Monday, July 15, 2024

Lung Cancer Treatment Advances with Japan’s Approval of Tagrisso Combination Therapy

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Japan has approved AstraZeneca’s Tagrisso (osimertinib) in combination with pemetrexed and platinum-based chemotherapy for the 1st-line treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC). This approval is based on results from the FLAURA2 Phase III trial, which demonstrated that Tagrisso plus chemotherapy significantly extended median progression-free survival (PFS) by nearly nine months compared to standard care.

The FLAURA2 trial results, published in The New England Journal of Medicine, showed that Tagrisso combined with chemotherapy reduced the risk of disease progression or death by 38% compared to Tagrisso monotherapy, the current 1st-line global standard. The median PFS for the combination therapy was 25.5 months, compared to 16.7 months for Tagrisso alone, marking an 8.8-month improvement.

An Independent central review confirmed these findings, showing a median PFS of 29.4 months for the combination therapy, a 9.5-month improvement over Tagrisso monotherapy (19.9 months). Although overall survival (OS) data is still immature, an encouraging trend toward an OS benefit was observed with Tagrisso plus chemotherapy, as presented at the 2024 European Lung Cancer Congress (ELCC) in Prague.

Lung Cancer Remains Leading Cause of Death in Japan: New Tagrisso Combination Therapy Approved

Lung cancer is the leading cause of cancer-related deaths globally and in Japan. In Japan, lung cancer is the second most prevalent cancer, with over 135,000 new cases diagnosed annually. About 36% of NSCLC patients in Japan have EGFR mutations. The majority are diagnosed with advanced disease, highlighting the critical need for effective treatments. Professor Kunihiko Kobayashi from Saitama Medical University International Medical Center emphasized the importance of the FLAURA2 results, noting the significant improvement in PFS with the addition of chemotherapy.

This approval provides a new treatment option for patients with aggressive lung cancer, which is the leading cause of cancer death in Japan. Dave Fredrickson, Executive Vice President of AstraZeneca’s Oncology Business Unit, stated that this approval solidifies Tagrisso as the backbone therapy for EGFR-mutated lung cancer, offering effective 1st-line treatment options either as monotherapy or in combination with chemotherapy.

This combination is particularly important for patients with poorer prognoses, such as those with brain metastases or L858R mutations. The safety profile of Tagrisso plus chemotherapy aligns with the known profiles of the individual medicines. Adverse event (AE) rates were higher in the combination arm, primarily due to well-characterized chemotherapy-related AEs. Discontinuation rates due to AEs were 11% for combination therapy and 6% for monotherapy.

Lung Cancer

Tagrisso Approved in Over 100 Countries as AstraZeneca Leads in Lung Cancer Treatment Innovations

Tagrisso is approved as monotherapy in over 100 countries, including the US, EU, China, and Japan, for the 1st-line treatment of patients with locally advanced or metastatic EGFRm NSCLC and other indications. The combination of Tagrisso with chemotherapy is also approved in several countries for the 1st-line treatment of these patients. The FLAURA2 trial, which enrolled 557 patients across more than 20 countries, continues to assess OS as a key secondary endpoint. Tagrisso, a third-generation, irreversible EGFR-TKI, has proven efficacy in treating NSCLC, including central nervous system metastases. It has treated nearly 800,000 patients worldwide and is being explored for use across multiple stages of EGFRm NSCLC.

AstraZeneca’s commitment to lung cancer treatment includes ongoing research into neoadjuvant and early-stage adjuvant settings through trials like NeoADAURA and ADAURA2. The company is also investigating resistance mechanisms through the SAVANNAH, ORCHARD, and SAFFRON trials, testing combinations like Tagrisso plus savolitinib.

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AstraZeneca aims to improve lung cancer outcomes through early detection and innovative treatments, pushing the boundaries of science. Their portfolio includes leading medicines like Tagrisso, Iressa, Imfinzi, Imjudo, Enhertu, and Orpathys, along with a pipeline of new therapies. AstraZeneca is a founding member of the Lung Ambition Alliance, working globally to accelerate innovation in lung cancer care. In oncology, AstraZeneca strives to provide cures for various cancers, following the science to develop life-changing medicines. Their diverse portfolio and robust pipeline have the potential to transform cancer care and patient experiences, aiming to eventually eliminate cancer as a cause of death.


Resource: AstraZeneca, June 25, 2024

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