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Benefits throughout post-progression endpoints and outcomes were reported for osimertinib in combination with chemotherapy.
New study findings from AstraZeneca showed benefits in subsequent outcomes after disease progression among individuals treated with osimertinib (Tagrisso) in combination with chemotherapy, that were diagnosed with locally advanced or metastatic epidermal growth factor receptor mutated (EGFRm) non-small cell lung cancer (NSCLC). The results also displayed a promising increase in overall survival (OS) among individuals that were included in a 2 year follow up, according to study authors.
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Based on the positive results from the FLAURA2 phase 3 trial, Osimertinib with chemotherapy was approved in the US by the FDA, after an FDA priority review.
With 80 to 85% of 2.4 million individuals diagnosed with lung cancer being NSCLC, treatment with osimertinib could improve patient outcomes for EGFRm NSCLC.
The study authors noted that osimertinib is an irreversible EGFR-tyrosine kinase inhibitor of a 40 mg and 80 mg tablet that can be taken once daily to aid NSCLC. The treatment was reported as the only targeted therapy that could improve outcomes in the early stage, locally advanced stage, and the late stage of the disease.
The study authors noted that 557 individuals were included in the randomized, open-label, multi-center, global phase 3 trial, FLAURA2, and were treated with 80 mg of osimertinib with 500 mg/m2 of pemetrexed plus 75 mg/m2 of cisplatin, or carboplatin, every 3 weeks for 4 cycles. Individuals then received osimertinib with pemetrexed maintenance every 3 weeks.
The results displayed that osimertinib in combination with chemotherapy had a favorable trend of OS at 41% data maturity, which remained consistent in subgroups that involved sex, race, type of EGFR mutation, age at time of diagnosis, smoking history, performance status and central nervous system metastases status at baseline, according to study authors. The treatment also displayed benefits throughout post-progression endpoints and outcomes.
Trial Name: A Study of Osimertinib With or Without Chemotherapy as 1st Line Treatment in Patients With Mutated Epidermal Growth Factor Receptor Non-Small Cell Lung Cancer
ClinicalTrial.gov ID: NCT04035486
Sponsor: AstraZeneca
Estimated Completion Date: June 2026
“The improvement in post-progression outcomes with chemotherapy added to standard-of-care osimertinib is encouraging for patients with advanced EGFR-mutated lung cancer, particularly the encouraging trend toward [OS},” said Pasi A Jänne, MD, PhD, medical oncologist at Dana-Farber Cancer Institute and principal investigator for the trial, in a press release. “These results further validate the importance of this additional treatment option, especially for those patients whose cancer has spread to the brain, those with L858R mutations, or other cause for poorer prognosis.”
Adverse events were reported to be at its highest following the initial dose of chemotherapy to osimertinib. However, the adverse events reduced during the maintenance phase of the trial, according to study authors.
“FLAURA2 reinforces Tagrisso as the backbone therapy in EGFRm [NSCLC] either as monotherapy or in combination with chemotherapy, delivering the longest reported progression-free survival benefit in the 1st-line advanced setting. We’re excited to see a favorable trend toward overall survival and look forward to seeing this data mature over time,” said Susan Galbraith, executive vice president of Oncology R&D at AstraZeneca, in a press release.
