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Bristol Myers' Opdivo & Yervoy Win FDA Nod for Mesothelioma
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Bristol Myers Squibb (BMY - Free Report) announced that Opdivo (nivolumab) 360 mg every three weeks in combination with Yervoy (ipilimumab) 1 mg/kg every six weeks (injections for intravenous use) was approved by the FDA for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM).
Mesothelioma is a rare form of cancer that affects the lining of the lungs with poor prognosis. Per estimates, approximately 3,000 cases are diagnosed in the United States each year.
The regulatory nod was based on a pre-specified interim analysis from the phase III CheckMate-743 study wherein the combination of Opdivo and Yervoy demonstrated superior overall survival (OS) versus the platinum-based standard of care chemotherapy with a median OS (mOS) of 18.1 months versus 14.1 months, respectively. These results were observed after 22.1 months of minimum follow-up.
This is the third indication for an Opdivo + Yervoy-based combination to address the first-line treatment of a form of thoracic cancer. Approval of additional indications will boost the sales potential of this combo therapy, which is also approved by the FDA as a first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1≥1% as determined by an FDA-approved test and are without EGFR or ALK genomic tumor aberrations. The same is also approved in combination with limited chemotherapy for the first-line treatment of adult patients with metastatic or recurrent NSCLC with no EGFR or ALK genomic tumor aberrations regardless of the PD-L1 expression.
Concurrently, Bristol Myers announced results of CheckMate -915 program, a randomized phase III study evaluating Opdivo in combination with Yervoy compared to only Opdivo in patients who have had a complete surgical removal of stage IIIb/c/d or stage IV melanoma. However, results showed that the combination did not result in a statistically significant improvement in recurrence-free survival (RFS) in the intent-to-treat population. Nevertheless, the study reinforced the established benefit of Opdivo monotherapy as a standard of care in the adjuvant setting.
Bristol-Myers’ shares have lost 8.5% in the year so far compared with the industry's decline of 3%.
We note that Opdivo is currently approved in many regions including the United States, the EU and Japan for several cancer indications. The company continues to evaluate Opdivo alone or in combination therapies with Yervoy and other anti-cancer agents.
Approval of additional indications should boost Opdivo sales, which were not impressive in the second quarter. Notably, the drug faces stiff competition from Merck’s (MRK - Free Report) Keytruda and Roche’s (RHHBY - Free Report) Tecentriq.
Bristol-Myers currently carries a Zacks Rank #3 (Hold). Horizon Therapeutics is a better-ranked stock in the biotech sector, sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Horizon’s earnings per share estimates have increased 86 cents in the past 60 days for 2020 and 5 cents for 2021 in the past 30 days.
5 Stocks Set to Double
Each was hand-picked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2020. Each comes from a different sector and has unique qualities and catalysts that could fuel exceptional growth.
Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.
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Bristol Myers' Opdivo & Yervoy Win FDA Nod for Mesothelioma
Bristol Myers Squibb (BMY - Free Report) announced that Opdivo (nivolumab) 360 mg every three weeks in combination with Yervoy (ipilimumab) 1 mg/kg every six weeks (injections for intravenous use) was approved by the FDA for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM).
Mesothelioma is a rare form of cancer that affects the lining of the lungs with poor prognosis. Per estimates, approximately 3,000 cases are diagnosed in the United States each year.
The regulatory nod was based on a pre-specified interim analysis from the phase III CheckMate-743 study wherein the combination of Opdivo and Yervoy demonstrated superior overall survival (OS) versus the platinum-based standard of care chemotherapy with a median OS (mOS) of 18.1 months versus 14.1 months, respectively. These results were observed after 22.1 months of minimum follow-up.
This is the third indication for an Opdivo + Yervoy-based combination to address the first-line treatment of a form of thoracic cancer. Approval of additional indications will boost the sales potential of this combo therapy, which is also approved by the FDA as a first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1≥1% as determined by an FDA-approved test and are without EGFR or ALK genomic tumor aberrations. The same is also approved in combination with limited chemotherapy for the first-line treatment of adult patients with metastatic or recurrent NSCLC with no EGFR or ALK genomic tumor aberrations regardless of the PD-L1 expression.
Concurrently, Bristol Myers announced results of CheckMate -915 program, a randomized phase III study evaluating Opdivo in combination with Yervoy compared to only Opdivo in patients who have had a complete surgical removal of stage IIIb/c/d or stage IV melanoma. However, results showed that the combination did not result in a statistically significant improvement in recurrence-free survival (RFS) in the intent-to-treat population. Nevertheless, the study reinforced the established benefit of Opdivo monotherapy as a standard of care in the adjuvant setting.
Bristol-Myers’ shares have lost 8.5% in the year so far compared with the industry's decline of 3%.
We note that Opdivo is currently approved in many regions including the United States, the EU and Japan for several cancer indications. The company continues to evaluate Opdivo alone or in combination therapies with Yervoy and other anti-cancer agents.
Approval of additional indications should boost Opdivo sales, which were not impressive in the second quarter. Notably, the drug faces stiff competition from Merck’s (MRK - Free Report) Keytruda and Roche’s (RHHBY - Free Report) Tecentriq.
Bristol-Myers currently carries a Zacks Rank #3 (Hold). Horizon Therapeutics is a better-ranked stock in the biotech sector, sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Horizon’s earnings per share estimates have increased 86 cents in the past 60 days for 2020 and 5 cents for 2021 in the past 30 days.
5 Stocks Set to Double
Each was hand-picked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2020. Each comes from a different sector and has unique qualities and catalysts that could fuel exceptional growth.
Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.
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