Bristol Myers’ HCC Combo Drug Accepted for FDA Review – Bristol-Myers Squibb (NYSE:BMY)

Bristol Myers BMY announced that the FDA has accepted its supplemental Biologics License Application (sBLA) for the immunotherapy drug, Opdivo (nivolumab), in combination with Yervoy (ipilimumab).

The sBLA seeks approval of Opdivo plus Yervoy as a potential first-line treatment option for adult patients with unresectable hepatocellular carcinoma. A final decision from the regulatory body in the United States is expected on Apr 21, 2025.

Bristol Myers’ application is based on results from the late-stage CheckMate-9DW study.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 with the investigator’s choice of Lenvima or Nexavar. The combination therapy also demonstrated a safety profile consistent with previously reported dataand was manageable with established protocols. Additionally, no new safety signals were identified.

Per BMY, 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.

Please 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 Bristol Myers have lost 5.6% year to date against the industry’s 1.1% growth.

Image Source: Zacks Investment Research

Opdivo is also approved both as a monotherapy and in combination with Yervoy to treat several other 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 HCC patients who have been previously treated with Nexavar. 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.

Bristol Myers withdrew the indication for Opdivo as a single agent for patients with HCC from the United States in 2021.

We remind the investors that last month, the European Medicines Agency (EMA) validated the company’s type II variation application for the Opdivo/Yervoy combo therapy as a potential first-line treatment option for adult patients with unresectable or advanced HCC who have not received any prior systemic therapy.

The EMA’s validation confirmed that the submission is complete and the centralized procedure review has begun in the EU.

However, Bristol Myers faces competition from other large drugmakers in the HCC market, like AstraZeneca.

AstraZeneca’s 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.

Zacks Rank & Other Stocks to Consider

BMY currently carries a Zacks Rank #2 (Buy).

Some other top-ranked stocks in the overall healthcare sector are Illumina, Inc. and Arcturus Therapeutics. While ILMN sports a Zacks Rank #1 (Strong Buy), ARCT carries a Zacks Rank #2 at present.

In the past 60 days, estimates for Illumina’s 2024 earnings per share have moved up from $1.07 to $3.16. Earnings per share estimates for 2025 have improved from $2.93 to $4.50. Year to date, shares of ILMN have lost 4.8%.

Illumina’s earnings beat estimates in each of the trailing four quarters, the average surprise being 463.46%.

In the past 60 days, estimates for Arcturus Therapeutics’ 2024 loss per share have improved from $4.39 to $2.60. The estimate for 2025 is currently pegged at earnings of 21 cents per share. Year to date, shares of Arcturus Therapeutics have plunged 30.6%.

Earnings of Arcturus Therapeutics beat estimates in each of the last four quarters, delivering an average earnings surprise of 56.73%.

To read this article on Zacks.com click here.