AstraZeneca AZN reported positive results from the ongoing phase III FLAURA-2 study evaluating the combination of Tagrisso (osimertinib) and chemotherapy for first-line treatment of patients with locally advanced (Stage IIIB-IIIC) or metastatic (Stage IV) EGFR-mutated (“EFGRm”) non-small cell lung cancer (“NSCLC”).
Data from the FLAURA-2 study demonstrated that treatment with the Tagrisso-chemotherapy combination led to a statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival (“PFS”) compared with those who received only Tagrisso.
The FLAURA-2 study also showed that the Tagrisso-chemotherapy combination reduced the risk of disease progression or death by 38%. Study investigators also reported that the combination extended median PFS by nearly nine months.
AstraZeneca did not report any data on overall survival, the study’s secondary endpoint, claiming the data to be immature. However, management claimed that the combination treatment demonstrated a favorable trend.
Currently, Tagrisso is the current first-line standard of care for EFGRm NSCLC. It is currently approved for three indications in the EFGRm NSCLC set by the FDA.
Some analysts also noted that the above result sets a new bar for Johnson & Johnson JNJ. J&J is currently evaluating the combination of its own EFGR/MET-targeted antibody therapy Rybrevant (amivantamab) and oral EFGR inhibitor lazertinib against Tagrisso alone in first-line EFGRm NSCLC in the pivotal phase III MARIPOSA study. J&J is expected to report data from this study before this year’s end.
AstraZeneca’s shares have lost 1.8% year to date against the industry’s 9.1% growth.
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In a separate press release, AstraZeneca also reported positive results from the phase III MANDARA study evaluating a head-to-head comparison of Fasenra (benralizumab) against GSK’s GSK Nucala (mepolizumab) in patients with eosinophilic granulomatosis with polyangiitis (“EGPA”).
The MANDARA study achieved its primary endpoint. Data from the study showed that a single monthly injection of 30mg Fasenra achieves remission rates comparable to GSK’s Nucala, the current standard of care for EGPA patients.
AstraZeneca plans to report complete data from the study at a future medical meeting.
Currently, GSK’s Nucala is the only FDA-approved treatment for EGPA indication. The GSK drug requires monthly administration of three separate subcutaneous injections at 100mg.
Fasenra is approved in the United States as an add-on maintenance treatment for severe eosinophilic asthma (“SEA”). The FDA granted orphan drug designation to Fasenra for EGPA in 2018.
An FDA approval to Fasenra in EGPA will likely benefit AstraZeneca in a target market that GSK is currently dominating. Also, Fasenra’s administration at a lower dosage than GSK’s Nucala and at lesser intervals is likely to benefit AstraZeneca in the long run.
AstraZeneca PLC Price
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Zacks Rank & Stock to Consider
AstraZeneca currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the overall healthcare sector is Annovis Bio ANVS, which carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 30 days, estimates for Annovis Bio’s 2023 loss per share have narrowed from $4.89 to $4.38. During the same period, the loss estimates per share for 2024 have improved from $3.18 to $2.77. Year to date, shares of ANVS have lost 14.0%.
Earnings of Annovis Bio beat estimates in three of the last four quarters while missing the mark on one occasion, witnessing an earnings surprise of 13.40% on average. In the last reported quarter, Annovis’ earnings beat estimates by 6.14%.
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