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Bayer Reports Encouraging NSCLC Drug Data, Gets Approval for Eylea 8mg
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Bayer (BAYRY - Free Report) announced positive results from the expansion part of the ongoing early to mid-stage study on pipeline candidate BAY 2927088.
BAY 2927088 is an oral, reversible tyrosine kinase inhibitor (TKI) that potently inhibits mutant human epidermal growth factor receptors 2 (HER2), including HER2 exon 20 insertions and HER2 point mutations, as well as epidermal growth factor receptors (EGFR) with high selectivity for mutant versus wild-type EGFR.
The phase I/II SOHO-01 study evaluates the safety and preliminary efficacy of BAY 2927088 in advanced HER2-mutant non-small cell lung cancer (NSCLC).
Year to date, shares of Bayer have lost 13.9% against the industry’s growth of 24.5%.
Image Source: Zacks Investment Research
BAYRY’s Clinical Trial Program for BAY 2927088
The objective of the expansion phase of the study was to determine the safety, tolerability and pharmacokinetics of BAY 2927088 in patients with HER2-mutant NSCLC.
The enrolled patients received oral BAY 2927088 20 mg twice daily. 43 out of 45 patients enrolled were evaluated for efficacy, with a confirmed objective response rate (ORR) of 72.1%, including one complete response.
Median duration of response (DOR) and progression-free survival (PFS) were 8.7 months and 7.5 months, respectively. The most frequent mutation in these patients was HER2 YVMA insertions. The patients with this mutation showed an ORR of 90%, a DoR of 9.7 months and a PFS of 9.9 months.
The safety profile of BAY 2927088 was found to be manageable and consistent with the previous reports. However, treatment-related adverse events (TRAEs) were reported in 95.5% of patients, with grade 3 TRAEs reported in 40.9%.
These data support the ongoing investigation of BAY 2927088 in patients with advanced NSCLC harboring HER2 mutations.
Bayer recently announced that the first patient has been enrolled in the phase III SOHO-02 study assessing the efficacy and safety of BAY 2927088 as first-line therapy in patients with advanced non-small cell lung cancer whose tumors have activating HER2 mutations.
BAYRY’s Eylea 8mg Approval in the EU
Bayer also announced that The European Medicines Agency has approved the pre-filled syringe for the administration of Eylea 8mg in the European Union. The approved indications are neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME).
Eylea 8 mg has been developed to reduce the disease burden and extend treatment intervals with comparable efficacy and safety to the standard-of-care drug Eylea 2 mg. The positive results from the PULSAR and PHOTON led to the approval in nAMD and DME in the EU with the unprecedented labeling that allows for extended treatment intervals of up to five months in appropriate patients.
Eylea 8 mg is approved as Eylea HD in the United States. Eylea is being jointly developed by Bayer and Regeneron Pharmaceuticals (REGN - Free Report) .
Regeneron maintains exclusive rights to Eylea 2 mg (aflibercept 2 mg) and Eylea HD in the United States. Bayer has licensed exclusive marketing rights outside the United States, where the companies equally share the profits from the sales of Eylea 2 mg and Eylea 8 mg following any regulatory approval.
Bayer’s Efforts to Strengthen Pharma Business
Bayer is looking to strengthen its pharmaceutical portfolio amid generic competition for Xarelto.
Sales in the Pharmaceuticals Division increased 4.5% to €4.6 billion in the second quarter of 2024, driven by the strong performance of the cancer drug Nubeqa and CKD drug Kerendia. Eylea also continues to perform well.
Bayer is working on the label expansion of its approved drugs and simultaneously developing new drugs. Bayer is also working on the label expansion of Nubeqa and Kerendia in various indications. This should further fuel sales of these drugs.
Pipeline and regulatory setbacks have weighed on the stock in recent times. In light of these challenges, Bayer is implementing a new operating model to reduce hierarchies, eliminate bureaucracy, streamline structures and accelerate decision-making processes. The company is also undertaking significant job cuts.
BAYRY’s Zacks Rank & Stocks to Consider
BAYRY currently carries a Zacks Rank #3 (Hold). A couple of better-ranked large-cap pharma companies are Eli Lilly (LLY - Free Report) and Novartis (NVS - Free Report) . While LLY sports a Zacks Rank #1 (Strong Buy), Novartis carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Estimates for Eli Lilly’s 2024 earnings have risen from $15.52 to $16.49 per share over the past 30 days. For 2025, the bottom-line estimate has risen from $22.19 to $23.96 over the same timeframe. Year to date, Lilly’s shares have risen 64.7%.
Estimates for NVS’ 2024 earnings have risen from $7.45 to $7.50 per share over the past 30 days. For 2025, the bottom-line estimate has risen from $8.27 to $8.30 over the same timeframe.
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Bayer Reports Encouraging NSCLC Drug Data, Gets Approval for Eylea 8mg
Bayer (BAYRY - Free Report) announced positive results from the expansion part of the ongoing early to mid-stage study on pipeline candidate BAY 2927088.
BAY 2927088 is an oral, reversible tyrosine kinase inhibitor (TKI) that potently inhibits mutant human epidermal growth factor receptors 2 (HER2), including HER2 exon 20 insertions and HER2 point mutations, as well as epidermal growth factor receptors (EGFR) with high selectivity for mutant versus wild-type EGFR.
The phase I/II SOHO-01 study evaluates the safety and preliminary efficacy of BAY 2927088 in advanced HER2-mutant non-small cell lung cancer (NSCLC).
Year to date, shares of Bayer have lost 13.9% against the industry’s growth of 24.5%.
Image Source: Zacks Investment Research
BAYRY’s Clinical Trial Program for BAY 2927088
The objective of the expansion phase of the study was to determine the safety, tolerability and pharmacokinetics of BAY 2927088 in patients with HER2-mutant NSCLC.
The enrolled patients received oral BAY 2927088 20 mg twice daily. 43 out of 45 patients enrolled were evaluated for efficacy, with a confirmed objective response rate (ORR) of 72.1%, including one complete response.
Median duration of response (DOR) and progression-free survival (PFS) were 8.7 months and 7.5 months, respectively. The most frequent mutation in these patients was HER2 YVMA insertions. The patients with this mutation showed an ORR of 90%, a DoR of 9.7 months and a PFS of 9.9 months.
The safety profile of BAY 2927088 was found to be manageable and consistent with the previous reports. However, treatment-related adverse events (TRAEs) were reported in 95.5% of patients, with grade 3 TRAEs reported in 40.9%.
These data support the ongoing investigation of BAY 2927088 in patients with advanced NSCLC harboring HER2 mutations.
Bayer recently announced that the first patient has been enrolled in the phase III SOHO-02 study assessing the efficacy and safety of BAY 2927088 as first-line therapy in patients with advanced non-small cell lung cancer whose tumors have activating HER2 mutations.
BAYRY’s Eylea 8mg Approval in the EU
Bayer also announced that The European Medicines Agency has approved the pre-filled syringe for the administration of Eylea 8mg in the European Union. The approved indications are neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME).
Eylea 8 mg has been developed to reduce the disease burden and extend treatment intervals with comparable efficacy and safety to the standard-of-care drug Eylea 2 mg. The positive results from the PULSAR and PHOTON led to the approval in nAMD and DME in the EU with the unprecedented labeling that allows for extended treatment intervals of up to five months in appropriate patients.
Eylea 8 mg is approved as Eylea HD in the United States. Eylea is being jointly developed by Bayer and Regeneron Pharmaceuticals (REGN - Free Report) .
Regeneron maintains exclusive rights to Eylea 2 mg (aflibercept 2 mg) and Eylea HD in the United States. Bayer has licensed exclusive marketing rights outside the United States, where the companies equally share the profits from the sales of Eylea 2 mg and Eylea 8 mg following any regulatory approval.
Bayer’s Efforts to Strengthen Pharma Business
Bayer is looking to strengthen its pharmaceutical portfolio amid generic competition for Xarelto.
Sales in the Pharmaceuticals Division increased 4.5% to €4.6 billion in the second quarter of 2024, driven by the strong performance of the cancer drug Nubeqa and CKD drug Kerendia. Eylea also continues to perform well.
Bayer is working on the label expansion of its approved drugs and simultaneously developing new drugs. Bayer is also working on the label expansion of Nubeqa and Kerendia in various indications. This should further fuel sales of these drugs.
Pipeline and regulatory setbacks have weighed on the stock in recent times. In light of these challenges, Bayer is implementing a new operating model to reduce hierarchies, eliminate bureaucracy, streamline structures and accelerate decision-making processes. The company is also undertaking significant job cuts.
BAYRY’s Zacks Rank & Stocks to Consider
BAYRY currently carries a Zacks Rank #3 (Hold). A couple of better-ranked large-cap pharma companies are Eli Lilly (LLY - Free Report) and Novartis (NVS - Free Report) . While LLY sports a Zacks Rank #1 (Strong Buy), Novartis carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Estimates for Eli Lilly’s 2024 earnings have risen from $15.52 to $16.49 per share over the past 30 days. For 2025, the bottom-line estimate has risen from $22.19 to $23.96 over the same timeframe. Year to date, Lilly’s shares have risen 64.7%.
Estimates for NVS’ 2024 earnings have risen from $7.45 to $7.50 per share over the past 30 days. For 2025, the bottom-line estimate has risen from $8.27 to $8.30 over the same timeframe.