Results From FLAURA2 Phase III Trial Show Great Benefit from Tagrisso/Chemotherapy Combination in Lung Cancer Patients

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In combination with chemotherapy, Tagrisso (osimertinib) has showed consistent benefit after disease progression in patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC), according to AstraZeneca.¹ In addition, results from the Phase III FLAURA2 trial showed a favorable trend toward overall survival (OS) improvement at two years of follow up.

“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 overall survival,” Pasi A. Jänne, MD, PhD, medical oncologist at Dana-Farber Cancer Institute and principal investigator for the trial said 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.”¹

According to the American Cancer Society, estimates for lung cancer in the US for 2024 are at about 234,580 new cases. In general, about 10%-15% of all cases are small cell lung cancer (SCLC), while 80%-85% are NSCLC.²

At 41% data maturity, the Tagrisso plus chemotherapy arm results showed a favorable trend in OS at 95% confidence interval (CI) 0.57-0.97 and hazard ratio (HR) at 0.75. In addition, the combination showed a consistent benefit across prespecified post-progression endpoints of time to first subsequent treatment (HR 0.73; 95% CI 0.56-0.94), time to progression on 2nd-line therapy (HR 0.70; 95% CI 0.52-0.93), and time to second subsequent treatment (HR 0.69; 95% CI 0.51-0.93).¹

In February 2024, FDA approved Tagrisso for use in combination with platinum-based chemotherapy in adults with locally advanced or metastatic EGFRm NSCLC harboring EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.^3,4 The approval was made based off earlier results from the FLAURA2 trial.

“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,” Dave Fredrickson, executive vice president, oncology business unit, AstraZeneca said in an earlier press release. “This approval reinforces Tagrisso as the backbone of EGFR-mutated lung cancer treatment either as monotherapy or in combination with chemotherapy. This news is especially important for those with a poorer prognosis, including patients whose cancer has spread to the brain and those with L858R mutations.”³

Tagrisso is also approved as monotherapy in more than 100 countries, including the United States. It displayed an improvement in patient outcomes in both early-stage disease in the ADAURA Phase III trial, locally advanced stages in the LAURA Phase III trial, and late-stage disease in the FLAURA Phase III trial and FLAURA2 Phase III trial.¹

“FLAURA2 reinforces Tagrisso as the backbone therapy in EGFRm non-small cell lung cancer either as monotherapy or in combination with chemotherapy, delivering the longest reported progression-free survival benefit in the 1st-line advanced setting,” Susan Galbraith, executive vice president, oncology R&D, AstraZeneca said in a press release. “We’re excited to see a favorable trend toward overall survival and look forward to seeing this data mature over time.”¹

References

1. Tagrisso with the addition of chemotherapy showed favourable trend in overall survival in EGFR-mutated advanced lung cancer with further follow up in FLAURA2 Phase III trial. News release. March 21, 2024. Accessed March 25, 2024. https://www.astrazeneca.com/media-centre/press-releases/2024/tagrisso-the-addition-chemotherapy-showed-favourable-trend-overall-survival-egfr-mutated-advanced-lung-cancer-further-follow-flaura2-phase-iii-trial.html

2. Key Statistics for Lung Cancer. American Cancer Society. Updated January 29, 2024. Accessed March 25, 2024. https://www.cancer.org/cancer/types/lung-cancer/about/key-statistics.html

3. Tagrisso with the addition of chemotherapy approved in the US for patients with EGFR-mutated advanced lung cancer. AstraZeneca. News release. February 19, 2024. Accessed March 25, 2024. https://www.astrazeneca.com/media-centre/press-releases/2024/tagrisso-plus-chemo-approved-in-us-for-lung-cancer.html

4. FDA approves osimertinib with chemotherapy with chemotherapy for EGFR-mutated non-small cell lung cancer. FDA. February 16, 2024. Accessed March 25, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-osimertinib-chemotherapy-egfr-mutated-non-small-cell-lung-cancer