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MRK Stock Dips After SMMT's Cancer Drug Outshines Keytruda in Study
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Merck’s (MRK - Free Report) stock declined 2% on Monday after Summit Therapeutics’ (SMMT - Free Report) investigational bispecific antibody, ivonescimab, outperformed Merck’s blockbuster PD-L1 inhibitor Keytruda in a first-line lung cancer study.
SMMT’s Ivonescimab Shows Meaningful Benefit Over MRK’s Keytruda
The phase III HARMONi-2 study evaluated ivonescimab monotherapy against Keytruda monotherapy as a first-line treatment for PD-L1-positive advanced non-small cell lung cancer (NSCLC). The study was conducted in China with Summit’s collaboration partner, Akeso.
Data from a primary analysis showed that ivonescimab monotherapy led to a statistically significant improvement in the study’s primary endpoint, progression-free survival (PFS). The median PFS was 11.14 months in the ivonescimab arm versus 5.82 months in the Keytruda arm.
PFS improvement was seen in patients across all subgroups, including PD-L1 high and low- expressing tumors, and squamous and non-squamous histologies. Both the overall response rate as well as the disease control rate were higher in the ivonescimab arm compared to the Keytruda arm.
However, the rate of side effects was higher in the ivonescimab arm compared to the Keytruda arm. In the ivonescimab arm, 20.8% of the patients experienced serious treatment-related side effects versus 16.1% in the Keytruda arm. Overall survival was not mature at the time of data cut-off.
Based on positive data from the HARMONi-2 study, Summit plans to initiate a phase III study called HARMONi-7, which will compare ivonescimab monotherapy to Keytruda monotherapy in first-line PD-L1 high, advanced NSCLC in early 2025.
Summit Therapeutics presented the data at the World Conference on Lung Cancer. Its shares rose around 56% on Monday. Summit Therapeutics does not have any approved drug in its portfolio and does not generate any revenues at present. If ivonescimab is approved, it can generate significant sales for the company.
Merck’s stock has risen 5.9% so far this year compared with an increase of 24.0% for the industry.
Image Source: Zacks Investment Research
How Does Ivonescimab Data Affect Merck’s Stock?
Keytruda is the market leader for treating NSCLC. It is one of the most successful cancer drugs ever.
Keytruda is already approved for the treatment of many cancers globally and accounts for around 50% of Merck’s pharmaceutical sales. Keytruda is approved for 40 distinct cancer indications. Its sales are gaining from rapid uptake across earlier-stage indications as well as continued strong momentum in metastatic indications. The drug has played an instrumental role in driving Merck’s steady revenue growth in the past few years. However, Keytruda patents are set to lose exclusivity in 2028. Till then, its sales are expected to remain strong. Keytruda sales continue to grow year over year as well as sequentially. It generated sales of more than $14 billion in the first half of 2024.
Ivonescimab is the first drug to have shown clinically meaningful benefit over Keytruda in a phase III study in NSCLC. However, we believe ivonescimab will not pose any immediate challenge to an established drug like Keytruda but has shown potential to be a threat over the long term.
In the past 60 days, 2024 earnings estimates for Roche have improved from $2.44 per share to $2.68 per share. For 2025, earnings estimates have improved from $2.64 per share to $2.87 per share over the same timeframe. Roche’s shares have risen 8% year to date.
Estimates for Lilly’s 2024 earnings have risen from $13.61 to $16.23 per share over the past 60 days. For 2025, earnings estimates have risen from $19.27 to $23.45 per share over the same timeframe. Year to date, Lilly’s stock has risen 55.9%.
Lilly beat estimates in each of the last four quarters, delivering a four-quarter average earnings surprise of 69.07%.
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MRK Stock Dips After SMMT's Cancer Drug Outshines Keytruda in Study
Merck’s (MRK - Free Report) stock declined 2% on Monday after Summit Therapeutics’ (SMMT - Free Report) investigational bispecific antibody, ivonescimab, outperformed Merck’s blockbuster PD-L1 inhibitor Keytruda in a first-line lung cancer study.
SMMT’s Ivonescimab Shows Meaningful Benefit Over MRK’s Keytruda
The phase III HARMONi-2 study evaluated ivonescimab monotherapy against Keytruda monotherapy as a first-line treatment for PD-L1-positive advanced non-small cell lung cancer (NSCLC). The study was conducted in China with Summit’s collaboration partner, Akeso.
Data from a primary analysis showed that ivonescimab monotherapy led to a statistically significant improvement in the study’s primary endpoint, progression-free survival (PFS). The median PFS was 11.14 months in the ivonescimab arm versus 5.82 months in the Keytruda arm.
PFS improvement was seen in patients across all subgroups, including PD-L1 high and low- expressing tumors, and squamous and non-squamous histologies. Both the overall response rate as well as the disease control rate were higher in the ivonescimab arm compared to the Keytruda arm.
However, the rate of side effects was higher in the ivonescimab arm compared to the Keytruda arm. In the ivonescimab arm, 20.8% of the patients experienced serious treatment-related side effects versus 16.1% in the Keytruda arm. Overall survival was not mature at the time of data cut-off.
Based on positive data from the HARMONi-2 study, Summit plans to initiate a phase III study called HARMONi-7, which will compare ivonescimab monotherapy to Keytruda monotherapy in first-line PD-L1 high, advanced NSCLC in early 2025.
Summit Therapeutics presented the data at the World Conference on Lung Cancer. Its shares rose around 56% on Monday. Summit Therapeutics does not have any approved drug in its portfolio and does not generate any revenues at present. If ivonescimab is approved, it can generate significant sales for the company.
Merck’s stock has risen 5.9% so far this year compared with an increase of 24.0% for the industry.
Image Source: Zacks Investment Research
How Does Ivonescimab Data Affect Merck’s Stock?
Keytruda is the market leader for treating NSCLC. It is one of the most successful cancer drugs ever.
Keytruda is already approved for the treatment of many cancers globally and accounts for around 50% of Merck’s pharmaceutical sales. Keytruda is approved for 40 distinct cancer indications. Its sales are gaining from rapid uptake across earlier-stage indications as well as continued strong momentum in metastatic indications. The drug has played an instrumental role in driving Merck’s steady revenue growth in the past few years. However, Keytruda patents are set to lose exclusivity in 2028. Till then, its sales are expected to remain strong. Keytruda sales continue to grow year over year as well as sequentially. It generated sales of more than $14 billion in the first half of 2024.
Ivonescimab is the first drug to have shown clinically meaningful benefit over Keytruda in a phase III study in NSCLC. However, we believe ivonescimab will not pose any immediate challenge to an established drug like Keytruda but has shown potential to be a threat over the long term.
MRK’s Zacks Rank & Stocks to Consider
Merck currently has a Zacks Rank #3 (Hold).
Merck & Co., Inc. Price and Consensus
Merck & Co., Inc. price-consensus-chart | Merck & Co., Inc. Quote
Some better-ranked drug/biotech companies are Roche (RHHBY - Free Report) and Eli Lilly (LLY - Free Report) , both with a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, 2024 earnings estimates for Roche have improved from $2.44 per share to $2.68 per share. For 2025, earnings estimates have improved from $2.64 per share to $2.87 per share over the same timeframe. Roche’s shares have risen 8% year to date.
Estimates for Lilly’s 2024 earnings have risen from $13.61 to $16.23 per share over the past 60 days. For 2025, earnings estimates have risen from $19.27 to $23.45 per share over the same timeframe. Year to date, Lilly’s stock has risen 55.9%.
Lilly beat estimates in each of the last four quarters, delivering a four-quarter average earnings surprise of 69.07%.