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Bristol-Myers Announces Data on Immuno-oncology Drug Opdivo
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Bristol-Myers Squibb Company (BMY - Free Report) recently announced encouraging data from various trials on Opdivo.
The company announced first report of five-year overall survival (OS) data from the phase I dose-ranging study CA209-003. The study evaluated Opdivo in patients with previously treated advanced non-small cell lung cancer (NSCLC).
Overall survival was an exploratory endpoint in this study. The estimated OS rate at five years was 16% in heavily pre-treated NSCLC patients, which is much higher than the historical rate of 5%. CA209-003 represents the longest follow-up analysis of data from a clinical trial testing an anti-PD-1 immunotherapy.
Concurrently, Bristol-Myers also announced the first overall survival (OS) data from the phase III trial CheckMate-067. This phase III, double-blind, randomized trial evaluated the combination of Opdivo plus Yervoy or Opdivo monotherapy versus Yervoy monotherapy in 945 patients with previously untreated advanced melanoma.
The results showed that Opdivo in combination with Yervoy and as a monotherapy reduced the risk of death by 45% and 37% respectively, compared with Yervoy alone. With a minimum follow-up of 28 months, the median OS had not yet been reached in either of the two Opdivo treatment groups and was 20 months for the Yervoy monotherapy group. The two-year OS rates were 64% for the Opdivo plus Yervoy combination, 59% for Opdivo alone and 45% for Yervoy alone.
However, the randomized phase III trial, CheckMate-143, which evaluated the efficacy and safety of Opdivo in patients with first recurrence of glioblastoma multiforme (GBM), did not meet its primary endpoint of improved overall survival over Roche’s (RHHBY - Free Report) Avastin monotherapy.
While Bristol-Myers’ share price decreased 7.3% in the last 12 months, the Zacks classified Large Cap Pharmaceuticals industry gained 6.1%.
We remind investors that Opdivo is approved for varied indications in both EU and the U.S. Opdivo has received approvals for several indications including melanoma, head and neck, lung, kidney and blood cancer. The Opdivo+Yervoy regimen is also approved in multiple markets for the treatment of melanoma.
The drug recorded sales of $3.4 billion in 2016, up from $942 million in 2015. Bristol-Myers is working on expanding the label of Opdivo further. Opdivo became the first PD-1 inhibitor to be approved for a hematological malignancy – classical Hodgkin lymphoma in both the U.S. (May 2016) and the EU (Nov 2016). In Nov 2016, Opdivo gained the FDA approval for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after platinum-based therapy.
Label expansion into additional indications would give the product access to a higher patient population and increase the commercial potential of the drug.
Zacks Rank & Stocks to Consider
Bristol-Myers currently carries a Zacks Rank #3 (Hold).
A couple of better-ranked stocks in the health care sector are Heska Corporation and Retrophin, Inc. . Both the stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Heska’s earnings per share estimates increased from $1.53 to $1.65 for 2017 and from $1.90 to $2.01 for 2018 over the last 30 days. The company posted a positive surprise in three of the four trailing quarters with an average beat of 291.54%.
Retrophin’s loss per share estimates narrowed from 85 cents to 72 cents for 2017 and from 67 cents to 53 cents for 2018 over the last 60 days. The company posted positive earnings surprises in two of the four trailing quarters, with an average beat of 80.55%.
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Bristol-Myers Announces Data on Immuno-oncology Drug Opdivo
Bristol-Myers Squibb Company (BMY - Free Report) recently announced encouraging data from various trials on Opdivo.
The company announced first report of five-year overall survival (OS) data from the phase I dose-ranging study CA209-003. The study evaluated Opdivo in patients with previously treated advanced non-small cell lung cancer (NSCLC).
Overall survival was an exploratory endpoint in this study. The estimated OS rate at five years was 16% in heavily pre-treated NSCLC patients, which is much higher than the historical rate of 5%. CA209-003 represents the longest follow-up analysis of data from a clinical trial testing an anti-PD-1 immunotherapy.
Concurrently, Bristol-Myers also announced the first overall survival (OS) data from the phase III trial CheckMate-067. This phase III, double-blind, randomized trial evaluated the combination of Opdivo plus Yervoy or Opdivo monotherapy versus Yervoy monotherapy in 945 patients with previously untreated advanced melanoma.
The results showed that Opdivo in combination with Yervoy and as a monotherapy reduced the risk of death by 45% and 37% respectively, compared with Yervoy alone. With a minimum follow-up of 28 months, the median OS had not yet been reached in either of the two Opdivo treatment groups and was 20 months for the Yervoy monotherapy group. The two-year OS rates were 64% for the Opdivo plus Yervoy combination, 59% for Opdivo alone and 45% for Yervoy alone.
However, the randomized phase III trial, CheckMate-143, which evaluated the efficacy and safety of Opdivo in patients with first recurrence of glioblastoma multiforme (GBM), did not meet its primary endpoint of improved overall survival over Roche’s (RHHBY - Free Report) Avastin monotherapy.
We remind investors that Opdivo is approved for varied indications in both EU and the U.S. Opdivo has received approvals for several indications including melanoma, head and neck, lung, kidney and blood cancer. The Opdivo+Yervoy regimen is also approved in multiple markets for the treatment of melanoma.
The drug recorded sales of $3.4 billion in 2016, up from $942 million in 2015. Bristol-Myers is working on expanding the label of Opdivo further. Opdivo became the first PD-1 inhibitor to be approved for a hematological malignancy – classical Hodgkin lymphoma in both the U.S. (May 2016) and the EU (Nov 2016). In Nov 2016, Opdivo gained the FDA approval for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after platinum-based therapy.
Label expansion into additional indications would give the product access to a higher patient population and increase the commercial potential of the drug.
Zacks Rank & Stocks to Consider
Bristol-Myers currently carries a Zacks Rank #3 (Hold).
A couple of better-ranked stocks in the health care sector are Heska Corporation and Retrophin, Inc. . Both the stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Heska’s earnings per share estimates increased from $1.53 to $1.65 for 2017 and from $1.90 to $2.01 for 2018 over the last 30 days. The company posted a positive surprise in three of the four trailing quarters with an average beat of 291.54%.
Retrophin’s loss per share estimates narrowed from 85 cents to 72 cents for 2017 and from 67 cents to 53 cents for 2018 over the last 60 days. The company posted positive earnings surprises in two of the four trailing quarters, with an average beat of 80.55%.
Zacks’ Best Private Investment Ideas
In addition to the recommendations that are available to the public on our website, how would you like to follow all Zacks' private buys and sells in real time?
Our experts cover all kinds of trades… from value to momentum . . . from stocks under $10 to ETF and option moves . . . from stocks that corporate insiders are buying up to companies that are about to report positive earnings surprises. You can even look inside exclusive portfolios that are normally closed to new investors. Starting today, for the next month, you can have unrestricted access. Click here for Zacks' private trades >>