AstraZeneca’s Tagrisso-Chemo Combination Bags FDA Approval

The Food and Drug Administration (FDA) has granted approval to AstraZeneca’s Tagrisso (osimertinib) for adults diagnosed with locally progressed or metastatic non-small cell lung cancer (NSCLC) that has specific mutations (EGFR exon 19 deletions or exon 21 L858R mutations) detected through an FDA-approved examination. This approval allows Tagrisso to be used alongside platinum-based chemotherapy in this patient population.

Tagrisso has prior approval as monotherapy for the following indications: initial therapy for individuals with locally progressing or metastatic EGFRm NSCLC, supplementary therapy for preliminary EGFRm NSCLC, and NSCLC patients who tested positive for the T790M mutation and had either locally progressed or metastatic EGFR.

Dave Fredrickson, EVP of AstraZeneca’s Oncology Business Unit, remarked, “This important new treatment option can delay disease progression by nearly nine additional months, establishing a new benchmark with the longest reported progression-free survival benefit in the 1st-line advanced setting.”

He emphasized that the approval solidifies Tagrisso’s role as a fundamental component in the treatment of EGFR-mutated lung cancer, whether used alone or in conjunction with chemotherapy. He underscored the significance of this announcement for individuals facing more challenging prognoses, such as those with brain metastases or bearing the L858R mutation.

Approximately nine times more potent than wild type, Tagrisso binds permanently to these particular EGFR mutant forms as an inhibitor of the tyrosine kinase of the EGFR domain. This activity reduces tumor development and spread by specifically inhibiting EGFR-mediated, unregulated proliferation of malignant cells and cell signaling.

The most recent green light came from the Phase III FLAURA 2 study, which was a randomized, multicenter, open-label experiment (NCT04035486). Patients with advanced NSCLC who had not had systemic therapy for advanced illness and had an EGFR exon 19 loss or exon 21 L858R mutation were included in the study.

Investigator- and RECIST v1.1-assessed progression-free survival (PFS) was the main outcome of the research. Overall survival (OS) was the secondary endpoint, with objective response rate (ORR) and duration of response (DOR) being other important objectives.

The median progression-free survival (PFS) for patients given Tagrisso in combination with chemotherapy (n = 279) was 25.5 months, while for patients given Tagrisso alone (n = 278) it was 16.7 months. With 45% of predetermined fatalities reported before OS data were mature, this study could not draw any firm conclusions.

In comparison to the Tagrisso monotherapy group, which had an ORR of 69%, the combination group clocked 77%. The median DOR for the combination group was nearly 25 months, whereas for the monotherapy group it was 17.9 months. The Tagrisso cohort had a median exposure length of 22.3 months, while the monotherapy group recorded just over 19 months.

When it came to safety, 38% of patients who took the Tagrisso combination suffered significant adverse events (AEs), and 7% of those patients had fatal toxicities.  44% of patients experienced adverse events (AEs) that resulted in dosage pauses or reductions; in the monotherapy group, this number was 10%; and in the treatment cessation group, it was 11%.

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