Results From FLAURA2 Phase III Trial Show Great Benefit from Tagrisso/Chemotherapy Combination in Lung Cancer Patients
Combination demonstrated a favorable trend toward overall survival in non-small cell lung cancer patients.
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
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.
Investigational Pain Therapy Cebranopadol Succeeds in Second Phase III Clinical Trial
March 6th 2025Tris Pharma’s first-in-class oral dual-NMR agonist achieved its primary endpoint in the ALLEVIATE-2 study by demonstrating a statistically significant and high level of pain reduction compared to placebo.
Reaching Diverse Patient Populations With Personalized Treatment Methods
January 20th 2025Daejin Abidoye, head of solid tumors, oncology development, AbbVie, discusses a number of topics around diversity in clinical research including industry’s greatest challenges in reaching diverse patient populations, personalized treatment methods, recruitment strategies, and more.
Phase III Data Show Efficacy of Tezspire Treating Chronic Rhinosinusitis with Nasal Polyps
March 4th 2025Phase III WAYPOINT trial shows Tezspire (tezepelumab) significantly reduces nasal polyp size and congestion severity in patients with severe, uncontrolled chronic rhinosinusitis with nasal polyps, while also decreasing the need for surgery and systemic glucocorticoids.
