LONDON (dpa-AFX) - AstraZeneca Plc. (AZN.L, AZN) announced that new study results presented at the European Lung Cancer Congress (ELCC) 2025, demonstrated the role of the company's TAGRISSO (osimertinib), as monotherapy and as the backbone for novel combinations, across stages and settings of epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC).
In LAURA Phase III trial, TAGRISSO continues to demonstrate improved overall survival trend in unresectable, Stage III setting. SAVANNAH and ORCHARD Phase II trials showed the addition of savolitinib or datopotamab deruxtecan-dlnk to TAGRISSO upon disease progression demonstrates strong clinical activity, the company said in a statement.
According to the company, updated results from the LAURA Phase III trial showed an improved trend towards overall survival (OS) benefit with TAGRISSO compared to placebo in patients with unresectable, Stage III EGFRm NSCLC. Median OS was 58.8 months in patients treated with TAGRISSO versus 54.1 months with placebo, despite 78% of patients on placebo receiving subsequent treatment with TAGRISSO upon progression. The trial will continue to assess OS as a key secondary endpoint at the final analysis.
TAGRISSO previously demonstrated a statistically significant and highly clinically meaningful improvement in progression-free survival (PFS). Safety results and discontinuation rates due to adverse events (AEs) were as expected and no new safety concerns were identified.
AstraZeneca noted that results from the SAVANNAH Phase II trial showed TAGRISSO plus savolitinib (300 mg twice-daily [BID]) demonstrated a clinically meaningful and durable objective response rate (ORR) in patients with EGFRm NSCLC with high levels of MET overexpression and/or amplification whose disease progressed on treatment with 1st-line TAGRISSO. Among patients screened for enrollment in SAVANNAH, an estimated 62% had tumors with MET overexpression and/or amplification, and approximately 34% met the defined high MET level cut-off.
TAGRISSO plus savolitinib demonstrated a confirmed ORR of 56%, with a median duration of response (DoR) of 7.1 months. Median PFS (mPFS) was 7.4 months.
Meanwhile the company noted that first results from the TAGRISSO plus datopotamab deruxtecan-dlnk module of the ORCHARD Phase II platform trial showed the combination demonstrated promising efficacy and manageable safety in patients with advanced EGFRm NSCLC whose disease progressed on treatment with TAGRISSO.
The safety profile of TAGRISSO plus datopotamab deruxtecan-dlnk was consistent with the known safety profiles of each medicine and no new safety concerns were identified at either dose level.
The company announced that an exploratory post-hoc analysis of the FLAURA2 Phase III trial assessed PFS by length of exposure to pemetrexed maintenance treatment in patients with locally advanced (Stage IIIB-IIIC) or metastatic (Stage IV) EGFRm NSCLC. Patients were treated with TAGRISSO with the addition of chemotherapy (pemetrexed plus cisplatin) followed by maintenance treatment with TAGRISSO and chemotherapy (pemetrexed) or TAGRISSO alone. Results showed an mPFS of more than two years regardless of length of pemetrexed maintenance exposure, with a trend associating longer PFS with longer pemetrexed treatment.
The safety profile of TAGRISSO plus chemotherapy was consistent with the established profiles of the individual medicines. Grade 3 or higher chemotherapy-related AEs were reported in 16% of patients who received maintenance treatment for 3 to less than 9 months, and 10% for patients who received maintenance for 9 or more months.
TAGRISSO plus chemotherapy previously demonstrated a statistically significant and clinically meaningful improvement in PFS.
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