cell lung cancer. It enrolled 557 patients across more than 150 centers in over 20 countries. Patients received Tagrisso plus chemotherapy every three weeks for four cycles, followed by Tagrisso with pemetrexed maintenance. The primary endpoint is PFS, with ongoing assessment of OS as a secondary endpoint.

Lung Cancer

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Tagrisso’s Proven Clinical Activity

Tagrisso is a third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including CNS metastases. It has treated nearly 800,000 patients worldwide and continues to be explored for various stages of EGFR-mutated non-small cell lung cancer. The drug has demonstrated efficacy in early-stage, locally advanced, and late-stage disease through trials like ADAURA, LAURA, and FLAURA.

AstraZeneca continues to investigate Tagrisso in neoadjuvant settings and address resistance mechanisms through trials like SAVANNAH, ORCHARD, and SAFFRON. The company’s comprehensive lung cancer portfolio includes leading medicines like Tagrisso, Iressa, Imfinzi, and Enhertu, and collaborations with other biotech companies to develop new treatments.

AstraZeneca aims to revolutionize oncology by providing cures for cancer in every form. The company focuses on understanding cancer complexities to develop life-changing medicines. AstraZeneca’s diverse portfolio and innovative pipeline aim to redefine cancer care and ultimately eliminate cancer as a cause of death.

AstraZeneca is a global, science-led biopharmaceutical company headquartered in Cambridge, UK. It focuses on discovering, developing, and commercializing prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals. AstraZeneca’s innovative medicines are available in over 125 countries and are used by millions of patients worldwide.

 

Resource: AstraZeneca, July 05, 2024

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