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Bristol-Myers Reports Data from Opdivo Combination Studies
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Bristol-Myers Squibb Company (BMY - Free Report) announced updated results from the multi-arm phase Ib study, CheckMate -012, evaluating the safety and tolerability (primary endpoints) of Opdivo as monotherapy, or in combination with Yervoy, at different doses and schedules in chemotherapy-naïve advanced non-small cell lung cancer patients. Data were presented at the International Association for the Study of Lung Cancer.
Note that Bristol-Myers’ year-to-date share price movement shows that the stock has underperformed the Zacks classified Large Cap Pharma industry. The stock has lost 19.3% so far this year, in comparison to a drop of 8.4% for the industry.
Coming back to the news, updated data with a median follow-up of 16 months included pooled efficacy findings for the Opdivo and Yervoy combination cohorts – Opdivo 3 mg/kg every two weeks plus Yervoy 1 mg/kg every six or 12 weeks.
In the pooled combination cohorts, the median progression-free survival in patients with PD-L1 expression ≥1% was 12.7 months, while patients with PD-L1 expression ≥50% failed to achieve the same. For patients with ≥50% PD-L1 expression, the one-year overall survival rate was 100% in the pooled combination cohorts. Additionally, the confirmed objective response rates in all the treated patients was 43%, nearly double the response rate reported with Opdivo monotherapy (23%).
With longer follow-up in the study, the Opdivo-Yervoy combination demonstrated a safety profile that was consistent with the previously reported study data.
Bristol-Myers plans to move the combination into the ongoing phase III study, CheckMate -227, for the first-line treatment of advanced lung cancer.
In a separate press release, Bristol-Myers and partner Seattle Genetics, Inc. presented preliminary data from an ongoing phase I/I study on Opdivo, in combination with latter's Adcetris, in relapsed or refractory classical Hodgkin lymphoma (HL) patients at the annual meeting of the American Society of Hematology.
The combination data on 42 patients, including 29 evaluable for response, demonstrated a 90% objective response rate and a 62% complete response rate with a tolerable safety profile in pre-transplant relapsed or refractory classical HL patients.
The reported study results are encouraging. The companies are of the opinion that these data support the continued evaluation of the combination in HL.
We note that Opdivo and Adcetris are being evaluated as a combination treatment in several other ongoing phase I/II studies. These include studies on patients with relapsed or refractory disease, including diffuse large B-cell lymphoma, and other rare subtypes of B-cell, including mediastinal B-cell lymphoma and mediastinal gray zone lymphoma. Lately, the companies have extended the evaluation of Opdivo and Adcetris into the front-line treatment of older HL patients.
Note that Opdivo is approved in both the U.S. and the EU for several cancer indications. Bristol-Myers is working on further expanding its label. Bristol-Myers is also collaborating with several other companies for the evaluation of Opdivo in combination with their cancer regimens.
Bristol-Myers carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector are Sucampo Pharmaceuticals, Inc. and Vanda Pharmaceuticals, Inc. (VNDA - Free Report) . Both the stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Sucampo’s earnings estimates increased from $1.03 to $1.22 for 2016 and from $1.30 to $1.58 for 2017 over the last 60 days. The company posted a positive surprise in all of the four trailing quarters with an average beat of 35.55%.
Vanda’s loss estimates narrowed from 62 cents to 52 cents for 2016, while its earnings estimates increased from 13 cents to 22 cents for 2017 over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 56.65%. Its share price has surged almost 68% year to date.
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Bristol-Myers Reports Data from Opdivo Combination Studies
Bristol-Myers Squibb Company (BMY - Free Report) announced updated results from the multi-arm phase Ib study, CheckMate -012, evaluating the safety and tolerability (primary endpoints) of Opdivo as monotherapy, or in combination with Yervoy, at different doses and schedules in chemotherapy-naïve advanced non-small cell lung cancer patients. Data were presented at the International Association for the Study of Lung Cancer.
Note that Bristol-Myers’ year-to-date share price movement shows that the stock has underperformed the Zacks classified Large Cap Pharma industry. The stock has lost 19.3% so far this year, in comparison to a drop of 8.4% for the industry.
Coming back to the news, updated data with a median follow-up of 16 months included pooled efficacy findings for the Opdivo and Yervoy combination cohorts – Opdivo 3 mg/kg every two weeks plus Yervoy 1 mg/kg every six or 12 weeks.
In the pooled combination cohorts, the median progression-free survival in patients with PD-L1 expression ≥1% was 12.7 months, while patients with PD-L1 expression ≥50% failed to achieve the same. For patients with ≥50% PD-L1 expression, the one-year overall survival rate was 100% in the pooled combination cohorts. Additionally, the confirmed objective response rates in all the treated patients was 43%, nearly double the response rate reported with Opdivo monotherapy (23%).
With longer follow-up in the study, the Opdivo-Yervoy combination demonstrated a safety profile that was consistent with the previously reported study data.
Bristol-Myers plans to move the combination into the ongoing phase III study, CheckMate -227, for the first-line treatment of advanced lung cancer.
In a separate press release, Bristol-Myers and partner Seattle Genetics, Inc. presented preliminary data from an ongoing phase I/I study on Opdivo, in combination with latter's Adcetris, in relapsed or refractory classical Hodgkin lymphoma (HL) patients at the annual meeting of the American Society of Hematology.
The combination data on 42 patients, including 29 evaluable for response, demonstrated a 90% objective response rate and a 62% complete response rate with a tolerable safety profile in pre-transplant relapsed or refractory classical HL patients.
The reported study results are encouraging. The companies are of the opinion that these data support the continued evaluation of the combination in HL.
We note that Opdivo and Adcetris are being evaluated as a combination treatment in several other ongoing phase I/II studies. These include studies on patients with relapsed or refractory disease, including diffuse large B-cell lymphoma, and other rare subtypes of B-cell, including mediastinal B-cell lymphoma and mediastinal gray zone lymphoma. Lately, the companies have extended the evaluation of Opdivo and Adcetris into the front-line treatment of older HL patients.
Note that Opdivo is approved in both the U.S. and the EU for several cancer indications. Bristol-Myers is working on further expanding its label. Bristol-Myers is also collaborating with several other companies for the evaluation of Opdivo in combination with their cancer regimens.
BRISTOL-MYERS Price and Consensus
BRISTOL-MYERS Price and Consensus | BRISTOL-MYERS Quote
Zacks Rank & Key Picks
Bristol-Myers carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector are Sucampo Pharmaceuticals, Inc. and Vanda Pharmaceuticals, Inc. (VNDA - Free Report) . Both the stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Sucampo’s earnings estimates increased from $1.03 to $1.22 for 2016 and from $1.30 to $1.58 for 2017 over the last 60 days. The company posted a positive surprise in all of the four trailing quarters with an average beat of 35.55%.
Vanda’s loss estimates narrowed from 62 cents to 52 cents for 2016, while its earnings estimates increased from 13 cents to 22 cents for 2017 over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 56.65%. Its share price has surged almost 68% year to date.
Zacks' Top Investment Ideas for Long-Term Profit
How would you like to see our best recommendations to help you find today’s most promising long-term stocks? Starting now, you can look inside our portfolios featuring stocks under $10, income stocks, value investments and more. These picks, which have double and triple-digit profit potential, are rarely available to the public. But you can see them now. Click here >>