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Merck (MRK) Keytruda Adjuvant Lung Cancer sBLA Accepted by FDA
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Merck (MRK - Free Report) announced that the FDA has accepted for review its supplemental biologics license application (sBLA) seeking approval of its blockbuster PD-L1 inhibitor, Keytruda for treating adjuvant stage IB-IIIA non-small cell lung cancer (NSCLC), following complete surgical resection. The FDA is expected to give its decision on Jan 29, 2023.
The sBLA was based on data from the phase III KEYNOTE-091 study, also known as EORTC-1416-LCG/ETOP-8-15 – PEARLS.
The study had dual primary endpoints of disease-free survival (DFS) regardless of PD-L1 expression and DFS in patients whose tumors express high levels of PD-L1 (tumor proportion score [TPS] ≥50%). In the interim analysis, conducted by an independent Data Monitoring Committee, adjuvant treatment with Keytruda led to a significant improvement in DFS for patients regardless of PD-L1 expression, one of the dual primary endpoints compared to placebo.
However, DFS in patients whose tumors express PD-L1 (tumor proportion score [TPS] ≥50%) did not reach statistical significance at the time of interim analysis. The study will continue to evaluate DFS in patients whose tumors express high levels of PD-L1 (TPS ≥50%) as well as the other secondary endpoints. Merck has the option to provide further data during the review process.
Merck’s stock has risen 10.9% this year so far compared with an increase of 0.9% 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 of 2022, up 23% year over year.
Keytruda sales are gaining from the continued uptake in lung cancer and increasing usage in other cancer indications. Keytruda is continuously growing and expanding into new indications and markets globally. Numerous recent approvals and the expected launch of many additional indications, including in earlier lines of therapy, can further boost sales.
Merck is now focusing on evaluating a Keytruda-based regimen in earlier lines and earlier stages of certain cancers. KEYNOTE-091 was Merck’s seventh pivotal study on Keytruda in the earlier stages of cancer that met the primary endpoint.
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.
The Zacks Consensus Estimate for Sesen Bio’s2022 loss has declined from 33 cents to 32 cents per share in the past 60 days. Shares of SESN have declined 20.9% in the year-to-date period.
Earnings of Sesen Bio beat estimates in three of the last four quarters and missed the mark on one occasion, the average surprise being 69.9%.
The Zacks Consensus Estimate for Alkermes’ 2022 loss per share has narrowed from 14 cents to 3 cents in the past 60 days. Shares of ALKS have risen 17.5% year to date.
Earnings of Alkermes beat estimates in each of the last four quarters, the average being 350.5%.
The Zacks Consensus Estimate for BELLUS Health’s 2022 loss per share has narrowed from 87 cents to 76 cents while that for 2023 has gone down from $1.11 per share to 98 cents per share in the past 60 days. Shares of BLU have declined 3.6% year to date.
BELLUS Health delivered a four-quarter average negative earnings surprise of 2.68%.
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Merck (MRK) Keytruda Adjuvant Lung Cancer sBLA Accepted by FDA
Merck (MRK - Free Report) announced that the FDA has accepted for review its supplemental biologics license application (sBLA) seeking approval of its blockbuster PD-L1 inhibitor, Keytruda for treating adjuvant stage IB-IIIA non-small cell lung cancer (NSCLC), following complete surgical resection. The FDA is expected to give its decision on Jan 29, 2023.
The sBLA was based on data from the phase III KEYNOTE-091 study, also known as EORTC-1416-LCG/ETOP-8-15 – PEARLS.
The study had dual primary endpoints of disease-free survival (DFS) regardless of PD-L1 expression and DFS in patients whose tumors express high levels of PD-L1 (tumor proportion score [TPS] ≥50%). In the interim analysis, conducted by an independent Data Monitoring Committee, adjuvant treatment with Keytruda led to a significant improvement in DFS for patients regardless of PD-L1 expression, one of the dual primary endpoints compared to placebo.
However, DFS in patients whose tumors express PD-L1 (tumor proportion score [TPS] ≥50%) did not reach statistical significance at the time of interim analysis. The study will continue to evaluate DFS in patients whose tumors express high levels of PD-L1 (TPS ≥50%) as well as the other secondary endpoints. Merck has the option to provide further data during the review process.
Merck’s stock has risen 10.9% this year so far compared with an increase of 0.9% 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 of 2022, up 23% year over year.
Keytruda sales are gaining from the continued uptake in lung cancer and increasing usage in other cancer indications. Keytruda is continuously growing and expanding into new indications and markets globally. Numerous recent approvals and the expected launch of many additional indications, including in earlier lines of therapy, can further boost sales.
Merck is now focusing on evaluating a Keytruda-based regimen in earlier lines and earlier stages of certain cancers. KEYNOTE-091 was Merck’s seventh pivotal study on Keytruda in the earlier stages of cancer that met the primary endpoint.
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.
Merck currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Stocks to Consider
Some better-ranked biotech stocks are Sesen Bio , Alkermes (ALKS - Free Report) and BELLUS Health . While Alkermes and Sesen Bio have a Zacks Rank of 1, BELLUS Health has a Zacks Rank of 2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
The Zacks Consensus Estimate for Sesen Bio’s2022 loss has declined from 33 cents to 32 cents per share in the past 60 days. Shares of SESN have declined 20.9% in the year-to-date period.
Earnings of Sesen Bio beat estimates in three of the last four quarters and missed the mark on one occasion, the average surprise being 69.9%.
The Zacks Consensus Estimate for Alkermes’ 2022 loss per share has narrowed from 14 cents to 3 cents in the past 60 days. Shares of ALKS have risen 17.5% year to date.
Earnings of Alkermes beat estimates in each of the last four quarters, the average being 350.5%.
The Zacks Consensus Estimate for BELLUS Health’s 2022 loss per share has narrowed from 87 cents to 76 cents while that for 2023 has gone down from $1.11 per share to 98 cents per share in the past 60 days. Shares of BLU have declined 3.6% year to date.
BELLUS Health delivered a four-quarter average negative earnings surprise of 2.68%.