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Amgen's Imdelltra Cuts Lung Cancer Death Risk by 40% in Phase III
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Key Takeaways
AMGN's Imdelltra cut death risk by 40% and extended median OS by 5.3 months vs. standard chemo.
The DeLLphi-304 study showed median OS of 13.6 months for Imdelltra vs. 8.3 months for control.
Imdelltra also improved PFS, symptom relief, and was well-tolerated with mostly mild to moderate side effects.
Amgen (AMGN - Free Report) announced encouraging new data from its interim analysis of the global late-stage study evaluating Imdelltra (tarlatamab-dlle) for treating patients with small cell lung cancer (SCLC), who progressed on or after one line of platinum-based chemotherapy.
According to the updated interim analysis results, SCLC patients treated with Imdelltra experienced a 40% reduction in the risk of death. Treatment with the drug also significantly extended median overall survival (OS) by more than five months compared with standard-of-care (SOC) chemotherapy.
At the median follow-up of 11.2 months for Imdelltra and 11.7 months for the control group, results from the global phase III DeLLphi-304 study demonstrated a median OS of 13.6 months in the Imdelltra group compared with the 8.3 months observed in the SOC group. The drug also showed a statistically significant improvement in median progression-free survival (PFS) compared with SOC chemotherapy.
Amgen’s Imdelltra was overall well-tolerated and demonstrated a safety profile consistent with its known profile. Most adverse events related to treatment were mild to moderate in severity.
Year to date, AMGN stock has gained 10.7% against the industry’s 3.9% decline.
Image Source: Zacks Investment Research
We remind investors that in April 2025, Amgen announced that the phase III DeLLphi-304 study evaluating Imdelltra for the SCLC indication met its primary endpoint of OS and key secondary endpoint of PFS at the planned interim analysis. Furthermore, Imdelltra demonstrated a significant improvement in patient-reported outcomes related to cancer-associated symptoms, including dyspnea and cough, compared with the control arm.
SCLC is an aggressive and highly lethal form of lung cancer, accounting for roughly 15% of more than 2.4 million global lung cancer cases annually. Despite initially responding well to first-line platinum-based chemotherapy, most patients relapse within months. Overall, the five-year survival rate for SCLC remains low, at just 5-10% across all stages.
The updated data reinforces the drug’s potential in transforming patient outcomes and the SCLC treatment paradigm.
FDA Approval of AMGN’s Imdelltra for SCLC
Amgen’s Imdelltra, a delta-like ligand 3 targeting Bispecific T-cell Engager (BiTE) therapy, was approved by the FDA in 2024 for pre-treated extensive-stage small cell lung cancer (ES-SCLC) patients under the accelerated approval pathway.
With this approval, Imdelltra became the first DLL3-targeting BiTE therapy that activates the patient's T cells to attack DLL3-expressing tumor cells. DLL3 is a protein that is expressed on the surface of SCLC cells in most patients. However, Imdelltra’s label includes a Boxed Warning for "serious or life-threatening cytokine release syndrome and neurologic toxicity.”
The drug recorded sales of $81 million in the first quarter of 2025, representing a sequential increase in sales of 21%, driven by volume growth.
The continued approval of Imdelltra will depend on the success of AMGN’s ongoing phase III DeLLphi-304 study, which will serve as the confirmatory study for the ES-SCLC indication.
Imdelltra is Amgen’s second FDA-approved BiTE molecule, the first being Blincyto, which is approved for treating B-cell precursor acute lymphoblastic leukemia. Blincyto is a key contributor to Amgen’s top line and generated sales of $370 million in first-quarter 2025, rising 52% from the year-ago period, driven by broad prescribing across both academic and community segments.
In the past 60 days, estimates for Bayer’s earnings per share have increased from $1.19 to $1.25 for 2025. During the same time, earnings per share have increased from $1.28 to $1.31 for 2026. Year to date, shares of Bayer have gained 48.4%.
BAYRY’s earnings beat estimates in one of the trailing four quarters, matched twice and missed on the remaining occasion, the average negative surprise being 13.91%.
In the past 60 days, estimates for Lexicon’s loss per share have narrowed from 37 cents to 32 cents for 2025. During the same time, loss per share estimates for 2026 have narrowed from 35 cents to 31 cents. Year to date, shares of LXRX have lost 15.8%.
LXRX’s earnings beat estimates in three of the trailing four quarters and missed the same on the remaining occasion, delivering an average surprise of 11.97%.
In the past 60 days, estimates for Amarin’s loss per share for 2025 have narrowed from $5.33 to $2.78. During the same time, loss per share estimates for 2026 have narrowed from $4.13 to $2.04. Year to date, shares of AMRN have gained 21%.
AMRN’s earnings beat estimates in two of the trailing four quarters, matched once and missed the same on the remaining occasion, delivering an average surprise of 29.11%.
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Amgen's Imdelltra Cuts Lung Cancer Death Risk by 40% in Phase III
Key Takeaways
Amgen (AMGN - Free Report) announced encouraging new data from its interim analysis of the global late-stage study evaluating Imdelltra (tarlatamab-dlle) for treating patients with small cell lung cancer (SCLC), who progressed on or after one line of platinum-based chemotherapy.
According to the updated interim analysis results, SCLC patients treated with Imdelltra experienced a 40% reduction in the risk of death. Treatment with the drug also significantly extended median overall survival (OS) by more than five months compared with standard-of-care (SOC) chemotherapy.
At the median follow-up of 11.2 months for Imdelltra and 11.7 months for the control group, results from the global phase III DeLLphi-304 study demonstrated a median OS of 13.6 months in the Imdelltra group compared with the 8.3 months observed in the SOC group. The drug also showed a statistically significant improvement in median progression-free survival (PFS) compared with SOC chemotherapy.
Amgen’s Imdelltra was overall well-tolerated and demonstrated a safety profile consistent with its known profile. Most adverse events related to treatment were mild to moderate in severity.
Year to date, AMGN stock has gained 10.7% against the industry’s 3.9% decline.
Image Source: Zacks Investment Research
We remind investors that in April 2025, Amgen announced that the phase III DeLLphi-304 study evaluating Imdelltra for the SCLC indication met its primary endpoint of OS and key secondary endpoint of PFS at the planned interim analysis. Furthermore, Imdelltra demonstrated a significant improvement in patient-reported outcomes related to cancer-associated symptoms, including dyspnea and cough, compared with the control arm.
SCLC is an aggressive and highly lethal form of lung cancer, accounting for roughly 15% of more than 2.4 million global lung cancer cases annually. Despite initially responding well to first-line platinum-based chemotherapy, most patients relapse within months. Overall, the five-year survival rate for SCLC remains low, at just 5-10% across all stages.
The updated data reinforces the drug’s potential in transforming patient outcomes and the SCLC treatment paradigm.
FDA Approval of AMGN’s Imdelltra for SCLC
Amgen’s Imdelltra, a delta-like ligand 3 targeting Bispecific T-cell Engager (BiTE) therapy, was approved by the FDA in 2024 for pre-treated extensive-stage small cell lung cancer (ES-SCLC) patients under the accelerated approval pathway.
With this approval, Imdelltra became the first DLL3-targeting BiTE therapy that activates the patient's T cells to attack DLL3-expressing tumor cells. DLL3 is a protein that is expressed on the surface of SCLC cells in most patients. However, Imdelltra’s label includes a Boxed Warning for "serious or life-threatening cytokine release syndrome and neurologic toxicity.”
The drug recorded sales of $81 million in the first quarter of 2025, representing a sequential increase in sales of 21%, driven by volume growth.
The continued approval of Imdelltra will depend on the success of AMGN’s ongoing phase III DeLLphi-304 study, which will serve as the confirmatory study for the ES-SCLC indication.
Imdelltra is Amgen’s second FDA-approved BiTE molecule, the first being Blincyto, which is approved for treating B-cell precursor acute lymphoblastic leukemia. Blincyto is a key contributor to Amgen’s top line and generated sales of $370 million in first-quarter 2025, rising 52% from the year-ago period, driven by broad prescribing across both academic and community segments.
Amgen Inc. Price and Consensus
Amgen Inc. price-consensus-chart | Amgen Inc. Quote
AMGN’s Zacks Rank and Stocks to Consider
Amgen currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Bayer (BAYRY - Free Report) , Lexicon Pharmaceuticals (LXRX - Free Report) and Amarin (AMRN - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 60 days, estimates for Bayer’s earnings per share have increased from $1.19 to $1.25 for 2025. During the same time, earnings per share have increased from $1.28 to $1.31 for 2026. Year to date, shares of Bayer have gained 48.4%.
BAYRY’s earnings beat estimates in one of the trailing four quarters, matched twice and missed on the remaining occasion, the average negative surprise being 13.91%.
In the past 60 days, estimates for Lexicon’s loss per share have narrowed from 37 cents to 32 cents for 2025. During the same time, loss per share estimates for 2026 have narrowed from 35 cents to 31 cents. Year to date, shares of LXRX have lost 15.8%.
LXRX’s earnings beat estimates in three of the trailing four quarters and missed the same on the remaining occasion, delivering an average surprise of 11.97%.
In the past 60 days, estimates for Amarin’s loss per share for 2025 have narrowed from $5.33 to $2.78. During the same time, loss per share estimates for 2026 have narrowed from $4.13 to $2.04. Year to date, shares of AMRN have gained 21%.
AMRN’s earnings beat estimates in two of the trailing four quarters, matched once and missed the same on the remaining occasion, delivering an average surprise of 29.11%.