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Bristol Myers (BMY) Fails to Meet Goal in Opdivo NSCLC Study
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Bristol Myers (BMY - Free Report) recently announced that a late-stage study, seeking to expand the label of its cancer combination drug, Opdivo (nivolumab) and Yervoy (ipilimumab), failed to meet the primary endpoint of progression-free survival in unresectable, locally advanced stage III non-small cell lung cancer (NSCLC).
The phase III CheckMate -73L study evaluated Opdivo with concurrent chemoradiotherapy (CCRT) followed by Opdivo plus Yervoycompared with CCRT followed by AstraZeneca’s (AZN - Free Report) Imfinzi (durvalumab) in 925 patients with unresectable stage III NSCLC.
The total patient population of the NSCLC study was randomized into three arms receiving either Opdivo in combination with CCRT followed by Opdivo plus Yervoy (Arm A), Opdivo in combination with CCRT followed by Opdivo monotherapy (Arm B), or CCRT followed by durvalumab (Arm C).
Specified secondary endpoints in the study included overall survival, objective response rate, time to response, duration of response and additional safety and efficacy endpoints.
However, Bristol Myers reported that no new safety signals were identified in the CheckMate -73L study. The adverse events following treatment in Arm A of the study were overall consistent with the known profiles of Opdivo and Yervoy.
The company is currently completing a detailed evaluation of the data available from the phase III CheckMate -73L study, which will be presented at a later medical conference.
Year to date, shares of Bristol Myers have lost 12.4% compared with the industry’s 6.6% decline.
Image Source: Zacks Investment Research
Currently, Opdivo is approved both as a monotherapy and in combination with Yervoy to treat a plethora of cancer indications, including several in NSCLC in many countries, including the United States and EU.
Despite the failure of the CheckMate -73L study, Opdivo and Opdivo-based combinations have shown efficacy benefits in the neoadjuvant, adjuvant or perioperative settings across several cancers, including that of the lung, bladder, esophageal/gastroesophageal junction and melanoma, to date.
BMY is currently evaluating Opdivo in different ongoing clinical studies spread across all phases in a variety of tumor types.
Opdivo has also been a key factor driving top-line growth for Bristol Myers in 2023. The drug recorded $9 billion in sales, representing an uptick of 10% year over year.
Currently, Merck (MRK - Free Report) markets Keytruda (pembrolizumab) as the standard of care in the frontline treatment of metastatic NSCLC. Keytruda, also an anti-PD-1 therapy like Opdivo, is MRK’s blockbuster oncology drug. It is approved for several types of cancer, accounting alone for 47% of the company’s pharmaceutical sales in 2023.
Keytruda is continuously growing and expanding into new indications and markets globally, bolstering Merck’s position in the oncology market. MRK’s Keytruda is presently approved to treat eight indications in earlier-stage cancers in the United States.
AstraZeneca’s Imfinzi, also an anti-PD-L1 therapy, was first approved in 2017 for the treatment of patients with locally advanced or metastatic urothelial carcinoma.
Currently, AZN’s Imfinzi is the global standard of care in the curative-intent setting of unresectable stage III NSCLC for patients whose disease has not progressed after CCRT.
Imfinzi is also approved for various other cancer indications in different settings across the world. The drug is a key revenue driver for AstraZeneca’s oncology portfolio, which generated sales of $4.2 billion in 2023, up 55% year over year.
Zacks Rank and Stock to Consider
Bristol Myers currently carries a Zacks Rank #3 (Hold).
In the past 30 days, the Zacks Consensus Estimate for Ligand’s 2024 earnings per share has remained constant at $4.56. During the same time frame, the estimate for Ligand’s 2025 earnings per share has remained constant at $5.27. Year to date, shares of LGND have gained 22.2%.
Ligand beat estimates in each of the trailing four quarters, delivering an average surprise of 56.02%.
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Bristol Myers (BMY) Fails to Meet Goal in Opdivo NSCLC Study
Bristol Myers (BMY - Free Report) recently announced that a late-stage study, seeking to expand the label of its cancer combination drug, Opdivo (nivolumab) and Yervoy (ipilimumab), failed to meet the primary endpoint of progression-free survival in unresectable, locally advanced stage III non-small cell lung cancer (NSCLC).
The phase III CheckMate -73L study evaluated Opdivo with concurrent chemoradiotherapy (CCRT) followed by Opdivo plus Yervoycompared with CCRT followed by AstraZeneca’s (AZN - Free Report) Imfinzi (durvalumab) in 925 patients with unresectable stage III NSCLC.
The total patient population of the NSCLC study was randomized into three arms receiving either Opdivo in combination with CCRT followed by Opdivo plus Yervoy (Arm A), Opdivo in combination with CCRT followed by Opdivo monotherapy (Arm B), or CCRT followed by durvalumab (Arm C).
Specified secondary endpoints in the study included overall survival, objective response rate, time to response, duration of response and additional safety and efficacy endpoints.
However, Bristol Myers reported that no new safety signals were identified in the CheckMate -73L study. The adverse events following treatment in Arm A of the study were overall consistent with the known profiles of Opdivo and Yervoy.
The company is currently completing a detailed evaluation of the data available from the phase III CheckMate -73L study, which will be presented at a later medical conference.
Year to date, shares of Bristol Myers have lost 12.4% compared with the industry’s 6.6% decline.
Image Source: Zacks Investment Research
Currently, Opdivo is approved both as a monotherapy and in combination with Yervoy to treat a plethora of cancer indications, including several in NSCLC in many countries, including the United States and EU.
Despite the failure of the CheckMate -73L study, Opdivo and Opdivo-based combinations have shown efficacy benefits in the neoadjuvant, adjuvant or perioperative settings across several cancers, including that of the lung, bladder, esophageal/gastroesophageal junction and melanoma, to date.
BMY is currently evaluating Opdivo in different ongoing clinical studies spread across all phases in a variety of tumor types.
Opdivo has also been a key factor driving top-line growth for Bristol Myers in 2023. The drug recorded $9 billion in sales, representing an uptick of 10% year over year.
Bristol Myers Squibb Company Price and Consensus
Bristol Myers Squibb Company price-consensus-chart | Bristol Myers Squibb Company Quote
Currently, Merck (MRK - Free Report) markets Keytruda (pembrolizumab) as the standard of care in the frontline treatment of metastatic NSCLC. Keytruda, also an anti-PD-1 therapy like Opdivo, is MRK’s blockbuster oncology drug. It is approved for several types of cancer, accounting alone for 47% of the company’s pharmaceutical sales in 2023.
Keytruda is continuously growing and expanding into new indications and markets globally, bolstering Merck’s position in the oncology market. MRK’s Keytruda is presently approved to treat eight indications in earlier-stage cancers in the United States.
AstraZeneca’s Imfinzi, also an anti-PD-L1 therapy, was first approved in 2017 for the treatment of patients with locally advanced or metastatic urothelial carcinoma.
Currently, AZN’s Imfinzi is the global standard of care in the curative-intent setting of unresectable stage III NSCLC for patients whose disease has not progressed after CCRT.
Imfinzi is also approved for various other cancer indications in different settings across the world. The drug is a key revenue driver for AstraZeneca’s oncology portfolio, which generated sales of $4.2 billion in 2023, up 55% year over year.
Zacks Rank and Stock to Consider
Bristol Myers currently carries a Zacks Rank #3 (Hold).
A better-ranked stock from the drug/biotech industry is Ligand Pharmaceuticals (LGND - Free Report) , sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, the Zacks Consensus Estimate for Ligand’s 2024 earnings per share has remained constant at $4.56. During the same time frame, the estimate for Ligand’s 2025 earnings per share has remained constant at $5.27. Year to date, shares of LGND have gained 22.2%.
Ligand beat estimates in each of the trailing four quarters, delivering an average surprise of 56.02%.