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Bristol Myers (BMY) Gains on Positive Opdivo Data in NSCLC
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Shares of Bristol Myers Squibb (BMY - Free Report) gained 4.6% after it announced positive results from a late-stage study on immuno-oncology drug, Opdivo (nivolumab), in the lucrative indication of non-small cell lung cancer (NSCLC).
The phase III randomized, open-label, multi-center study — CheckMate -816 — is evaluating Opdivo plus chemotherapy compared to chemotherapy alone as neoadjuvant treatment in patients with resectable NSCLC.
The study met a primary endpoint of improved pathologic complete response (pCR) in patients who received Opdivo plus chemotherapy before surgery. The study results showed that significantly more patients treated with Opdivo plus chemotherapy before surgery did not show any evidence of cancer cells in their resected tissue as compared to those who were treated with only chemotherapy.
Per the company, CheckMate -816 is the first and only phase III study to demonstrate a benefit with an immune checkpoint inhibitor in combination with chemotherapy as a neoadjuvant treatment in non-metastatic NSCLC.
Opdivo has shown benefit as an adjuvant or post-surgical treatment option in other cancer types and the positive results from CheckMate -816 demonstrate its potential in the neoadjuvant setting of resectable NSCLC.
The study is currently ongoing to assess the other primary endpoint of event-free survival (EFS), to which the company remains blinded, as well as key secondary endpoints. In non-metastatic NSCLC, Bristol Myers Squibb and collaborators are exploring the use of immunotherapy in the neoadjuvant, adjuvant and peri-operative settings, as well as in association with chemoradiation.
The company will discuss potential regulatory options with health authorities. NSCLC is one of the most common types of lung cancer, representing up to 84% of diagnoses, and hence reflects a significant market opportunity.
Bristol-Myers’ shares have lost 5.9% in the year so far against the industry's growth of 2.2%.
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.
Opdivo in combination with Yervoy is also approved by the FDA as a first-line treatment of patients with metastatic 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.
Approval of additional indications should boost Opdivo’s 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, particularly for the NSCLC indication.
The company was also in the news earlier this week when it entered into a definitive agreement to acquire clinical-stage biopharmaceutical company, MyoKardia , for $225 per share in cash or a total value of $13.1 billion.
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Bristol Myers (BMY) Gains on Positive Opdivo Data in NSCLC
Shares of Bristol Myers Squibb (BMY - Free Report) gained 4.6% after it announced positive results from a late-stage study on immuno-oncology drug, Opdivo (nivolumab), in the lucrative indication of non-small cell lung cancer (NSCLC).
The phase III randomized, open-label, multi-center study — CheckMate -816 — is evaluating Opdivo plus chemotherapy compared to chemotherapy alone as neoadjuvant treatment in patients with resectable NSCLC.
The study met a primary endpoint of improved pathologic complete response (pCR) in patients who received Opdivo plus chemotherapy before surgery. The study results showed that significantly more patients treated with Opdivo plus chemotherapy before surgery did not show any evidence of cancer cells in their resected tissue as compared to those who were treated with only chemotherapy.
Per the company, CheckMate -816 is the first and only phase III study to demonstrate a benefit with an immune checkpoint inhibitor in combination with chemotherapy as a neoadjuvant treatment in non-metastatic NSCLC.
Opdivo has shown benefit as an adjuvant or post-surgical treatment option in other cancer types and the positive results from CheckMate -816 demonstrate its potential in the neoadjuvant setting of resectable NSCLC.
The study is currently ongoing to assess the other primary endpoint of event-free survival (EFS), to which the company remains blinded, as well as key secondary endpoints. In non-metastatic NSCLC, Bristol Myers Squibb and collaborators are exploring the use of immunotherapy in the neoadjuvant, adjuvant and peri-operative settings, as well as in association with chemoradiation.
The company will discuss potential regulatory options with health authorities. NSCLC is one of the most common types of lung cancer, representing up to 84% of diagnoses, and hence reflects a significant market opportunity.
Bristol-Myers’ shares have lost 5.9% in the year so far against the industry's growth of 2.2%.
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.
Opdivo in combination with Yervoy is also approved by the FDA as a first-line treatment of patients with metastatic 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.
Approval of additional indications should boost Opdivo’s 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, particularly for the NSCLC indication.
The company was also in the news earlier this week when it entered into a definitive agreement to acquire clinical-stage biopharmaceutical company, MyoKardia , for $225 per share in cash or a total value of $13.1 billion.
Bristol-Myers currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
More Stock News: This Is Bigger than the iPhone!
It could become the mother of all technological revolutions. Apple sold a mere 1 billion iPhones in 10 years but a new breakthrough is expected to generate more than 27 billion devices in just 3 years, creating a $1.7 trillion market.
Zacks has just released a Special Report that spotlights this fast-emerging phenomenon and 6 tickers for taking advantage of it. If you don't buy now, you may kick yourself in 2021.
Click here for the 6 trades >>