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Merck's (MRK) Keytruda Head and Neck Cancer Study Fails
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Merck (MRK - Free Report) announced that a phase III study evaluating its blockbuster PD-L1 inhibitor, Keytruda, in earlier stages of head and neck cancer failed to meet its primary endpoint of event-free survival (EFS)
The phase III KEYNOTE-412 study evaluated Keytruda in combination with concurrent chemoradiation therapy (CRT) followed by Keytruda as maintenance therapy (the Keytruda regimen) compared to placebo plus CRT for treating unresected locally advanced head and neck squamous cell carcinoma (HNSCC), a very challenging cancer to treat.
The final analysis of the study showed that there was an improvement in EFS in patients treated with the Keytruda regimen compared to the placebo arm. However, the data failed to meet statistical significance.
Keytruda is presently approved for certain later stages of HNSCC in the United States, Europe and some other countries. The KEYNOTE-412 study was evaluating Keytruda in earlier stages of HNSCC. Several other registration-enabling studies are investigating Keytruda as monotherapy and in combination with other medicines for the neoadjuvant and adjuvant treatment of resectable locally advanced HNSCC.
Merck stock has risen 16.9% this year so far compared with an increase of 10.9% for the industry.
Image Source: Zacks Investment Research
Keytruda is already approved for the treatment of many cancers globally. The drug recorded sales of $4.81 billion in the first quarter, up 23% year over year.
Keytruda sales are gaining from continued uptake in lung cancer and increasing usage in other cancer indications. Numerous recent approvals and the expected launch of many additional indications, including in earlier lines of therapy, can further boost sales. Keytruda is presently approved to treat five indications in earlier-stage cancers in the United States. In the United States, Merck expects over half of Keytruda’s growth to come from indications in early-stage (neoadjuvant/adjuvant) treatment settings through 2025 and to represent roughly 25% of total global Keytruda sales by that time. At present, almost 20 studies are ongoing that are investigating Keytruda in earlier disease states across multiple types of cancer.
Some other drugmakers worth considering are Jazz Pharmaceuticals (JAZZ - Free Report) , BioNTech (BNTX - Free Report) and Pfizer (PFE - Free Report) . While Jazz Pharmaceuticals sports a Zacks Rank of 1, Pfizer and BioNTech have a Zacks Rank of 2 (Buy).
Jazz Pharmaceuticals stock is up 22.5% this year so far. Earnings estimates for 2022 have gone up from $17.05 per share to $17.06 per share over the past 60 days while those for 2023 have increased from $18.14 per share to $18.15 per share.
Earnings of Jazz Pharmaceuticals beat estimates in three of the last four quarters and missed the mark on one occasion, the average surprise being 12.81%.
BioNTech’s stock is down 36.4% this year so far. Earnings estimates for 2023 have gone up from $15.60 per share to $16.27 per share over the past 60 days.
Earnings of BioNTech beat estimates in all the last four quarters, the average surprise being 56.87%.
Pfizer stock is down 13.9% this year so far. Earnings estimates for 2022 have gone up from $6.56 per share to $6.59 per share while that for 2023 have gone up from $5.31 per share to $5.37 per share over the past 60 days.
Earnings of Pfizer beat estimates in three of the last four quarters while missing on one occasion, the average surprise being 14.76%.
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Merck's (MRK) Keytruda Head and Neck Cancer Study Fails
Merck (MRK - Free Report) announced that a phase III study evaluating its blockbuster PD-L1 inhibitor, Keytruda, in earlier stages of head and neck cancer failed to meet its primary endpoint of event-free survival (EFS)
The phase III KEYNOTE-412 study evaluated Keytruda in combination with concurrent chemoradiation therapy (CRT) followed by Keytruda as maintenance therapy (the Keytruda regimen) compared to placebo plus CRT for treating unresected locally advanced head and neck squamous cell carcinoma (HNSCC), a very challenging cancer to treat.
The final analysis of the study showed that there was an improvement in EFS in patients treated with the Keytruda regimen compared to the placebo arm. However, the data failed to meet statistical significance.
Keytruda is presently approved for certain later stages of HNSCC in the United States, Europe and some other countries. The KEYNOTE-412 study was evaluating Keytruda in earlier stages of HNSCC. Several other registration-enabling studies are investigating Keytruda as monotherapy and in combination with other medicines for the neoadjuvant and adjuvant treatment of resectable locally advanced HNSCC.
Merck stock has risen 16.9% this year so far compared with an increase of 10.9% for the industry.
Image Source: Zacks Investment Research
Keytruda is already approved for the treatment of many cancers globally. The drug recorded sales of $4.81 billion in the first quarter, up 23% year over year.
Keytruda sales are gaining from continued uptake in lung cancer and increasing usage in other cancer indications. Numerous recent approvals and the expected launch of many additional indications, including in earlier lines of therapy, can further boost sales. Keytruda is presently approved to treat five indications in earlier-stage cancers in the United States. In the United States, Merck expects over half of Keytruda’s growth to come from indications in early-stage (neoadjuvant/adjuvant) treatment settings through 2025 and to represent roughly 25% of total global Keytruda sales by that time. At present, almost 20 studies are ongoing that are investigating Keytruda in earlier disease states across multiple types of cancer.
Zacks Rank & Other Stocks to Consider
Merck has a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Some other drugmakers worth considering are Jazz Pharmaceuticals (JAZZ - Free Report) , BioNTech (BNTX - Free Report) and Pfizer (PFE - Free Report) . While Jazz Pharmaceuticals sports a Zacks Rank of 1, Pfizer and BioNTech have a Zacks Rank of 2 (Buy).
Jazz Pharmaceuticals stock is up 22.5% this year so far. Earnings estimates for 2022 have gone up from $17.05 per share to $17.06 per share over the past 60 days while those for 2023 have increased from $18.14 per share to $18.15 per share.
Earnings of Jazz Pharmaceuticals beat estimates in three of the last four quarters and missed the mark on one occasion, the average surprise being 12.81%.
BioNTech’s stock is down 36.4% this year so far. Earnings estimates for 2023 have gone up from $15.60 per share to $16.27 per share over the past 60 days.
Earnings of BioNTech beat estimates in all the last four quarters, the average surprise being 56.87%.
Pfizer stock is down 13.9% this year so far. Earnings estimates for 2022 have gone up from $6.56 per share to $6.59 per share while that for 2023 have gone up from $5.31 per share to $5.37 per share over the past 60 days.
Earnings of Pfizer beat estimates in three of the last four quarters while missing on one occasion, the average surprise being 14.76%.