On Sunday, AstraZeneca Plc (AZN) released results from the final overall survival (OS) analysis of the FLAURA2 Phase 3 trial in previously untreated patients with locally advanced (Stage IIIB-IIIC) or metastatic (Stage IV) non-small cell lung cancer (NSCLC) whose tumors have EGFR exon 19 deletion or exon 21 L858R mutations.
Patients were treated with Tagrisso (osimertinib) with the addition of chemotherapy plus cisplatin or carboplatin every three weeks for four cycles, followed by Tagrisso with pemetrexed maintenance every three weeks.
The trial showed that Tagrisso with pemetrexed and platinum-based chemotherapy demonstrated a statistically significant and clinically meaningful improvement in the key secondary endpoint of OS compared to Tagrisso monotherapy.
Also Read: AstraZeneca’s Latest Drug Offers Hope For Millions Battling Hard-To-Control Blood Pressure
In the final OS analysis, Tagrisso plus chemotherapy demonstrated a median OS of nearly four years (47.5 months) compared to approximately three years (37.6 months) for Tagrisso monotherapy.
At 57% data maturity, results showed Tagrisso plus chemotherapy reduced the risk of death by 23% compared to Tagrisso monotherapy.
An estimated 63.1% of patients treated with the combination were alive at three years, and 49.1% of patients were alive at four years, compared to 50.9% and 40.8%, respectively, in the monotherapy arm.
The observed OS benefit for Tagrisso plus chemotherapy versus Tagrisso monotherapy was consistent across all prespecified subgroups. Patients in the control arm received standard of care, including chemotherapy, upon progression, supporting the relevance of the OS results.
With longer follow-up, the safety profile of Tagrisso plus chemotherapy continued to be manageable and consistent with the established profiles of the individual medicines.
Price Action: AZN stock is trading lower by 0.83% to $81.02 at last check Monday.
Read Next:
Photo by Piotr Swat via Shutterstock
