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Bristol Myers' (BMY) Opdivo Data Positive for Neoadjuvant NSCLC
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Bristol Myers (BMY - Free Report) announced encouraging results from the phase III CheckMate -816 study in patients with resectable non-small cell lung cancer (NSCLC).
Data showed that neoadjuvant treatment with three cycles of Opdivo (nivolumab) in combination with chemotherapy significantly improved event-free survival (EFS), a primary endpoint, compared to chemotherapy alone in the patient population.
Opdivo with chemotherapy reduced the risk of disease recurrence, progression or death 37% across randomized patients when administered before surgery. Median EFS was 31.6 months in patients receiving the combination compared to 20.8 months for patients treated with chemotherapy alone.
Further, favorable early overall survival (OS) results were observed with Opdivo in combination with chemotherapy even though the data is still immature and the analysis did not reach any statistical significance. At two years, 83% patients treated with neoadjuvant Opdivo and chemotherapy were alive compared to 71% with chemotherapy alone.
We note that in March 2022, the FDA approved Opdivo in combination with platinum-doublet chemotherapy every three weeks for three cycles for adult patients with resectable (tumors ≥4 cm or node positive) NSCLC in the neoadjuvant setting. This nod was based on the EFS and pathologic complete response (pCR) results from the CheckMate -816 study.
Per management, these results from the late-stage CheckMate -816 study represent the first demonstration of clear and significant benefits with neoadjuvant immunotherapy-based treatment over chemotherapy alone for these patients, initially seen with increased pathologic complete response and now with an improved EFS and a positive trend in OS.
These patients face a high probability of recurrence after surgery and hence the OS trends are encouraging.
Opdivo-based treatments showed an improved efficacy in the neoadjuvant or adjuvant treatment of four tumor types, namely lung cancer, bladder cancer, esophageal/gastroesophageal junction cancer and melanoma.
The European Commission (EC) recently approved the label expansion of Opdivo-based combinations for several indications.
The performance of the immuno-oncology drug Opdivo, approved for multiple cancer indications, has been solid of late. Opdivo is one of the top revenue generators for BMY and the continued label expansion of the drug for additional indications should further boost its growth potential.
Shares of Bristol Myers have rallied 23.4% year to date against the industry’s decline of 13.9%.
Image Source: Zacks Investment Research
The European Medicines Agency (EMA) also validated BMY’s type II variation application for Opdivo in combination with chemotherapy for the neoadjuvant treatment of patients with resectable stage IB to IIIA NSCLC.
The FDA recently approved a new, first-in-class, fixed-dose combination of Opdivo and relatlimab (novel LAG-3-blocking antibody) administered as a single intravenous infusion for the treatment of adult and pediatric patients, aged 12 years and above with unresectable or metastatic melanoma (a kind of skin cancer). The drug is approved under the brand name Opdualag.
Approval of these new drugs adds a revenue stream, which should bolster growth in the coming quarters.
The solid performance of key drugs, namely Revlimid and Eliquis along with Opdivo maintains a momentum for BMY and should fuel further growth. Bristol Myers is also focusing on diversifying its revenue base, which is yielding results.
However, competition is stiff for Opdivo from the likes of Merck’s (MRK - Free Report) blockbuster drug Keytruda. Keytruda, approved for various oncology indications, is the key driver for MRK.
Continued label expansions of the drug boosted Merck’s top line.
Loss estimates for VYGR have narrowed to $1.35 from $2.20 for 2022 in the past 60 days. Earnings of Voyager surpassed estimates in three of the trailing four quarters and missed the same once, the average surprise being 41%.
Loss estimates for VTGN have narrowed to 22 cents from 27 cents for 2022 in the past 60 days. Earnings of VistaGen surpassed estimates in two of the trailing four quarters and missed the same twice, the average negative surprise being 70.63%.
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Bristol Myers' (BMY) Opdivo Data Positive for Neoadjuvant NSCLC
Bristol Myers (BMY - Free Report) announced encouraging results from the phase III CheckMate -816 study in patients with resectable non-small cell lung cancer (NSCLC).
Data showed that neoadjuvant treatment with three cycles of Opdivo (nivolumab) in combination with chemotherapy significantly improved event-free survival (EFS), a primary endpoint, compared to chemotherapy alone in the patient population.
Opdivo with chemotherapy reduced the risk of disease recurrence, progression or death 37% across randomized patients when administered before surgery. Median EFS was 31.6 months in patients receiving the combination compared to 20.8 months for patients treated with chemotherapy alone.
Further, favorable early overall survival (OS) results were observed with Opdivo in combination with chemotherapy even though the data is still immature and the analysis did not reach any statistical significance. At two years, 83% patients treated with neoadjuvant Opdivo and chemotherapy were alive compared to 71% with chemotherapy alone.
We note that in March 2022, the FDA approved Opdivo in combination with platinum-doublet chemotherapy every three weeks for three cycles for adult patients with resectable (tumors ≥4 cm or node positive) NSCLC in the neoadjuvant setting. This nod was based on the EFS and pathologic complete response (pCR) results from the CheckMate -816 study.
Per management, these results from the late-stage CheckMate -816 study represent the first demonstration of clear and significant benefits with neoadjuvant immunotherapy-based treatment over chemotherapy alone for these patients, initially seen with increased pathologic complete response and now with an improved EFS and a positive trend in OS.
These patients face a high probability of recurrence after surgery and hence the OS trends are encouraging.
Opdivo-based treatments showed an improved efficacy in the neoadjuvant or adjuvant treatment of four tumor types, namely lung cancer, bladder cancer, esophageal/gastroesophageal junction cancer and melanoma.
The European Commission (EC) recently approved the label expansion of Opdivo-based combinations for several indications.
The performance of the immuno-oncology drug Opdivo, approved for multiple cancer indications, has been solid of late. Opdivo is one of the top revenue generators for BMY and the continued label expansion of the drug for additional indications should further boost its growth potential.
Shares of Bristol Myers have rallied 23.4% year to date against the industry’s decline of 13.9%.
Image Source: Zacks Investment Research
The European Medicines Agency (EMA) also validated BMY’s type II variation application for Opdivo in combination with chemotherapy for the neoadjuvant treatment of patients with resectable stage IB to IIIA NSCLC.
The FDA recently approved a new, first-in-class, fixed-dose combination of Opdivo and relatlimab (novel LAG-3-blocking antibody) administered as a single intravenous infusion for the treatment of adult and pediatric patients, aged 12 years and above with unresectable or metastatic melanoma (a kind of skin cancer). The drug is approved under the brand name Opdualag.
Approval of these new drugs adds a revenue stream, which should bolster growth in the coming quarters.
The solid performance of key drugs, namely Revlimid and Eliquis along with Opdivo maintains a momentum for BMY and should fuel further growth. Bristol Myers is also focusing on diversifying its revenue base, which is yielding results.
However, competition is stiff for Opdivo from the likes of Merck’s (MRK - Free Report) blockbuster drug Keytruda. Keytruda, approved for various oncology indications, is the key driver for MRK.
Continued label expansions of the drug boosted Merck’s top line.
Bristol-Myers currently carries a Zacks Rank #3 (Hold). Two better-ranked stocks in the biotech sector are Voyager Therapeutics (VYGR - Free Report) and VistaGen Therapeutics (VTGN - Free Report) , both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Loss estimates for VYGR have narrowed to $1.35 from $2.20 for 2022 in the past 60 days. Earnings of Voyager surpassed estimates in three of the trailing four quarters and missed the same once, the average surprise being 41%.
Loss estimates for VTGN have narrowed to 22 cents from 27 cents for 2022 in the past 60 days. Earnings of VistaGen surpassed estimates in two of the trailing four quarters and missed the same twice, the average negative surprise being 70.63%.