We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Bristol Myers' (BMY) Opdivo Positive in Late-Stage NSCLC Study
Read MoreHide Full Article
Bristol Myers Squibb (BMY - Free Report) announced that the late-stage CheckMate-77T study achieved its primary goal in non-small cell lung cancer (NSCLC) patients.
CheckMate-77T is a phase III randomized, double-blind, placebo-controlled, multi-center study evaluating neoadjuvant Opdivo (nivolumab) with chemotherapy followed by surgery and adjuvant Opdivo versus neoadjuvant chemotherapy and placebo followed by surgery and adjuvant placebo in 452 patients with resectable stage IIA to IIIB NSCLC. The primary endpoint of the trial is event-free survival (EFS). Secondary endpoints include overall survival (OS), pathologic complete response and major pathologic response.
The study met its primary endpoint of EFS as assessed by the Blinded Independent Central Review as the perioperative regimen of neoadjuvant Opdivo with chemotherapy, followed by surgery and adjuvant Opdivo showed a statistically significant and clinically meaningful improvement in EFS compared with neoadjuvant chemotherapy and placebo, followed by surgery and adjuvant placebo.
The study represents the company’s second positive late-stage study with an immunotherapy-based combination for the treatment of non-metastatic NSCLC.
NSCLC is the most common type of lung cancer and non-metastatic cases account for most NSCLC diagnoses.
Most non-metastatic NSCLC patients are cured by surgery, but roughly 30% to 55% develop recurrence and die despite resection. Hence, there is an imminent need for treatment options administered before surgery (neoadjuvant) and/or after surgery (adjuvant) to improve long-term outcomes.
The study is currently being conducted to assess the secondary endpoint of OS.
Bristol Myers will complete a full evaluation of the available data from CheckMate-77T. Results will be discussed with health authorities.
Opdivo, a programmed death-immune checkpoint inhibitor, is approved for various cancers, either as monotherapy or in combination with other agents - metastatic melanoma, NSCLC and advanced renal cell carcinoma.
Opdivo and Opdivo-based combinations have shown improved efficacy in the neoadjuvant, adjuvant or perioperative treatment of four tumor types: lung cancer, bladder cancer, esophageal/gastroesophageal junction cancer and melanoma.
Approval in additional settings will further boost sales of this blockbuster drug. Sales of Opdivo came in at $4.3 billion in the first half of 2023.
Opdivo faces competition from Merck’s (MRK - Free Report) Keytruda for many of its approved indications.
Keytruda is one of the leading drugs for Merck and is approved for lung cancer, breast cancer and kidney cancer, among others.
Shares of the company have lost 17.9% year to date compared with the industry's decline of 15.6%.
Image Source: Zacks Investment Research
Bristol Myers is currently in transition mode as it shifts its mature product portfolio, which is facing generic competition, to new drugs.
The approval of additional new drugs and the label expansion of existing ones will enable Bristol Myers to diversify its product base and offset the slowdown in top-line growth as Revlimid and Eliquis face generic competition.
New drugs like Opdualag, Reblozyl, Breyanzi and Sotyktu have already added a new stream of revenues to BMY’s top line.
Zacks Rank and Stocks to Consider
Bristol Myers currently carries a Zacks Rank #3 (Hold).
Some well-placed stocks in the industry are Eton Pharmaceuticals (ETON - Free Report) and Dynavax Technologies (DVAX - Free Report) . Eton currently sports a Zacks Rank #1 (Strong Buy) and Dynavax carries a Rank #2 (Buy).
Loss estimates for Eton for 2023 have narrowed to 10 cents from 31 cents in the past 60 days, while earnings estimates for 2024 are pegged at 26 cents per share.
Loss estimates for Dynavax for 2023 have narrowed to 23 cents from 56 cents in the past 90 days, while earnings estimates for 2024 are pegged at 3 cents per share.
See More Zacks Research for These Tickers
Pick one free report - opportunity may be withdrawn at any time
Image: Shutterstock
Bristol Myers' (BMY) Opdivo Positive in Late-Stage NSCLC Study
Bristol Myers Squibb (BMY - Free Report) announced that the late-stage CheckMate-77T study achieved its primary goal in non-small cell lung cancer (NSCLC) patients.
CheckMate-77T is a phase III randomized, double-blind, placebo-controlled, multi-center study evaluating neoadjuvant Opdivo (nivolumab) with chemotherapy followed by surgery and adjuvant Opdivo versus neoadjuvant chemotherapy and placebo followed by surgery and adjuvant placebo in 452 patients with resectable stage IIA to IIIB NSCLC. The primary endpoint of the trial is event-free survival (EFS). Secondary endpoints include overall survival (OS), pathologic complete response and major pathologic response.
The study met its primary endpoint of EFS as assessed by the Blinded Independent Central Review as the perioperative regimen of neoadjuvant Opdivo with chemotherapy, followed by surgery and adjuvant Opdivo showed a statistically significant and clinically meaningful improvement in EFS compared with neoadjuvant chemotherapy and placebo, followed by surgery and adjuvant placebo.
The study represents the company’s second positive late-stage study with an immunotherapy-based combination for the treatment of non-metastatic NSCLC.
NSCLC is the most common type of lung cancer and non-metastatic cases account for most NSCLC diagnoses.
Most non-metastatic NSCLC patients are cured by surgery, but roughly 30% to 55% develop recurrence and die despite resection. Hence, there is an imminent need for treatment options administered before surgery (neoadjuvant) and/or after surgery (adjuvant) to improve long-term outcomes.
The study is currently being conducted to assess the secondary endpoint of OS.
Bristol Myers will complete a full evaluation of the available data from CheckMate-77T. Results will be discussed with health authorities.
Opdivo, a programmed death-immune checkpoint inhibitor, is approved for various cancers, either as monotherapy or in combination with other agents - metastatic melanoma, NSCLC and advanced renal cell carcinoma.
Opdivo and Opdivo-based combinations have shown improved efficacy in the neoadjuvant, adjuvant or perioperative treatment of four tumor types: lung cancer, bladder cancer, esophageal/gastroesophageal junction cancer and melanoma.
Approval in additional settings will further boost sales of this blockbuster drug. Sales of Opdivo came in at $4.3 billion in the first half of 2023.
Opdivo faces competition from Merck’s (MRK - Free Report) Keytruda for many of its approved indications.
Keytruda is one of the leading drugs for Merck and is approved for lung cancer, breast cancer and kidney cancer, among others.
Shares of the company have lost 17.9% year to date compared with the industry's decline of 15.6%.
Image Source: Zacks Investment Research
Bristol Myers is currently in transition mode as it shifts its mature product portfolio, which is facing generic competition, to new drugs.
Bristol Myers Squibb Company Price and Consensus
Bristol Myers Squibb Company price-consensus-chart | Bristol Myers Squibb Company Quote
The approval of additional new drugs and the label expansion of existing ones will enable Bristol Myers to diversify its product base and offset the slowdown in top-line growth as Revlimid and Eliquis face generic competition.
New drugs like Opdualag, Reblozyl, Breyanzi and Sotyktu have already added a new stream of revenues to BMY’s top line.
Zacks Rank and Stocks to Consider
Bristol Myers currently carries a Zacks Rank #3 (Hold).
Some well-placed stocks in the industry are Eton Pharmaceuticals (ETON - Free Report) and Dynavax Technologies (DVAX - Free Report) . Eton currently sports a Zacks Rank #1 (Strong Buy) and Dynavax carries a Rank #2 (Buy).
You can see the complete list of today’s Zacks #1 Rank stocks here.
Loss estimates for Eton for 2023 have narrowed to 10 cents from 31 cents in the past 60 days, while earnings estimates for 2024 are pegged at 26 cents per share.
Loss estimates for Dynavax for 2023 have narrowed to 23 cents from 56 cents in the past 90 days, while earnings estimates for 2024 are pegged at 3 cents per share.