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.
EMA Begins Review of Bristol Myers' (BMY) Opdivo Plus Yervoy for HCC
Read MoreHide Full Article
Bristol Myers Squibb (BMY - Free Report) announced that the European Medicines Agency (EMA) has validated its type II variation application for immunotherapy drug Opdivo (nivolumab), in combination with Yervoy (ipilimumab).
The application seeks approval of Opdivo plus Yervoy as a potential first-line treatment option for adult patients with unresectable or advanced hepatocellular carcinoma (HCC) who have not received any prior systemic therapy.
The application is based on results from the late-stage CheckMate -9DW trial, and the validation of the same confirms that the submission is complete and the EMA’s centralized procedure review has begun.
Results from the phase III CheckMate -9DW study showed that Opdivo plus Yervoy demonstrated a statistically significant and clinically meaningful improvement in overall survival compared to the investigator’s choice of Lenvima or Nexavar. The safety profile for Opdivo plus Yervoy remained consistent with previously reported data and was manageable with established protocols, with no new safety signal identified.
Liver cancer is the third most frequent cause of cancer death worldwide and HCC is the most common type of primary liver cancer. HCC accounts for 75-85% of all liver cancers. It is mostly detected at a very advanced stage, wherein effective treatment options are limited and usually associated with poor outcomes.
We note that Opdivo, in combination with Yervoy, is already indicated in the United States for the treatment of adult patients with HCC who have been previously treated with Nexavar. This indication is approved under accelerated approval, based on the overall response rate and duration of response.
Shares of BMY have lost 16.9% year to date compared with the industry’s decline of 3%.
Image Source: Zacks Investment Research
Opdivo is approved both as a monotherapy and in combination with Yervoy to treat a plethora of cancer indications in many countries, including the United States and the EU.
As a single agent, it was first granted approval in 2017 under the FDA’s accelerated approval program, making it the first immunotherapy agent to be approved for use in this setting. However, CheckMate-459, the confirmatory randomized study of Opdivo versus Nexavar in the first-line setting, did not achieve statistical significance for its primary endpoint of overall survival, per the pre-specified analysis.
BMY withdrew the indication for Opdivo as a single agent for patients with HCC from the United States in 2021.
AstraZeneca’s (AZN - Free Report) Imfinzi (durvalumab), in combination with Imjudo (tremelimumab), is approved in the EU for the first-line treatment of adult patients with advanced or unresectable HCC.
AZN’s Imfinzi is an immunotherapy that is approved to treat certain cancers, either as monotherapy or in combination with Imjudo.
Currently, BMY is looking to expand its new product portfolio amid generic challenges for Revlimid and Eliquis. Approval of new drugs and label expansion of the existing ones are important for BMY and the going has been good in that regard.
The FDA recently approved a label expansion of its oncology drug Krazati (adagrasib). The drug has been approved in combination with Erbitux as a targeted treatment option for adult patients with KRASG12C-mutated locally advanced or metastatic colorectal cancer.
The FDA recently approved a label expansion of BMY’s another lung cancer drug, Augtyro, for the treatment of adult and pediatric patients aged 12 years and above with solid tumors that have a neurotrophic tyrosine receptor kinase gene fusion, are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy.
Entrada’s loss per share estimate for 2024 has narrowed from 14 cents to 13 cents in the past 60 days, and the same for 2025 has narrowed from $3.44 to $3.21 in the past 30 days.
In the past 60 days, estimates for CORT’s 2024 earnings per share have improved from 90 to 95 cents. Shares of CORT have rallied 47.3% in the past three months.
CORT’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 33.7%.
See More Zacks Research for These Tickers
Normally $25 each - click below to receive one report FREE:
Image: Shutterstock
EMA Begins Review of Bristol Myers' (BMY) Opdivo Plus Yervoy for HCC
Bristol Myers Squibb (BMY - Free Report) announced that the European Medicines Agency (EMA) has validated its type II variation application for immunotherapy drug Opdivo (nivolumab), in combination with Yervoy (ipilimumab).
The application seeks approval of Opdivo plus Yervoy as a potential first-line treatment option for adult patients with unresectable or advanced hepatocellular carcinoma (HCC) who have not received any prior systemic therapy.
The application is based on results from the late-stage CheckMate -9DW trial, and the validation of the same confirms that the submission is complete and the EMA’s centralized procedure review has begun.
Results from the phase III CheckMate -9DW study showed that Opdivo plus Yervoy demonstrated a statistically significant and clinically meaningful improvement in overall survival compared to the investigator’s choice of Lenvima or Nexavar. The safety profile for Opdivo plus Yervoy remained consistent with previously reported data and was manageable with established protocols, with no new safety signal identified.
Liver cancer is the third most frequent cause of cancer death worldwide and HCC is the most common type of primary liver cancer. HCC accounts for 75-85% of all liver cancers. It is mostly detected at a very advanced stage, wherein effective treatment options are limited and usually associated with poor outcomes.
We note that Opdivo, in combination with Yervoy, is already indicated in the United States for the treatment of adult patients with HCC who have been previously treated with Nexavar. This indication is approved under accelerated approval, based on the overall response rate and duration of response.
Shares of BMY have lost 16.9% year to date compared with the industry’s decline of 3%.
Image Source: Zacks Investment Research
Opdivo is approved both as a monotherapy and in combination with Yervoy to treat a plethora of cancer indications in many countries, including the United States and the EU.
As a single agent, it was first granted approval in 2017 under the FDA’s accelerated approval program, making it the first immunotherapy agent to be approved for use in this setting. However, CheckMate-459, the confirmatory randomized study of Opdivo versus Nexavar in the first-line setting, did not achieve statistical significance for its primary endpoint of overall survival, per the pre-specified analysis.
BMY withdrew the indication for Opdivo as a single agent for patients with HCC from the United States in 2021.
AstraZeneca’s (AZN - Free Report) Imfinzi (durvalumab), in combination with Imjudo (tremelimumab), is approved in the EU for the first-line treatment of adult patients with advanced or unresectable HCC.
AZN’s Imfinzi is an immunotherapy that is approved to treat certain cancers, either as monotherapy or in combination with Imjudo.
Currently, BMY is looking to expand its new product portfolio amid generic challenges for Revlimid and Eliquis. Approval of new drugs and label expansion of the existing ones are important for BMY and the going has been good in that regard.
The FDA recently approved a label expansion of its oncology drug Krazati (adagrasib). The drug has been approved in combination with Erbitux as a targeted treatment option for adult patients with KRASG12C-mutated locally advanced or metastatic colorectal cancer.
The FDA recently approved a label expansion of BMY’s another lung cancer drug, Augtyro, for the treatment of adult and pediatric patients aged 12 years and above with solid tumors that have a neurotrophic tyrosine receptor kinase gene fusion, are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy.
Zacks Rank & Stocks to Consider
BMY currently carries a Zacks Rank #3 (Hold).
A couple of better-ranked stocks in the healthcare sector are Entrada Therapeutics (TRDA - Free Report) and Corcept Therapeutics (CORT - Free Report) , both carrying a Zacks #1 Rank (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Entrada’s loss per share estimate for 2024 has narrowed from 14 cents to 13 cents in the past 60 days, and the same for 2025 has narrowed from $3.44 to $3.21 in the past 30 days.
In the past 60 days, estimates for CORT’s 2024 earnings per share have improved from 90 to 95 cents. Shares of CORT have rallied 47.3% in the past three months.
CORT’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 33.7%.